Medical devices with wrapped construction

Abstract

Medical devices may have a wrapped construction. A tubular device may include a helically wound matrix flat film that is sealed along its length. The seal may correspond to a face or edge of the wound matrix flat film and may extend in a helical path along the tubular device. The tubular device may be formed by helically wrapping the flat matrix film around a mandrel. A surface of the flat matrix film may include a surface modification. Any of these apparatuses may include marking, including printing on the flat matrix film prior to wrapping. Reinforcement materials may be sealed within the matrix and integrated into the tubular device. A consolidation film may be applied over the flat matrix film, and energy applied to activate the flat matrix film. The consolidation film may apply a constrictive force during consolidation.

Description

MEDICAL DEVICES WITH WRAPPED CONSTRUCTIONCLAIM OF PRIORITY

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 676,325, filed on July 26, 2024, and titled “MEDICAL DEVICES WITH WRAPPED CONSTRUCTION,” which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND

[0003] Medical devices often include elongate tubular structures, such as catheters, overtubes, shields, endoscopes, trocars, guidewires, surgical instruments, sheaths, dynamically rigidizing devices, and shields. Such tubular structures may provide a means for inserting medical devices in the body and accessing anatomical locations, for example, to perform a medical procedure. The elongate shape may allow for navigation through the body, such as portions of the gastrointestinal system, cardiovascular system, neurovascular system, respiratory system, urogenital tracts, for ENT activities, in joints, in the abdominal or pelvic cavities, or other passages or portions of and within the body.

[0004] In some cases, it may be beneficial for a tubular structure to have a rigid construction, while in other cases it may be beneficial for the tubular structure to have a flexible construction. There are significant advantages to both highly flexible shafts as well as significant advantages to rigid shafts; however, each also has disadvantages. For example, flexible endoscopes and catheters may rely on reaction forces generated by pushing against the tissue of adjacent organs or a body cavity being explored to navigate around comers or bends in the anatomy. Device flexibility and stiffness values may be problematic when navigating through body regions having highly tortuous passages, areas that are comparatively open, or passages of varying (or large) luminal diameter, particularly when the pathway is long. Highly flexible tubes may buckle, prolapse, loop, or may have trouble supporting additional tools or devices. Highly rigid tubes may be difficult to navigate within the body and can cause damage to the anatomy if they are forced through certain anatomical pathways. In some cases, it may be beneficial for a tubular structure to be able to transition between flexible and rigid configurations on demand. In some cases, it may be beneficial for a tubular structure to be able to function together with anothernested device, and which also may be able to transition between flexible and rigid configurations on demand.

[0005] Many of these tubular structures are made using extrusion manufacturing techniques. Extrusion methods typically involve melting a polymer material (e.g., pellets or powder) and forcing the polymer while in molten form through a die, which shapes the polymer into the shape that hardens as it cools. Some of the disadvantages of using extrusion methods is that it may be expensive, difficult and / or time consuming to produce tube having desired characteristics, such as particular degrees of flexibility, durometer, rigidity, wall thickness, component integration, etc. For example, it can be difficult to produce tubes having thin walls, which may provide advantages such as more flexibility and reduced overall diameter. In addition, it can be difficult and / or time consuming to produce tubes having multiple layers or that include reinforcement materials. Even if it is possible to produce tubes having desired characteristics, the throughput using extrusion can be low, which can increase costs and delay production of the final medical device. In some cases a new die has to be made for each application. Further, typical extrusions are monolithic and have a limited ability to vary the composition or properties within the wall cross section.

[0006] Described herein are apparatuses and methods that may address these needs. These methods and apparatuses may provide advantages over existing methods and apparatuses as will be discussed below.SUMMARY OF THE DISCLOSURE

[0007] The materials, methods and apparatuses described herein relate to tubular structures, and more particularly to tubular medical structures such as catheters, endoscopes and other elongate tubular devices. In particular, described herein are methods adapted for forming rod or tubular structures configured to be part of a rigidizing apparatus, and apparatuses formed by these methods. For example, these methods may include helically wrapping one or more matrix layers around a mandrel and helically wrapping a consolidation film over the one or more matrix layers before applying a controlled temperature to consolidate the matrix layers, while limiting or preventing deformation of the matrix layers. These methods may precisely control the pitch of the wrapping as well as the tension while applying each layer, including the consolidation film.

[0008] These methods may enable multiple layers deposited simultaneously or in-sequence. These methods enable the simultaneous or in-sequence deposition of a larger number of highly disparate layers, including reinforcement layers. Also described herein are methods for coating these apparatuses, including methods of forming one or more coated layers. Also describedherein are methods and apparatuses for marking, including forming markings that can be on the surface or embedded.

[0009] Generally described herein are methods and apparatuses (e.g., systems and devices) related to tubular structures. The tubular structures are well suited for applications in medical devices. For example, the tubular structures may be integrated into a medical device or function as an add-on to a medical device. The tubular structures may include, or be part of, catheters, over-tubes, endoscopes, trocars, guidewires, surgical instruments, dynamically rigidizing devices, sheaths, shields, or other medical devices or components.

[0010] The tubular structures may have a wrapped construction, where one or more polymer films wrap around a central lumen to define walls of the tubular structure. In some cases, the films are wrapped in a helical arrangement around the central lumen. The wound material may be sealed along a length of the tubular structure and include a seam extending in a helical path from a proximal end region to a distal end region of the tubular structure. In some cases the tubes may be sealed structures, and in some cases they may be used in applications in which the construction does not need to result in a fully sealed structure. The seam may correspond to an edge of the helically wound material. The seam may correspond to faces of the helically wound material. In some cases, the helically wound material may include a flat matrix film.

[0011] In some cases, the tubular structure may include a composite material. For example, the polymer material of the tubular structure may include one or more reinforcement materials. In some examples, the reinforcement material is a thread, filament or wire that winds around the central lumen. The thread may be at least partially embedded within the polymer material. In some cases, the thread(s) may wind in a helical arrangement around the central lumen. The reinforcement material may be the same as the polymer material of the film or may be a different material than the polymer material of the film. In some examples, the reinforcement material may include one or more metal materials, one or more metals, one or more polymer materials and / or one or more inorganic materials.

[0012] The material of the wrapped films may include a ‘matrix’ material in that it can be used to support the walls of the tubular structure and / or one or more reinforcement materials (if used). The matrix material may be pliable or moldable when exposed to a predetermined amount of energy (e.g., heat, light, ultrasound, pressure) and / or the passage of time and solidify, for example, when the energy is removed (e.g., upon cooling or when a thermoset material has been activated). In some examples, the matrix material includes one or more polymer materials (e.g., one or more thermoset materials or one or more thermoplastic elastomer, plastic, plastomer, nylon, polyester, polyolefin, pebax, polypropylene, polyimide, polyamide, and / or thermoplastic polyurethane materials). If used, the reinforcement material may become at least partiallysurrounded by or embedded in the matrix material. In some examples, the reinforcement material is a thread or wire that winds around the central lumen and is at least partially embedded within the matrix material.

[0013] In some cases, at least some of the wrapped films are made of a transparent (e.g., clear) or semi-transparent material (e.g., to visible light). For example, a matrix material may be made of a transparent or semi-transparent polymer material. This may allow markings, dyes, filament, wires and / or other materials laminated between layers of matrix film to be at least partially visible by a user. This may be useful in providing identification (e.g., part numbers) and / or measurement features (e.g., lines) or marketing related media or information related to use of the medical device. Additionally, markings could be printed on the outside of the layers. The polymer may have a pigment added such that it is opaque or of a background color that enhances printability or markings.

[0014] These methods for forming tubular structures, for example, as part of a medical device, may allow for high volume and cost-efficient manufacture of tubular structures. In any of these methods, multiple films and / or filaments may be simultaneously wrapped (at different longitudinally-offset positions). Markings may be applied concurrent with forming, including marking (or applying an already -marked) intermedial / internal film, e.g., matrix film. In some cases the methods of forming these structures may performed as a continuous process. In any of these cases, all or some of the components may include decorative features (e.g. colored filaments). All or some components (e.g., layers) may also be transparent to certain non-visible wavelengths, allowing, for instance, for embedding of computer readable elements, such as RF ID tags.

[0015] The tubular structure may be formed by helically wrapping one or more polymer films around a mandrel and consolidating the wrapped film(s) into the tubular structure. A consolidation film (e.g., shrink-wrap film) may be placed around the wrapped film(s). The consolidation film may be particularly useful; the consolidation film forms a layer that maintains the positions of the underlying wrapped films and / or filaments relative to each other but does not necessarily combine with them. The consolidation film may be removable once fabrication (and / or storage and / or shipping) is complete. The helically wrapped consolidation film may be applied under controlled tension and may apply tension in a helical pattern as the material is heated to allow the underlying film layers to fuse with each other without substantial flowing of these underlying layers. Helically wrapping the consolidation film allows for any length of tubing to be formed of virtually any diameter. The methods described herein may also reduce a substantial amount of waste and consume less energy. Although in some examples a tube of consolidation material (e.g., shrink-wrap material) may be applied, such tubes aredisadvantageous, as they must be applied with a gap between the tube and the outer surface that may be variable and require shrink-wrapping before applying a constrictive force on the forming tube. This may result in less control and greater variability. The heat used to shrink a tubular consolidation layer may affect the consolidation of the underlying matrix films, resulting in distortion. Thus, in any of these methods and apparatuses, the consolidation layer may be a film that is wrapped (e.g., helically) around the polymer film(s). Secondary layers may be wound at the same helix angle, different helix angles, same helix direction, or opposite helix direction. Secondary layers may be deposited as a discrete step, or they may be deposited in conjunction with the deposition of another layer or multiple layers.

[0016] Energy (e.g., heat) may be applied to the assembly at a sufficient intensity and / or for a long enough time to fuse the matrix film material (e.g., polymer material) of the underlying film(s). The energy may be controlled, in combination with the consolidation film (and the tension applied by the consolidation film) to fuse the layers. The consolidation layer can be configured to radially shrink in the helically-wrapped pattern, thereby applying a radially inward constrictive force immediately on the wrapped film(s) to ensure that the application of heat to the underlying matrix film forms a cohesive, leak-free tubular structure. Any additional material, such as one or more filaments, additional films, etc. including one or more a reinforcement materials (e.g., reinforcement thread), markings, may become at least partially embedded or surrounded within the polymer material. Filaments, including reinforcement filaments, may be held in position by the helically wrapped constricting consolidation film, and the softened but non-flowing material and / or the pressure from the consolidation film, may prevent migration of the filaments and / or distortion of the matrix layers. Specifically, the matrix material may be fused to itself or to adjacent materials. In some cases, it is not (and may be prevented from being) flowed or “squished” sideways during the consolidation process. Once consolidated (and in some cases, cooled), the helically wrapped matrix material may be removed from the mandrel.

[0017] In some cases, the one or more films may have a surface modification. In some cases, the surface modification may be applied to the film(s) prior to wrapping around the mandrel. The surface modification can change a surface characteristic of the film. For example, the surface modification may decrease or increase the friction of the surface of the film. In some examples, the surface modification has anti-proliferative or anti-thrombotic, hydrophobic and / or hydrophilic properties.

[0018] In some cases, the tubular structure may include a single layer of helically wrapped material. In other examples, the tubular structure may include multiple layers of helically wrapped material. In some cases, the multiple layers are arranged in a nested configuration. For example, the multiple layers may be concentrically arranged.

[0019] In some examples, the tubular structures may be used in devices that can transition between rigid and flexible configurations. Such “rigidizing” devices (e.g., “dynamically rigidizing”) or apparatuses may be actuated by any of multiple modalities and mechanisms. For example, in some cases, the rigidizing devices may be actuated by negative pressure and / or positive pressure bladder-actuated methodologies. The methods described herein may also include the application of these additional layers, including a rigidizing layer (which may or may not comprise a plurality of crossing lengths of filaments, such as a knitted, woven, braided, etc. tube) and / or a bladder layer (which may be elastic or non-elastic and may be applied continuously or separately, e.g., after forming the tubular structure).

[0020] In one example, the tubular member is part of a pressure-actuated rigidizing system that is installed at the factory. In another example, the tubular member is part of a pressure- actuated rigidizing shield apparatus that is configured to convert an endoscope into a rigidizing endoscope and may be added by a user in the field, i.e. field installable. The configuration may be an overtube, including its subcomponent tubular members, including its ICWT (inner coil wound tube) or its OCWT (outer coil wound tube). The apparatus includes a rigidizing shield body that includes concentrically arranged layers. The concentrically arranged layers include the elongate tubular member forming a support layer, a rigidizing layer, and a bladder layer. The bladder layer is configured to receive pressure to drive the rigidizing layer relative to (either away from or against) the elongate tubular member, thereby rigidizing at least a portion of the endoscope.

[0021] Any of the medical devices described herein (and formed by these methods) may be operated manually, robotically (e.g., telerobotically, including locally (including within the same room or within the same facility), or at a far distance, including to remote locations across the city, state, country, or to a remote location around the world) and / or a combination of manually and robotically operated.

[0022] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.

[0023] These and other aspects and details are described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Novel features of embodiments described herein are set forth with particularity in the appended claims. A better understanding of the features and advantages of the embodiments may be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings.

[0025] FIGS. 1A-1E illustrate example aspects of forming an example wrapped tubular device.

[0026] FIGS. 2A-2H illustrate an example formation of a wrapped tubular device having four helically wrapped matrix films.

[0027] FIGS. 3A-3D illustrate example side views (e.g., cross-sections) or end views of portions of different examples of wrapped films.

[0028] FIGS. 4A-4D illustrate example section views of different example configurations of wrapped films.

[0029] FIGS. 5A-5F illustrate example side views (e.g., cross-sections) of portions of different examples of wrapped materials.

[0030] FIGS. 6A and 6B illustrate side and section views, respectively, of an example multiple-layered wrapped device assembly.

[0031] FIG. 7 illustrates an example side view of an example of wound and counter-wound reinforcement wires.

[0032] FIGS. 8A-8F illustrate example aspects of different tapered mandrels.

[0033] FIGS. 9A-9C illustrate examples of different materials for forming tubular devices: FIG. 9A shows an example of a sheet of matrix film wound onto a master spool or reel; FIG. 9B shows examples of different spools of smaller cut matrix films; and FIG. 9C shows examples of spools of different types of fibers that may be used as reinforcement materials.

[0034] FIG. 10A schematically illustrates an example system for manufacturing wrapped tubular devices.

[0035] FIG. 10B schematically illustrates an example system for manufacturing wrapped tubular devices.

[0036] FIGS. 10C and 10D shows perspective and top views, respectively, of a system for manufacturing wrapped tubular devices.

[0037] FIGS. 10E and 10F show perspective views of the right and left ends for receiving and holding a mandrel, forming part of the system for manufacturing wrapped tubular devices shown in FIGS. 10C-10D.

[0038] FIGS. 10G-10H show top and side views of a winding sub-assembly for a system for manufacturing wrapped tubular devices similar to that shown in FIGS. 10C-10D.

[0039] FIG. 11 is a flowchart illustrating an example process for manufacturing wrapped tubular devices.

[0040] FIGS. 12A and 12B show an example of a flat film (e.g., flat matrix film) including markings and alignment markings (e.g., fiducial markings) printed thereon. FIG. 12B shows theflat film of FIG. 12A helically wrapped and consolidated to form a tubular body as described herein.

[0041] FIGS. 13A and 13B illustrates examples of a tubular body including various markings that may be made thereon, either directly to the tubular body outer surface during or after fabrication (including pre-consolidation) or printed onto a flat film that is wrapped as described in FIGS. 12A-12B. There are a multitude of potential number orientations and printing styles.

[0042] FIG. 13C illustrates an example of a printed sheet of matrix material that may run for very long printing lengths, then to be cut and rolled for helically wrapping, as described herein.

[0043] FIG. 13D illustrates another example of a printed tubular body as described herein.

[0044] FIG. 13E shows an example of a method forming a very long length high volume printed matrix layer as described herein.

[0045] FIG. 13F schematically illustrates an example of a method of directly printing onto a tubular body as part of the fabrication process.

[0046] FIGS. 13G-13I illustrate an example of a stamping printing head that may be used with any of the methods and apparatuses described herein. FIG. 13G shows a perspective view, FIG. 13H shows a side view and FIG. 131 shows a top view.

[0047] FIGS. 13J-13L show top perspective, side perspective and end perspective views, respectively, of an array of stamping printing heads similar to those shown in FIGS. 13G-13I.

[0048] FIG. 14 shows an example of a method of further processing one example of a tubular device (either on or off of the mandrel) to form a ridigizing apparatus.

[0049] FIG. 15A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be formed of the tubular devices described herein and is configured to be rigidized by the application of negative pressure.

[0050] FIG. 15B is an enlarged view showing one example of the arrangement of layers within the elongate rigidizable device of FIG. 15 A.

[0051] FIG. 16A is a section through an elongate rigidizable device (e.g., rigidizing overtube) that may be formed of the tubular devices described herein and is configured to be rigidized by the application of positive pressure.

[0052] FIG. 16B is an alternative sectional view showing one example of the arrangement of layers within the elongate rigidizing device of FIG. 16 A.

[0053] FIG. 17A shows an example of a rigidizable device (e.g., rigidizing overtube) that may be formed of the tubular devices described herein and includes a knit rigidizing layer, shown with the knit rigidizing layer exposed.

[0054] FIG. 17B shows an example of a rigidizable device (e.g., rigidizing overtube) such as the one shown in FIG. 17A with the outer layer(s) covering the knit rigidizing layer.

[0055] FIG. 17C is an enlarged view of one example of a knit.

[0056] FIG. 17D shows a section view through an example of a knit over an inner tubular member.

[0057] FIG. 18A shows an example of a weft knit.

[0058] FIG. 18B shows an example of a warp knit.

[0059] FIG. 18C shows an example of a knit material formed of a single continuous filament.

[0060] FIG. 19A is an example of a woven rigidizing layer formed of fdament; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0061] FIG. 19B is an example of a woven rigidizing material formed of monofilaments that are woven together; this woven rigidizing layer may be used as part of a rigidizable device (e.g., rigidizing overtube) as described herein.

[0062] FIG. 19C shows another example of a woven material.

[0063] FIGS. 20A and 20B show examples of braided material that may be used as (or as part of) a rigidizing layer of a rigidizable device (e.g., rigidizing overtube) as described herein. FIG. 20B shows a braided layer that is discontinuous.

[0064] FIG. 21A illustrates an example section view of an endoscope with a tubular rigidizing shield to provide dynamic rigidization.

[0065] FIG. 21B shows a section through a portion of the endoscope and shield shown in FIG. 21A.

[0066] FIG. 22 illustrates one example of a robotic system for performing any of the methods described herein.

[0067] FIGS. 23 A and 23B illustrate an example of a cardiovascular system that may be formed, at least in part, by the methods and apparatuses described herein.

[0068] FIG. 24 shows an example of a neurovascular system that may be formed, at least in part, by the methods and apparatuses described herein.

[0069] FIG. 25 shows an example of a section through a consolidated wrapped assembly as described herein, including a counter wound filament.

[0070] FIG. 26 shows an example of a section through a consolidated wrapped assembly as described herein including a fiber / filament reinforcement as described herein.DETAILED DESCRIPTION

[0071] The apparatuses and methods described herein include tubular devices having a helically wrapped construction for at least one (or more) layer. The tubular bodies of theseapparatuses may be formed by helically wrapping one or more flat films and / or fibers around a mandrel and fusing the wrapped matrix film material together. The resulting structures may retain some of the helical shape although the matrix film(s) may be fused and reinforced. This helical pattern may provide surprising mechanical advantages and allow for compact, flexible and lightweight structures that may be used in a variety of settings, including but not limited to medical device and more specifically including, but not limited to rigidizing medical apparatuses. Furthermore, the methods of forming such structures may be performed with greater speed and efficiency resulting in significant savings in time and cost, as well as substantially reducing waste.

[0072] For example, described herein are methods of forming an elongate tubular member (e.g., for a medical device, including a rigidizing medical device), that may include: helically wrapping a flat matrix film around a mandrel. Optionally, a surface of the flat matrix film may be coated or otherwise modified, e.g., with a surface modification. The mandrel may be prepared with a release layer (or coating) so that the formed elongate tube may be removed without sacrificing the mandrel. The release layer may itself have a transferable layer or coating on it. One or more flat matrix films (of the same or different materials) may be helically wrapped around the mandrel. In any of the methods and apparatuses described herein the matrix materials may be different; for example, the matrix materials may have different durometers; in some cases the matrix materials may be similar (e.g., chemically similar) but may have different durometers. One or more filaments (e.g., wires, threads, fibers, yarns, etc.) may be concurrently or sequentially wrapped. In general, multiple flat matrix films (and in some cases one or more filaments) may be wrapped from different longitudinal positions, starting with the first flat matrix film, so that as the mandrel is advanced and rotated, each subsequent flat matrix film and / or filament may be helically wrapped atop the prior helically wrapped flat matrix film and mandrel. In some instances the carriages with films and reinforcements may move back and forth relative to the mandrel, and in some cases they may be fixed while the mandrel moves axially. In some instances the mandrels achieve continuous end-to-end motion and flow, and in other instances the mandrels are loaded, wound, and then unwound individually. The methods described herein may optimize or vary the rate at which the mandrel is spinning, the rate at which the mandrel is advancing (while spinning), the pitch angle of each helically wrapping flat film, the movement of the films and reinforcements back and forth and with varying angles of deposition, the size of each flat film, the tension on each flat film as it is wrapped, the amount (or absence) of overlap on each flat film, the pitch angle and / or rate of any filament being wrapped.

[0073] In practice, the different matrix films and / or filaments may be applied simultaneously from different longitudinal positions as the mandrel is rotated and advanced. For simplicity themethods and apparatuses described herein are described in terms of the mandrel rotating and moving longitudinally (e.g., in the proximal-to-distal direction) but this could be reversed; for example, the flat matrix film(s) and / or filaments may be rotated relative to the mandrel and / or advanced distally (or retracted proximally). Similarly, the mandrel may be rotated while the flat film moves longitudinally, or vice versa (e.g., so that there is a relative winding and longitudinal motion between the elements to achieve a helically wound construction).

[0074] Once the pre-consolidation structure is formed by the helically wrapped components (e.g. one or more, e.g., two, three, four, five, six, seven, eight, nine, 10, or more flat matrix film layers, and / or one or more, e.g., two three, four, five, six, seven, eight, nine, 10, or more filaments) are on the mandrel, a removable consolidation film may be applied by helically wrapping the consolidation film over the flat matrix film(s), and any filament(s). The methods and apparatuses described herein may control the tension on the applied consolidation film, and / or the pitch (angle) it is applied, as well. The consolidation film is typically applied with an overlap along one edge as it is wrapped (e.g., a 2% or more overlap, 5% or more, 7.5% or more, 10% or more, 15% or more, 20% or more 25% or more, 30% or more, 35% or more, 40% or more, 45 % or more, 50% or more, 55% or more, 60% or more, 70% or more 75% or more, etc., between 5%-95%, between 10%-70%, between 10% and 50%, etc.).

[0075] Once the consolidation film is helically wrapped over (and in an overlapping manner), the pre-consolidation assembly may be consolidated by applying energy. For example, thermal energy (e.g., from the environment, induced in the mandrel and / or reinforcement layer, absorbed light, etc.) may be applied to activate the flat matrix film, while the consolidation film applies a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the elongate tubular member having a leak-free surface. In general, when consolidating the matrix material, the helically-wrapped matrix materials may fuse together without flowing by the application of the helically applied pressure from the helically-wrapped consolidation film and by controlling the applied energy (e.g., heat). This may prevent irregularities in the resulting wall, may maintain the helically wrapped layered structure and may keep any filaments / supports in position. Consolidation may be done continuously with processing (e.g., while rotating and advancing the mandrel) or it may be done after wrapping a mandrel and removing it from the device, e.g., in an oven. The thermal energy may be applied in a non-contact manner (e.g., by convection, by thermal radiation, etc.) or induced in the mandrel or materials of construction by current or induction. Further post-consolidation processing may be performed on the mandrel or the consolidated the elongate tubular member may be removed from the mandrel. The consolidation layer can be removed either before or after mandrel removal.

[0076] FIG. 1A shows an example of a film 103 being wrapped around a mandrel 101. In this example, the film 103 is a flat strip of material that is unwound from a reel or spool 105. The mandrel 101 may be rotated to wind the film 103 onto its outer surface. The mandrel 101 and / or the spool 105 may be longitudinally translated relative to the other so that the film 103 winds onto the mandrel in a helical configuration.

[0077] The width 107 of the film 103 may vary. In some cases, the width 107 may be associated with the diameter of the tubular device being formed (and therefore the outer diameter of the mandrel). For example, in some examples, a ratio of the diameter of mandrel 101 to a width 107 of the film 103 may range from about of 1 to 2 (1:4) to about 4:1 (e.g., 1:4, 1:3, 1:2, 1:1, 2:1, 3:1, 4:1 or any ratio therebetween). That is, the width 107 of the film relative to diameter of the mandrel 101 may range from about 25% to about 400% (e.g., 25%, 50%, 75%, 100%, 125%, 150%, 200%, 400%, etc. or between about 25%-400%). In one example, the mandrel 101 has a diameter of 0.5 inches and the width 107 of the film 103 may be around 0.5 inches, 1 inch or 2 inches. In other examples, this ratio or percentage may have a greater range. In some examples, the width 107 of the film 103 on a 0.5 inch diameter mandrel may be at least about 1 / 8 inches (e.g., 1 / 8 inches, 1 / 4 inches, 1 / 2 inches, 3 / 4 inches, 1 inch, 2 inch, or greater).

[0078] In the example shown in FIG. 1A, the film 103 is wound around the mandrel 101 such that there is a gap 109 between the turns of the film 103. In some examples, a percentage of the gap 109 relative to the width 107 ranges from about 1% to about 90% (e.g., between about l%-75%, 5%-90%, 5%-75%, 10%-90%, 10%-75%, 10%-50%, 10-30%, etc.). In some examples, the gap may be zero. In some examples, the gap may be negative (i.e., overlap). In some cases, the helically wrapped flat matrix film 103 forms a layer (e.g., first layer) around the mandrel 101. In general, when the flat matrix film is wrapped as shown in FIG. 1A with a gap, a second flat matrix film is wrapped over it, overlapping on both sides with the first matrix film. For example, a second layer (e.g., adjacent layer) of film (not shown in FIG. 1A) may then be helically wound over the first helically wrapped film 103 layer (e.g., first layer). The second helically wrapped film may be wrapped in the same way (e.g., with the same pitch) and may be wrapped concurrently but from a different longitudinal positions, further distally (as the mandrel is advancing distally), than the first film 103 is wrapped. For example, by rotating and advancing the mandrel 101 relative to the spool 105 (or a second spool) that includes a second film. The second layer of film may or may not include a gap as it wraps. The second flat film may have the same width as the first flat film. The overlaying layers of flat film may be wrapped such that adjoining flat surfaces (faces) fuse and sealingly couple the two layers together, creating a unified leak-free structure. The axial width of the gap 109 between the turns of the film 103 may be associated with the width 107 of the film 103.. In some instances, the film may unspool whilethe mandrel rotates and the film advances. In some instances, the film may unspool while it is in a fixed position, and the mandrel may rotate and advance.

[0079] In other examples, the film 103 is wrapped such that there is no gap 109 between windings of the film. For example, lengthwise edges of the film 103 may contact and / or overlap axially around the mandrel 103. The film 103 can then be activated to sealingly couple (fusing the adjacent helical edges) contacting / overlapping lengthwise edges of the film 103, thereby forming a unified leak-free structure. This may also be used to eliminate any gaps (or make them negligible) on coated layers.

[0080] The flat matrix film 103 may be applied over the mandrel 101 as tension force is applied to the film 103. The film 103 may be held in place by the applied tension against the mandrel 101. For example, the spool 105 and the mandrel 101 may be held at a controlled distance with respect to each other as the they are translated with respect to each other.Resistance may be applied to increase tension on the film wrapping around the mandrel. In some cases, the tension may be quantified and measured during the winding process. Too much tension may cause too much film stretch or may cause a normal force between the mandrel and the wrapping to be too high, inhibiting release of the film 103 from the spool 105. However, a normal force that is too low may create wrinkles in the wrapped film 103. The tension forces may be measured with a force sensor as the spool 105 is moved relative to the mandrel 101 (or vice versa), for example, on a stage or platform.

[0081] The flat matrix film 103 may generally comprise one or more matrix materials that provide support and form the walled structure of the tube and / or that may at least partially surround one or more reinforcement materials. The film 103 may therefore be referred to as a flat matrix film or simply “film.” The matrix material may be configured to at least partially melt so that it can fuse together with itself and / or with another matrix material (e.g., another matrix film) when exposed to the applied energy (e.g., heat, light, pressure, ultrasonic energy) and / or the passage of time.

[0082] In some examples, the flat matrix film 103 is made of one or more of a thermoplastic elastomer (TPE), a thermoplastic urethane (TPU), a plastic, a plastomer, a nylon, a polyester, a polyolefin, a pebax, a polypropylene, a polyimide, and / or a polyamide. The film 103 may be in the form of a flat film, or have a different cross-section shape (e.g., oblong or round). In some cases, the film 103 may include multiple types of material and / or multiple layers of material.

[0083] FIG. IB shows an example of a side sectional view of the film 103 (not to scale). The film 103 includes a first (e.g. top) surface 115 that is wound closest to the mandrel 101 and corresponds to an inner surface of the helically wound tubular structure. A second (e.g., bottom) surface 117 of the film 103 is wound facing away from the first surface 115 and corresponds tothe radially outward-facing surface of the helically wound tubular structure. Alternately, the second surface 117 may face the mandrel and the first surface 115 may face away from the mandrel. The film 103 has a first edge 111 and a second edge 113 opposite the first edge 111. A thickness 119 of the film 103 may vary depending on the composition of the film 103, the diameter of the mandrel 101, and other factors. In some examples, the thickness 119 of the film 103 ranges from about 0.0001 inches to about 0.05 inches (e.g., between about 0.0001 and 0.05 inches, between about 0.0001 and 0.01 inches, between about 0.005 and 0.01 inches, between about 0.0005 and about 0.050 inches, etc.).

[0084] In some cases, the film 103 may include fibers. In some cases, the fibers may add strength or durability to the film 103. The fibers may be advantageous for low durometer matrix material, for example, if the fibers are aligned with the slitting direction of the film 103. For example, this may prevent the film 103 material from stretching random amounts while being removed from a backing. In some cases fibers may be aligned with the wrap direction and may have minimal impact on CWT stiffness.

[0085] In some examples, the film 103 includes one or more surface modifications. For example, the film 103 may include a coating on one of its surfaces. In other examples, instead of a separate coating, the surface modification be a physical and / or chemical modification to a surface of the film 103. In the example shown in FIG. IB, the film 103 includes a coating 121 on a first surface 115 (e.g., upper, inward-facing surface, when helically wound) of the film 103. Thus, the coating may be on the lumen of the tubular structure being formed. Likewise, the outermost layer may correspond to a coated surface of a matrix layer that will face outwards when wrapped. In FIG. IB the surface 117 is shown as a coating.

[0086] The surface modification may be a physical and / or chemical modification to a surface of the film and / or may include one or more separate coatings. For example, one or more surfaces of the film may be processed by texturing, bead blasting, particle embedding, chemical treatments, etching, plasma treatment, corona treatment, surface activation, adhesives, adhesive primers, and the like. If the surface modification includes one or more coatings, the coating(s) may be applied in many different manners, including by rolling, brushing, solution casting, vapor deposition (including parylene), spraying, sponging, dipping (including through baths), plasma, silk screening, roll coating, slot dye coating, or spin coatings. Coatings can be applied in various forms, with liquid forms often cured or cross-linked by the application of heat or the delivery of UV energy, and the passage of time.

[0087] The surface modification may have particular physical and / or chemical properties. For example, the surface modification may be configured to provide or enhance medical properties of the resulting tubular structure. In some examples, the surface modification has anti-proliferative or anti-thrombotic, hydrophobic, hydrophilic, hemocompatible, biocompatible, procoagulant, antimicrobial, growth promoting or inhibiting, X-ray or MRI image enhancing, drug-eluting or drug delivery, antibiotic, anti-encrustive, pH modulating, antiproliferative, endothelialization promoting, cell adhesion promoting, MR signal emitting, radiodense, echogenic, catalytic, immune modulating and / or anti-hemolytic properties.

[0088] In some cases, the surface modification may have surface characteristics that are different from the film. The surface modification may enable advanced performance of the resultant medical device and may be an important part of the design and manufacturing of the medical device. The surface modifications may be applied individually to devices or be preapplied to the film en masse (e.g., to flat rolls of films) when they are still constituent materials. The surface modifications may be applied to an inward-facing surface of the film (e.g., 115), to an outward-facing surface of the film (e.g., 117) or both inward-facing and outward-facing surfaces (e.g., 117 and 115).

[0089] FIG. 1C shows an example of processing a sheet of film 103 into strips 128 of the film. The film 103 may start out as a large sheet in a wide format sheet that is unspooled from a master spool 123. In some examples, the durometer of the film 103 may range between about 40A and 90A (e.g., 40A to 80A, 40A to 70A, etc.). Lower durometers (e.g., 10A to 40A) may also be used. The range of durometers may depend on the size of the catheter being formed. Smaller catheters, e.g., for neurovascular applications, may employ higher durometer ranges (e.g., 45A-100A) while maintaining sufficient or excellent flexibility, while larger catheters may use a lower durometer range (e.g., 10A-45A or less). FIG. 9A shows an example of a sheet of film wound onto a master spool or reel. In some examples, the wide format sheet of film 103 has a width of about 24 inches or greater (e.g., 24 inches, 36 inches, 48 inches, 60 inches, etc.).

[0090] In the example shown in FIG. 1C, one or more coatings 121 is / are deposited onto the film 103 as the film 103 is unspooled. The surface modification coating(s) 121 may be applied at a certain deposition rate (e.g., x milliliters per square meter). The coating(s) 121 may be applied using one or more methods. For example, the coating(s) 121 may be sprayed, applied between a gap (as in slot dye), and / or with a drum or sponge roller. In the example shown, the coating material is sprayed onto the film 103 in liquid form by a dispenser 127, which is supplied by a reservoir 129 of the coating material.

[0091] The coating(s) 121 may be cured, activated, or bonded to the film 103. For example, the coating(s) 121 may be cured by exposure to a thermal and / or light source 131. The coated film 103 may then be cut or slit into strips 128 using, for example, a cutting device 133. For a given mandrel diameter, the slit to width films may be different widths or some of them may be advantageously the same width, thereby allowing uniform helical wrapping. The coated strips offilm may be respooled onto individual spools 105. FIG. 9B shows examples of different spools of smaller cut film. The coated strips of film 103 on the spools 105 may then be used to form one or more layers of a wrapped tubular devices, such as depicted in FIG. 1A.

[0092] In some cases, the spools 105 of film 103 may be stored and used later to form the wrapped tubular devices. In some cases, the spools 105 may include enough film 103 for a manufacturing shift (e.g., to run continuously for over an 8-hour shift). If the film 103 does not have a desired width, it can be cut / slit into thinner widths at that point, or at a later point. In this manner, a large continuous process can be performed that processes, for example, a year or more worth of material in a single run, with no dedicated coating operations required thereafter. This may dramatically save on labor costs, facility costs, chemical exposure, and environmental remediation. In addition, the spooling of the coated film 103 onto itself may protect the coating(s) 121 from exposure to the external atmospheric environment and / or temperatures, thereby providing protection to the coating(s) 121 until the coated film 103 is ready to use. In this way, the spools 105 of film 103 may provide a structure that resists degradation of the coating(s) 121.

[0093] In some examples, the strips of film 103 may include wire terminations. The wire terminations may be achieved through tapes or other adhesives. Monofilament or metallic wires may be terminated without adhesive through use of cold-forming. By wrapping a tensile member around a small pin, the member can be shape-set to a diameter smaller than the mandrel 101. Doing so, the wire may apply a light compressive load onto the mandrel 101 and remain in place following cutting of the tensile member.

[0094] FIGS. ID and IE show examples of the film 103 being activated using different forms of energy. After being wrapped around the mandrel 101 into a tubular structure, as described above, a consolidation film forming layer 140 is helically wrapped around the film 103 (or multiple layers of film). The consolidation film 104 may comprise a heat shrink material such as a heat shrink flat films. The consolidation film may be wrapped in helical configuration over the matrix film 103. The consolidation film 140 may be wrapped in the same direction as the matrix film 103 or in the opposite direction of the matrix film 103.

[0095] FIG. ID shows an example in which energy is applied to consolidate by heating elements 137 and 139 which are used to activate the matrix film 103. These elements may be inside, outside, or both. As used herein “activate” may refer to causing the matrix layer to fuse with itself and / or with an adjacent layer after absorbing energy. In this example, one or more first heating elements 139 are arranged within an inner region (e.g., lumen) of the mandrel 101 to heat the inner regions of the tubular wrapped film 103, and one or more second heating elements 137 are arranged around an outer region (e.g., exterior) of the tubular wrapped film 103. In someexamples, the one more first heating elements 139 may be within and / or around an outer surface of the mandrel 101. Mandrel 101 may be solid (i.e., a rod) or it may be hollow (i.e., a tube). In some cases the energy may be applied by the application of heat from outside of the mandrel (as in an oven), rather than by conduction.

[0096] Thermal energy from the heating elements 137 and 139 can cause adjacent or overlapping edges of the layers of film 103 to weld or fuse together (e.g., in cases where there is no gap 109), or for film 103 to weld or fuse together with one or more additional layers of film. Heat from the heating elements 137 and / or 139 may also cause the consolidation layer 140 to shrink, thereby reducing a diameter of the consolidation layer 140 and applying a radially inward constrictive and / or compressive force against the film 103. Because the one or more second heating elements 137 are arranged nearer to the consolidation layer 140, these second heating element(s) 137 may be more responsible for causing the consolidation layer 140 to shrink. Shrinking of the consolidation layer may apply additional constrictive force that may be particularly helpful when preventing flowing of the matrix material while encouraging fusing of the adjacent layers.

[0097] FIG. IE shows another example for consolidating the wrapped film 103, in this case, using the application of light. One or more first light sources 143 are arranged within an inner region (e.g., lumen) of the mandrel 101 to heat the inner regions of the tubular wrapped film 103, and one or more second light sources 141 are arranged around an outer region (e.g., exterior) of the consolidation layer 140. In some examples, the one more first light sources 143 may be within and / or around an outer surface of the mandrel 101. Light from the light sources 143, 141 can generate thermal energy that cause adjacent or overlapping edges of the layers of film 103 to weld or fuse together (e.g., in cases where there is no gap 109), or for film 103 to weld or fuse together with one or more additional layers of film. Light from the light sources 143, 141 (e.g., especially from the second light source(s) 141) may also cause the consolidation layer 140 to shrink, thereby creating an inward radial force against the film 103. In some examples, one or more of the first and second light sources 143, 141 include ultraviolet (UV) light source(s).

[0098] In each of the examples of EIGS. ID and IE, the heat elements and / or light sources may be arranged axially along and / or radially around the wrapped tubular film 103 and consolidation layer 140 to control the location of the application of energy. Lor example, energy may be localized to certain regions of the film 103 and / or consolidation layer 140. In some cases, the heat and / or light sources are arranged to create an even application of the energy along the length of the wrapped tubular film 103 and / or consolidation layer 140, and / or radially around the wrapped tubular film 103 and / or consolidation layer 140. In some cases, the overlapping regionsof the wrapped film 103 may be locally augmented (e.g., using one or more surface modifications), for example, to enhance the welding or fusion of adjacent layers of film 103.

[0099] In some cases, the heat elements and / or light sources on the inner region of the film 103 (e.g., first heating element(s) 139 and / or first light source(s) 143) may be configured to emit a different intensity of heat and / or light than the those on the outer region of the consolidation layer (e.g., second heating element(s) 137 and / or second light source(s) 141). This may allow for optimizing the energy required for fusing the film 103 versus for shrinking the consolidation layer 140.

[0100] The heat and light activation of FIGS. ID and IE are only examples. Other energy sources may alternatively or additionally be used. For example, one or more ultrasound transducers may be used to produce ultrasound sufficient to weld or fuse adjoining regions of the wrapped film 103 and / or shrink the consolidation layer 140. In some cases, a combination of heat, light and / or ultrasound energy sources are used.

[0101] FIGS. 2A-2H show an example of tubular structure formed by wrapping four layers of matrix film. FIG. 2A shows a first film 203 helically wound around a mandrel 201, thereby forming a first layer of the film 203. As discussed herein, an axial width 207 of the film 203 may depend, at least in part, on a diameter 202 of the mandrel 201. For example, the width 207 may range from about 25% to about 200% of the diameter 202.

[0102] In some cases, a release layer (not shown in FIGS. 2A-2H) is wrapped around the mandrel 201 prior to wrapping the first film 203. Such release layer may be configured to facilitate removal of the resulting consolidated device from the mandrel. In some cases, the release layer is a wrapped thin film (e.g., a cellophane film, a fluoropolymer film, PTFE, ETFE, a polytetrafluoroethylene (e.g., Teflon) and / or other low friction film, such as polypropylene, and / or a cellulose film). In other cases, the release film is a sprayed on or otherwise coated film. The release layer may also contain a transferable coating or first layer of the composite structure (i.e., the release layer may be the backer for the first layer of matrix material or transferable coating).

[0103] For example, any of these methods may include helically wrapping the release film around the mandrel while maintaining a tension on the release film as it is wrapped. The tension while wrapping may be, for example, between about 0.02 and 2 N. As mentioned, in some examples the release film may be cellulose film applied with a very precise tension.

[0104] In the example shown, the first film 203 is wound such that there is an axial gap 214 between adjacent edges of the helically wound first film 203. In other examples, the first film 203 may be wound such that there is no gap between the windings of the first film 203. In other examples, the first film 203 may be wound such that the gap is a negative number relative to thewindings of the first film 203 (i.e., there is an overlap). The gap 214 may have a width 209 that depends, at least in part, on the width 207 of the first film 203. For example, the width 209 may range from about 1% to about 20% of the width 207 of the first film 203. A pitch angle 210 at which the first film 203 is wound relative to a longitudinal axis of the mandrel 201 may be controlled and monitored as the film 203 is applied over the mandrel 201 and tension force is applied. The film 203 may be held in place by the applied tension against the mandrel, which may be quantified and controlled (including tension and / or angle) to provide efficient and wrinkle-free wrapping.

[0105] FIG. 2B shows a second film 206 helically wound over the first film 203. In the example shown, the second film 206 has the same width 208 as the width 207 of the first film 206. In other examples, the second film 206 may have a different width 208 (e.g., be wider or narrower) than the width 207 of the first film 206. In this example, the second film 206 is wound in the same direction as the first film 203. In other examples, the second film 206 may be wound in the opposite direction (counter wound) with respect to the first film 203.

[0106] Also in this example, a pitch angle 212 in which the second film 206 is wound is the same as the pitch angle 210 in which the first film 103 is wound. In other examples, the pitch angle 212 in which the second film 206 is wound may be different than the pitch angle 210 in which the first film 103 is wound. In some examples, the pitch angle 210 ranges from about 10 degrees to about 80 degrees (e.g., between about 15 degrees and about 60 degrees, about 15 degrees and about 55 degrees, between about 15 degrees and about 50 degrees, between about 15 degrees and about 45 degrees, between about 15 degrees and about 40 degrees, between about 15 degrees and about 35 degrees, between about 15 degrees and about 30 degrees, between about 20 degrees and about 80 degrees, between about 25 degrees and about 80 degrees, between about 30 degrees and about 80 degrees, between about 35 degrees and about 80 degrees, between about 40 degrees and about 80 degrees, etc.)

[0107] In the example shown, the second film 206 is wound such that a gap 216 is between adjacent edges of the helically wound second film 206. In other examples, the second film 206 may be wound such that there is no gap between adjacent edges of the second film 206. In this example, the gap 216 of the second film 206 has a width 218 that is the same as the width 209 of gap 214 of the first film 203. In other examples, the width 218 of the gap 216 of the second film 206 may be different (e.g., wider or narrower) than the width 209 of the gap 214 of the first film 203.

[0108] The second film 206 may be wound such that it overlaps the gap 214 between the windings of the helically wound first film 203. Likewise, the gap 216 of the second film 206 may overlap the non-gapped portion of the first film 203. The overlapping regions (e.g., faces orsurfaces) of the first film 203 and the second film 206 may be sealed together to form a leak-free tubular layer.

[0109] FIG. 2C shows a filament (e.g., reinforcement thread) 220 helically wrapped around the wrapped second film 206 and first film 203. The filament 220 may include a metal material (e.g., titanium, copper, stainless steel, and / or shape memory material (e.g., nitinol)), polymer material (e.g., aramids, UHMWPE, PET, carbon, fiberglass, and / or Vectran), and / or inorganic material (e.g., ceramic, basalt, and / or silicon-based material). In some examples, the diameter of the filament 220 may range from about 5 microns to about 1 mm. For example, the filament (thread) may have an aggregate monofilament diameter of about 6 microns to an aggregate monofilament bundle diameter of approximately .030” (approximately 0.8 mm). As described herein, more than one thread 220 may be used. For example, the filament may be a monofilament or a bundle of filaments. Filaments may be coated to promote adhesion / wetting with the matrix or may be coated / encapsulated in a re-flowable material that can merge and bond with the matrix material(s).

[0110] The thread 220 may be wound or counter wound with respect to the direction of one or both of the first film 203 and second film 206. In this example, the thread 220 is wound at a pitch angle 222 that is different than the pitch angle 210 of the first film 203 and the pitch angle 212 of the second film 206. In other examples, the pitch angle 222 may be the same as one or both of the pitch angles 210 and 212. 0.1 mmlO cm In some examples, the pitch may be 1 pitch per inch, up to several hundred pitch per inch. The pitch may be 30 or 40 pitch per inch. The pitch may vary as a function of location. The reinforcement may be one material along a certain portion of the length, and another material along another portion of the length. The reinforcements could be different materials at different pitches and could co-exist in the same region. For example, the main portion (say, the proximal 90%) of a device’s length could be a fiber (which may perform well in tension and may be very low cost). The distal region could be a metal wire (which does very well in both tension and compression and might be preferential relative to reciprocating loads and local buckling). The fiber could have a pitch for its length and then could ‘run’ into the distal region at a different pitch, as it is covered by the metal wire. The fiber could be continuous for the entire continuous length - albeit at different pitches along the length), whereas the wire (e.g., metal wire) could be deposited in local discrete zones.

[0111] FIG. 2D shows a third film 233 helically wrapped over the wrapped thread 220, second film 206, and first film 203. In the example shown, the third film 233 has the same width 237 as the width 207 of the first film 206 and the width 208 of the second film 206. In other examples, the third film 233 may have a different width 237 (e.g., wider or narrower) than one or both of the width 207 of the first film 206 and the width 208 of the second film 206. In thisexample, the third film 233 is wound in the same direction as the first film 203 and the second film 206. In other examples, the third film 233 may be wound in the opposite direction (counter wound) with respect to one or both of the first film 203 and the second film 206. The third film may have a gap (i.e., 239 is a positive value), no gap (i.e., 239 is zero), or an intentional overlap (i.e., 239 as a negative value).

[0112] In this example, a pitch angle 230 in which the third film 233 is wound is the same as the pitch angle 210 of the first film 203 and the pitch angle 212 of the second film 206. In other examples, the pitch angle 230 in which the third film 233 is wound may be different than one or both of the pitch angles 210 and 212. In the example shown, the third film 233 is wound such that a gap 234 is between adjacent edges of the helically wound third film 233. In other examples, the third film 233 may be wound such that there is no gap between adjacent edges of the third film 233. In this example, the gap 234 of the third film 233 has a width 239 that is the same as the width 209 of gap 214 of the first film 203 and the width 218 of the gap 216 of the second film 206. In other examples, the width 239 of the gap 234 of the third film 233 may be different (e.g., wider or narrower) than one or both the widths 209 and 218 of the gaps 214 and 216.

[0113] FIG. 2E shows a fourth film 246 helically wrapped over the wrapped third film 233, thread 220, second film 206, and first film 203. The fourth film 246 is wrapped so that it covers the gaps 234 between adjacent edges of the third film 233, thereby covering the thread 220, second film 206, and first film 203. In the example shown, the fourth film 246 has the same width 248 as the widths 207, 208, 237 of the first, second and third films 203, 206, 233. In other examples, the fourth film 246 may have a different width 248 (e.g., wider or narrower) than one or more of the widths 207, 208, 237 of the first, second and third films 203, 206, 233. In this example, the fourth film 246 is wound in the same direction as the first, second, and third films 203, 206, 233. In other examples, the fourth film 246 may be wound in the opposite direction (counter wound) with respect to one or more of the first, second, and third films 203, 206, 233.

[0114] In this example, a pitch angle 240 in which the fourth film 246 is wound is the same as the pitch angles 210, 212, 230 of the first, second and third films 203, 206, 233. In other examples, the pitch angle 240 of the fourth film 246 may be different than one or more of the pitch angles 210, 212, 230 of the first, second and third films 203, 206, 233. In the example shown, the fourth film 246 is wound such that a gap 242 is between adjacent edges of the helically wound fourth film 246. In other examples, the fourth film 246 may be wound such that there is no gap between adjacent edges of the fourth film 246. In this example, the gap 242 of the fourth film 246 has a width 244 that is the same as the widths 209, 218, 239 of the gaps 214, 216, 234 of the first, second and third films 203, 206, 233. In other examples, the width 244 of thegap 242 of the fourth film 246 may be different (e.g., wider or narrower) than one or more of the widths 209, 218, 239 of the gaps 214, 216, 234 of the first, second and third films 203, 206, 233.

[0115] As described herein, any of the first 203, second 206, third 233, and fourth 246 films may include one or more surface modification, such as one or more coatings and / or surface texture. Such surface modifications may be formed on these films prior to wrapping. The surface modifications may be the same or different on any of the surfaces. In some examples, an inner surface of the first film 203 may include a surface modification, which will result in a tubular structure with an inner lumen modified surface after consolidation. Alternatively or additionally, an outer surface of the fourth film 246 may include a surface modification, which will result in a tubular structure with an outer modified surface after consolidation.

[0116] The first 203, second 206, third 233, and fourth 246 films with the thread 220 sandwiched between can form a multi-layered pre-consolidated assembly 249.

[0117] FIG. 2F shows a consolidation layer 250 (e.g., heat-shrink tube or film) applied around and covering at least a portion of the pre-consolidated assembly 249. As described herein, in some cases, the consolidation layer 250 may include a strip of heat-shrink film that is wound around the pre-consolidated assembly 249. In some cases, the heat-shrink film of the consolidation layer 250 may be wound helically around the pre-consolidated assembly 249. For example, the heat-shrink film of the consolidation layer 250 may be helically wound in the same direction and / or with the same pitch as one or more of the first 203, second 206, third 233, and fourth 246 films. Example materials for a consolidation layer 250 film may include one or more thermoplastic materials. In some examples, materials for the consolidation layer 250 film may include, but are not limited to, a thermoplastic urethane (TPU), polyethylene terephthalate (PET), ethylene tetrafluoroethylene (ETFE), polyimide and / or polypropylene. Films may be monolithic (i.e., one material of a continuous construction) in cross-section or they may be muti-material composite, including with release coatings or transferrable coatings.

[0118] Once the consolidation layer 250 is applied over the pre-consolidated assembly 249, energy may be applied to fuse at least portion of the polymer (matrix) materials of the first 203, second 206, third 233, and fourth 246 films together and to consolidate the assembly 249 into a unitary tubular structure 200. The energy supplied for fusing the polymer (matrix) materials may also be sufficient to cause the consolidation layer 250 to radially shrink, creating an inward radial force against the outer portion of the pre-consolidated assembly 249. The inward radial force provided by the consolidation layer 250 may ensure that the polymer (matrix) materials of the first 203, second 206, third 233, and fourth 246 adequately combine and / or reflow into a cohesive structure. This may also prevent or reduce the occurrence of voids, poor integration, and / or sub-optimal matrix flow. As described herein, in some cases, the energy for sufficientlyfusing the polymer (matrix) materials of the pre-consolidated assembly 249 may be different (e.g., different intensity, location, and / or duration) than the energy for causing the consolidation layer 250 to sufficiently shrink radially inward. In some cases, the diameter of the consolidation layer 250 is configured to reduce by at least a predetermined ratio or percentage. For example, in some examples, the consolidation layer 250 has a shrinkage ratio ranging from about 1.6 to 1 (1.6:1) to about 2 to 1 (2:1) (e.g., 1.6:1, 1.7:1, 1.8:1, 1.9:1, or 2:1). In some examples the shrink percentages may be between about 5% to 35% (e.g., 5% to 20%, 10% to 25%, 25% to 35%, etc.).

[0119] A consolidation layer 250 that is a flat film may have advantages over other form factors, such as extruded tubes. When exposed to the energy (e.g., heat and / or light), the film may restructure so as to create a strain on the underlying structure such that its change in length correspond to applying a radially consolidating pressure on the laminate. This can be enhanced by axially (or bi-axially) orienting the consolidation layer 250 film. For example, the consolidation layer 250 film may be helically wrapped around the pre-consolidated assembly 249. The strip of the consolidation layer 250 film may be wrapped in the same direction and / or pitch as one or more of the first 203, second 206, third 233, fourth 246 films and thread 220, or in the opposite direction and / or a different pitch as one or more of the first 203, second 206, third 233, fourth 246 films, and thread 220. A consolidation layer 250 film may provide varying consolidation forces depending on how it is wrapped. For example, the tension in which a wrapped consolidation layer 250 film provides may be modulated by the amount of overlap, thickness, and processing temperature of the consolidation layer 250 film. In addition, polymer materials may be at a considerably lower cost as a flat film compared to being extruded as a tube. Some flat film polymer materials may be configured to be heated to very high temperatures (e.g., higher than extruded tubes).

[0120] In addition, using a consolidation layer 250 film may provide design versatility. For example, a single film may be used for a wide range of designs / diameters, reducing inventory requirements and making it easier to multi-source materials. Further, a consolidation layer 250 film may be easier to remove compared to extruded tubing. A consolidation layer 250 film may be more easily surface textured and / or coated at overlapping regions, which may provide several advantages. From a landfill standpoint, compared to tubular fluoropolymer heat shrink tubing, PET flat film volume can amount to up to 20 times less volume, and be much less environmentally intensive to create. Further, many polymer materials available in film form (e.g., PET) may be more readily recyclable.

[0121] In some cases, the consolidation layer 250 may include an extruded material instead of or in addition to a wrapped film material. For example, at least a portion of the consolidationlayer 250 may be applied by overlay extrusion or co-extrusion of material over the preconsolidated assembly 249, or ejecting material from a die directly over the pre-consolidated assembly 249. In some cases, an extrusion heat shrink material may be locally used to achieve a certain surface finish or consistent wall thickness, with a majority of consolidation performed by a heat shrink film. Heat shrink extrusion terminations may present challenges in that they may create high stress on the polymer matrix of the pre-consolidated assembly 249 during consolidation. Stress relief features, such as slitting the tubing and / or adding one or more washers, may ease this transition.

[0122] FIG. 2G shows the tubular structure 200 after removal of the consolidation layer 250. As consolidated, the fused polymer matrix of the first 203, second 206, third 233, fourth 246 films form walls of the tubular structure 200 that are leak-free. FIG. 2H shows the tubular structure 200 after removal from the mandrel 201. The tubular structure 200 includes the helically wound first 203, second 206, third 233, fourth 246 films that are sealed along the length of the device 200. The device 200 may include a visible helical path (e.g., corresponding to an edge of one or more of the helically wound first 203, second 206, third 233, fourth 246 films) from a proximal end region 260 to a distal end region 262 of the device 200. The thread 202 is encased within the fused matrix materials of the first 203, second 206, third 233, fourth 246 films, forming a continuous exterior surface for the device 200.

[0123] The device 200 may correspond to, or be integrated into, a medical device, such as a catheter, an overtube, an endoscope, trocar, guidewire, surgical instrument, sheath, dynamically rigidizing device or shield. In some cases, the device 200 may be further processed (e.g., by cutting, drilling, polishing, coating, and / or other manufacturing processing) for integration into a medical device. In some examples, the device 200 have a predetermined range of flexibility, depending on the application of the device 200. For example, some applications, the device 200 may be sufficiently flexible to act as part of a rigidizing overtube of an endoscope.

[0124] The example of FIGS. 2A-2H show formation of a tubular structure 200 having four layers of wrapped films 203, 206, 233, 246. In other examples, the tubular structure 200 may include less or more wrapped films. For example, the thread 220 may be encased within a single inner wrapped film and / or a single outer wrapped film. In other examples, the thread 220 may be encased within three or more inner wrapped films and / or three or more outer wrapped films. In some cases, there are more or less inner wrapping films than outer wrapped films. In some examples, the device does not include any thread 200 or other reinforcement structure.

[0125] FIGS. 3A-3D show side views of portions of different example configurations of wrapped films. FIG. 3A shows an example including two layers of film. A first film 303 is wrapped helically around a mandrel 301 such that there are gaps 314 between adjacent edges ofthe first film 303. In this case, the first film 303 includes a surface modification 321, such as a texture and / or coating, that modifies surface properties of the first film 303. A second film 306 is wrapped helically around the first film 303 such that there are gaps 316 between adjacent edges of the second film 306. The gaps 316 of the second film 306 are offset with respect to the gaps 314 of the first film 303 so that overlapping regions of the faces or surfaces of the two films may be fused together during consolidation. Once removed from the mandrel 301, the resulting dual layered tubular structure will include an inner surface that includes the surface modification 321. In some examples the surface coating 321 is a hydrophilic coating; in such cases an overlap of this edge may poorly bond and could create delamination issues when it becomes wet, thus it may be preferred to leave a gap or directly abut the film in such cases.

[0126] FIG. 3B shows an example including two layers of film having a different configuration. A first film 323 is wrapped helically around a mandrel 331 such that there are gaps 324 between adjacent edges of the first film 323. A second film 326 is wrapped helically around the first film 323 such that there are gaps 326 between adjacent edges of the second film 326. The gaps 326 of the second film 326 are offset with respect to the gaps 324 of the first film 323 so that overlapping regions (and surfaces and faces) of the two films may be fused together during consolidation. In this case, the second film 326 includes a surface modification 341, such as a texture and / or coating, which modifies surface properties of the second film 326. Once removed from the mandrel 331, the resulting dual layered tubular structure will include an outer surface that includes the surface modification 341.

[0127] FIG. 3C shows an example including a single layer device. A film 353 is wrapped helically around a mandrel 351 such that there are no gaps between adjacent edges of the film 353. In this example, the edges of the film 353 are adjacent and contact one another such that the contacting surfaces of the edges can be fused together during consolidation to form a leak-free tubular structure. In this case, the film 353 includes a surface modification 361 on an inner surface of the film 353 so that, once removed from the mandrel 351, the resulting single layered tubular structure will include an inner surface that includes the surface modification 361. In other examples, the outer surface of the film 353 may include the surface modification 361 such that the outer surface of the resulting single layer tubular structure will include the surface modification 361. In other cases, both the outer and inner surfaces of the film 353 may include the surface modification 361.

[0128] FIG. 3D shows another example of a single layer device. The film 373 is wrapped helically around a mandrel 371 such that edges of the film 373 overlap at overlapping regions 377 that include adjacent edges of the film 373. During consolidation, the overlapping regions 377 of the film 373 can be fused together to form a leak-free tubular structure. In this case, thefilm 373 includes a surface modification 391 on an inner surface of the film 373 so that, once removed from the mandrel 371, the resulting single layered tubular structure will include an inner surface that includes the surface modification 391. In other examples, the outer surface of the film 373 may include the surface modification 391 such that the outer surface of the resulting single layer tubular structure will include the surface modification 391. In other cases, both the outer and inner surfaces of the film 373 may include the surface modification 391.

[0129] FIGS. 4A-4D show example section views of different example configurations of wrapped films. FIG. 4A shows an example where a film 403 is helically wrapped such that there is a gap 409 between adjacent edges of the film 403. FIG. 4B shows an example where adjacent edges 419 of a helically wrapped film 423 contact each other (i.e., no gap) so that they can be fused together. FIG. 4C shows an example where adjacent edges of a helically wrapped film 443 overlap at overlap regions 429, and the film 443 can be fused at the overlap regions 429. FIG. 4D shows an example where adjacent edges of a helically wrapped film 463 contact at a clasping region 439. In the example shown, the clasping region 439 protrudes radially outward; however, in other examples, the clasping region 439 may be folded over to one side of an outer surface of the tubular shaped film 463. Alternately, the region could be trimmed after fusion.

[0130] FIGS. 5A-5F show sectional views of portions of different example layer configurations having reinforcement materials. FIG. 5A shows an example portion (e.g., layer) 503 of a tube-shaped structure that includes two strips of helically wrapped materials: a matrix film 505 (e.g., polymer material (s)) and a reinforcement material 507 (e.g., metal, carbon fiber / filament, including resin impregnated), that are wrapped in conjunction to form a single reinforcement layer 503. The reinforcement material 503 may be one layer of an overall wrapped assembly, which includes one or more first layers of matrix film wrapped beneath the reinforcement material 503 and one or more second layers of matrix films wrapped over the reinforcement material 503. When consolidated, the matrix film 505 between the reinforcement material 507 can fuse with upper and lower matrix films. In some cases, this may help to encase the reinforcement material 503 within the matrix material. In this example, both the first and second of materials 505, 507 have a rectangular cross-section. These figures are not to scale (e.g., the films forming the first and second materials may be substantially flat). In one specific example, the first material 505 is an extruded matrix material having a flat cross-section, and the second material 507 is a metal flat wire.

[0131] FIG. 5B shows an example of a layer 523 of a reinforcement material 527 similar to FIG. 5A, except that the matrix material 525 has a circular cross-section (e.g., circular extruded material).

[0132] FIG. 5C shows an example of a layer 543 of reinforcement material 545 (e.g., metal flat wire) that is covered with a coating 547. The coating 547 may be applied to surfaces of the reinforcement material 545 using any of number of methods, such as a spray, vapor deposition, and / or dip coating method as the wire is passed through a bath. In some cases, the coating 549 is made of a matrix material (e.g., polymer), which may help to encase the reinforcement material 545, as discussed. The reinforcement material 545 may be wrapped around the mandrel (e.g., over one or more layers of matrix film) such that there are gaps 549 between windings of the reinforcement material 545.

[0133] FIG. 5D shows an example of a layer 563 that is similar to that of the layer 543 of FIG. 5C, except that the reinforcement material 545 with coating 567 is arranged with no gap between windings.

[0134] FIG. 5E shows an example of a layer 583 that includes bundles of reinforcement material 585 (e.g., metal round wires or fiber monofilaments) that are coated with a coating 587. In the example shown, the bundles of reinforcement material 585 are spaced apart by gaps 589. In other examples, there may not be gaps between the bundles of reinforcement material 585.

[0135] FIG. 5F shows an example of the layer 563 of FIG. 5D with underlying layers 596 of matrix material and overlaying layers 595 of matrix material. The coating 567 may include a matrix material, and which the reinforcement material 567 is wrapped, may be configured to at least partially fuse with the matrix materials of the underlying layers 596 and overlaying layers 595 of matrix material, thereby helping to encase the reinforcement material 567 in the matrix material.

[0136] FIGS. 6A and 6B show an example of a multiple-layered tube-shaped device 600 wrapped around a mandrel 601 during production. In this example, a release layer 602 is wrapped first around a mandrel 601. The release layer 602 may be configured to facilitate removal of the wrapped device after consolidation is complete. The release layer 602 may include one or more films wrapped around the length of the mandrel 601. The release layer 602 may be wound in a helical fashion around the mandrel 601. The release layer 602 may include a low friction (e.g., slippery) material, such as fluoropolymer materials, that is added to backers (e.g., plastic, paper), or with a material that is monolithic (i.e., same material across its cross section). In some cases, the release layer 602 may include one or more coatings (e.g., sprayed or dipped). In some cases, the release layer 602 is a sacrificial layer of material. In some cases, more than one release layer 602 is used. In some cases, the release layer may have a transferable coating that transfers to tube shaped structure during consolidation. In some cases, the backer for the first matrix layer may be the release layer.

[0137] The device 600 includes a first (e.g., inner) matrix layer 603, which may include one or more films of helically wound matrix films, is wrapped over the release layer 602. One or more of the films of the first matrix layer 603 may include one or more surface modifications, such as one or more coatings. The surface modification(s) may be applied to the matrix film(s) prior to wrapping.

[0138] A second (e.g., mid-layer) matrix layer 604, which may include one or more films of helically wound matrix films, is wrapped over the first matrix layer 603. In this example, the second matrix layer 604 includes markings (e.g., lines, letters, words, and / or logos). In some examples, the markings may include length markings to indicate particular lengths along the device. For example, an endoscope may include length markings to indicate lengths from a tip of the endoscope (e.g., in centimeters). This may be useful for knowing the depth of entry into the patient, as well as what portion of the device remains un-entered. Other markings could be useful for describing part numbers, and / or other indicators, such as company logos, branding, user advice and / or user inputs. There may be advantages to adding these markings in a manner that could be readily applied to disposable devices, as described herein. There may be advantages to markings that could be applied within the matrix material and seen through subsequent layers, such that none of the markings were on the outside, exposed to wear and to patient contact, and such that no subsequent parts, processes and / or services are required. In some examples, the markings may be deposited by: marker, paintbrush, silk screening, printing or via printheads, laser marking, flexography, pigment deposition, spray, stencils, and / or with inks and / or dyes. The markings may be deposited within the laminate structure of the device 600, with subsequent clear or semi-clear layers applied on top, and then with the laminate heated and consolidated, without the markings notably moving.

[0139] In any of these examples, the markings could be pre-printed directly onto the matrix material, such that they are then laminated in without the need for printing during the continuous winding process. The pre-printed matrix material could have fiducials, e.g., lines or shapes that may be used to line up for proper orientation, such that a controller (e.g., deposition controls system or subsystem) could optically observe the relative position of the mating fiducials, which may be input into a controller / control system to, in real time, modulate tension and / or angle such that the fiducials (and therefore the images and markings) are appropriately matched / aligned.

[0140] A first reinforcement material 606 may be applied over the second matrix layer 604. In this case, the reinforcement material 606 is in the form of a thread (or wire) that is helically wound. The reinforcement material 606 may include one or more hoops, braids, fibers and / or wires. The reinforcement material 606 may include one or more metal threads or wires (e.g., flat and / or round wires) and / or high-performance fibers. For example, the reinforcement material600 may include plastics (e.g., polyether ether ketone (PEEK)). Fibers may include aramids, ultra-high-molecular- weight polyethylene (UHMWPE), polyethylene terephthalate (PET), carbon, fiberglass, ceramic, basalt and / or Vectran). FIG. 9C shows examples of spools of different types of thread that may be used as reinforcement materials.

[0141] In the example shown, a second reinforcement material 607 is counter- wound around the first reinforcement material 606. FIG. 7 shows an example of a second reinforcement thread 707 (e.g., flat wire) that is counter-wound over a first reinforcement thread 706 (e.g., flat wire).

[0142] In some cases, reinforcement material may be in the form of conductors or tubes (e.g., laser-cut tubes). Tubes (e.g., laser-cut tube) of small diameter may be wound from a spool and then straightened as they enter the process. The tubes may start as long-length straight sections that are abutted end-to-end to enter the continuous process, with laser cutting as part of either a separate process (i.e., laser cut before they are part of the continuous process, or as part of a continuous process). In some examples, deposition of the reinforcement material may change along the length of the device 600.

[0143] In the example of FIGS. 6A and 6B, the device 600 includes a third (e.g., outer) matrix layer 608, which may include one or more layers of helically wound matrix films, that is wrapped over the first and second reinforcement materials 606, 607. The third matrix layer 608 covers the first and second reinforcement materials 606, 607 and the markings 605 of the underlying second matrix layer 604. The third matrix layer 608 may be transparent or semitransparent so that the markings 605 on the underlying second matrix layer 604 may be visible from the outer surface of the device 600 once fabricated.

[0144] A consolidation layer 609 is applied over the third matrix layer 608 and the whole multi-layered device 600 assembly. The consolidation layer 609 may be a shrink wrap tube or shrink wrap film that is configured to shrink upon application of energy (e.g., heat and / or light). If in the form of a film, the consolidation layer 609 may be helically wrapped around the device 600 assembly.

[0145] When energy is applied to the consolidation layer 609 and the device 600 assembly, the matrix material of adjacent first, second, and third matrix layers 603, 604 and 608 can fuse (e.g., by partially melting together), thereby embedding and protecting the reinforcement materials 606, 607 and markings 605 within the laminated structure. In addition, energy (from the same or different energy source) may cause the consolidation layer 609 to compress radially inward toward the mandrel 601, thereby creating a radially inward force that constrains the matrix materials of the first, second, and third matrix layers 603, 604 and 608. This constraining force can prevent the reinforcement materials 606, 607 and / or markings 605 from shifting out of place.

[0146] Once the laminated device 600 is consolidated, the consolidation layer 609 may be removed from the device 600. Then the device 600 may be removed from the mandrel, e.g., facilitated by the release layer 602. In some cases, the release layer 602 and / or the consolidation layer 609 are disposed of (e.g., not reused).

[0147] Note that any of the layers of device 600 may include a surface modification (e.g., coating). For example, one or both sides (inner and / or outer surfaces) of any of the first (e.g., inner) matrix layer 603, second (e.g., mid-layer) matrix layer 604, and third (e.g., outer) matrix layer 608 may include a surface modification, as described herein. In some cases, these surface modifications may be applied prior to wrapping around the mandrel 601.

[0148] In some examples, the mandrels may have a tapered shape and include multiple sections to facilitate removal of the wrapped devices after consolidation. FIGS. 8A-8F show example aspects of different tapered and sectioned mandrels. FIG. 8A shows an example mandrel 801 that includes multiple tapered sections 803, 805 and 807, in which small ends of the sections are joined to large ends of adjoining sections (small end-to-large end configuration). FIG. 8B shows an example mandrel 821 that includes multiple tapered sections 823, 825 and 827, in which large ends of the sections are joined to large ends of adjoining sections (and large end-to-large end) configuration. After the tubular wrapped structure is manufactured (e.g., consolidated), the wall of the tubular wrapped structure may be cut into sections 1064 at locations where the sections of the mandrel are joined. Then, the sections of the tubular wrapped structure can be removed from each mandrel section, creating a collection of tubular wrapped devices 1090 and a collection of mandrel sections 1060, 1050, which may be reused again.

[0149] FIGS. 8C and 8D show examples where tapered sections of two different mandrels 841 and 861 have engagement features (e.g., keys). The engagement features include alternating male 842 and female 844 features that key together such that their faces abut and such that they can transmit torque from one section of the mandrel through to an adjacent section of the mandrel (e.g., as the mandrel is rotated). FIGS. 8E and 8F show example front views of corresponding male and female engagement features, respectively, of mandrel sections.Surface modifications

[0150] As described herein, the films may include surface modifications. Such surface modifications may be important in the manufacture and / or enhance the performance of the medical devices. The surface modifications may modify the properties of one or more surfaces of the matrix films. The modified surfaces may in inward facing or outward facing. They may be along an entire length or along a portion of the length. They may be a single material and asingle layer, or they may be a single material with multiple layers or they may be multiple materials with multiple layers.

[0151] Surface modifications may be useful to create surfaces that are anti-proliferative or anti-thrombotic, hydrophobic, hydrophilic, hemocompatible, biocompatible, procoagulant, antimicrobial, growth promoting or inhibiting, X-ray or MRI image enhancing, drug-eluting or drug delivery, antibiotic, anti-encrustive, pH modulating, antiproliferative, endothelialization promoting, cell adhesion promoting, MR signal emitting, radiodense, echogenic, catalytic, immune modulating, anti-hemolytic.

[0152] Tubular medical devices often have other things go through their bore or over their outer surface, such that providing low sliding friction surface may be beneficial. For example, an endoscope may be nested within an overtube. Without low-friction coatings, these systems could not effectively move relative to anatomy, tissues, or other devices or instruments. Low-friction surfaces (e.g., coatings) enable lower forces, great user control, and efficacy amongst tortuous anatomy.

[0153] It may be clinically valuable to have an endoscope or an overtube that is slippery. Slippery devices slide by the gastrointestinal tract with lower force, potentially reducing complications and reducing colon distortion, mesenteric stretch, and looping. The devices are typically lubricated by the user. It would be advantageous to have reduced sliding force, and hydrophilic coatings should provide this enhanced performance. Additionally, it would be advantageous to not have the lubricant, as the lubricant can migrate and aggregate on the scope tip, impairing vision. However, for manual procedures, this reduced sliding force impairs the user’s control, as it impairs their ability to grip the shaft to axially and rotationally manipulate the shaft. A robotic system eliminates this need, as the robotic endoscope and the robotic overtube are manipulated with robotic methods that do not require gripping a slippery shaft.

[0154] Surface modification manufacturing methods may include texturing, bead blasting, particle embedding, chemical treatments, etching, plasma treatment, corona treatment, surface activation, adhesives, adhesive primers, and the like. Surface modifications may include the application of coatings. Coatings are applied in many different manners, including by rolling, brushing, solution casting, vapor deposition (including parylene), spraying, sponging, dipping (including through baths), plasma, silk screening, roll coating, slot dye coating , or spin coatings. Coatings can be applied in various forms, with liquid forms often cured or cross-linked by the application of heat or the delivery of UV energy, and the passage of time.

[0155] Parylene coating has many advantages, but it is not as lubricious as a hydrophilic. It is deposited in a vacuum chamber, which may not be amenable to a continuous process, includinghigh velocity manufacturing. Such coating may not be applied inside lumens that are long and small.

[0156] Hydrophilic coatings may give the best-in-class lowest sliding forces, which can be important performance criteria for a long flexible device that snakes through the body, often in conjunction with other paired devices. The coatings may not last for ultra-high cycle counts, but they may last long enough for single use. They may shed particulates. The particulates that are shed may fall within guidelines for vascular devices. They may also be adequate for other clinical uses.

[0157] Hydrophilic coatings are well known and are widely used in medical devices. These are readily applied to outer surfaces and frequently used on exteriors of catheters, for example, to facilitate tracking through the vasculature. However, application of such coatings to inner surfaces is difficult, particularly for very low and very small lumens. The application of hydrophilic coatings is traditionally expensive and cumbersome. Thus, there is a need for constituent materials and processes that could be delivered at a lower cost.

[0158] There are a number of different coating chemistries used to create hydrophilic coatings, including polyvinylpyrrolidone, poly(ethylene oxide), poly(propylene oxide), poly(ethylene glycol), poly(n- vinyl lactam) polyacrylamide, methylcellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, polyacrylic acids, hydroxyethyl methacrylate, polyvinyl alcohols, polyvinyl ethers, hyaluronan, polyurethanes, silicone hydrogel, soy-based hydrogels, and fluorocarbon-sulfone compounds. The slipperiness achieved through the use of these coatings may exceed the slipperiness achieved by a fluoropolymer layer, including through the use of liners. Liners may be used and may have certain advantages.

[0159] Traditional methods of applying coatings are often slow and expensive. Activating a coating (curing) may damage the underlying material. They may require a high labor input and are single-piece flow and not amendable to a continuous process. They often involve chemicals that create high costs for environmental and employee compliance and mitigation, creating higher tertiary costs. The surface modification processes described herein may be designed for continuous processes, which have a low-per-part cost, and that may be applied to devices surfaces - both inside and outside - regardless of device diameter.

[0160] The processes described herein may include the use of a master spool that is coated (e.g., as it is unspooled). For example, a primer and a hydrophilic may be deposited onto the film, as described herein. The surface modification (e.g., coating) may be applied at a certain deposition rate (for example, x milliliters per square meter). It can be applied with multiple methods, for example, sprayed, applied between a gap (as in slot dye), with a drum or sponge roller. The coating may be cured, activated, or bonded. If the primer needs to be cured before thehydrophilic coating is applied, a second coating method and cure method may be employed. It may then be respooled and stored. If not coated at the desired width, it can be slit into thinner widths (the same or different) at that point, or at a later point. In this manner, a large continuous process can be performed that processes, say, a year or two- or three-year’s worth of material in a single run, with no dedicated coating operations required thereafter. This can save on labor costs, facility costs, chemical exposure, and environmental remediation. This slit material may be helically wrapped around a mandrel, as described herein. It can be laminated into a structure at temperature without degradation of the coating to the substrate, or without detrimental degradation of the coating’s efficacy.

[0161] Surface modifications may also be used to create a modular liner. PTFE and other low friction common liners traditionally do not bond well. By modifying the surface so that it will bond to the matrix material, it may be possible to bond a helically wound flat strip of this material as a first (e.g., innermost) or last (e.g., outermost) layer. This imparts several advantages. It overcomes manufacturing issues and costs associated with thin films. The liner can be thinner and more uniform. Perhaps most advantageously, the helical cut may reduce the effective stiffness of the liner, as the stiffness value of coated elastomers can be radically lower than that of plastics. A multi-start helix may be advantageous as it will have less local flexural bias. Finally, as with flat film in other portions of this document, it may offer more design freedom and reduced inventory requirements as the same liner may be used for multiple products, at most changing the slit widths.Manufacturing Processes

[0162] FIG. 10A illustrates a first example of a manufacturing process and system 1000 for manufacturing elongate tubular members for medical devices as described herein. In this example, the system is configured to receive and operate upon one or more mandrels 1021. The mandrel(s) may be part of the system or may be used with the system. The mandrel may be any of the mandrels described herein. As described above, the mandrel may be coated and / or at least partially covered with a release film or material, such as a PTFE or Teflon™ film, or a cellulose film. In some cases the mandrel may be rotated and advanced relative to components configured to receive and operate on the mandrel. For example, any of these systems may include a mandrel driver 1024. The mandrel driver may be configured to rotate and / or laterally move (advance, withdraw) the mandrel. In some cases multiple mandrel drivers may be used. In some cases a separate mandrel driver may be used for rotation and for laterally moving the mandrel. In some cases the same mandrel drive may both rotate and laterally move the mandrel. The mandrel drive may include a bushing and / or one or more rollers for advancing and / or rotating the mandrel. Oneor more mandrel supports 1053 (e.g., guide supports or bushings) may also be used. In FIG. 10A the distal end includes a mandrel support 1053. Optionally in some examples the mandrel drive (or a second mandrel driver) may be positioned at the distal end. Although the mandrel driver 1024 is shown in the proximal end in FIG. 10A, in some cases the mandrel driver may be positioned in a middle region, intermediate between the distal and proximal ends (which may optionally include a passive support, such as a guide support and / or bushing.

[0163] The mandrel driver may be controlled by a controller 1072 and / or may be computer or manually controlled. The mandrel drive may be configured to control the rate of lateral movement (e.g., advancing by about 0.01 mm / sec or faster (e.g., between about 0.01 mm / sec and 10 cm / second, between about 0.1 mm / second and Icm / second, between about 0.1 mm / second and 5 mm / second, etc.). Any appropriate advancement speed may be used. The advancement speed may be linked to the rotational speed (e.g., the faster the rotation, the faster the advancement). The mandrel driver may be configured to rotate the mandrel at any appropriate rate, such as about 1 rotation / second (e.g., between about 0.1 rotation / second and 100 rotations per second or faster, between about 0.1 rotation / second and 50 rotations / second, between about 0.1 rotations / second and about 40 rotations / second, between about 0.1 rotations / second and about 30 rotations / second, between about 0.1 rotations / second and about 20 rotations / second, between about 0.1 rotations / second and about 10 rotations / second, between about 0.1 rotations / second, etc.).

[0164] In any of these systems, the system may include one or more, e.g., a plurality, of spool assemblies 1055a, 1055b, 1055c, 1055d, 1055e, which are configured to hold and apply a film so that the film helically wraps around the mandrel during operation of the system. In FIG. 10A, the system shown a first spool assembly 1055a that is configured to apply the release film (e.g., Teflon™ film), that is most proximally located, so that it covers the surface of the mandrel. As mentioned above, one or more additional films and filaments may be applied over the release film. For example, in FIG. 10A, a second spool assembly 1055b is shown distal to the first spool assembly 1055a. The second spool assembly 1055b may couple to a spool of a first flat matrix film so that it may be unspooled to helically wrap around the mandrel. In FIG. 10A an optional third spool assembly 1055c is shown distal to the second spool assembly 1055b, and may be configured to apply a second flat matrix film on top of, and in some cases laterally offset from, the first flat matrix film.

[0165] Any of the spool assemblies described herein may be configured to allow the controlled unspooling and application of the flat films (e.g., flat matrix films). The flat film may be passively pulled off of the spools 1045, 1045b, 1045c, 1045d, 1045e that are attached to the spool assemblies. Some or all of the spool assemblies may be configured to control the tensionand / or angle of the spool associated with the spool assembly. For example, the spool assembly may be configured to increase or decrease the tension (e.g., by increasing or decreasing the resistance to rotation of the spool and / or the position of an interference member in contact with the film as it comes off of the spool (not shown). The force of the tension on the flat film may be measured by one or more sensors that form part of the spool assembly. In any of these apparatuses, the spool assembly may include one or more actuators for adjusting the tension and / or the angle between the spool and the mandrel. For example, the spool assembly may include an arm that is movably adjustable to adjust the angle and / or distance between the spool and the mandrel. Each of the spool assemblies may be controlled by a spool control sub-system and / or directly by the controller 1072. Any of these apparatuses may also actively control rotation of the spool (either clockwise and / or counterclockwise) instead or in addition to passively rotating the spools on the spool assemblies.

[0166] In FIG. 10A the system also includes an optional (shown by dashed lines) third spool assembly 1055c that may include another flat matrix film on a third spool 1045c that may be applied over (including overlapping over) the first flat matrix film. The same matrix material may be used or a different matrix material may be used. The third spool assembly 1055c may be positioned so that the additional flat matrix material is applied at the same or a different wrapping angle on the mandrel as the first flat matrix film. In some cases it may be preferred to apply the first and second flat matrix films at the same angle but longitudinally offset, to avoid any gaps, particularly where the first flat matrix film is applied with spaces between the edges of the first helically-wrapped flat matrix film strip.

[0167] Any of these apparatuses may include a filament applicator that is configured to apply a filament in a helical wrapping pattern around the mandrel and onto the matrix film. In any of these methods and apparatuses the filament may be applied in a braided pattern (or woven pattern). In FIG. 10A the system includes a filament wrapping driver 1073. In this example the filament wrapping driver also include a bushing through which the mandrel (e.g. the partially- wrapped mandrel) passes. This bushing may support and / or may drive the mandrel or the bushing may be configured to pass the mandrel without contact with the mandrel and / or the outer surface (e.g., wrapped matrix film(s)). In FIG. 10A the filament wrapping driver 1073 is further configured to rotate around the mandrel so that the filament (on a filament spool 1046, which may passively and / or actively rotate) may spin around the rotating mandrel to apply the filament onto the mandrel and onto the flat matrix film, as described above. Any appropriate filament (which may be a monofilament, and / or a bundle of filaments) may be applied. Alternatively, in some cases the filament may be applied using spool assembly that is similar to the spool assemblies for the flat films. The filament wrapping driver 1073 may control tension and / orangle, and / or pitch of the filament being applied. For example, the pitch may be controlled by controlling the rotational speed of the arm holding the spool 1046. One or more actuators may change the position and / or rotation of the spool relative to the mandrel. In some cases the spool assemblies holding the spools of flat matrix film or other films (e.g., release film, consolidation film, etc.) may be configured as filament wrapping drivers, and / or may be configured to rotate about the elongate body of the mandrel, which may also be rotating.

[0168] In FIG. 10A an optional third (or more) flat matrix film may be present on a third spool 1045d controlled by a spool assembly 1055d. In some cases this third flat matrix film may be applied over the filament to seal the filament (e.g., support filament) within the matrix material by fusing the matrix material over and / or around the filament(s). Any number of additional spool assemblies may be included for applying additional films, as described herein. In FIG. 10A the spool assemblies are configured so that the pitch angle of the thin films is in the same direction and may be approximately the same. In some cases the orientation of the spool assemblies may be different.

[0169] The last spool assembly 1055e, e.g., the most distal spool assembly, in FIG. 10A is a consolidation film assembly that is configured to helically wrap the consolidation film (on a spool 1045e of consolidation film, such as a shrink-wrap film material) around the mandrel and layers of matrix material film. Additional helically-wrapped layers may be added, but the last layer is preferably the consolidation layer or other medication (e.g., pressure-based modification) layer.

[0170] Any of these systems may also include an energy applicator 1089 (e.g., heater, optical energy applicator, etc.) that may be part of a consolidation station 1059 for consolidating the matrix film(s) on the mandrel. In FIG. 10A the energy applicator is a heater that may apply a controlled temperature to the mandrel and film(s) so that the matrix film, which may have the lowest melting temperature. The energy applicator 1089 (including the consolidation station 1059) may be controlled (e.g., by the controller) to apply energy to fuse the matrix material to itself, where the matrix material contracts either the same matrix material or a similar matrix material. The energy applicator may be controlled so that the matrix material only partially melts, e.g., to adhere to adjacent matrix materials, but may be prevented (by controlling the time / duration and amount of energy, e.g., heat, applied).

[0171] Any of these systems may include one or more sensor or monitors for monitoring and / or providing feedback to the controller 1072 and / or user (e.g., via one or more user outputs, including video monitor, lights / LEDs, sounds, haptics, etc.). In FIG. 10A the apparatus includes a sensing subsystem 1044 with one or more sensors. The sensors (e.g., sensing sub-system) may be coupled to the controller 1072 either directly or indirectly. In some cases an optical sensor1046 or sensors may be used. For example, in FIG. 10A an optical sensor 1046 may be used to monitor the wrapping of one or more of the films and / or filaments. Multiple sensors (e.g., cameras) may be used. A control loop may be used to maintain the pitch and / or tension (e.g., using input from the one or more sensors and controlling the spool mount assembly. Any number of sensors may be used, including sensors for sensing tension on each of the spool mount assemblies and / or filament wrapping driver. One or more sensors may be configured for sensing rotation rate of the mandrel and / or lateral movement of the mandrel. One or more sensor may be used to sense the applied energy and / or temperature of the assembly (e.g., by the consolidation station, etc.).

[0172] The controller may receive input from and may provide output (e.g., power, command signals, etc.) to the various components. The controller may include one or more processors, including but not limited to one or more microprocessors. A processor may include hardware that runs the computer program code. Specifically, the term ‘processor’ may include a controller and may encompass not only computers having different architectures such as single / multi-processor architectures and sequential (Von Neumann) / parallel architectures but also specialized circuits such as field-programmable gate arrays (FPGA), application specific circuits (ASIC), signal processing devices and other devices.

[0173] In operation the system shown in FIG. 10A may form an elongate tubular member of a high pressure rigidizing medical device by helically wrapping a first flat matrix film around the mandrel while the mandrel is rotated and advanced distally. The system may wrap a second flat matrix film over the mandrel to cover the first flat matrix film. In any of these apparatuses (e.g., systems) one or both an inner surface of the first flat matrix film and / or an outer surface of the second flat matrix film may comprises a surface modification, a described herein. The system may apply one or more support filaments at a pitch that is different from the helically wrapped flat matrix films. The system may helically wrap a consolidation film over the mandrel to cover the first and second flat matrix films. Finally, the system may apply energy to activate (e.g., fuse) the first and second flat matrix films. The consolidation film may apply a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the elongate tubular member having a leak-free surface. Once completed, the elongate tubular member may be removed from the mandrel or additional (on-mandrel) processing may be performed.

[0174] The flat film production and assembly may be arranged to create a continuous process device construction. Continuous processes may allow for efficient and low cost of manufacture. FIG. 10B shows an example system 1000’ for manufacturing wrapped tubular devices 1090 in a continuous manufacturing process. The system 1000’ may include an assembly of mandrels and spools of matrix films that are arranged to manufacture multiple tubular devices. Any of thesystems described herein may include one or more of: a mandrel rack 1001, a mandrel transfer station 1051. a mandrel loading station (e.g., mandrel geometry and mandrel end-geometry to transmit torque station) 1052, guide supports or bushings 1053, spools with angle controls and tensile force control system 1054, spool mount assemblies 1055, rotational input and an axial advance system 1056, reinforcement spools and applicators (e.g., orbiting elements) 1057, bath- applied matrices station 1062, co-wound matrices station 1058, local augmentation station 1063, consolidation station 1059, separation station (e.g., for tubular devices and / or mandrel) 1060, and tube removal station 1061.

[0175] The mandrels may be arrayed in the mandrel rack 1050 and then loaded into the continuous operation by a loader 1051. The mandrels may be placed end-to-end, abutted, with the keyed mating male and female end features so that they can transmit torque relative to each other. The system 1000’ may provide for both rotational and axial advancement of the mandrel with respect to the spool of film to provide helical wrapping of the film. Mandrel supports may be provided so that the mandrels run true. As mentioned, the system may include sensing, e.g., sensing sub-system, that may include feedback (e.g., optical feedback) that may monitor, in real time, material deposition to ensure that the system runs consistently. The sensing subsystem may include one or more sensors (optical sensors, contact sensors, temperature sensors, rotational sensors, force sensors, pressure sensors, etc.) that may be arranged and configured to detect operational parameters, including (but not limited to) sensing tension and / or angle of the spools for the tape (e.g., matrix, release film, consolidation layer, filament, etc.), sensing (e.g., optically) the wrapping pattern, spacing, etc.) on the mandrel, sensing mandrel position (angular and / or linear position), sensing applied energy (e.g., of the thermal applicator, optical applicator, etc.), sensing (optically) presence and or uniformity of coating. Any of these sensors may provide input to the controller (e.g. control circuitry) that may be used to regulate operation of the device, including but not limited to tension and / or angle of each film and / or filament as it is being applied, energy applied to fuse the matrix layers, advancing and / or rotating the mandrel, etc., or perform QIP functions.

[0176] The spool mount assemblies 1055 may include spool mount plates and spool angular adjusters, which may include angular gages. The spool tensile force controls 1054 may be configured to control tension on the films and angular adjustment of the films as they are rolled onto the mandrel(s) and may include tensile force sensors.

[0177] For a given mandrel size, the slit- to- width films may have different widths. In some cases, the slit-to-width films may have the same width, thereby allowing uniform helical wrapping. The films may have controlled and monitored angle of application and tension application force.

[0178] The edges of the matrix films may be wrapped such that adjacent edges abut each other, overlap each other, or include a gap between each other. In cases where there are intentional gaps between adjacent edges, a second layer of film may be wrapped to cover the gaps. In some cases, the second layer of film also includes gaps that are offset with respect to the gaps of the first layer of film. The welding, fusing and consolidation may be performed in a manner such that adjacent and / or overlapping edges reliably adhere together to create a sealed tube.

[0179] Layers of film may be held in place by layer tension and applied by helically winding. Other matrix layers and consolidation films may be applied. Reinforcements may be applied to provide certain advantages for device performance. In some cases, surface modifications on the film(s) may be oriented on inward facing surfaces (faces) to provide particular functionality to inner surfaces of the tube. Alternatively or additionally, surface modification may be oriented on outward facing surfaces to provide particular functionality to outer surfaces of the tube.

[0180] If the mandrels are small (e.g., 0.1 inches or less), they may be made of wire or beading, including from spooled material. After use, they may be pulled out or necked for removal. These may be disposable or single-use mandrels. For mandrels of larger diameters (e.g., 0.25 inches or greater, such as 0.3 inches or greater, 0.4 inches or greater, 0.5 inches or greater, 0.6 inches or greater, etc.), the mandrels may be too big and / or stiff to be as easily pulled out as smaller mandrel. Such larger mandrels may include a release film or coating applied to their surface to facilitate removal. Larger mandrels may be configured to be reused to save costs.

[0181] In some cases, these mandrels may be tapered (e.g., between 0.001 inches and 0.010 inches per foot). Tapered mandrels may be arranged in repeating patterns, such as ‘big end to small end’ or ‘small end to small end, big end to big end.’ Tapering may help with the deposition of the matrix films so that there is reduced amounts of geometry discontinuity in the winding, thereby resulting in less film distortion. Markers may be applied during the winding process to facilitate machine based cutting at tapered joints.

[0182] The mandrels may include a release film that is applied before the matrix film is applied, such that the tubular devices can be readily released from the mandrels after consolidation.

[0183] Energy for consolidation may be applied in a local or distributed fashion. The energy sources may include thermal application heads and / or ultrasonic weld heads. In some cases, the energy sources may be distributed axially along the length of the mandrel and / or radially around the mandrel.

[0184] In some cases, the system 1000 may allow for augmenting the matrix film. For example, a location- specific dispenser for spraying material may be provided in the system. Reinforcements may be applied, for example, by an orbiting head that dispenses a hoop fiber or a braid array.

[0185] The system 1000 may be configured to control the advancement rate for winding the film onto the mandrel. In one example, the winding rate may be about one foot every twelve seconds, which may create about 500,000 units per year. To reach this speed, if the hoop pitch is 30 per inch, the mandrel would need to rotate at roughly 360 rotations every 12 seconds, or 1800 rpm. Multiple simultaneous hoop-dispensing heads may be provided to allow the orbiting speed to be a commensurate multiple less. By spinning the film around the mandrel, and by spinning the films at different speeds with respect to each other, different film pitches and layer thicknesses can be achieved. This also works for tensile members.

[0186] A marking dispense head may be used to dispense material for marking the tubular device. In some cases, outer layers of film may be deposited over layers with markings to cover and protect the markings. In some cases, the markings may be pre-applied to the films. In some cases it may be advantageous to apply an additional layer (e.g., additional matrix layer) over the markings (weather applied directly by printing or incorporated into a helically wrapped thin film, or both). In some cases, marking may be made to facilitate machine recognition of where to cut the tube (between tapered mandrel sections).

[0187] The consolidation flat film may be applied with a modulated pitch angle and tension, like the helically wound matrix film. In some cases, the consolidation film may be a different width such that it overlaps at a different amount than the matrix film(s). The wrapped matrix with consolidation film may pass through a heating head or laminator to consolidate the consolidation film. In some cases, the film matrix itself may also be consolidated at this time. Alternately, the mandrels may be separated and then baked en masse in an oven. After baking, the mandrels may be removed from the consolidated wrapped tubes and paced in a mandrel rack that is then positioned for reuse. The consolidation film may be removed from the consolidated wrapped tubes.

[0188] In some examples, as the devices move through manufacturing in a continuous process. Various processes may be performed as the devices progress through manufacturing. For example, the marking dispensing head can be configured to orbit or orbit along with the device, such that from that orbit, it can move axially and rotationally in accordance with device progression, so as to print and dispense its markings on the device. This can be done after the initial layer(s) but before the final layer(s). This can also be performed on an outer layer, before the consolidation layer is applied.

[0189] FIGS. 10C-10H illustrate another example of a manufacturing process and system 1080 for manufacturing elongate tubular members for medical devices as described herein. In this example, the system is configured to engage with and operate upon a mandrel 1021. Mandrels may be inserted by connecting to a first (e.g., left, proximal) mandrel mount or holder 1075 (shown in FIG. 10E) and a second (e.g., right, distal) mandrel mount or holder 1076 (shown in FIG. 10F). The mandrel may be part of the system or may be used with the system. The mandrel may be any of the mandrels described herein. As described above, the mandrel may be coated and / or at least partially covered with a release film or material, such as a PTFE film, Teflon™ film, cellulose film, cellophane film, etc. The mandrel may be coupled on the proximal and / or distal ends to a drive. In this example, the mandrel is coupled at the proximal end to a mandrel drive 1040, to rotate the mandrel relative to the winding sub-assembly 1078.

[0190] In the variation shown in FIGS. 10C- 1 OH, the mandrel rotates while the winding subassembly 1078 advances over a drive track 1079, 1079’. The winding sub-assembly 1078 is driven along the track by a winding sub-assembly drive that drives a drive belt 1080 coupled to the base 1081 of the winding sub-assembly 1078. A separate drive (winding sub-assembly drive) may be used or same drive used to rotate the mandrel (e.g., mandrel drive 1040) may be used. In this example, the same drive 1040 is used, with gears 1082 that may coordinate advancement of the winding sub-assembly along the drive track 1079, 1079’ while rotating the mandrel 1021. A controller (not shown in FIG. 10C) may be used to control and coordinate operation of the winding sub-assembly 1078 and the rotation of the mandrel. As mentioned, the mandrel drive may include a bushing and / or one or more rollers for advancing and / or rotating the mandrel. One or more mandrel supports (e.g., guide supports or bushings) may also be used. In FIG. 10C the mandrel drive is coupled to the first end and may insert a keyed member into the proximal end of the mandrel or may otherwise couple to the mandrel to apply torque to the mandrel and in some cases, lateral force (compression and / or tension). Thus, in FIG. 10C-10H the mandrel rotates in position while the winding sub-assembly 1078 moves laterally 1083 to wind / counterwind multiple tapes and / or filaments over the mandrel to form the layered structures described herein. Optionally in some examples the mandrel drive (or a second mandrel driver) may be positioned at the opposite end (coupled to the second mandrel mount 1076).

[0191] As mentioned, the mandrel drive may be controlled by a controller and / or may be computer controlled or manually controlled. The mandrel drive may be configured to control the rate of mandrel rotation. As mentioned above, the mandrel driver may be configured to rotate the mandrel at any appropriate rate, such as about 1 rotation / second (e.g., between about 0.1 rotation / second and 100 rotations per second or faster, between about 0.1 rotation / second and 50 rotations / second, between about 0.1 rotations / second and about 40 rotations / second, betweenabout 0.1 rotations / second and about 30 rotations / second, between about 0.1 rotations / second and about 20 rotations / second, between about 0.1 rotations / second and about 10 rotations / second, between about 0.1 rotations / second, etc.).

[0192] The drive for the winding sub-assembly may be configured to laterally move 1083 the winding sub-assembly 1078 along the mandrel. Note that in some cases both the mandrel and the winding sub-assembly may move laterally relative to each other. In this example, the winding sub-assembly may be configured to advance (from left to right, e.g., proximal to distal) from the first mount to the second mount, at a predetermined rate. For example in the drive assembly for the winding sub-assembly may be configured to advance the winding sub-assembly 1078 at a constant or variable rate of, e.g., about 0.01 mm / sec or faster, e.g., between about 0.01 mm / sec and 10 cm / second, between about 0.1 mm / second and Icm / second, between about 0.1 mm / second and 5 mm / second, etc.). Any appropriate advancement speed may be used. The advancement speed may be linked to the rotational speed (e.g., the faster the rotation, the faster the advancement).

[0193] The winding sub-assembly 1078 may include one or preferably more, e.g., a plurality, of film spools (or spool assemblies) 1055a, 1055b, 1055c which are configured to hold and apply a film so that the film helically wraps around the mandrel during operation of the system. In FIG. 10C, the system shown a first spool assembly 1055a that is configured to apply the release film (e.g., a Teflon™ film, a cellophane film, etc.), that is most distally located, so that it covers the surface of the mandrel first, before the other tapes and / or filaments. One or more additional films and / or filaments may be applied over the release film. In this example a second spool assembly 1055b is shown applying a second tape proximal to the first spool assembly. The second spool assembly may couple to a spool of a first flat matrix film so that it may be unspooled to helically wrap around the mandrel. One or more filaments may also be applied concurrently with the flat matrix film (tapes). In FIG. 10C four fiber spools 1084a, 1084b, 1084c, 1084d. For example, a flat ribbon of reinforcing material (e.g., a metallic ribbon, which may be a flat ribbon) maybe wrapped around the mandrel (over the release material) before or after a first flat matrix film (e.g., a soft TPU material) is wound as described herein. In any of these examples a second filament or fiber, such as a ceramic filament, basalt filament, metallic filament, etc. may be counter-wound over the reinforcing material (e.g., helical metallic ribbon). Counter winding may be achieved by feeding the counter wound filament from the opposite side of the mandrel at an angle that is opposite from the angle of the reinforcing material. Any number of additional spool assemblies may be included. In general these spool assemblies for the film (tapes) and / or for the filaments may include additional guide elements, such as pulleys, capstans, rotors, guidesurfaces, channels, etc. The spool assemblies may also include one or more biases, e.g., springs, configured to apply or maintain tension on the film / tape and / or filaments during operation.

[0194] The spool assemblies described herein may be configured to allow the controlled unspooling and application of the flat films (e.g., flat matrix films). As mentioned above, the flat film may be passively pulled off of the spools 1045, 1045b, 1045c, 1045d, 1045e that are attached to the spool assemblies. The spool assemblies may be configured to control the tension and / or angle of the spool associated with the spool assembly For example, the spool assembly may be configured to increase or decrease the tension (e.g., by increasing or decreasing the resistance to rotation of the spool and / or the position of an interference member in contact with the film as it comes off of the spool (not shown). The force of the tension on the flat film may be measured by one or more sensors that form part of the spool assembly and / or winding subassembly 1078. In any of these apparatuses, the spool assembly may include one or more actuators for adjusting the tension and / or the angle between the spool and the mandrel. For example, the spool assembly may include an arm that is movably adjustable to adjust the angle and / or distance between the spool and the mandrel. The spool assemblies for the film / tape and / or filaments may be part of the winding sub-assembly and may be mounted to the moving base 1081.

[0195] In any of these apparatuses any number of sensors may be included and may provide data to the controller and / or output directly to the user. For example the apparatus may include one or more optical sensors for sensing relative position of the winding sub-assembly and the mandrel and / or for monitoring the position of the film (e.g., tape) as it is laid down on the spool, including the pitch and / or overlap. As mentioned, the apparatus may include a sensing subsystem with one or more sensors. The sensors (e.g., sensing sub-system) may be coupled to the controller either directly or indirectly. In some cases an optical sensor or sensors may be used.

[0196] As mentioned, any of these systems may also include an energy applicator (e.g., heater, optical energy applicator, etc.) that may be part of a consolidation station for consolidating the matrix film(s) on the mandrel. The energy applicator may be on the winding sub-assembly or may be sperate from the winding sub-assembly. In some cases the energy applicator may be part of the second mandrel mount or holder 1076. The energy applicator may apply a controlled temperature to the mandrel and film(s) so that the matrix film, which may have the lowest melting temperature. The energy applicator may be controlled by the controller.Bath matrices

[0197] In some examples, the manufacturing system 1000 may include a bath-applied matrices station 1062 for introducing a matrix material onto the reinforcement and / or carrierstrand(s). Matrix material may be applied by running the reinforcement strand through a bath of molten or solvated resin, thereby bringing in materials that can be integrated into the device wall. These materials may be the same as other matrix elements, or they may have distinctive properties.

[0198] Bath applied matrix methods may involve utilizing a material that preferentially bonds to the reinforcement, that then preferentially bonds to the matrix (for example, acting as a tie layer: (Material A to Material B, and then Material B to Material C, with an end result superior to that which could be achieved by Material A directly to Material C). Matrix material may be applied by running a reinforcement through a bath of molten or solvated resin. The reinforcement may be un-spooled, run over rollers or pins or supports through a bath, and then emerge with a pre-engineered amount of material as it then joins the remainder of the structure. The carrier strand can be a reinforcing material as described elsewhere in this document, or it can be a different material. For example, it could be a multi-strand fiber with very weak tensile strength such that its impact on the overall properties of the finished tube is minimal. The amount of matrix material taken with the strand and thus applied to the tube can be metered in multiple ways. The exit of the matrix bath could have a nozzle of a specific diameter to control the amount of matrix material exiting the bath. The strand can be tuned relative to the nozzle diameter to further achieve the desired properties in the final tube. For example, a smaller strand with a larger nozzle may allow more matrix to come through thus creating a more flexible tube. Alternatively, a small nozzle with a larger strand may be better suited when the strand is a reinforcement strand providing structural integrity to the tube. The matrix material may be electrically or thermally insulating to the carrier strand. The carrier strand may be electrically or thermally conductive to provide communication of information, current, or energy from one end of the tube to the other. The matrix material may be a non-bonding material to the carrier such as PTFE such that the carrier strand can move relative to the matrix after curing. The carrier strand may be removed from the tube after application, leaving at least a portion of the matrix behind on the tube. The carrier strand could also be a material with properties that degrade during postprocessing to further reduce its impact on the overall structure. For example, elevated temperatures compared to the consolidation process temperatures could melt or otherwise decrease the strength of the carrier strand. In this case, the carrier can be thought of as a sacrificial element with the purpose of applying the matrix material to the appropriate locations.Extrusion co-wound applied matrices

[0199] In some examples, the manufacturing system 1000 includes a co-wound matrices station 1058. See FIGS. 5A and 5B, showing multiple materials are wound in parallel to co-existwithin a wall. In some cases, the station 1058 is configured to apply an extrusion of matrix material - for example, of round or rectangular cross section. These extrusions may be wound in conjunction with a reinforcement element. This may enable the deposition of matrix material between reinforcements as an alternative (or in addition to) to applying it as a flat film on either side. As the matrix is heated and consolidated, this extrusion may then co-join with the remainder of the structure. The extrusion may be a matrix material that is the same or different than other matrix materials. For example, the extrusion may be a lower durometer than surrounding matrix materials, thus allowing the reinforcement elements to move more freely and creating a more flexible tube while gaining the benefits of inner and outer layer higher durometers. The extrusion may be pulled through dies to reduce the diameter of the extrusion to the desired value when applied to the tube. Tension may also be used to control the diameter of the extrusion.Release from mandrel

[0200] The system 1000 may include a tube removal station 1061 that may be configured to release the elongate devices 1090 from the mandrel 1001 through one or more methods. In some examples, a tensile load is applied to the mandrel to neck it down. Some tubes are created over metal wires that are, after the tube is created, pulled so that they neck down, reducing their diameter, and then can be removed. This wire can be stored on spools and then unspooled during the manufacturing process. This process may be expensive, as the wire may need to be reprocessed if it is to be used again. Other methods may include coatings on the mandrel, tapers, or use of release films, including sacrificial release films. Release films may be created from slippery materials, such as fluoropolymers materials, that are added to backers (plastic, paper), or with a material that is monolithic (same material across its cross section). The release films may be applied with an engineered tension from a spool. Too much tension and the normal force can be too high, inhibiting release. A normal force that is too low creates wrinkles. Tension forces are measured as the spool is moved relative to the mandrel on a stage and with a force sensor.

[0201] In some cases, the mandrel may be held static in a vice while the elongate device is grasped, twisted, and pulled from the mandrel. The mandrel may also actuate to aid in removal. Use of consolidating agents such as tubular fluoropolymer heat shrink tubing and flat films can provide structural support during removal. The opposite may be true where removing consolidating agents prior to removing elongate devices from mandrels can reduce the normal force on the elongate devices and aid in removal.Advantages of flat film matrices over extruded tubing

[0202] Many flexible medical devices include polymer tubing made by tubular extrusion. The wound film matrices described herein include a number of advantages over tubular extruded films. Generally, flat films may be available at lower cost, thinner, lower durometer, and / or may be made into tubes that are larger diameter. Flat films may more readily adapt to different catheter sizes, thereby reducing lead-times, tooling, and inventory. Flat films may offer more design flexibility. Flat films may enable higher throughput and lower cost coating processes. Flat films may more readily enable continuous processes device manufacture. Flat film printing processes are highly developed, with machine rates of speed as fast as 400 meters per minute.

[0203] Typical methods for creating flat film matrix materials include solution casting, flat die extrusions, and extrusion blow molding. Processes such as extrusion blow molding can process material into flat films at a dramatically higher rate than a tubular extrusion that typically needs to enter a cooling bath. This allows the cost of the flat films to be dramatically less. Tubular extrusions may suffer at lower durometers. However, the solution casting of flat films may be agnostic to durometer. For example, solution casting can create films as low as shore durometer 10A-40A, compared to a typical minimum of 60A or 70A for tubular extrusions.

[0204] In some cases, tubular extrusions (especially larger diameter extrusions) may struggle to create wall thicknesses of below 0.004 inches. However, solution cast films can be 10 times thinner. Thinner walls may enable thinner devices, enhanced flexibility, and create a wider designer’s toolset, as each layer may create the opportunity to optimize a parameter in a manner that a single thicker layer would not offer.

[0205] Thinner layers may also enable the construction of multi-material or multi-durometer wall cross section tubes. An inner or outer layer can be very thin, and optimized to accept a coating, or be precoated, while the majority of the matrix is optimized for mechanical properties, the very thin inner or outer layer contributing less to the overall matrix properties.

[0206] Tubular extrusion methods may also struggle to create large diameter tubes with thin walls and with low durometers. Using flat films, tubes can be created with arbitrarily large diameters and with high flexibility and / or low bending stiffness. This may be important for steerable devices, especially in robotics where force feedback may be required. Variations in flexibility may cause errors in force feedback and / or positioning.

[0207] Table 1 summarizes some comparisons between aspects of standard extruded tubing consolidation methods versus flat film heat shrink consolidation methods.Table 1

[0208] FIG. 11 is a flowchart indicating an example process for manufacturing of a tubular device according to some examples. The method may start by receiving a mandrel that is pretreated for release (e.g., having a release surface or layer) or that is wrapped with a release layer 1101. In some cases the method may include forming a release layer over a mandrel. For example, the release layer may be formed by helically wrapping a release film (e.g., Teflon™ film) over the mandrel. The release layer may be configured to facilitate removal of the tubular device once it has been consolidated. The release layer may include a thin strip of low frictionfilm (e.g., PTFE) that is wrapped around the mandrel. Alternatively or additionally, the release layer may include a spray-on or dipped coating.

[0209] In general, these methods may include rotating while advancing the mandrel 1102, as mentioned above. However, in some cases the mandrel may be held stationary (or just rotated, or just advanced) and the other components described above (e.g., spools, energy applicators, etc.) may be moved, e.g., rotated and / or moved laterally, relative to the mandrel.

[0210] In the example method shown in FIG. 11, as the mandrel is advanced and rotated, multiple helical wrappings may be made from different positions along the lateral (proximal-to- distal) longitudinal length of the mandrel. For example, a first matrix flat matrix film may be wrapped helically around the mandrel by rotating and advancing the mandrel 1103 and allowing a first elongate thin film to be drawn off of a spool of flat matrix film at a pitch angle relative to the mandrel. Thus, a first matrix layer is wrapped around the release layer 1103. The first matrix layer may include a matrix material that is configured mold into a desired shape upon application of energy and / or by the passage of time. The matrix material may include one or more polymer materials (e.g., thermoplastics). The first matrix layer may include one or more helically wrapped films of the matrix material. One or more additional flat matrix films and / or filaments 1105 may be similarly wrapped around the mandrel and over top of each other, with materials on more distally positioned spools of materials (matrix, filaments, etc.) being added over the more proximally positioned materials. One or more reinforcement materials (e.g., filaments, such as wires, threads, etc.) may be wrapped around the wrapped first and / or second (or more) matrix layer(s).

[0211] As will be described in further detail below, any of these methods and apparatuses may be configured to apply markings to the elongate tube, including marking an inner layer or applying a pre-marked layer, prior to consolidation 1106. In some cases an additional matrix layer may be wrapped around / over the marked layer and any underlying layers (e.g., reinforcement material, first matrix layer, etc.). The additional matrix layer(s) may include one or more helically wrapped films of the matrix material. The first matrix layer, the second matrix layer, and the reinforcement material therebetween may be referred to as pre-consolidated assembly prior to applying energy to consolidate (e.g., fuse the matrix material).

[0212] A consolidation layer may then be applied over the pre-consolidated assembly 1109. The consolidation layer may include a shrink wrap tube or film that is wrapped over the preconsolidated assembly. The consolidation layer is preferably helically wrapped, as described above, and may be configured to apply radially inward (consolidation) force when energy is applied to the matrix material. This may help secure the shape of the elongate tubular member and may prevent flowing of the matrix material while enhancing fusing of the matrix material.Thus, any of these methods may include consolidating the pre-consolidation assembly by applying energy (e.g., heat) to the pre-consolidation assembly 1111. FIGS. 10A-10B above illustrated examples in which the energy for consolidation was applied locally as the mandrel was rotated and advanced. In some cases the energy may be applied to the entire mandrel at the same time, e.g., in an oven or other chamber for applying consolidation energy. Thus, the tubular device is formed by consolidating the pre-consolidated assembly. Any appropriate energy may be applied (e.g., heat, light, pressure, vibration or any combination thereof). The energy can be chosen to fuse the matrix material. For example in some cases the energy may be applied to at least partially melt, the matrix material such that first and second layers of matrix material at least partially fuse together, thereby encasing the reinforcement material. The energy can also be chosen to cause the consolidation layer to shrink and provide sufficient radial inward force on the pre-consolidated assembly as it is melting and fusing, thereby preventing voids or other defects from forming, and preventing the reinforcement material from shifting.

[0213] Following consolidation one or more post-processing techniques may be applied. For example, post-processing may include applying one or more additional layers, including a rigidizing layer and / or bladder layer and / or additional support layer, as described in detail below. This may be performed on the mandrel post-consolidation 1112. This may include first removing the consolidation layer. Alternatively, in some cases the methods or apparatuses may add additional layers for forming a rigidizing device prior to consolidation).

[0214] The tubular device may be removed from the mandrel 1113. In some cases, the tubular device may have an apparent line that winds helically along the length of the device from a proximal end region to a distal end region of the device. The line may correspond to a seal, face or edge of one or more of the helically wrapped matrix films and / or helically wrapped consolidation film (now removed). Once removed from the mandrel, the tubular device may be integrated into a medical device, such as a catheter or other elongate medical device.Marking

[0215] As described above, any of these methods may incorporate marking into the fabrication process for the elongate tubular members described herein. Marking may be performed directly onto the elongate tubular member as it is formed and / or one or more components (e.g., a flat matrix film) may be pre-marked prior to helically wrapping it onto the mandrel.

[0216] For example, FIG. 12A illustrates an example of a strip of flat matrix film 1200 that has been printed onto with a pattern including numerical markings 1224 showing depth measurements. The flat matrix film material also includes markings 1234 for aligning the flatmatrix material as it is applied. These alignment marking may be lines, circles, shapes (e.g., boxes), crosses, dots, etc. that can be used as fiduciary marking. The system (e.g., controller) may be configured to detect these marking and adjust the tension and / or angle and / or movement of the spools or flat matrix material and / or mandrel in order to maintain the proper relative alignment of the markings 1234 and therefore the other larger markings (for example, 1224).

[0217] FIG. 12B shows an example of an elongate tubular member formed with a pre-printed flat matrix material similar to that shown in FIG. 12A. In this example the markings (e.g., alphanumeric markings 1224) on the device are oriented along the length and may provide measurement indicators for depth or position. The elongate tubular member is formed by helically wrapping the various flat films, as described above. In FIG. 12B the helical wrapping is apparent in the helical path 1226 from a proximal end region to a distal end region formed by the seal. The seal corresponds to a face or edge of the helically wound matrix flat film having fused with either itself (when wrapped in an overlapping manner) or with a second flat matrix film that overlaps. As described above, this seal is apparent when examining the device, e.g., under magnification or to the naked eye.

[0218] In any of these methods and apparatuses, the matrix film may include a surface modification. For example, the surface modification may be a coating, such as (but not limited to) a hydrophilic coating. The hydrophilic coating may be applied by spray, brush, dip, or solution casting. In some cases the hydrophilic coating layer is created by solution casting, as (e.g., at the same time) the matrix film is created by solution casting.

[0219] FIGS. 13A-13B illustrates another example of a pre-printed strip of flat matrix film 1300 that may include colors, letter s / numbers, markings, etc. FIG. 13A shows the strip 1300 (e.g., a matrix strip) that has been printed to include alphanumeric indicators 1324 correlating to the length of depth on the tubular member (e.g., endoscope) and also includes fiduciary markings 1334 to assist in helically wrapping the strip when forming the tubular member as described herein. The strip may be printed directly, e.g., directly onto the flat polymeric matrix film. For example, a large sheet of matrix film (e.g., 48 inches by 60 inches or larger, e.g., a continuous roll that is 48 inches wide, etc. and may be hundreds or thousands of feet long, sufficient for a very large number of devices) may be printed and cut into the spools of matrix film as described above. The strip may be helically wound as part of the medical device 1301, using the fiduciary marking 1334 to align the strip so that the markings 1324 are in their correct relative position. FIG. 13C shows one example of an elongate sheet that may be printed with a pattern while the sheet is flat. The printed pattern shown is similar to the pattern shown in FIGS. 13 A, including alphanumeric characters 1324, fiduciary markings 1334, and an identification code 1328. In FIG.13C, the pattern repeats itself at width that may be cut to form ribbons that may be wrapped helically as a matrix film as described above.

[0220] Virtually any pattern may be printed onto the film and the resulting pattern wrapped as a layer of the elongate tubular structure. In FIG. 13D, the pattern includes a gradient (which may be a color gradient and / or a monochromatic gradient) 1329, alphanumeric characters 1324, codes (e.g., scan codes 1330), hyperlink codes, serial numbers 1328, images, logos, etc. A variety of clinically useful information could be included. In some cases, variety of important marketing or branding information could be included. Any combination of these may be included.

[0221] FIG. 13E illustrates an example of printing on a roll of matrix film 1350. In this example the pattern is printed in color as the matrix material spools off of the roll. As mentioned above, any appropriate type of printing may be used, and any image / character / pattem. Once printed, the material may be cut or slit 1352 into strips as shown, and the individual strips rolled onto spools for use with the fabrication technique described herein.

[0222] In general, a printed layer (e.g., a helically wound strip of printed matrix material) may face inward, such that it has no direct patient contact. Or a printed layer may be further covered by additional, e.g., clear or substantially clear matrix material. The outer layer of matrix material may be helically wrapped over the more inner layer and may protect the inner layers. This may result in a protective layer over the printed layer that may prevent damage, fading, wear, etc. of the print layer, and may also isolate the ink from the patient, although biocompatible and non-toxic printing may be used. Alternatively or additionally, printing may be performed by a laser (e.g., etching, cutting, reacting, etc.).

[0223] Also described herein are direct printing methods and apparatuses for printing on the outer surface(s) of the tubular member as it is forming or thereafter. For example, FIG. 13F illustrates one example of printing on a tubular member that is still forming. In FIG. 13F, the outer helically-wrapped film (e.g., matrix film) may be directly printed on by a print head 1388 that may move relative to the mandrel and / or that may remain relatively fixed while the mandrel 1387 is rotated and / or advanced to print directly on the outer surface. For example, FIG. 13F schematically illustrates formation of an apparatus including a first helically wrapped film 1366 forming a tube 1387 once the release layer has been included. In this example a printer, e.g. print head 1388 may print directly onto the film (e.g., matrix material). The printer may be held still while the mandrel is rotated and / or advanced. In some cases he opposite side of the film may include an anticoagulant or other coating. The printer may secure a base layer (e.g., with coating on inside, and print on outside. In some cases the printed film may be made while forming the tubular elongate body, e.g., prior printing directly onto the matrix material film 1366 and movingthe print head 1388 (or holding it fixed as the mandrel is moved). Optionally, the print head may move back and forth. Printing may be done while forming the elongate tubular body; in some cases printing may be performed as part of the process. In FIG. 13F a second matrix material layer 1336’ is also shown and may wrap over and cover the printed layer (which may be visible through the outer matrix layer.

[0224] FIGS. 13G-13L illustrate another example of a direct printing method and apparatus. For example, FIG. 13G shows an example of a print head 1390 that includes a rotating print surface 1392 which may be mounted onto a rack 1393 with a plurality of other print heads (as shown in FIGS. 13J-13L). The print head 1390 includes an ink well 1391 that can be refilled, and that inks the print surface. FIGS. 13H and 131 show the print head 1390 of FIG. 13G engaged over a consolidated elongate body 1394 as described herein. In FIG. 131 the print head is shown connected to a print driver 1395 driving rotation of a shaft 1396 that is rotated to drive rotation of the print surface 1392. As shown in FIGS. 13J-13L, the individual print heads 1390, 1390’, 1390” may be connected to a single rack and a print drive to form a printer 1399 having multiple parallel print heads that may be precisely spaced apart to apply calibration markings on the devices described herein. In use a consolidated device, e.g., formed into an overtube, shield, etc. may be coupled to the printer 1399 and marked by rotating either the device, the printer, or both. FIGS. 13K and 13L illustrate operation of a printer as described above.Rigidizing Devices

[0225] As mentioned above, the elongate tubular members described herein may be part of a rigidizing device. For example, these elongate tubular members may be formed as an inner layer of a rigidizing device and / or an outer layer of the tubular rigidizing device. In some cases the device may also include a bladder layer and one or more rigidizing layers. The rigidizing layer may be formed of a plurality of lengths of filament that may cross over each other; in the absence of significant radial pressure (e.g., from the bladder layer) the filaments may slide relative to each other and the assembly including the inner and / or outer layers may bend flexibly.

[0226] Any of the methods and apparatuses described herein may be adapted to include forming the rigidizing structure including a rigidizing layer and bladder layer. For example, FIG. 14 schematically illustrates an example of a method of forming a rigidizing device that includes forming one or more layers as described herein (e.g., using a fabrication methods similar to that shown in FIG. 11), and then removing the consolidation film while still on the mandrel 1401 to apply additional layers, that may then be themselves consolidated using a new consolidation layer. Thus, in any of these methods and apparatuses the consolidation film may be removed (e.g., helically unspooled). Thereafter, one or more additional layers may be added by helicallywrapping or otherwise. Alternatively one or more layers (e.g., tubular layers) may be inserted into the consolidated tubular body, or the consolidated tubular body may be inverted over the one or more layers. For example, as shown in FIG. 14, a rigidizing layer (e.g., knit, mesh, etc.) may be added 1403, including forming it directly or sliding it over an outward-facing surface of the consolidated film. Alternatively or additionally one or more bladder layers (or an out-and- back bladder layer, e.g., inverting over itself) may be formed over the rigidizing layer (or vice versa, e.g., within the rigidizing layer by inverting or insertion) 1405. The order of adding he bladder and / or rigidizing layer may be switched, depending on the construction of the rigidizing layer. In some examples the rigidizing layer may be a knitted, woven, or braided layer, which may be formed directly on the mandrel and / or underlying layer. FIG. 21A illustrates an example of a rigidizing device that may incorporate an elongate tubular device having an elongate tubular member of a medical device 1402.

[0227] In some variations the layers may be part of an outer coil- wound tube (OCWT) for a rigidizing device (such as a rigidizing shield), in which a rigidizing layer is inside of the consolidated tubular body. In some cases, a bladder layer may also be arranged inside the consolidated tubular body. In variations in which the layers are part of an inner coil-wound tube (ICWT) one or more additional layers may be included, e.g., over the tube 1405, and the layers may include an additional tube forming the OCWT.

[0228] For example, a rigidizing (dynamically rigidizing) apparatus may be a rigidizing overtube that includes an elongate rigidizing body formed of a plurality of different layers; pressure may be applied (either positive and / or negative pressure) to set the flexibly / rigidity of the elongate body. For example, that elongate body of the rigidizing apparatus may include a support layer (e.g., a cylindrical / tubular support layer that may be reinforced, e.g., by a wire coil or otherwise), a rigidizing layer (which may be formed of multiple lengths of overlapping strands, fibers, filaments, etc., e.g., a knitted, woven, braided, etc. cylindrical layer), and a compression layer (e.g., a bladder layer) that may be compressed by the application of positive and / or negative pressure against the rigidizing layer. In the more flexible configurations of the elongate body, the multiple lengths of strands of the rigidizing layer may slide against each other freely or with little friction. In some cases the compression layer may be driven against the lengths of strands of the rigidizing layer to restrict their relative movement (e.g., sliding) which results in an increase stiffness. In general, the greater the pressure applied by the compression layer, which may be function of the applied pressure, the greater the stiffness (e.g., the lower the flexibility) of the rigidizing layer, and therefore the elongate body. Examples of alternative configuration for rigidizing and controlling the stiffness / rigidity are provided below, e.g., in reference to FIGS. 15A-15B, 16A-16B, 17A-17D, 18A-18C, 19A-19C and 20A-20B. Thesupport layer may be configured as an inner support layer (e.g., an inner coil- wound tube, ICWT) or an outer support layer (e.g., an outer coil-wound tube), or both. Thus, the bladder may be configured as a single layer or multiple layers and may be driven against the inner (ICWT) or outer (OCWT) layers. The methods and apparatuses described herein may be used to form all or some of these layer, including in particular, an inner coil wound tube (ICWT) and / or an outer coil- wound tube (ICWT).RIGIDIZING OVERTUBES

[0229] The rigidizable apparatuses (e.g., rigidizable overtube) and methods described herein may be part of a medical access system for diagnosing and treating regions of the body that are otherwise hard to access and operate within, particularly during minimally or non-invasive procedures. In particular, these methods and apparatuses may be used in highly tortuous and / or unsupported regions of the body. These methods and apparatuses may be used in combination with, and / or may modify and improve the rigidizable devices and methods of using them described in U.S. patent no. 11,135,398 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), U.S. patent application no. 17 / 604,203 (also titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), PCTUS2021024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), PCTUS2021034292 (titled “RIGIDIZING DEVICES”), PCTUS2022014497, titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES,” PCTUS2022019711, titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 265,934, “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON,” U.S. provisional patent application 63 / 296,478, titled “RECONFIGURABLE STRUCTURES,”

[0230] U.S. provisional patent application 63 / 308,044, “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. provisional patent application 63 / 324,011, “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES, U.S. provisional patent application 63 / 342,618, “EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES,” U.S. provisional patent application 63 / 335,720, “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY,” and U.S. provisional patent application 63 / 332,686, “MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE,” each of which is herein incorporated by reference in its entirety.

[0231] Rigidizing apparatuses as described herein may be configured to rigidize when negative pressure and / or positive pressure is applied. These rigidizing apparatuses as describedherein may be used in conjunction with other rigidizing devices that rigidize with other methods, including those that do not rely upon the application of positive or negative pressure. For example, a rigidizing device may be configured to include multiple layers arranged into an elongate catheter-like body. The device may include a handle or other manipulator and may include a connection to one or more pressure sources. Applying pressure from the pressure source may be controlled by multiple methods, including operation of a handle or an electronically controlled device. Control may result in a pressure differential that causes the device to transition between a highly flexible configuration, allowing the tubular body to readily bend, when steered or otherwise guided (e.g., over a guidewire, etc.), and one or more (e.g., a continuum) of rigid configurations. In some examples, particularly (but not exclusively) in reference to apparatuses that rigidize based on the application of positive pressure, the rigidity of the elongate body is proportional to the applied pressure differential, so that the greater the pressure differential, the more rigid the device may become over at least a range of pressure differential values.

[0232] In general, these apparatuses may include multiple layers, including a rigidizing layer and at least one of an outer or inner layer. Many of these examples also include a compression layer that may engage with the rigidizing layer, and in some examples the apparatus may include a combined rigidizing layer / compression layer. Described herein are rigidizing layers that may be particularly well suited to rapid and precise actuation over a variety of pressures, including in particular positive pressures (e.g., high positive pressures, i.e., atm of about 2 or more, 4 or more, 6 or more, 8 or more, 10 or more, 15 or more, 20 or more, 30 or more, etc.). Negative pressures (i.e., vacuum) may also be used. Negative pressures on one side of a bladder may be used in conjunction with and simultaneously with the application of positive pressure on the other side of the bladder. Any of these apparatuses may also be configured so that at least some of the inner and / or outer layers making up the rigidizable device have different durometers on the inner and outer portion of either the inner or outer layers. Also described herein are apparatuses and methods including nested sets of rigidizable apparatuses, which may include any of these rigidizable devices. Any of these apparatuses may include one or more torsional enhancing layers for improving torsional control, particularly when included as part of a nested pair of rigidizable devices (e.g., as part of the inner, or child, device).

[0233] FIG. 15A illustrates an example of a transverse section through an elongate rigidizing device, showing the arrangements of the many layers that may be included. In this example the rigidizable device 100 is configured to be actuated by the application of a negative pressure (e.g., vacuum). The device 100 shown includes an inner layer (115) that may be reinforced (e.g., by including one or more reinforming members, such as a helically arranged strip, ribbon or wire),an optional slip layer (113), a gap (111), a rigidizing layer (109), configured in this example as a braid layer, a second gap (107) and an outer layer (101). In some examples a vacuum may be applied between the outer layer and the inner layer to rigidize. For example, a port configured to couple to the source of negative pressure may be located at the proximal end of the device and may be in fluid communication with the gap region 107 between the flexible outer layer 101 and the rigidizing layer 109, e.g., braided layer. Thus, in this example the outer layer may act as a compression layer. FIG. 15B shows a section through one wall region B of the cylindricalshaped body of the device. Applying suction may allow the outer layer 101 to be drawn onto the rigidizing layer, causing it to rigidize, limiting or preventing bending of the device.

[0234] Another example of a rigidizable device is shown in FIGS. 16A-16B. In this example the device may also be an elongate, e.g., catheter or tubular- shaped device similar to that in FIGS. 15A-15B but may be rigidized by the application of positive pressure. For example, FIG. 16A shows a section transverse to the long axis of an elongate rigidizable device. In this example, the layers forming the device are arranged so that an inner reinforced layer 2115 is the most radially-inward layer and may be reinforced, e.g., by a helically wound ribbon, strip, cable, etc. The device may also include an optional slip layer 2113 which may reduce the friction between the inner layer and the more radially-outward layers. The slip layer may be a powder, or it may be a lubricious layer or a layer of lubricious material. A first gap 2112 layer is shown separating the inner layer 2115 and / or the slip layer 2113 from a compression layer, configured in this example as a bladder layer 2121. A second (or intermediate) gap layer 2111 spaces the bladder layer from the rigidizing layer 2109, shown in this example as a braid layer. A third gap layer 2107 is positioned between the rigidizing layer and an outer layer 2101. The outer layer in this example (similar to the inner layer 2115) is reinforced, for example, by a helically wound filament, wire, fiber, band, etc. Although not shown, when actuated by the application of positive pressure between the compression (e.g., bladder) layer and the inner layer, the bladder layer may push the braid layer into the outer layer to rigidize the rigidizing layer. In FIG. 16B, the inner reinforced layer (ICWT) shows a wire having a round profile as part of the inner layer 2115; in any of these apparatuses, the reinforcement wire may have a rectangular profile. In some examples multiple wires may be used (e.g., two or more layers of rectangular- and / or roundprofile wire arranged on top of each other).

[0235] Both examples of devices shown in FIGS. 15A-15B and 16A-16B may include additional optional layers or components. Further, the compositions of the rigidizing layers may be modified in order to improve performance. In particular the rigidizing layer may be modified to include structures (e.g., knits, wovens, braids, scales, plates, arrays of filaments, granules, and combinations thereof, etc.) that may enhance or improve performance. Rigidizing elements maybe used as one type alone, or in conjunction with other rigidizing elements. In some examples the inner and / or outer layers may be modified to enhance or improve performance, including the addition of torsional control components, and / or modulating the durometer of the inner and outer regions of these layers.

[0236] Further, any of the rigidizable devices described herein may be configured as nested apparatuses that may be nested to provide enhanced performance. For example, a nested apparatus (system) may include an outer rigidizable device (e.g., rigidizing overtube) and an inner rigidizable device (e.g., rigidizing endoscope). The inner rigidizing device (e.g., scope) can be, for example, configured to receive pressure (positive and / or negative pressure) to rigidize from a more flexible to a less flexible configuration. Any of these rigidizing devices may include an air / water channel and a working channel that can extend with the inner rigidizing device.Knit Rigidizing Layers

[0237] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer formed of a knit material or knit layer (e.g., knit tube). The knit rigidizing layer, which may be referred to herein equivalently as a knit rigidizing layer or a knitted rigidizing layer, may be formed of a single fiber or may be knitted from multiple fibers. The fiber forming the knit may be a yarn, a filament, a mono-filament, a plurality of filaments, a strand, a thread, a wire, etc. The fiber may be made of a natural or synthetic material, including polymeric materials, metals and metal alloys, and a composite or a combinations thereof. In some cases the knit is formed of a polymeric material. The fiber may be continuous, in which each of the filament lengths forming the rigidizing layer are part of a single fiber, or they may be broken up into multiple filament lengths. For example, the knit material may be single fiber that is broken / cut at regular or irregular lengths.

[0238] FIGS. 17A and 17B illustrate an example of a rigidizable device 500 including a knit rigidizing layer (e.g., tube) 505. In FIG. 17A the outermost layer (outer layer 515) is removed for clarity; FIG. 17B shows the rigidizable device with the outer layer 515 covering the other layers. This outer layer may be a reinforced outer layer, such as an outer coil-wound tube. In FIG. 17A the rigidizable device includes the knit rigidizing layer 505 extending over the elongate body of the device, including over a compression layer 507 (e.g., bladder) and an inner layer 509. The inner layer and the outer layer 515 may both be reinforced. This example, which is similar to the configuration shown in FIGS. 16A-16B (with the rigidizing layer 2109 configured as a knit layer 505), may be rigidized by the application of positive pressure between the compression layer 507 and the inner layer 509, which may drive the compression layer radially outward against the outer layer 515. Any of the other layers shown in FIGS. 17A-17B may be optionally included,including the gap regions / layer and the optional slip layer (which may not be necessary). This configuration may alternatively be actuated by the application of negative pressure, e.g., between the outer layer and the compression layer (including the region of the knit), which may draw the compression layer against the knit layer by the vacuum, rigidizing the layer.

[0239] A rigidizable device such as that shown in FIGS. 18A-18B may alternatively be configured so that positive pressure is applied between a compression layer (e.g., bladder) and the outer layer 515 (outer reinforced layer). In some examples the compression layer may be positioned between the outer layer and the knit rigidizing layer, so that positive pressure applied between the outer layer and the compression layer may rigidize the knit layer by driving the compression layer against the knit layer into the inner (reinforced) layer. As in the configuration shown in FIGS. 18A-18B, the device may alternatively be actuated by the application of negative pressure, e.g., between the inner layer and the compression layer (including the region of the knit).

[0240] Alternatively, the rigidizable device including a knit rigidizing layer may be configured as shown in FIGS. 15A-15B and may be actuated by the application of negative pressure. In some examples the outer layer or the inner layer may be configured to as the compression layer (e.g., bladder) and may engage with the knit rigidizing layer when vacuum is applied. Examples of these alternative arrangements are described in FIGS. 20A-20N, below, and may include a knit rigidizing layer. Any of these apparatuses may include one or more longitudinal members (e.g., tendons, wires, etc.) instead of or in addition to the knit, woven or braided layer. In some cases just the distal end region (e.g., distal x cm, where x may be, for example, 2 cm or more, 5 cm or more, 7 cm or more, 10 cm or more, 12 cm or more, 15 cm or more, 17 cm or more, 20 cm or more, 22 cm or more, 25 cm or more, 27 cm or more, 30 cm or more, etc.).

[0241] FIG. 17C illustrates one example of a portion of a knit layer 505 formed of a single filament 518 that forms interlocking loops. In the example shown in FIG. 17C the knit includes a plurality of stich loops each having a length, y, and a curved head and foot region having a length x. The stitch pattern shown in FIG. 17C is a weft knit pattern, but other knit patterns may be used. FIG. 17D shows an example of a transverse section through a knit layer positioned adjacent to a compression layer 507. In this example the knit layer is a tube having 28 strand segments that are formed of the same strand into loops (e.g., 14 loops that are arranged with the wale of the knit in parallel with the long axis of the device). The knit tube has a diameter, z, and the spacing between adjacent loops, n, is approximately equal around the circumference of the knit tube. The spacing between the stitch width, p, and the spacing, n, may vary along the length of the knit tube. The dimensions are illustrative only.

[0242] FIGS. 18A-18B illustrate two different examples of knits 600, 600’ that may be used. FIG. 18A shows a weft knit, similar to that shown in FIG. 17C. In this example the knit is formed of one or more strands (which may be continuous or broken / cut), forming stitch loops 602 that each include a head region 604, a pair of legs 606 and a first and second foot 608 where each foot engages with the head of a stitch loop in a course above or below the original stitch loop course. The connection between the feet of adjacent stitch loops may be referred to as the sinker (the sinker may also correspond to a head when the knit is rotated 180 degrees). In FIG. 18A the wale direct 612 extends up / down, and the course 610 extends right to left. Typically, a wale is a column of loops running lengthwise, corresponding to the warp of woven fabric in FIG. 18A. The course is a crosswise row of loops, corresponding to the filling of the resulting knit.

[0243] FIG. 18B illustrates an example of a warp knit 600’. In this example the warp knit also has a course 610’ and wale 612’ direction but the feet of each loop engage with the head region of a knit loop in a row (in the course direction) that is offset, as shown, forming a pattern of overlap 612 and underlap 614 lengths. The knit rigidizing layers described herein may use any appropriate pattern and may arrange the direction (course or wale direction) relative to the elongate axis (length) of the device. For example, the knit structure (the knit rigidizing layer) may be configured so that a wale direction of the knit extends in a long axis of the flexible tube. Alternatively, the knit structure may be configured so that a wale direction of the knit structure is perpendicular to a long axis of the flexible tube. Depending on the stitch length (y) relative to the loop diameter (p) and / or the spacing between loops (n), which may be related, it may be beneficial to arrange the knit rigidizing layer so that that either the wale or the course is arranged in parallel or perpendicular to the long axis of the elongate body of the rigidizable device. In any of the examples described herein, the knit structure may comprise an average loop length that is longer than the loop width. For example, the loop length may be two times or greater (e.g., 3x, 4x, 5x, 6x, 7x, 8x, 9x, lOx, 20x, 40x, 60x, 80x, lOOx or more) than an average loop width. Because knits (including knit tubes) may be stretched and compressed in bending without buckling or wrinkling, they may be particularly useful in the rigidizable devices described herein.

[0244] As shown in FIG. 18C a knit rigidizing layer 600” may be formed of a single knitted fiber 618. As mentioned above the fiber may be formed of a single filament (monofilament) or a bundle of filaments (multi-filament). The pattern shown therefore includes a plurality of lengths of filaments (e.g., an array of filament lengths) that cross each other in the knit pattern. In FIG. 18C the plurality of lengths of filaments that cross over and under each other are all part of the same fiber or strand. In some examples the knitted fiber or strand may be cut or divided intomultiple separate filament lengths. The knit material (e.g., the fiber) may be formed of any appropriate material, such as a metal, metal alloy, polymeric material, natural fiber, etc.Woven and Braided Rigidizing Layers

[0245] In any of the rigidizable devices described herein (and any nested systems or methods including them) may include a rigidizing layer that is woven. FIGS. 19A-19C illustrate an example of a woven a rigidizing layer 705 that may be used as the rigidizing layer of the rigidizable device and may be arranged as shown in FIGS. 15A-15B, 16A-16B or 17A-17D. In FIG. 19A the weave includes a plurality of parallel fibers that form a set of intersecting fibers; in FIG. 19A the fibers intersect with each other at 90 degree angles, but this angle may vary (e.g., between about 30 degrees and 150 degrees, 45 degrees and 135 degrees, 50 degrees and 130 degrees, 70 degrees and 110 degrees, 80 degrees and 100 degrees, etc.). The pattern of intersecting filament lengths (e.g., the array of filament lengths) includes individual filament lengths that cross over and under each other as shown; a first filament length 718 crosses over a second filament length 728 and under a third filament length 725. In this example, the pattern shown in an under-over pattern, but this pattern may be different for other examples of rigidizing layers; in FIG. 19A the pattern is one over, one under. In some examples the pattern may be two over two under, or two over and one under, etc. Any appropriate fiber (e.g., strand) may be used to form the rigidizing layer, a mentioned for knit rigidizing layers above. In the woven rigidizing layer shown in FIG. 19A the fiber is a muti-filament fiber including a bundle of multiple filaments forming each strand. FIG. 19B shows an example of a woven rigidizing layer 705’ formed of a monofilament, also arranged with parallel strands 718’, 728’ arranged in a woven pattern similar to that shown in FIG. 19A. The woven pattern may be any desired tightness (e.g., pore size). In general, as shown in FIG. 19C, multiple different lengths of fibers 718”, 728” are used to form the woven pattern 705”.

[0246] FIGS. 20A and 20B illustrate examples of braided rigidizing layers. In FIG. 20A the braid 800 is formed of a plurality of fibers 818, 828 that are arranged in an over-and-under pattern having a braid angle relative to the long axis (e.g., the long axis of the device when included as the rigidizing layer). In general, the braid angle (relative to the centerline along the central axis) of the braided rigidizing layer (tube) may be 45 degrees or less (e.g. less than 45 degrees, 40 degrees or less, less than 40 degrees, 35 degrees or less, less than 35 degrees, 30 degrees or less, 20 degrees or less, less than 20 degrees, etc. In FIG. 20A the different filaments forming the braid layer are continuous and unbroken. However in some examples it may be beneficial to include breaks or cuts, as illustrated in FIG. 20B. In this example, the material includes a plurality of breaks or cuts 838 in the braided strands. Although such an arrangementmay be undesirable in a fabric or even in a braid used as part of a medical device, this disrupted (e.g., broken or cut) arrangement may be beneficial in the context of a rigidizing layer. Thus, in FIG. 20B the braided pattern 800’ forming the rigidizing layer (e.g., rigidizing tube) may enhance flexibility in the un-rigidized configuration, while permitting a high degree of rigidizing in the actuated state. Thus, in FIG. 20 the strands 818, 828’ cross over and under each other in the braid pattern shown but are cut 838 periodically along their lengths. The number or density of the cuts may be varied; in some examples the fibers may be cut after every crossing over or under another fiber, while in other examples the fibers may be cut after every 2 (or 3, or 4, or 5, or more) crossings. The cut pattern may be non-uniform. In some examples it may be beneficial to have the cuts or breaks distributed at a density of between about one cut / break for every third crossing, etc. (e.g., between every second and every 25thcrossing, every third and every 20thcrossing, etc.).

[0247] Other rigidizing layers (e.g., knit, woven, etc.) may also include breaks or cuts. These breaks or cuts may be formed during fabrication by laser cutting, mechanical cutting, or any other appropriate cutting technique.Basalt Filaments

[0248] In any of the apparatuses and methods described herein it may be particularly beneficial to use a basalt filament and / or ceramic filaments. The basalt and / or ceramic filament may be resin impregnated. In some cases the basalt and / or ceramic filament may be used in place of, or in addition to, a metallic wire. For example in any of these methods and apparatuses the basalt and / or ceramic filament (with or without resin) may be used as part of the filament wrapped as described above. Thus, these filaments may be used when helically wrapping to provide support. The cross-section of the filament may be round (e.g., single basalt filaments) or rectangular (e.g., an assembly of filaments that may be combined, e.g., by a resin) or other shape. Multiple strands of filaments may be used.

[0249] For example, any of the rigidizing apparatuses described above may use a basalt and / or ceramic filament as part of the rigidizing layer, which may include a plurality of strand lengths that pass over each other. In some cases these strands may pass over each other as part of a knitted, wove, braided, etc. structure. As mentioned above (e.g., in reference to FIGS. 15A- 15B, 16A-16B, 17A-17D, 18A-18C, 19A-19C, and 20A-20B, the rigidizing layer may be formed of one or more lengths of fdaments that cross over each other; in the methods and apparatuses described herein, the rigidizing layer may be formed as a braid (knit, weave, etc.) that is comprised of basalt that may be resin impregnated. Ceramic and / or basalt may provide superior properties in practice.

[0250] In any of the tubular structures described herein, long elements, including fibers, including groupings of monofilaments, can be ceramic and / or basalt filaments. The basalt or ceramic filaments may be impregnated by passing (as shown in FIG. 5 and 10B, above) through a bath of epoxy that can include an exit orifice. Doing so may entail impregnating the fibers a liquid resin, for example, an epoxy that is subsequently cured to create a rigid solid structure. The process may transform a basalt fiber (which typically has limited compression stiffness) into a more rigid and stiffer shape, for example circular or round bundle, creating a wire (which can have significantly enhanced compression stiffness). This process can be repeated en masse, for example as multiple filaments can go through multiple orifices en-masse, for example, a group of 96 (between 2-150, between 2-125, between 2-100, e.g.), so that they become the inputs of wire filaments to a braider, to create a braid, for example, a multi-filament resin reinforced composite wire, as shown in Fig 20A.

[0251] For example, any of these apparatuses may include a rigidizing device comprising: an elongate flexible tube, a variable stiffness layer comprised of resin impregnated basalt fibers, an inlet configured to attach to a source of pressure; and a bladder layer configured to move relative to the variable stiffness layer when pressure is applied or removed through the inlet, wherein the rigidizing device is configured to change between a flexible configuration in which the resin impregnated fibers are configured to move relative to each other and a rigid configuration in which the bladder layer limits the resin impregnated fibers from moving relative to each other when pressure is applied or removed through the inlet.

[0252] As mentioned, any of the structures described herein may be configured as inner coilwound tubes (ICWT) that may include one or more coil-wound “wires” or bands (e.g., ribbons) that may be formed of basalt or ceramic, or composites of basalt and epoxy or ceramic and epoxy. Alternatively or additionally, the tubular members described herein may be configured to from an inner coil- wound tube (ICWT) that may also encapsulate or incorporate the basalt or ceramic filament.

[0253] In general, the filament (e.g., basalt, ceramic, etc.) may be encapsulated within the layer formed as described herein. In some cases the filament may be chemically bonded and adhered, e.g., to an epoxy. Although these methods and apparatuses are describing the use of basalt filaments, other filaments (non-metallic filaments may be used, including aramids and / or fiberglass.Pressure-driven Rigidization

[0254] As mentioned above, in general, these apparatuses may be configured to be rigidized by the application of pressure. The layers forming the device are arranged as concentric tubes. Insome examples the device includes an inner layer (tube), an outer layer (tube) and a compression layer (e.g., bladder) and a rigidizing layer. A first gap layer may be present between the outer layer and the rigidizing layer. A port may be present at an end (e.g., a proximal end region) of the device to couple to the source of pressure (e.g., positive pressure). A second gap layer may be present between the compression layer and the rigidizing layer, and / or between the rigidizing layer and the inner layer. The device may be flexible as each of these layers may slide relative to each other when bending the device. In particular, the rigidizing layer may flex and slide relative to the inner layer and the compression layer.

[0255] In some examples the compression layer may be a bladder into which the positive pressure is applied. Positive pressure applied the compression layer may drive it against the rigidizing layer, so that it is compressed between the compression layer and the inner layer (and / or any intervening layers). Compressing the rigidizing layer rigidizes the device. Any bends or curves are preserved without changing the shape.

[0256] In the example shown above (e.g., in FIGS. 18A and 18B), any appropriate rigidizing layer 952 may be used, including knit compression layers, woven, braided, granules, scales, etc.

[0257] In some examples, particularly those having elastic (e.g., elastomeric) compression layers and rigidizing layers formed of filament lengths that cross over and under each other, the compression layer may deform into the rigidizing layer, which may enhance the rigidity of the device. For example, as pressure is applied, the compression layer (e.g., bladder) may apply force directly to the rigidizing layer. Depending on the bladder type, the bladder may deform, depress, or interdigitate into the space around and between the elements (e.g., filaments, wires, etc.) of the rigidizing layer. Conforming to the overlapping (over-and-under) fiber or filament lengths may help lock the rigidizing layer relative to the inner layer (or in some examples outer layer) to which it is being compressed. The application of positive pressure in this manner may therefore increase rigidization as positive pressure is increased even beyond what is otherwise expected. Thus a rigidizing layer comprising a plurality of filament lengths crossing over and under each may be generally configured so that, in the flexible configuration, the filament (e.g., fiber) lengths may shear relative to each other. However, when positive pressure is applied, the deformable compression layer may be pushed against the rigidizing layer so that the compression layer may conform to or deform into or between the plurality of filament lengths to prevent shear of the plurality of filament lengths relative to each other.

[0258] Aspects of the present disclosure may be integrated into a robotically-enabled medical system capable of performing a variety of medical procedures, including both minimally invasive procedures - such as laparoscopy - and non-invasive procedures - such as endoscopy.Among endoscopy procedures, the system may be capable of performing colonoscopy, enteroscopy, bronchoscopy, ureteroscopy, gastroscopy, etc.

[0259] In addition to performing the breadth of procedures, the system may provide additional benefits, such as enhanced imaging and guidance to assist the physician. Additionally, the system may provide the physician with the ability to perform the procedure from an ergonomic position without the need for awkward arm motions and positions. Still further, the system may provide the physician with the ability to perform the procedure with improved ease of use such that one or more of the instruments of the system can be controlled by a single user. An apparatus (e.g., a system, devices, etc.) for operating and / or dispensing a robotic scope may be configured extend (distally) and / or retract (proximally) to control operation of the flexible tubular member.

[0260] In general, these apparatuses may be used to deliver a flexible tubular member, including in particular, a nested endoscope that include both an outer “overtube” an inner endoscope or catheter that may be moved proximally / distally relative to each other and may each be rigidized to guide and / or steer the device through the patient’s body. These apparatuses may include a telescoping set of links, and in particular vertically-arranged links. For example, the apparatuses (device, systems, etc.) described herein may be configured as a portion of a robotic system for delivery of a pair of a nested endoscope device, including an inner endoscope and an outer overtube, that are each capable of relatively high and low levels of compliance.

[0261] The apparatuses described herein may have a generally linear form factor and may therefore provide a linear kinematic system for delivery of devices. The primary linear axis that may position the apparatus (e.g., the overtube of the endoscope) into the patient includes a telescoping mechanism formed of a link assembly. The bidirectional telescoping action of this link assembly may allow the relatively long linear axis to be relatively short when its full extension is not needed, which addresses room size limitations in some facilities. In examples including flexible tubular member systems with both inner and outer members, the position of the inner endoscope relative to the outer overtube may be controlled by an independent linear axis. Although these apparatuses may be used with virtually any flexible tubular member, they may be particularly helpful when using a nested, and in particular rigidizing, endoscope, such as a dual rigidizing endoscope.Example: Selective Rigidizing Shield

[0262] FIGS. 21A-21B shows an example of a tubular member 1400, as described herein, used as an outer tube of a shield device 1401 for converting an endoscope 1402 into a rigidizing endoscope. The shield device 1401 is coaxially arranged over a portion of the endoscope 1402.The shield device 1401 includes a distal cap 1427 that engages with the distal end region of the endoscope 1402, and a proximal attachment 1420 that engages with a proximal handle 1408 of the endoscope 1402. The shield device 1401 includes inner shields 1415, 1417 that are inserted through to protect the inner lumen extending through the endoscope 1402. A bladder layer 1447 may be configured to seal and / or couple to the inside of the cap. Negative pressure and / or positive pressure may be applied via first and / or second ports 1429, 1431 to regions within the shield device 1401 to cause one or more layers (e.g., bladder layer 1447) to press against the outer tube 1400, thereby releasably rigidizing the shield device 1401. In some examples the application of positive and / or negative pressure may cause the bladder layer 1447 to compress against a rigidizing layer (e.g., braid, overlapping filaments, strands, strand segments, strand lengths, tendons, etc.), that is pressed against the outer tube 1400. As described herein, the outer tube 1400 may include multiple coaxial layers (e.g., coil or reinforced layers) that can support engagement and / or pressure applied from slip layers, rigidizing layers, bladder layers and / or sealing layers for functioning of the shield device 1401. The rigidizing shield device 1401 is configured to be flexible but may be selectively rigidized, e.g., converted between highly flexible and less flexible (e.g., rigid) states by the application of pressure (e.g., positive and / or negative pressure). The shield device 1401 may be robotically operated or may be manually operated.

[0263] FIG. 21B shows an example of a section through the endoscope covered by the rigidizing shield of FIG. 21A. In FIG. 21B the endoscope 1402 includes multiple lumen (e.g., a working channel / tool lumen 1416, a second lumen 2114, and an optics lumen 2190). Additional lumen (not shown for simplicity) may include pull wire (e.g., steering) channels, etc. The endoscope 1402 is held within the internal lumen 2106 of the shield 1401. The shield may be formed as described herein, e.g., from a consolidated wrapped assembly forming at least the outer reinforced layer 2101 (shown including an inner ribbon that is helically wrapped within the consolidated assembly. The shield also includes at least one bladder layer 2121 and a rigidizing layer 2109. In any of these apparatuses multiple bladder layers may be used, including an inverted (out and back) bladder layer, or a pair of separate bladder layers.Robotic apparatuses

[0264] As mentioned above, any of the methods and apparatuses described herein may be part of a robotic method / system. For example, the rigidizing apparatuses (e.g., rigidizing overtube) described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some cases the other components (e.g., steerable redirector, endoscope, etc.) may also or alternatively be part of the robotic system and the movements of these components may also be robotically controlled and / or implemented. Thus, any of these methods may beperformed by a robotic apparatus. In some examples the rigidizing apparatus may be configured as an outer tubular member (overtube) that is robotically controlled, e.g., configured as a robotically controlled overtube and / or endoscope assembly. FIG. 22 shows an exemplary apparatus 3100, including a rigidizing device configured as an overtube 3112; the system may optionally include the steerable redirector 3110. The overtube and steerable redirector can be separately or collectively be robotically controlled or manipulated (e.g., steering, movement, rotation, etc. including in some examples, rigidizing). The overtube and inner endoscope may be configured as illustrated in any of the examples described above, and may have the same general construction, or may be of different constructions. As shown in FIG. 22, the rigidizing overtube 3112 and the steerable redirector 3110 may be terminated together into a common structure, such as a cassette 3157, or two separate cassettes may be used. In some cases a single controller may coordinate movement of the one or more cassettes. The rigidizing overtube 3100 can be movable with respect to the steerable redirector 3110 by rotation of a driver mounted to the cassette 3157. The system may include actuators 3171a, 3171b that may connect to cables 3163a, b respectively, to steer (e.g., bend or deflect) the steerable region of the steerable redirector 3110 (and / or in some examples the rigidizing overtube 3112). Other steering mechanisms (e.g., pneumatics, hydraulics, shape memory alloys, EAP (electro-active polymers), or motors) are also possible. The cassette 3157 can further include bellows 3103a, 3103b that may connect to the pressure inlet of the rigidizing overtube 3112, to drive fluid through pressure lines 3105z, in some variations for rigidizing the overtube. As shown in this example, the cassette 3157 can include eccentric cams 3174a, b to control bellows 3103a, b. Alternatively, one or more linear actuators can be configured to actuate the bellows. As another alternative, the rigidizing overtube (and / or in some examples the steerable redirector) can be rigidized and de-rigidized through one or more pumps or pressure sources (e.g., via pressure line 3105z).

[0265] Although FIG. 22 shows an example of a robotic apparatus, any of these apparatuses may instead by manually operated. For example, a rigidizing overtube may be used with a scope (e.g., endoscope) that may be non-rigidizing. A manual system may include dual rigidizing members. Any of these apparatuses may be configured to operate both manually and robotically.Example: Cardiovascular Applications

[0266] The methods and apparatuses described herein may be used for cardiovascular apparatuses (e.g., devices, systems and methods), including, but not limited to, aspiration apparatuses in which one or more rigidizing apparatuses are used, and / or tubing, catheters, and the like, for treating cardiovascular indications. For example, these methods and apparatuses may be used to produce one or more components of a systems, and in particular catheters andassociated components, that may be used to provide access and support to one or more cardiovascular procedures for insertion into (e.g., of a stent, valve, etc.) and / or to remove material from (e.g., clot material) a vessel. For example, the methods and apparatuses described herein may be used to form a rigidizing aspiration sheath catheter that is adapted for use within a subject’s vasculature (e.g., blood vessels, heart, etc.). As used herein vascular may include any vascular region of the body, including, but not limited, to peripheral, neurovascular, etc. These apparatuses, e.g., rigidizing aspiration sheath catheters, may include an integrated valve (e.g., hemostasis valve region) to prevent or limit blood loss during the procedure without interfering with the ability of the apparatus to rigidizing / de-rigidize. These apparatuses may be sized and shaped for insertion into the vasculature. The rigidizing aspiration sheath catheters described herein may be converted between one or more flexible states that may be readily navigated through even a tortuous anatomy, and one or more more-rigid states, in which the shape (including any bends or curves) of the rigidizing aspiration sheath catheter is locked in position. Intermediate states may also be useful at certain times during the procedure. As used herein, the flexible state may be highly flexible and the rigid state is generally more rigid than the flexible state; in some examples the rigid state may be highly rigid.

[0267] For example, FIGS. 23 A and 23B illustrate examples of apparatuses (e.g., systems) having components (e.g., elongate tubular members) that may be formed as described herein. For example, FIG. 23A illustrates an example of an apparatus (e.g., a system) for clot aspiration including these components. In FIG. 23A the system 2310’ includes a rigidizing aspiration sheath catheter 2302 that is shown coupled to an insufflator 2312 to control transitioning between a rigid state and a flexible state. The aspiration system 2310’ also include an aspiration catheter 2304. The dynamically rigidizing aspiration sheath catheter 2302 includes a hemostatic valve region 2306. The hemostatic valve region includes a connection 2308 to a pressure source (e.g., insufflator 2312). The aspiration catheter 2304 extends proximally from the hemostatic valve region to an aspiration catheter handle 2314. Through the aspiration catheter handle, the aspiration catheter comprises a connection to a tube or other elongate element 2316 that connects to a vacuum activation valve 2318. The tube 2316 extends proximally to a clot capture chamber 2320. A vacuum pump 2324 is positioned at a proximal portion of the aspiration lumen 2316 and blood collection container 2322. One or more suction lines 2317 may connect the components. The suction line may also be formed as described herein. Thus, this system includes an aspiration catheter 2302 with an integrated hemostatic valve 2326 and a flush port 2336. The aspiration catheter is shown locking coupled to a mating attachment 2316 at a distal end of vacuum line. The mating attachment is configured to couple to a mating attachment connector on the distal end of the aspiration catheter for making a quick connection to the suction line 2317. A hand-triggered vacuum activation valve 2318 is shown connected in-line with the vacuum line and may be easily used to turn on / off suction through the apparatus. The vacuum line is also connected to a clot capture chamber 2320.

[0268] FIG. 23B shows an example of another configuration of a system similar to that shown in FIG. 23 A coupled to a patient. In FIG. 23B, the system includes a rigidizing aspiration catheter 2306. The aspiration catheter may be coupled to a hand-operated valve (extraction handle 2318) that connects the aspiration tube in-line with the clot capture container 2320, which is in turn connected in-line with a suction canister including one or more blood filters 2322. The suction cannister may be held under vacuum to a negative pressure set by a vacuum pump 2324.

[0269] The suction cannister may filter and / or treat the blood so that it may be reintroduced into the body. For example the suction canister 2322 may include filtration to remove clot material and / or may be treated with one or more agents to reduce or prevent infection and / or to reduce and prevent clotting (e.g., anticoagulants). The optional clot capture 2320 device may also filter clot material before it reaches the suction canister 2322. In general the filtered and / or treated blood may be reintroduced back into the body either directly or indirectly, e.g., by first passing to a blood bag 2326. Supplemental blood may be provided.

[0270] In general, the sterility of the operating sterile field may be maintained by keeping all of these elements (e.g., the blood bag, suction cannister, clot capture device, handle, etc.) within the sterile field. Any or all of these components may be single-use and / or reusable (and sterilizable).

[0271] The use of the helically wrapped methods for forming these apparatuses may be particularly beneficial, e.g., when forming the aspiration catheter, so that it may seal and provide structural support for applying negative pressure without requiring additional bulky support elements. These apparatuses may also be configured to be coupled (sealing coupled) to a hemostasis valve, as illustrated in FIGS. 23A-23B.

[0272] The rigidizing aspiration catheter may be inserted into an access site 2305 on the patient’s body, such as the femoral artery. Note that any appropriate access region may be used (e.g., radial, ulnar, axillary, brachial, dorsalis pedis, posterior tibial). In FIG. 23B the system is configured so that the material, including blood, is removed and returned via the same access site 2305. Alternatively, in some examples the return site may be a separate access site.

[0273] FIG. 24 Shows an example of a rigidizing neurovascular system that may be formed using any of the methods described herein. Thus, any of these apparatuses may be configured for use in the neurovasculature, as schematically shown in FIG. 24. FIG. 24 shows a schematic of a nested pair of rigidizing devices 2413, 2411 inserted through a patient’s neurovasculature, which may include the aortic arch, subclavian, carotid, vertebral basilar, posterior cerebral, circle ofWillis, the middle cerebral and / or the anterior cerebral regions. The apparatus itself may be formed of an ICWT and / or OCWT and may have a relatively small dimeter in cross-section.Counter-wound reinforcement

[0274] Any of these apparatuses and methods may include a counter-wound reinforcement filament to enhance the durability of the relatively low bending stiffness tubular composites (consolidated structures) described herein. A counter-wound reinforcement filament may reduce fatigue and may dramatically improve the performance of these apparatuses.

[0275] For example, any of these apparatuses may reinforce a relatively low bending stiffness polymer matrix using a high tensile strength filament, such as but not limited to a multifilament fiber that is counter- wound over (e.g., above, on top of) a metallic coiled or braided tubular construction. The counter-wound filament may improve the polymeric layers resistance to stretch when bending, resisting delamination upon multiple cycles of bending even up to 180 degrees or more. These filaments may also improve the adhesion of layers above and below the reinforcing metallic wire / cable (e.g., ribbon). In any of these cases, the counter-wound reinforcing filament may also improve adhesion of the layers by restricting the diameter increase in braided or coiled constructions when the tubular construction is put under an axial compressive load and may reduce the barreling effect (i.e., diameter increase) of coil and braid tubular constructions when subjected to axial compressive load. These counter- wound reinforcing filament may also increase the longitudinal rigidity in compression by constraining the braid radially against a high hoop strength structure and / or may reduce bending stiffness of the composite matrix by decreasing the amount of polymer needed to achieve high longitudinal rigidity and a minimal barreling effect. Finally, these counter- wound reinforcing filament may increase the torsional rigidity with minimal polymer by constraining the braid radially against a high hoop strength structure to limit its expansion and compression and may decouple the coil from the braid using a thin wall masking layer between to achieve low bending stiffness while maintaining high torsional and longitudinal rigidity with minimal braid barreling.

[0276] FIG. 25 shows an example of a section through one example of a consolidated tube of material including a counter-wound reinforcing filament. In FIG. 25, the consolidated material includes a coil- wound support material shown as a metallic ribbon 2503 that may provide hoop strength and kink resistance and may be wound in a first direction (e.g., clockwise) over the mandrel during formation, as described above. The metallic ribbon 2503 may be wound over a first tape of flat matrix film 2505, e.g., formed of a thermoplastic elastomer such as, but not limited to TPU (e.g., soft TPU), TPE, PEBAX, etc. A counter-wound reinforcing filament 2507 may be counter- wound in a second direction (e.g., counterclockwise) over the metallic ribbon.One or more additional wrappings 2505’ of a thermoplastic elastomer such as TPU (e.g., a “harder” TPU) may be wrapped over this and the assembly consolidated as described above. The counter- wound reinforcing filament 2507 may be a fiber such as any of the filers described herein (e.g., ceramic, metallic, basalt, polymeric, etc.). The pitch of the counter-wound reinforcing filament 2507 may be approximately the same (though in an opposite direction) than the reinforcing filament (e.g., metallic ribbon). In general, a low flexural modulus / durometer polymer with high coefficient of friction (tackiness) may be included (wrapped) to embed the metallic coil and prevent coil migration; this may include the thermoplastic material. The reinforcement coil (e.g., metallic coil 2503) may be wound onto a low flexural modulus polymer / durometer (40A-80A) layer at a pitch range that enables a low radius of kink.

[0277] In any of these apparatuses and methods, the counter-wound reinforcing filament may be a high tensile strength fiber (e.g., -lOOdTen) that is counter wound onto the metallic coil layer, either directly or over an intermediate winding. Counter winding may prevent the counterwound reinforcing filament from migrating through the first layer of low durometer polymer during a lamination cycle. In any of these apparatuses, the outer layer 2505’ of low flexural modulus / durometer polymer that bonds to the inner layer of polymer may provide a low bending stiffness composite.

[0278] FIG. 26 shows another example of a section through a consolidated tube of material formed as described herein. In this example the consolidated assembly also includes a metallic braid and a fiber reinforced composite that may enhance compression resistance and increase delamination resistance by restricting outer diameter (OD) during compressive forces.

[0279] In FIG. 26, the assembly includes a metallic inner coil 2603 that may provide hoop strength and may maintains a constant OD under external pressure. Although the reinforcement coil may be limited in its ability to maintain a constant OD under tension / compression, and a relatively poor axial stiffness and torsional stiffness, it may have a good kink resistance. The assembly may include a braid (braided construct) 2609 to provide torque transmission and flexibility. This braid may be applied manually or as part of the winding techniques described herein. The braid may generally allow a significant OD change under tension / compression, and under tension the OD of a braid typically reduces. When combined with the coil 2603, under tension, the braid 2609 cannot reduce its ID due to the hoop strength provided by the coil 2603. Thus this composite of the coil and braid may therefore give excellent tensile stiffness, kink resistance and torsional resistance (braids in general alone have good torsional stiffness).

[0280] This configuration may also include a counter- wound fiber reinforcement, e.g., counter wound to the direction of the reinforcing (e.g., metallic) coil. Counter winding may prevent the coil from increasing in diameter when compressing. A thermoplastic elastomer 2605’may be wound over this and the assembly consolidated. For example, a TECHNORA coil may be used that typically has a very high tensile stiffness but adds neglectable bending stiffness. Thus when the braid tries to lift off the inner coil the counter- wound fiber reinforcement can resist this. Thus this gives the composite structure compressive stiffness and durability.

[0281] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0282] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0283] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0284] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As usedherein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0285] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0286] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0287] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0288] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0289] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions.For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0290] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0291] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for thespecific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. A method of forming an elongate tubular member of a medical device, the method comprising: helically wrapping a flat matrix film around a mandrel, wherein a surface of the flat matrix film comprises a surface modification; helically wrapping a consolidation film over the flat matrix film; applying energy to activate the flat matrix film, wherein the consolidation film applies a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the elongate tubular member having a leak-free surface; and removing the elongate tubular member from the mandrel.

2. The method of claim 1, further comprising removing the consolidation film from the tubular member.

3. The method of claim 1, further comprising helically wrapping a flat release film around the mandrel before helically wrapping the flat matrix film.

4. The method of claim 1, further comprising helically wrapping a filament over the first flat matrix film before helically wrapping the consolidation film.

5. The method of claim 1, further comprising helically wrapping a second flat matrix film around the mandrel.

6. The method of claim 1, further comprising helically wrapping a second flat matrix film around the mandrel in a staggered manner so that an edge of the flat matrix film is covered by the second flat matrix film.

7. The method of claim 1, further comprising applying one or more markings before helically wrapping the consolidation film.

8. The method of claim 1, wherein the flat matrix film comprises: a thermoplastic elastomer (TPE), a thermoplastic urethane (TPU), a plastic, a plastomer, a nylon, a polyester, a polyolefin, a PEBAX, a polypropylene, a polyimide, and a polyamide.

9. The method of claim 1, wherein the flat matrix film comprises a thermoplastic polyurethane.

10. The method of claim 1, wherein the consolidation film comprises a heat shrink material.

11. The method of claim 3, wherein the flat release film comprises a fluoropolymer film.

12. The method of claim 3, wherein the flat release film comprises a cellulose film.

13. The method of claim 4, wherein the filament comprises a reinforcement filament.

14. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises applying the helically wrapping a tape of the flat matrix film having a width, wherein a ratio of the width of the tape to a diameter of the mandrel is between 0.5:1 and 2:1.

15. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises maintaining a tension on the flat matrix film as it is wrapped of between about 0.02 and 2 N.

16. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises wrapping the flat matrix film so that an edge the flat matrix film overlaps with itself on the mandrel.

17. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises wrapping the flat matrix film so that the flat matrix film does not overlap with itself on the mandrel.

18. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises unspooling a roll of the flat matrix film while rotating and advancing the mandrel.

19. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises applying the flat matrix film at an angle of between about 10 and about 80 degrees relative to the mandrel.

20. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises rotating and advancing the mandrel distally.

21. The method of claim 1, wherein helically wrapping the flat matrix film around the mandrel comprises rotating the mandrel at a rate of between 0.2 and 10 rotations / second.

22. The method of claim 1, wherein applying energy to activate the flat matrix film comprises applying thermal energy to fuse the flat matrix film.

23. The method of claim 3, wherein helically wrapping the release film around the mandrel comprises maintaining a tension on the release film as it is wrapped of between about 0.02 and 2 N.

24. A method of forming an elongate tubular member of a high pressure rigidizing medical apparatus, the method comprising: helically wrapping a first flat matrix film around a mandrel; helically wrapping a second flat matrix film over the mandrel to cover the first flat matrix film, wherein either or both an inner surface of the first flat matrix film and / or an outer surface of the second flat matrix film comprises a surface modification; helically wrapping a consolidation film over the mandrel to cover the first and second flat matrix films; applying energy to activate the first and second flat matrix films, wherein the consolidation film applies a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the elongate tubular member having a leak-free surface; and removing the elongate tubular member from the mandrel.

25. A medical device, the device comprising: an elongate tubular member comprising a helically wound matrix flat film that is sealed along its length, the elongate tubular member having a seal extending in a helical path from a proximal end region to a distal end region, wherein the seal corresponds to a face or edge of the helically wound matrix flat film.

26. The device of claim 25, wherein a longitudinal distance between adjacent regions of the seal has a width, wherein a ratio of the width to a diameter of an inner lumen of the elongate tubular member is between 0.25 : 1 and 4:1.

27. The device of claim 25, wherein the helically wound matrix flat film comprises: a thermoplastic elastomer, a plastic, a plastomer, a nylon, a polyester, a polyolefin, a polypropylene, a polyimide, a polyamide.

28. The device of claim 25, wherein the helically wound matrix flat film comprises a thermoplastic polyurethane.

29. The device of claim 25, wherein the helically wound matrix flat film comprises a thermoplastic elastomeric matrix material having a thickness of 0.008” or less.

30. The device of claim 25, wherein the helically wound matrix flat film comprises an elastomeric matrix material having a durometer of between 10A and 90 A.

31. The device of claim 25, wherein the helically wound matrix flat film comprises an elastomeric matrix material having a durometer of between 40 A and 70 A.

32. The device of claim 25, further comprising a consolidation layer comprising a helically wound flat heat shrink film.

33. The device of claim 32, wherein the helically wound flat heat shrink film comprises one or more of: Polyethylene Terephthalate (PET), Ethylene tetrafluoroethylene (ETFE), polypropylene, and / or polyimide.

34. The device of claim 25, further comprising a reinforcement material wrapped around the elongate tubular member.

35. The device of claim 34, wherein the reinforcement material comprise one or more of: a metal wire, an aramid fiber, an Ultra High Molecular Weight Polyethylene (UHMWPE) fiber, a Polyethylene Terephthalate (PET) fiber, a carbon fiber, Vectran, fiberglass, a ceramic fiber, and / or a basalt fiber.

36. The device of claim 25, further comprising a surface coating on an outer surface.

37. The device of claim 25, further comprising a surface coating on an inner surface.

38. The device of claim 25, wherein a pitch of the seal is 50% or less of a width of the seal.

39. A flexible medical device, the device comprising: an elongate tubular member comprising a helically wound first matrix flat film and a helically wound second matrix flat film that overlaps with the helically wound first matrix flat film, wherein the first and / or second matrix flat film are fused to themselves on their adjacent faces to seal the elongate tubular member along its length, the elongate tubular member having a seal extending in a helical path from a proximal end region to a distal end region, wherein the seal corresponds to a face or edge of the first and / or second helically wound matrix flat film; wherein a longitudinal distance between adjacent region of the seal has a width, wherein a ratio of the width to a diameter of an inner lumen of the elongate tubular member is between 0.25:1 and 4:1.

40. The device of claim 39, wherein the first matrix flat film and / or the second matrix flat film comprises a surface modification.

41. The device of claim 40, wherein the surface modification is a hydrophilic coating.

42. The device of claim 41, wherein the hydrophilic coating comprises a spray coating, a brush coating, a dip coating, or a solution casting.

43. The device of claim 41, wherein the material forming the hydrophilic coating is embedded within the first matrix flat film and / or the second matrix flat film.

44. A pressure-actuated rigidizing shield apparatus configured to convert an endoscope into a rigidizing endoscope, the apparatus comprising: a rigidizing shield body comprising a plurality of concentrically arranged layers including: an elongate tubular body forming a support layer, the elongate tubular body comprising a helically wound matrix flat film that is sealed along its length, the elongate tubular member having a seal extending in a helical path from a proximal end region to a distal end region, wherein the seal corresponds to a face of the helically wound matrix flat film; a bladder layer or bladder layers configured to receive pressure to drive the rigidizing layer against the elongate tubular member; and a rigidizing layer.

45. The apparatus of claim 44, wherein the rigidizing shield body is configured to be coupled to the endoscope by a user in the field.

46. The apparatus of claim 44, further comprising a distally sealed cap.

47. The apparatus of claim 44, wherein a longitudinal distance between adjacent region of the seal has a width, further wherein a ratio of the width to a diameter of an inner lumen of the elongate tubular member is between 0.5:1 and 2: 1.

48. The apparatus of claim 44, wherein the helically wound matrix flat film comprises a thermoplastic elastomeric matrix material.

49. The apparatus of claim 44, wherein the helically wound matrix flat film comprises a thermoplastic elastomeric matrix material having a thickness of 0.008” or less.

50. The apparatus of claim 44, wherein the helically wound matrix flat film comprises a thermoplastic elastomeric matrix material having a durometer of between 10A and 90A.

51. The apparatus of claim 44, wherein the helically wound matrix flat film has a durometer of between 40 A and 70 A.

52. The apparatus of claim 44, wherein the helically wound matrix flat film is consolidated by a flat heat shrink film.

53. The apparatus of claim 44, wherein the helically wound matrix flat film comprises a thermoplastic elastomeric matrix material comprises TPU, TPE, PEBAX or TipSiv.

54. The apparatus of claim 44, wherein the helically wound matrix flat film comprises: Thermoplastic Urethane (TPU), Polyethylene Terephthalate (PET), Ethylene tetrafluoroethylene (ETFE), polypropylene, and / or polyimide.

55. The apparatus of claim 44, wherein the elongate tubular body comprises a reinforcement material helically wrapped within the support wall.

56. The apparatus of claim 55, wherein the reinforcement material comprise one or more of: a metal wire, an aramid fiber, an Ultra High Molecular Weight Polyethylene (UHMWPE) fiber, a Polyethylene Terephthalate (PET) fiber, a carbon fiber, Vectran, fiberglass, a ceramic, and / or a basalt fiber.

57. The apparatus of claim 44, wherein the support layer comprises a surface coating.

58. The apparatus of claim 44, wherein a pitch of the seal is 50% or less of a width of the helically wound flat film of thermoplastic elastomeric matrix material.

59. The apparatus of claim 44, further comprising a proximal pressure inlet in fluid communication with the bladder layer.

60. The apparatus of claim 44, wherein the rigidizing shield body comprises a lumen that is configured to hold an endoscope.

61. A field-installable rigidizing apparatus, the apparatus comprising: a rigidizing shield body comprising a plurality of concentrically arranged layers including: an elongate tubular member forming a support layer, the elongate tubular body comprising a helically wound matrix flat film that is sealed along its length, theelongate tubular member having a seal extending in a helical path from a proximal end region to a distal end region; a rigidizing layer; and a bladder layer configured to receive pressure to drive the rigidizing layer relative to the elongate tubular member.

62. The apparatus of claim 61, further comprising: a cap at a distal end of the rigidizing shield comprising an imaging window; and a working channel extending through the rigidizing shield body and opening from the distal end.

63. A pressure-actuated rigidizing shield apparatus configured to convert an endoscope into a rigidizing endoscope, the apparatus comprising: a rigidizing shield body comprising a plurality of concentrically arranged layers including: an elongate tubular member forming a support layer, the elongate tubular member comprising a helically wound first matrix flat film and a helically wound second matrix flat film that overlaps with the helically wound first matrix flat film, wherein the first and / or second matrix flat film are fused together to seal the elongate tubular member along a helical length to form a seal extending in a helical path from a proximal end region to a distal end region; a rigidizing layer; and a bladder layer configured to receive pressure to drive the rigidizing layer relative to the elongate tubular member.

64. The apparatus of claim 63, further wherein the seal corresponds to an edge region of the first and / or second helically wound matrix flat film, wherein a longitudinal distance between adjacent region of the seal has a width and wherein a ratio of the width to a diameter of an inner lumen of the elongate tubular member is between 0.5:1 and 2:1.

65. A method of forming a shield apparatus for an endoscope, the method comprising: forming a tubular support layer by: helically wrapping a flat matrix film around a mandrel, wherein a surface of the flat matrix film comprises a surface modification; helically wrapping a consolidation film over the flat matrix film; applying energy to activate the flat matrix film, wherein the consolidation film applies a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the tubular support layer; andremoving the tubular support layer from the mandrel; and concentrically arranging a rigidizing layer and a bladder layer with the tubular support layer to form at last a portion of the shield apparatus.

66. The method of claim 65, further comprising securing a cap to the distal end of the tubular support layer.

67. The method of claim 65, wherein the bladder layer is inverted over itself to form a bladder chamber that is in fluid communication with a pressure port on the proximal handle.

68. The method of claim 65, wherein concentrically arranging the rigidizing layer and the bladder layer with the tubular support layer comprises concentrically arranging two bladder layers adjacent each other such that an area between the two layers is in fluid communication with a pressure port on a proximal handle.

69. The method of claim 58, further comprising sealing a distal region of the bladder layer to the cap.

70. The method of claim 65, further comprising securing an internal shield comprising an elongate tubular shaft within a lumen formed by the concentrically arranged support layer, rigidizing layer and the bladder layer to the cap, so that a lumen of the internal shield opens to a region outside of the shield apparatus through the cap.

71. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping a film having a thickness of 0.008” or less.

72. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping a film having a durometer of between 10A and 90 A.

73. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping a film having a durometer of between 40A and 70 A.

74. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping a film comprising a thermoplastic urethane (TPU)75. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping a consolidation film comprising one or more of: Polyethylene Terephthalate (PET), ethylene tetrafluoroethylene (ETFE), polypropylene, and / or poly imide.

76. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises forming a helical seal extending in a spiral from a proximal end region to a distal end region.

77. The method of claim 65, wherein forming the tubular support wall comprises wrapping a reinforcement material around the support wall.

78. The method of claim 77, wherein the reinforcement material comprise one or more of: a metal wire, an aramid fiber, an Ultra High Molecular Weight Polyethylene (UHMWPE) fiber, a Polyethylene Terephthalate (PET) fiber, a carbon fiber, and / or a basalt fiber.

79. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material over the mandrel comprises helically wrapping the flat film of thermoplastic elastomeric matrix material having a surface coating.

80. The method of claim 79, wherein the surface coating is a hydrophilic coating.

81. The method of claim 65, wherein helically wrapping the flat film of thermoplastic elastomeric matrix material comprises wrapping with a pitch of the edge of the spiral is 50% or less of a width of the flat film of thermoplastic elastomeric matrix material.

82. A method of forming an elongate tubular member of a medical device, the method comprising: forming a pre-consolidated assembly by: helically wrapping one or more first polymer films around a mandrel wrapping one or more reinforcement threads around the helically wrapped one or more first polymer films; helically wrapping one or more second polymer films around the wrapped one or more reinforcement threads and the one or more first polymer films; wherein one or more of the polymer films has a surface modification, applying a consolidation layer over the pre-consolidated assembly; applying energy to at least partially fuse polymer material of the one or more first and second polymer films together, thereby at least partially encasing the one or morereinforcement threads within the polymer material, wherein the consolidation layer applies a radially inward force that consolidates the pre-consolidated assembly into the elongate tubular member having a leak-free wall; and removing the elongate tubular member from the mandrel.

83. A method of forming an elongate tubular member of a high pressure rigidizing medical apparatus including markings, the method comprising: helically wrapping a first flat matrix film around a mandrel; helically wrapping a second flat matrix film over the mandrel to cover the first flat matrix film, wherein either or both a surface of the first flat matrix film and / or the second flat matrix film comprises a printed material printed thereon; helically wrapping a consolidation film over the mandrel to cover the first and second flat matrix films; applying energy to activate the first and second flat matrix films, wherein the consolidation film applies a constrictive force to the helically wrapped flat matrix film, until the flat matrix film forms the elongate tubular member having a leak-free surface; and removing the elongate tubular member from the mandrel.

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