Methods and systems for fabricating catheter shaft

Abstract

The present disclosure provides systems and methods for fabricating a catheter shaft for an endoscopic apparatus. A method of fabricating the catheter shaft for the endoscopic apparatus can comprise connecting ends of two laser cut tubes with a plug component, wherein the plug component has an outer diameter mated to an inner diameter of the ends of the two laser cut tubes to form a connection with interference fit; performing a subsequent operation on the connected two laser cut tubes, wherein the subsequent operation comprises at least one of over-braiding, over-coiling and over-extrusion; and separating the two laser cut tubes by cutting the plug component.

Description

Atorney Docket No. 55441-740601METHODS AND SYSTEMS FOR FABRICATING CATHETER SHAFTCROSS-REFERENCE

[0001] This application claims priority to U.S. Provisional Patent Application No.63 / 778,058, filed on March 26, 2025, which is entirely incorporated herein by reference.BACKGROUND

[0002] Steerable catheters are medical devices used for navigating and accessing various anatomical structures within the body during minimally invasive procedures. They are commonly employed in applications such as cardiovascular interventions, neurovascular procedures, and other diagnostic or therapeutic interventions that require precise maneuverability and control.SUMMARY

[0003] Steerable catheters in medical device may have reinforced shaft constructions. The reinforced shaft may leverage a variety of reinforcement types such as braided wires, coiled wires or laser cut hypotubes. Traditionally, braided reinforcements and coiled reinforcements can be applied in a continuous technique using specialized equipment to apply the braid or coil on top of a liner and prior to encasing the reinforcement in an outer jacket. While braids and coils can provide certain local customization along the length of the shaft such as by modifying the pitch of the wires to make the shaft stiffer or more flexible, such catheter shaft construction has limited flexibility for adjusting the shaft stiffness.

[0004] Compared to braiding and coiling, laser cut hypotube reinforcement layers can provide better flexibly with more customization options and a wider array of possible stiffnesses by varying the cut pattern. Laser cut hypotubes offer improved design adaptability, allowing for intricate patterns and geometries tailored to specific performance requirements. This versatility facilitates customization, optimizing torque response, flexibility, and pushability for various catheter applications. However, the catheter manufacturing process employing laser cut hypotubes can be inefficient because laser cut hypotube may have a fixed length (e.g., no longer than 12 feet), making subsequent manufacturing process or secondary operations (e.g., over-braiding, over-coiling and overextrusion) on the fixed length hypotubes difficult, time-consuming and costly. For instance, in a secondary over-coating / over-jacketing process, a laser cut hypo-tube is fed through anAtorney Docket No. 55441-740601extruder to coat a layer of thermoplastic polymer. The fixed and short length hypotube can make it challenging to perform the process in a continuous fashion.

[0005] The present disclosure provides systems, devices, platforms, methods, and techniques for continuous secondary processing such as over-braiding, over-coiling and over-extrusion on laser cut hypotubes. This beneficially improves the catheter manufacturing process and reduces the overall cost of laser cut hypotubes as a reinforcement layer in catheter manufacturing.

[0006] In an aspect of the present disclosure, a method of fabricating a catheter shaft for an endoscopic apparatus or instrument is provided. The method comprises: (a) connecting ends of two laser cut tubes with a plug component, wherein the plug component has an outer diameter mated to an inner diameter of the ends of the two laser cut tubes to form a connection; (b) performing a subsequent operation on the connected two laser cut tubes, where the subsequent operation comprises at least one of over-braiding, over-coiling and over-extrusion; and (c) separating the two laser cut tubes by cutting the plug component. The method overcomes the traditional limitation that laser-cut tubes (LCTs) are supplied in fixed lengths (typically about 0.5 m to about 5 m) that are ill-suited for continuous over-braiding, over-coiling, or over-extrusion machinery, by temporarily linking adjacent LCTs with a removable plug to form a continuous tube assembly capable of reel-to-reel secondary processing before clean separation back to original individual lengths.

[0007] In some cases, the connection may be an interference fit, snag fit, press fit, friction fit, or other type of fit. In some cases, the connection may utilize other suitable coupling means such as involving a hook or other structures.

[0008] In some embodiments, the plug component has flaps to form the connection with the ends of the two laser cut tubes. In some embodiments, the plug component has a tapered tubular body that determines an insertion depth between the end of the two laser cut tubes and the plug component. In some cases, the tapered tubular body adapts to a middle segment for separating the two laser cut tubes. The taper profile may be linear, stepped, or curved, reducing the plug OD by about 5% to about 40% from the flap region to the middle segment. A shelf feature at the flap-to-taper transition abuts the cut end-face of the LCT to establish a precise, repeatable insertion depth that ensures coaxial alignment of the two connected LCTs to within about ±0.05 mm. The flaps are configured to elastically deform upon insertion into the LCT inner diameter and exert a radially outward spring force against the ID wall, creating a frictional or interference engagement that resists axial pull-out forces of about 0.5 N to about 50 N generated during spool winding and secondary processing operations.Atorney Docket No. 55441-740601

[0009] In some embodiments, at least one of the two laser cut tubes have a pattern to provide a desired stiffness to the catheter shaft. In some cases, the pattern is a ball and socket pattern and wherein the plug component has a pin feature to provide reinforcement to the ball and socket pattern. In some embodiments, (b) comprises winding the connected two laser cut tubes over a spool prior to performing the subsequent operation.

[0010] In an aspect, a first end of a first laser cut tube is connected to a second end of a second laser cut tube using a plug component. The plug includes a middle segment that has a smaller outer diameter than the outer diameter of the laser cut tubes. The reduced diameter of the middle segment enables both visual and dimensional identification of a cutting location after secondary processing so that the tubes can be separated without damaging the laser cut material. After the tubes are connected, the combined assembly is subjected to at least one secondary operation that may include over braiding, over coiling, or over extrusion of a polymer jacket. Following completion of these operations, the tubes are separated by cutting the plug at the middle segment.

[0011] In some embodiments, the plug includes flaps that engage the inner diameter of the first and second tubes. The flaps may be pre tensioned so that they deform slightly during insertion and establish an interference, press, snag, or friction fit. This engagement can help maintain axial stability of the connection during bending, winding, or tension loads that occur during processing operations. The compliance of the flaps may also accommodate inner diameter tolerances of the laser cut tubes while maintaining secure retention during processing.

[0012] In certain embodiments, the plug includes a tapered tubular body. The taper may determine an insertion depth into the ends of the tubes and may assist with self centering of the plug during assembly. The taper may also transition into the middle reduced diameter segment in a manner that provides a clean step or valley that is easy to detect visually or with sensors during automated cutting. These structural features help ensure coaxial alignment between adjacent laser cut tubes and assist in maintaining uniform processing conditions through the secondary operations.

[0013] The laser cut tubes may include patterns designed to provide specific stiffness profiles to the catheter shaft. Patterns can include helical patterns, lattice structures, and ball and socket geometries. In some embodiments, the pattern is a ball and socket pattern in which ball shaped regions articulate within socket shaped regions to achieve controlled flexibility. For such patterns, the plug may include a pin feature that extends through the joint region of the pattern. The pin can support the ball and socket interface during winding and processing,Atorney Docket No. 55441-740601thereby preventing excessive tensile or torsional loads that could deform the articulation features.

[0014] In further embodiments, the connected tubes are wound around a spool prior to performing secondary operations. Winding allows the tubes to be processed in a continuous manner using standard catheter manufacturing equipment. The spool may have a diameter chosen to prevent plastic deformation of the laser cut features. For example, the spool diameter may be in the range of about fifty millimeters to about five hundred millimeters depending on tube size, tube wall thickness, and pattern geometry. Proper selection of spool diameter can help maintain the elastic behavior of thin metal webs within the laser cut structure.

[0015] In some aspects, the secondary operations include over braiding followed by over extrusion. A braiding machine may apply a braided reinforcement layer over the connected tubes, after which an extruder deposits a polymer jacket. Suitable jacket materials may include poly ether block amide, polyurethane, nylon, or polytetrafluoroethylene. Following over extrusion, the reduced diameter middle segment of the plug can be used as a positional reference to cut the structure back into its original tube lengths. Using the middle segment as a cutting indicator helps avoid removing material from the laser cut tubes themselves and can reduce scrap.

[0016] After separation, a remaining portion of the cut plug may be retained inside one of the tubes to serve as a wire feeding aid. The remaining plug segment can act as a leader for routing pull wires, a working channel, or electronic conductors through the inner diameter of the laser cut tube. This approach can reduce assembly time and minimize the risk of damaging the jacket or the cut pattern during wire installation

[0017] In some embodiments, the plug includes additional retention structures such as threads, grooves, barbs, or ridges on its outer surface. These features may engage with holes or grooves in the inner surface of the laser cut tube. In certain designs, eyelets may be incorporated into the tube wall, and the plug may include retention features on both its distal and proximal portions to engage these eyelets. Such features can restrict axial motion of the plug during secondary operations and help maintain alignment across the connected tubes.

[0018] Suitable materials for the plug include polypropylene, polyethylene, polyvinyl chloride, silicone, stainless steel, Nitinol, acrylic, or polyurethane. These materials may be selected based on stiffness, temperature compatibility with extrusion processes, and ability to deform elastically during insertion and removal. The specific choice of material may depend on tube geometry, processing loads, and desired retention forces.Atorney Docket No. 55441-740601

[0019] In some aspects, a laser cut tube may include a sacrificial distal or proximal geometry. After the tubes are separated, the sacrificial geometry may be removed to reveal a keying geometry. The keying geometry can provide a reference feature for downstream assembly steps. For example, the keying feature may allow precise cutting of a polymer jacket to a predetermined length relative to the laser cut tube. This can improve consistency across manufactured shafts and reduce manual measurement requirements.

[0020] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] A better understanding of the features and advantages of the present subject matter will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings of which:

[0022] FIG. 1 illustrates an example of a flexible endoscope, in accordance with some embodiments of the present disclosure.

[0023] FIG. 2 illustrates an example of an instrument driving mechanism (IDM) providing a mechanical interface to the handle portion of the robotic endoscope.

[0024] FIG. 3 and FIG. 4 illustrate an example of an IDM providing a mechanical interface to the handle portion of the robotic endoscope.

[0025] FIG. 5 illustrates an example of example of a distal tip of an endoscope.

[0026] FIG. 6 illustrates an example of a jacket applied over the catheter.

[0027] FIG. 7 illustrates an example of a jacket comprising multiple sections.

[0028] FIG. 8 and FIG. 9 illustrate different examples of laser-cut patterns.

[0029] FIG. 10 illustrates an example of wrapping coil.

[0030] FIGs. 11A-11C illustrate different examples of plugs.

[0031] FIG. 12 illustrates example steps of fabricating an over-extrude tube.

[0032] FIG. 13A-13C illustrate different examples of plugs.

[0033] FIG. 14A-14C illustrate an example of over-extrusion process.Atorney Docket No. 55441-740601

[0034] FIG. 15 illustrates an example of a computer system that is configured to implement methods provided herein.INCORPORATION BY REFERENCE

[0035] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.DETAILED DESCRIPTION

[0036] While preferred embodiments of the present subject matter have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the present subject matter. It should be understood that various alternatives to the embodiments of the present subject matter described herein may be employed in practicing the present subject matter.

[0037] In an aspect of the present disclosure, a method of fabricating a catheter shaft for an endoscopic apparatus or instrument is provided. The present disclosure provides systems, devices, platforms, methods, and techniques for continuous secondary processing such as over-braiding, over-coiling and over-extrusion on laser cut hypotubes. This beneficially improves the catheter manufacturing process and reduces the overall cost of laser cut hypotubes as a reinforcement layer in catheter manufacturing.

[0038] In some embodiments, the method comprises: (a) connecting ends of two laser cut tubes with a plug component, wherein the plug component has an outer diameter mated to an inner diameter of the ends of the two laser cut tubes to form a connection; (b) performing a subsequent operation on the connected two laser cut tubes, wherein the subsequent operation comprises at least one of over-braiding, over-coiling and over-extrusion; and (c) separating the two laser cut tubes by cutting the plug component.

[0039] In some cases, the connection may be an interference fit, snag fit, press fit, friction fit, or other type of fit. In some cases, the connection may utilize other suitable coupling means such as involving a hook or other structures.Atorney Docket No. 55441-740601

[0040] In some embodiments, the plug component has flaps to form the connection with the ends of the two laser cut tubes. In some embodiments, the plug component has a tapered tubular body that determines an insertion depth between the end of the two laser cut tubes and the plug component. In some cases, the tapered tubular body adapts to a middle segment for separating the two laser cut tubes.

[0041] In some embodiments, at least one of the two laser cut tubes have a pattern to provide a desired stiffness to the catheter shaft. In some cases, the pattern is a ball and socket pattern and wherein the plug component has a pin feature to provide reinforcement to the ball and socket pattern. In some embodiments, (b) comprises winding the connected two laser cut tubes over a spool prior to performing the subsequent operation.

[0042] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0043] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0044] As used herein a processor encompasses one or more processors, for example a single processor, or a plurality of processors of a distributed processing system for example. A controller or processor as described herein generally comprises a tangible medium to store instructions to implement steps of a process, and the processor may comprise one or more of a central processing unit, programmable array logic, gate array logic, or a field programmable gate array, for example. In some cases, the one or more processors may be a programmable processor (e.g., a central processing unit (CPU) or a microcontroller), digital signal processors (DSPs), a field programmable gate array (FPGA) and / or one or more Advanced RISC Machine (ARM) processors. In some cases, the one or more processors may be operatively coupled to a non-transitory computer readable medium. The non-transitory computer readable medium can store logic, code, and / or program instructions executable by the one or more processors unit for performing one or more steps. The non-transitory computer readable medium can include one or more memory units (e.g., removable media or external storage such as an SD card or random access memory (RAM)). One or moreAtorney Docket No. 55441-740601methods or operations disclosed herein can be implemented in hardware components or combinations of hardware and software such as, for example, ASICs, special purpose computers, or general purpose computers.

[0045] A system as described herein, includes an elongate portion or elongate member such as a catheter. The terms “elongate member”, and “catheter” are used interchangeably throughout the specification unless contexts suggest otherwise. The catheter may be steerable and may be employed in an endoscopic apparatus for passing through one or more instruments, or employed in a steerable instrument.

[0046] The terms hypotube(s), laser-cut hypotube(s), laser-cut tube(s), laser cut hypotube(s), laser cut tube(s), laser-cut shaft(s) and laser cut shaft(s) are used interchangeably throughout the specification unless contexts suggest otherwise.

[0047] When ranges are present, the ranges include the range endpoints. Additionally, every sub range and value within the range is present as if explicitly written out. The terms “about” and “approximately,” as used herein, when preceding a numerical value indicates the value plus or minus a range of 10%. For example, about 10 may be reasonably understood to convey 9, 10, or 11, or a range of numerical values spanning from 9 to 11. Whenever “about” or “approximately” precedes the first numerical value in a series of two or more numerical values, the term “about” or “approximately” applies to each of the numerical values in that series of numerical values.

[0048] The provided device or method can be utilized in fabricating catheters, catheter shaft, or shaft used for urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology with endoscopes, combined devices including endoscope and instruments, endoscopes with localization functions, instruments, one of skill in the art will appreciate that this is not intended to be limiting, and the devices described herein may be used for other therapeutic or diagnostic procedures in combination with various tools or instruments.

[0049] In some embodiments, the proposed methods and devices may enable continuous secondary processing techniques or secondary operations such as over-braiding, over-coiling, over-extrusion, or any combination thereof, on laser-cut hypotubes. For example, the hypotube may be processed with only an extruded polymer layer, or it may have a coil and braid applied prior to the extrusion operation to further achieve desired final shaft properties. In some embodiments, the proposed methods and devices can facilitate the integration of additional reinforcement layers onto hypotubes during the manufacturing process, enhancing their structural properties and performance characteristics.Atorney Docket No. 55441-740601

[0050] In some embodiments, the proposed methods and devices may allow for the continuous processing of laser-cut hypotubes for secondary operations on the outer diameter by linking the fixed-length hypotubes in a manner that enables continuous processing while also protecting sensitive laser-cut patterns and facilitating downstream assembly operations. The proposed methods and devices can be applied to assemblies that comprising solely of laser-cut hypotubes, as well as assemblies that may combine laser-cut hypotubes with other reinforcements, such as coils and similar structures.

[0051] In some embodiments, manufacturing a steerable catheter shaft may comprise first fabricating hypotubes with desired laser cut patterns to achieve desired stiffness and performing secondary operations on the laser cut hypotubes for various purposes. For instance, the secondary operations may comprise over-braiding by applying braided materials around the laser-cut hypotubes, which can improve tensile strength, torsional stiffness, and flexibility while maintaining a lightweight profile. In some embodiments, braid fixation methods may include glue, resistance weld, thin wall PET heat shrink, and wrap-around tape. The braiding process may allow for various patterns and materials to be used, providing customization options based on specific application requirements. In some embodiments, the secondary operations may comprise over-coiling by wrapping coiled materials around the hypotubes, providing additional support and enhancing the catheter's ability to withstand various mechanical stresses. In some embodiments, the secondary operations may comprise over-extrusion which may allow for the application of polymeric materials over the hypotubes, thereby improving biocompatibility or lubricity, making the catheters easier to navigate through anatomical pathways. This catheter shaft manufacturing process can enable the creation of a composite structure that combines the benefits of both the hypotube, and the additional materials applied during over-extrusion.

[0052] As described above, performing the secondary operations or subsequent manufacturing process on the traditional fixed length laser cut hypotubes can be inefficient. The proposed methods and devices may improve the catheter manufacturing process by allowing for a continuous secondary operations and reducing the labor required for conducting secondary processes compared to traditional methods often involve multiple steps and manual labor, which can be time-consuming and costly. By enabling continuous processing, the present disclosure can streamline the production workflow, potentially reducing the need for extensive manual intervention and minimizing the risk of errors during assembly. In some embodiments, the overall cost of laser-cut hypotubes as a reinforcement layer in catheter manufacturing may be lowered compared to traditional methods. TheAtorney Docket No. 55441-740601efficiency gained from continuous processing can lead to reduced production times and lower labor costs, making the manufacturing of steerable catheters more economically viable.

[0053] An endoscope or steerable instrument may comprise a steerable shaft for delivering diagnostics and therapeutics to different parts of a body. The distal ends of these shafts are commonly steered with tendons (also referred to as pull wires) in one or more directions. A steerable section where the distal ends of tendons connected to is referred to as a bending section. In some embodiments, the bending section can be stiff (i.e., low deflection) in compression, extension and torsion thereby preventing prolapsing and maintaining stability, while being less stiff in flexion to be steerable with capability of spring-back and low hysteresis.

[0054] The catheter shaft manufacturing method and process can be utilized for manufacturing a catheter for various devices. FIGs. 1-7 show examples of endoscopic device and / or instruments comprising a catheter manufactured using the methods herein. In an aspect of the invention, a flexible endoscope with improved performance (e.g., improved reliability) at reduced cost is provided. FIG. 1 illustrates an example of a flexible endoscope 100, in accordance with some embodiments of the present disclosure. As shown in FIG. 1, the flexible endoscope may comprise a handle / proximal portion 109 and a flexible elongate member to be inserted inside of a subject. In some embodiments, the flexible elongate member may comprise a proximal shaft (e.g., insertion shaft 101), steerable tip (e.g., tip 105), and a steerable section (bending section 103). The bending section 103 is located between the distal tip 105 and insertion shaft 101. The bending section may comprise configurations as described later herein. In some embodiments, bending sections with joints or jointed steering segments can comprise of vertebrae that may not be linked via a flexure and can feature pivot points that may allow the distal and proximal vertebrae to rotate. In some embodiments, pivot points may be placed in sockets, which can help resist tensile loads. In some embodiments, pivot points may be stacked and can separate under light tensile loading.

[0055] The endoscope 100 may also be referred to as steerable catheter assembly as described elsewhere herein. In some cases, the endoscope 100 may be a single-use robotic endoscope. In some cases, the entire catheter assembly may be disposable. In some cases, at least a portion of the catheter assembly may be disposable. In some cases, the entire endoscope may be released from an instrument driving mechanism and can be disposed of. In some embodiment, the endoscope may contain varying levels of stiffness along the shaft, as to improve functional operation.Atorney Docket No. 55441-740601

[0056] As shown in FIG. 2, a robotic endoscope (e.g., bronchoscope, colonoscope, gastroscope, etc.) 220 may comprise a handle portion 213 and a flexible elongate member 211. In some embodiments, the flexible elongate member 211 may comprise a shaft, steerable tip, a steerable bending section and an anti-prolapse passive section. The robotic endoscope 220 can be the same as the steerable catheter assembly as described in FIG. 1. The robotic endoscope may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic endoscope may be released from the instrument driving mechanism and can be disposed of. In some cases, the endoscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary so that the kink resistance capability may be configurable along the length. The variable stiffness may be achieved by employing different laser cut patterns along the shaft.

[0057] The robotic endoscope can be releasably coupled to an instrument driving mechanism 220. The instrument driving mechanism 220 may be mounted to the arm of the robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic endoscope 210. The mechanical interface may allow the robotic endoscope 210 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the robotic endoscope can be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic endoscope may be coupled or released from the instrument driving mechanism manually without using a tool.

[0058] FIG. 2 shows an example of an instrument driving mechanism 220 providing mechanical interface to the handle portion 213 of the robotic endoscope. As shown in the example, the instrument driving mechanism 220 may comprise a set of motors that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion 213 of the catheter assembly may be mounted onto the instrumentdrive mechanism so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter.

[0059] As shown in FIG. 2, a robotic endoscope (e.g., gastroscope or colonoscope) 210 may comprise a handle portion 213 and a flexible elongate member 211. In some embodiments,Atorney Docket No. 55441-740601the flexible elongate member 211 may comprise a shaft, steerable tip, a steerable / active bending section and optionally an anti-prolapse passive section. The robotic gastroscope 210 can be the same as the steerable catheter assembly as described in FIG. 1. The robotic gastroscope may be a single-use robotic endoscope. In some cases, only the catheter may be disposable. In some cases, at least a portion of the catheter may be disposable. In some cases, the entire robotic gastroscope may be released from the instrument driving mechanism and can be disposed of. In some cases, the gastroscope may contain varying levels of stiffness along its shaft, as to improve functional operation. In some cases, a minimum bend radius along the shaft may vary so that the kink resistance or anti-prolapse capability may be configurable along the length.

[0060] The robotic gastroscope can be releasably coupled to an instrument driving mechanism 220. The instrument driving mechanism 220 may be mounted to the arm of the robotic support system or to any actuated support system as described elsewhere herein. The instrument driving mechanism may provide mechanical and electrical interface to the robotic gastroscope 210. The mechanical interface may allow the robotic gastroscope 210 to be releasably coupled to the instrument driving mechanism. For instance, the handle portion of the robotic gastroscope can be attached to the instrument driving mechanism via quick install / release means, such as magnets and spring-loaded levels. In some cases, the robotic gastroscope may be coupled or released from the instrument driving mechanism manually without using a tool.

[0061] FIG. 3 and FIG. 4 show an example of an instrument driving mechanism (IDM) 320 providing a mechanical interface to the handle portion of the robotic endoscope. In some cases, the IDM 320 for a robotic endoscope and one or more IDMs for one or more instruments (e.g., surgical instrument) 331,333 may be attached to the robotic arm 300. As shown in the example, the instrument driving mechanism (IDM) 320 for the robotic endoscope may comprise a set of motors 321 that are actuated to rotationally drive a set of pull wires of the flexible endoscope or catheter. The handle portion of the catheter assembly may be mounted onto the instrument drive mechanism 320 so that its pulley assemblies or capstans are driven by the set of motors. The number of pulleys may vary based on the pull wire configurations. In some cases, one, two, three, four, or more pull wires may be utilized for articulating the flexible endoscope or catheter. Similarly, the instrument driving mechanism (IDM) 331 for the surgical instrument herein may comprise a set of motors 335 that are actuated to rotationally drive a set of pull wires of the surgical instrument therebyAtorney Docket No. 55441-740601controlling the articulation of the bending sections of the surgical instrument, the roll movement and suture operation of the needle end effector as described above.

[0062] The handle portion may be designed allowing the robotic gastroscope to be disposable at reduced cost. For instance, classic manual and robotic gastroscopes may have a cable in the proximal end of the gastroscope handle. The cable often includes illumination fibers, camera video cable, and other optional sensor fibers or cables such as electromagnetic (EM) sensors, or shape sensing fibers. Such complex cable can be expensive, adding to the cost of the gastroscope. The provided robotic gastroscope may have an optimized design such that simplified structures and components can be employed while preserving the mechanical and electrical functionalities. In some cases, the handle portion of the robotic gastroscope may employ a cable-free design while providing a mechanical / electrical interface to the catheter.

[0063] FIG. 5 shows an example of a distal tip 500 of an endoscope. In some cases, the distal portion or tip of the endoscope 500 may be substantially flexible such that it can be steered into one or more directions (e.g., pitch, yaw). The endoscope may comprise a tip portion, bending section, and insertion shaft. In some embodiments, the endoscope may have variable bending stiffness along the longitudinal axis direction. For instance, the endoscope may comprise multiple sections having different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness / rigidity, varying structures in different segments (e.g., cuts, patterns), adding additional supporting components or any combination of the above. In some embodiments, the endoscope may have variable minimum bend radius along the longitudinal axis direction. The selection of different minimum bend radius at different locations along the endoscope may beneficially provide anti-prolapse capability while still allowing the endoscope to reach hard-to-reach regions. In some cases, a proximal end of the endoscope needs not be bent to a high degree thus the proximal portion of the endoscope may be reinforced with additional mechanical structure (e.g., additional layers of materials) to achieve a greater bending stiffness. Such a design may provide support and stability to the endoscope. In some cases, the variable bending stiffness may be achieved by using different materials during extrusion of the endoscope. This may advantageously allow for different stiffness levels along the shaft of the endoscope in an extrusion manufacturing process without additional fastening or assembling of different materials.

[0064] The distal portion of the endoscope may be steered by one or more pull wires. The distal portion of the endoscope may be made of any suitable material such as co-polymers, polymers, metals or alloys such that it can be bent by the pull wires. In some embodiments,Atorney Docket No. 55441-740601the proximal end or terminal end of one or more pull wires may be coupled to a driving mechanism (e.g., gears, pulleys, capstan etc.) via the anchoring mechanism as described above. The distal end or portion of one or more pull wires may be anchored or integrated to the distal portion of the endoscope, such that operation of the pull wires by the control unit may apply force or tension to the distal portion which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) at least the distal portion (e.g., flexible section) of the endoscope.

[0065] In some embodiments, laser-cut hypotubes (i.e., laser cut tubes) may refer to thinwalled metal tubes that are machined using laser technology. By using laser cutting techniques, different patterns can be made on the hypotube, which may change mechanical properties of a catheter shaft. The use of laser cutting can allow for a variety of mechanical properties (e.g., bending stiffness) and configurations. In some embodiments, the laser cut tubes may have a hexagonal cells pattern comprising of interconnected hexagonal shapes arranged in a repeating structure. The hexagonal cells pattern features a series of hexagons that may be closely packed together, creating a geometric design characterized by six sides. The arrangement of the hexagonal cells can create a uniform distribution of space and material, resulting in a continuous surface. The hexagonal cells can vary in size and spacing, allowing for customization in design based on specific requirements. In some embodiments, the laser-cut tubes may also feature a lattice cut pattern, which can comprise of interconnected geometric shapes that create a lightweight structure while allowing for flexibility and strength. In some embodiments, the laser-cut tubes may also feature a spiral cut pattern, which may comprise a continuous spiral design that can enhance flexibility and torsional strength. In some embodiments, the laser-cut tubes may also feature a ball and socket cut pattern may be employed, which may comprise spherical joints moving in gaps that enable enhanced articulation and movement at specific points, facilitating greater maneuverability. In some embodiments, the laser-cut tubes may also feature variable thickness cut patterns can be utilized to adjust the material thickness in different areas, allowing for variable bending properties based on the specific requirements of the catheter's application.

[0066] In some embodiments, a braided catheter may utilize a reinforcement technique that involves intertwining multiple strands of material, typically made from polymeric or metallic fibers, to create a flexible and strong structure. The braiding process can produce a composite layer that enhances the mechanical properties of the catheter, providing improved tensile strength, flexibility, and kink resistance. The braiding pattern can vary, allowing forAtorney Docket No. 55441-740601customization in terms of the density and orientation of the strands, which may influence the catheter's performance characteristics. Braided catheters may be designed to accommodate various applications, including those requiring precise navigation through complex anatomical pathways. The braided structure can allow for a degree of compliance, enabling the catheter to bend and flex without compromising its integrity. Additionally, the braiding technique can facilitate the integration of other materials or features, such as coatings for biocompatibility or lubricity, further enhancing the catheter's functionality. The manufacturing of braided catheters may involve specialized equipment that applies the braid over a liner before encasing it in an outer jacket.

[0067] In some embodiments, the braid may comprise a braid-on-coil, multi-lumen, and stepped shaft configurations. A braid-on-coil catheter comprises a braided layer applied over a coiled inner structure. Multi-lumen catheters may feature multiple channels within a single shaft, allowing for the simultaneous delivery of different fluids or the integration of various functionalities, such as pressure monitoring and fluid infusion. Stepped shaft catheters may comprise of segments with varying diameters along the length of the catheter.

[0068] In some embodiments, the shaft dimensions of steerable catheters may vary to accommodate different medical applications. The outer diameter (OD) range of the shaft can extend from about 2 French (about 0.0026 inches or about 0.66 mm) to about 24 French (about 0.315 inches or about 8.00 mm). The wall thickness of the catheter shaft may range from about 0.005 inches (about 0.13 mm) to about 0.038 inches (about 0.97 mm). The OD may be about 2 French (about 0.026 inches or 0.66 mm), about 2.5 French (approximately 0.033 inches or 0.84 mm), about 3 French (approximately 0.040 inches or 1.02 mm), about 4 French (approximately 0.047 inches or 1.19 mm), about 5 French (approximately 0.054 inches or 1.37 mm), about 6 French (approximately 0.061 inches or 1.55 mm), about 7 French (approximately 0.068 inches or 1.73 mm), about 8 French (approximately 0.075 inches or 1.91 mm), about 9 French (approximately 0.082 inches or 2.08 mm), about 10 French (approximately 0.089 inches or 2.26 mm), about 11 French (approximately 0.096 inches or 2.44 mm), about 12 French (approximately 0.103 inches or 2.62 mm), about 13 French (approximately 0.110 inches or 2.79 mm), about 14 French (approximately 0.117 inches or 2.97 mm), about 15 French (approximately 0.124 inches or 3.15 mm), about 16 French (approximately 0.131 inches or 3.32 mm), about 17 French (approximately 0.138 inches or 3.50 mm), about 18 French (approximately 0.145 inches or 3.68 mm), about 19 French (approximately 0.152 inches or 3.86 mm), about 20 French (approximately 0.159 inches or 4.04 mm), about 21 French (approximately 0.166 inches or 4.22 mm), about 22Atorney Docket No. 55441-740601French (approximately 0.173 inches or 4.40 mm), about 23 French (approximately 0.180 inches or 4.57 mm), or about 24 French (approximately 0.315 inches or 8.00 mm). In some embodiments, the wall thickness of the shaft of steerable catheters may vary within a range, for example from about 0.005 inches (0.13 mm) to about 0.038 inches (0.97 mm). The wall thickness can be about 0.005 inches (0.13 mm), about 0.010 inches (0.25 mm), about 0.015 inches (0.38 mm), about 0.020 inches (0.51 mm), about 0.025 inches (0.64 mm), about 0.030 inches (0.76 mm), about 0.035 inches (0.89 mm), or about 0.038 inches (0.97 mm).

[0069] In some embodiments, the materials used for braiding in steerable catheters may comprise steels (such as 304 stainless steel or 316 stainless steel), nylon, Nitinol, polyester, polypropylene, Kevlar, titanium, and PEEK (polyether ether ketone), carbon fiber, silicone, or biocompatible polymers.

[0070] In some embodiments, wire sizes used in steerable catheters may vary based on the design requirements. For round wire, the wire size can range from about 0.001 inches (0.025 mm) to about 0.004 inches (0.10 mm) with example intermediate sizes including about 0.0012 inches (0.030 mm), about 0.0014 inches (0.035 mm), about 0.0016 inches (0.040 mm), about 0.0018 inches (0.046 mm), or about 0.003 inches (0.076 mm). For flat wire, the wire size may range from about 0.0005 inches by 0.0003 inches (0.013 mm by 0.08 mm) to about 0.002 inches by 0.007 inches (0.05 mm by 0.18 mm), with example intermediate sizes such as about 0.001 inches by 0.004 inches (0.025 mm by 0.10 mm) or about 0.0015 inches by 0.005 inches (0.038 mm by 0.127 mm).

[0071] In some embodiments, braiding patterns used in steerable catheters may comprise various configurations to achieve specific mechanical properties. In some embodiments, braiding patterns may comprise a diamond pattern comprising of two wires under and two wires over, creating a diamond-shaped configuration. In some embodiments, braiding patterns may comprise a herringbone pattern featuring one wire placed under two wires and then over two wires, resulting in a distinctive herringbone design. In some embodiments, braiding patterns may comprise a half diamond pattern comprising one wire under one wire and over one wire, creating a simplified diamond-like structure.

[0072] In some embodiments, braiding cores used in steerable catheters may be applied directly onto the catheter or may comprise of materials such as PTFE (polytetrafluoroethylene) or HDPE (high-density polyethylene). The outer diameter (OD) of the braiding cores can range from about 0.2 mm to about 8.00 mm, with example intermediate values including about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm,Atorney Docket No. 55441-740601about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, about 5.0 mm, about 6.0 mm, about 7.0 mm, or about 7.5 mm.

[0073] In some embodiments, the elongate member may comprise a sleeve or jacket. FIG. 6 shows an example of a jacket 621 applied over the catheter. The jacket 621 may slip over the active bending section, anti -prolapse passive section, and proximal shaft of scope. The jacket may be formed of polymer or any suitable material such as PTFE, pebax, polyurethane, or nylon. In some cases, the jacket may be manufactured by polymer extrusion. The jacket may have multiple layers including braiding to provide torsional stiffness to the elongate member. In some embodiments, the jacket may have a variable stiffness profile along the length. For example, the jacket may have a two, three, four or more different stiffness or multiple segments 623, 625, 627, 629 with different stiffness along the length of the catheter by having extrusions of different durometers laminated together. In some cases, the stiffness of a segment closer to the distal end of the catheter (e.g., segment 623) may be smaller than the stiffness of a segment closer to the proximal end. The different segments 623, 625, 627, 629 may or may not correspond to the active bending section, passive section and proximal shaft.

[0074] FIG. 7 shows another example 730 of a jacket comprising a plurality of segments and / or layers having different stiffness. In some embodiments, the dimension, materials and / or features forming the various segments of the jacket may be selected to provide a smooth outer layer and / or variable stiffness. This beneficially provides sufficient support or stiffness in the proximal portion of the endoscope while maintaining flexibility in the distal portion of the endoscope. In the illustrated exploded view of the exemplary jacket, the jacket may comprise an inner layer 731 having a mid-level of stiffness. The inner layer 731 may be formed of pebax liner that is extend throughout the endoscope shaft. The jacket 730 may comprise a second layer 733 coming outside of the inner layer. In the illustrated example, the second layer may be formed of Stainless Steel braid. In some cases, stainless steel braid may be selected with optimal pitch and pattern to provide a desirable stiffness. The stainless steel braid may have pitch per inch (PPI) in an optimal range to provide desirable stiffness. For instance, a stainless steel braid with 70 pitch per inch (PPI) + / - 30 PPI (Full Pattern) may be utilized. The jacket 730 may further comprise a third component 732 formed of polyethylene terephthalate (PET) to encapsulate the stainless steel braid 733 at the distal end. The third component 732 may come outside of the stainless steel braid 733 and substantially locate at the distal end. The jacket may comprise an outer layer. The outer layer may comprise a plurality of segments 734, 735, 736. In some cases, the outer layer of the jacket may comprise a distal segment 734 formed of soft stiffness Pebax, a mid segment 735 formed of midAtorney Docket No. 55441-740601stiffness Pebax and a proximal segment 736 formed of high stiffness Pebax. The Pebax material forming the out layer of the jacket may contain low friction additives such as ProPell, Mobilize or similar to decrease the friction on the external surface of the jacket. It should be noted that the materials and dimension of the various segments are for illustration purpose only and one of skill in the art will appreciate that this is not intended to be limiting.

[0075] FIG. 8 and FIG. 9 show different examples of the features for the anti-prolapse passive section of a catheter shaft. FIG. 8 shows an example 800 of “ball and socket” cut pattern. The cut pattern may comprise a plurality of repeated gaps 801 and pivot features 803.As illustrated in the example, the minimum bend radius may be reached when the gaps 801 are closed on the inner curve thereby preventing the passive section from bending any further. In some cases, a bend radius at which all the gaps on the inner curve are closed may be defined as the minimum bend radius. The pivot features 803 may also help to prevent prolapse or kink by the interlocking configuration formed on the outer curve. In some cases, when the minimum bending radius is smaller than certain threshold (e.g., in order to achieve better flexibility or degree of bending), kink or prolapse may occur. The gap size and / or pitch of the repeated pattern may be selected to achieve a minimum bending radius that is above the threshold. In some cases, the threshold for the minimum bending radius may be determined based on empirical data (e.g., experiments data) and / or simulation results. In some embodiments, a laser-cut tube (LCT) for use in the fabrication method described herein may be a thin-walled metallic tube formed from stainless steel (e.g., 304 or 316L) or Nitinol, having an outer diameter (OD) of about 0.5 mm to about 8 mm and a wall thickness of about 0.05 mm to about 0.5 mm. The tube wall is processed by a laser cutting system to form a repeating pattern of slots, gaps, and structural bridges that govern the bending stiffness, torsional stiffness, kink resistance, and minimum bend radius of the resulting catheter shaft segment. In some embodiments, the laser cut pattern is a ball-and-socket pattern, wherein spherical pivot features 803 are interspersed with gap features 801 that close upon the inner curve of a bend to establish a mechanical stop defining the minimum bend radius. In some embodiments, the laser cut pattern is a continuous spiral pattern, wherein a helical slot wraps around the tube wall and interlocking outer-curve features 901 resist prolapse under compressive loading. In some embodiments, the laser cut pattern is a hexagonal cell pattern, a lattice pattern, or a variable-pitch pattern, each conferring different ratios of bending to torsional stiffness. The target bending stiffness at any cross-section may range from about 0.001 N m2to about 1.0 N m2, and the laser cutting process may achieve slot-width tolerances of about ±0.005 mm to about ±0.05 mm to precisely tune those mechanicalAtorney Docket No. 55441-740601properties. The fixed supply length of individual LCTs — typically about 0.5 m to about 5 m — is the manufacturing bottleneck that the plug-based continuous secondary-processing method described herein is designed to overcome.

[0076] FIG. 9 shows an example 900 of continuous spiral cut pattern with interlocking features 901. The cut pattern may comprise a plurality of gaps 903 and interlocking features 901. As illustrated in the example, the minimum bend radius may be reached when the gaps are closed on the inner curve thereby preventing the passive section from bending any further while the interlocking features on the outer curve come into contact or form a locking configuration. It should be noted that the examples of the cut pattern are for illustration purpose only, any other cut pattern may be used. As described above, the gaps, interlocking features or the pivot features can be formed using any suitable manufacturing method including but not limited to, laser cut, molding, machining, and the like.

[0077] The cut pattern for the active bending section, passive section and the proximal bending section may be different. In some cases, the cut pattern for the passive section may allow for isotropic bending and the features such as the gaps and interlocking features may effectively prevent kinking as described above. In some cases, a different cut pattern (e.g., braid structures) may be employed for the proximal shaft for providing high axial and torsional stiffness and greater control over the stiffness profile. The proximal shaft section may prevent kinking or prolapse due to the greater stiffness of the section. Such integrally formed features (cut pattern) beneficially prevent kinking or prolapse without requiring additional components.

[0078] FIG. 10 shows an example of wrapping coil 1010 material that can be used for overcoiling in steerable catheters. In some embodiments, coil materials may comprise options such as stainless steel, Nitinol, and polymer-based materials. Stainless steel coils can provide high tensile strength and durability, while Nitinol coils may offer unique properties such as shape memory and superelasticity, making them suitable for applications requiring flexibility and resilience. Polymer-based coils can provide lightweight options with good biocompatibility, which may be beneficial in specific medical applications. The structure of the coil can vary, with options including helical, spiral, or braided configurations. Helical coils may provide uniform support along the catheter shaft, while spiral coils can enhance flexibility and allow for greater bending without compromising structural integrity. Braided coils may offer a combination of strength and flexibility, making them suitable for complex anatomical navigation. Wrapping methods for coil materials can comprise continuous wrapping techniques, where the coil can be applied in a uniform manner around the catheterAtorney Docket No. 55441-740601shaft, or segmented wrapping, where distinct sections of coil can be applied at specific intervals. In some embodiments, coils may comprise radiopacity, allowing for visibility under fluoroscopy, and coatings that enhance lubricity or biocompatibility. In some embodiments, coils may be designed to provide varying stiffness along the catheter length, enabling tailored performance for different segments of the catheter. In some embodiments, coil diameters can range from about 0.5 mm to about 5.0 mm, with example intermediate sizes including about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm, or about 5.0 mm. In some embodiments, wire thicknesses may vary from about 0.1 mm to about 0.5 mm, with example intermediate thicknesses including about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, or about 0.45 mm.

[0079] In an aspect, a method of fabricating a catheter shaft for an endoscopic apparatus or instrument is provided. The method comprises: (a) connecting ends of two laser cut tubes with a plug component, where the plug component has an outer diameter mated to an inner diameter of the ends of the two laser cut tubes to form a connection; (b) performing a subsequent operation on the connected two laser cut tubes, where the subsequent operation comprises at least one of over-braiding, over-coiling and over-extrusion; and (c) separating the two laser cut tubes by cutting the plug component.

[0080] In some cases, the connection may be an interference fit, snag fit, press fit, friction fit, or other type of fit. In some cases, the connection may utilize other suitable coupling means such as involving a hook or other structures.

[0081] In some embodiments, the plug component has flaps to form the connection with the ends of the two laser cut tubes. In some embodiments, the plug component has a tapered tubular body that determines an insertion depth between the end of the two laser cut tubes and the plug component. In some cases, the tapered tubular body adapts to a middle segment for separating the two laser cut tubes. FIGs. 11A-11C show examples of a plug component 1100 for connecting laser cut tubes or hypotubes. In some embodiments, the plug component may have an elongated shape with flaps 1120 on at least one side or both sides. In some embodiments, the plug can comprise at least one flap, two flaps, three flaps or four flaps. The one or more flaps 1120 may be pre-tensioned to fit inside of an end of a laser cut tube and provide an interference fit with the inner diameter (ID) of the end of the laser cut tube. In some cases, the connection may be an interference fit, snag fit, press fit, friction fit, or any other type of fit. In some cases, the connection may include any other suitable couple means such as involving a hook or other structures. In some embodiments, the plug can interfaceAtorney Docket No. 55441-740601with the inner diameter (ID) and end features of the laser cut tubes. The design of the plug may vary. In some embodiments, flaps can be used to create interference with the ID of the laser-cut tubes, ensuring a secure fit.

[0082] In some embodiments, the plug may comprise a shelf to establish the insertion depth and tapers to a smaller outer diameter (OD) in the middle segment of the plug 1130. In some cases, the OD of the middle segment of the plug may be smaller than an OD of the connected laser cut tube. The smaller OD may facilitate the separation of the laser-cut tubes after the continuous subsequent operation. In some embodiments, the smaller OD may be visible and measurable after ends of laser-cut hypotubes are connected to the plug, allowing for a precise cutting operation that avoids cutting into the laser-cut hypotubes themselves. In some cases, the plug may also be used to facilitate assembly. For instance, the plug may be used to pull components such as electronics or working channels through the inner diameter (ID) of the laser cut shaft following separation of the shafts from one another. In some embodiments, the OD of the middle segment is at least about 10% smaller than the OD of the connected LCT ends, providing a step reduction reliably detectable by machine vision systems, laser micrometers, or manual tactile inspection. The reduced-OD middle segment may have an axial length of about 1 mm to about 20 mm, providing a sufficiently large cutting target to accommodate dimensional tolerances and operator variability. A cutting tool — such as a tubing cutter, laser, or blade — is directed to the center of the reduced-OD segment so that the cut passes entirely through the plug material without contacting the metallic LCT wall.

[0083] In some embodiments, the flaps are elongated extensions located on at least one side of the plug designed to interface with the inner diameter (ID) of laser-cut tubes. The flaps may be pre-tensioned and have a diameter (when relaxed) larger than the ID of the laser-cut tubes, allowing them to create a secure fit during insertion. The design of the elongated flaps can include cuts or notches that provide flexibility, enabling them to compress and extend as the plug is inserted into the laser-cut tubes. The flexibility of flaps can help accommodate variations in the inner diameter and ensure a snug connection, while also allowing for smooth movement and alignment within the catheter system. In some embodiments, the materials used for plugs that connect laser-cut tubes may comprise polypropylene, polyethylene (PE), polyvinyl chloride (PVC), silicone, Nitinol, stainless steel, acrylic, or polyurethane. In some embodiments, plugs can connect a proximal portion of a laser-cut hypotube (LCT) to a distal portion of another LCT. In some embodiments, the connection may involve linking a proximal LCT to a distal coil, utilizing the coil as a processing aid. In some embodiments, a distal LCT can be connected to a proximal coil. In some embodiments, a connection may beAtorney Docket No. 55441-740601made from coil to coil, serving as a processing aid. In some embodiments, the plug comprises about two to about eight flaps symmetrically arranged about the plug central axis to distribute engagement force uniformly around the LCT ID and minimize eccentric loading that could cause LCT misalignment. Each flap may have a width of about 0.1 mm to about 3 mm and a length of about 2 mm to about 25 mm, selected based on the LCT ID and the required engagement force. The flap contact surface may be smooth to reduce wear on the LCT inner wall, or may include micro-features such as ridges or dimples to increase the coefficient of friction to at least about 0.2 against the LCT inner wall material, ensuring reliable engagement under the combined axial and torsional loading conditions of secondary processing.

[0084] The outer diameter (OD) range of a plug may be dependent on the inner diameter (ID) of the laser cut tube or the coil. For example, the OD of the plug may match an ID of the hypotube such that the hypotube can wrap around the "drum" for braiding and extrusion without plastically deforming. The outer diameter (OD) range of a plug can extend from about 2 French (about 0.026 inches or about 0.66 mm) to about 24 French (about 0.315 inches or about 8.00 mm). The wall thickness of the plug may range from about 0.005 inches (about 0.13 mm) to about 0.038 inches (about 0.97 mm) or any other range depending on the application.

[0085] The length of the plugs can range from about 1 inch to about 10 inches, with intermediate example lengths including about 1.5 inches, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, about 4 inches, about 4.5 inches, about 5 inches, about 6 inches, about 7 inches, about 8 inches, about 9 inches, or about 10 inches. The density of the plugs can vary according to the materials used, with a range from about 0.8 g / cm3to about 8.0 g / cm3. Intermediate example densities may include about 0.8 g / cm3, about 1.0 g / cm3, about 1.4 g / cm3, about 1.2 g / cm3, about 6.5 g / cm3, about 8.0 g / cm3, about 1.2 g / cm3, about 1.1 g / cm3, about 1.5 g / cm3, and about 1.3 g / cm3. In some embodiments, the plug length is selected to provide about 3 mm to about 15 mm of flap engagement within each connected LCT end, which has been found to provide sufficient frictional engagement to withstand axial tensile forces of about 1 N to about 100 N and torsional moments of about 0.001 N m to about 0.5 N m encountered during over-braiding and over-extrusion. Longer plugs (e.g., about 4 inches to about 10 inches) are preferred when the connected assembly must be wound onto a spool, because the longer plug distributes bending stress over a greater arc length and reduces peak strain at the LCT-plug interface. Shorter plugs (e.g., about 1 inch to about 3 inches) areAtorney Docket No. 55441-740601preferred for straight-line processing where bending loads are negligible and minimizing scrap material in the separation zone is a priority.

[0086] In some embodiments, the plug component may be used to connect or link two or more hypotubes into a continuous laser cut hypotube thereby allowing for subsequent manufacturing process performed in a continuous fashion. In some cases, the method may comprise performing a subsequent operation on the connected laser cut tubes, where the subsequent operation comprises at least one of over-braiding, over-coiling and overextrusion; and after the completion of the continuous subsequent operations, separating the two laser cut tubes by cutting the plug component. In some embodiments, the connected tube assembly may be processed in a reel-to-reel fashion, wherein a motorized feed spool of plug-connected LCTs is continuously unwound and directed into the processing machinery while the processed tube assembly is simultaneously taken up on a take-up spool at the output side — a workflow analogous to continuous wire drawing or polymer fiber extrusion. A dancer roller or tension-control system may be disposed between the feed spool and the processing machine to maintain consistent tension on the connected tube assembly. The plug components, being at least partially compliant, can pass through nip points and die openings of processing machinery without causing stoppages, provided that the plug OD does not exceed the LCT OD by more than about 0 mm to about 0.5 mm. In some embodiments, the secondary operations may be performed in a fully continuous, reel-to-reel manner. In such a configuration, the spool of connected laser cut hypotubes acts as a feed spool that is continuously unwound and fed into the processing machinery, while the processed tube assembly is taken up on a take-up spool on the output side of the processing machine. This reel-to-reel configuration may be analogous to continuous wire drawing or polymer fiber extrusion processes, and it can substantially increase throughput compared to batch processing of individual fixed-length hypotubes. The use of plug components to connect individual hypotubes into a continuous strand enables this reel-to-reel approach without requiring any modifications to the secondary processing machinery itself.

[0087] FIG. 11A illustrates a first example of the plug component 1100 having elongated flaps 1120 on both sides. The flaps 1120 are pre-tensioned extensions that, when in a relaxed state, have a diameter slightly larger than the inner diameter of the laser cut tube, such that upon insertion of the plug into the tube end, the flaps compress radially and create a spring-loaded interference fit. The elongated shape of the flaps enables them to distribute the engagement force over a larger contact area with the inner surface of the laser cut tube, thereby reducing local stress concentrations on the tube wall. The plug 1100 may furtherAtorney Docket No. 55441-740601comprise a central shelf feature that abuts the cut end face of the laser cut tube to establish a precise insertion depth, ensuring that the two connected laser cut tubes are coaxially aligned with a controlled gap or abutment between their respective end faces.

[0088] FIG. 11B illustrates a second example of the plug component 1100 wherein the plug body tapers to a reduced outer diameter at a middle segment 1130. The tapered middle segment 1130 creates a distinct step change in diameter that is visually identifiable after the ends of the two laser cut tubes have been inserted over the plug. This step change may serve as a precise cutting target, allowing the operator to perform the separation cut (step (c) of the method) at the middle segment without inadvertently cutting into the body of either laser cut tube. In some embodiments, the middle segment 1130 may have an outer diameter that is at least about 10% smaller than the outer diameter of the connected laser cut tubes, providing a sufficiently large visual indicator. The reduction in diameter at the middle segment also reduces the cross-sectional area of material that must be cut through during the separation step, facilitating the cutting operation.

[0089] FIG. 11C illustrates a third example of the plug component 1100 configured with distal and proximal retention features, such as barbs or ridges, that extend radially outward from the plug body. These retention features engage corresponding eyelets or recesses on the inner surface of the laser cut tube ends. The retention features may be configured to allow insertion of the plug under a threshold insertion force while resisting axial pull-out forces above a threshold retention force, thereby ensuring that the connection remains intact during the mechanical stresses of the secondary operations. The eyelets in the laser cut tube may be formed as part of the laser cut pattern, integrating the retention interface into the tube geometry without requiring additional machining operations

[0090] FIG. 12 illustrates the full sequence of steps 1200 for fabricating an over-extruded catheter shaft tube. In a first step, individual laser cut hypotubes are connected in series via plug components 1201 to form a continuous tube assembly. The continuous tube assembly is then wound onto a spool 1203 for handling. The spool diameter is chosen to be sufficiently large to prevent plastic deformation of the laser cut hypotubes; for a typical metallic hypotube, this may correspond to a minimum spool diameter of about 100 mm. In a second step, the continuous tube assembly on the spool may be fed through a braiding machine such as a Steeger braiding machine to apply an over-braid layer 1205 around the connected tube assembly. The braided tube assembly may then be transferred to a secondary spool for feeding through an extruder. In a third step, the over-braided tube assembly is fed through an extruder to apply a polymer outer jacket. The extrusion process may involve a crosshead dieAtorney Docket No. 55441-740601that coats the tube assembly with a uniform polymer layer as it passes through. The polymer material, such as Pebax or polyurethane, can be selected in different durometer grades to create a variable stiffness profile along the length of the shaft by changing the extruded material at specified intervals. Following extrusion, the over-extruded tube assembly is cut to individual tube lengths 1207 by cutting through the plug at each middle segment. The cut may be performed using a tubing cutter, a laser, or a blade, guided by the visual indicator provided by the plug middle segment.

[0091] FIG. 12 illustrates an example of the over-extruding method 1200 and steps for fabricating an over-extrude tube. The hypotubes can be connected via plugs 1201 as described elsewhere herein, and the connected tubes may be wound over a spool to perform a continuous operation 1203. The spool may have a diameter selected to avoid plastic deformation of the tubes. The range of possible diameters for the spool may vary, typically from about 50 mm to about 500 mm, with example intermediate possible diameters including about 60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm, about 150 mm, about 200 mm, about 250 mm, about 300 mm, about 350 mm, about 400 mm, or about 450 mm, depending on the specific requirements of the manufacturing process and the material properties of the hypotubes. The length of plug-connected hypotubes wound over the spool may range from about 50 m to about 1000 m, with example intermediate lengths including about 200 m, about 300 m, about 400 m, about 500 m, about 600 m, about 700 m, about 800 m, and about 900 m, or any length below 50 m or greater than 1000 m.

[0092] In some embodiments, the connected laser cut tubes (LCTs) that are wound over the spool, may be subjected to an over-braiding operation 1205 using catheter manufacturing techniques, such as a Steeger braiding machine. The process may result in an over-braid being applied to the connected tubes, which can be then installed on a secondary spool. The secondary spool can be subsequently put through an extrusion process to apply the outer polymer jacket, which may consist of materials such as Pebax, polyurethane, or other suitable extrusion materials. In some embodiments, following the over-extrusion process, the parts can be cut to length such as the original length 1207. The cutting can be performed manually using the visible indicators provided by the plug, automated based on dimensional measurements of the plugs, a known hypotube distance or any combination thereof. In some embodiments, the spool maintains a controlled back-tension on the connected LCT assembly as it is fed into the braider or extruder, ensuring uniform braid lay angle and consistent jacket wall thickness. The over-braid may have a braid angle of about 30° to about 75° relative to the tube longitudinal axis; braid angles near 45° provide a balance between axial stiffness andAtorney Docket No. 55441-740601hoop strength. During over-extrusion, the connected tube assembly may be fed through a crosshead die at a line speed of about 0.1 m / min to about 10 m / min, with die temperature and extrudate pressure selected to achieve a jacket wall thickness of about 0.05 mm to about 0.5 mm.

[0093] The total length of the connected LCTs can be adjusted by connecting a variable number of laser cut tubes. This beneficially provides flexibility to adapt to different manufacturing processes, machine dimensions, and applications. In some embodiments, the total connected length ranges from about 10 m to about 5,000 m. The number of LCTs connected in a single processing run may range from about 2 LCTs to about 1,000 LCTs or more, each individual LCT having a length of about 0.5 m to about 5 m. Connecting a larger number of LCTs enables longer uninterrupted processing runs, reducing the frequency of machine setups and the amount of startup scrap generated at the beginning of each run.

[0094] FIGs. 13A-13C illustrate plug configurations specifically designed for use with more delicate laser cut patterns. FIG. 13 A shows a plug wherein the flaps extend sufficiently deep into the connected laser cut tube to span across the ball and socket joints of the laser cut pattern. By spanning the joints, the flaps provide internal support that prevents the joints from opening or collapsing under the axial and torsional loads that may be imposed during overbraiding. In some embodiments, the flaps may be reinforced by at least one pin 1140 disposed along the inner surface of the flap. The pin 1140 may be made of a flexible but dimensionally stable material such as PTFE, HDPE, silicone, or polyurethane, and may be bonded or integrally formed with the flap. The pin 1140 engages the joint gap of the ball and socket pattern, providing a physical barrier against joint closure under compressive loading. FIG. 13B shows a plug wherein the pins 1140 mate with dedicated holes formed in the laser cut hypotube adjacent to the end face, providing a positive mechanical interlock that resists both axial and rotational displacement. FIG. 13C shows a plug with barbed retention features that engage eyelets 1160 formed in the hypotube by the laser cutting process, providing a snap-fit engagement.

[0095] In some embodiments, the plug component may comprise features to reinforce regions of the hypotubes with easy-to-break cut patterns. FIG. 13A illustrates a plug designed for use with more fragile hypotube laser cut patterns, such as ball and socket joints. In some embodiments, the flaps on the plug may extend through the ball and socket joints. In some embodiments, the flaps on the plug may be reinforced on the inner diameter (ID) using at least one pin 1140. The at least one pin can be made of a flexible material, such as PTFE, HDPE, silicone, polyurethane, or rubber, and can serve to ensure that the ball and socketAtorney Docket No. 55441-740601joints are not subjected to high tensile or torsional forces during the over-braiding and overextrusion processing. In some embodiments, the pin 1140 has a cross-sectional diameter of about 0.1 mm to about 1.0 mm and a length sufficient to span at least one full ball-and-socket joint gap, typically about 0.5 mm to about 5 mm. The pin material may have a flexural modulus of about 1 MPa to about 500 MPa, providing sufficient stiffness to resist jointopening forces during processing while remaining flexible enough for removal after secondary operations. The tensile load capacity of the pin-reinforced plug connection may be about 5 N to about 200 N higher than an equivalent plug connection without pins.

[0096] In some embodiments, as shown in FIG. 13B, the plug may incorporate pins that mate with holes in the laser-cut hypotube, further reinforcing the connection and reducing reliance on normal forces applied to the ID via the flaps.

[0097] In some embodiments, the plug component may comprise different features for connecting with the end of the hypotube. In some embodiments, the plug can comprise threads 1150 on the outer surface that engage with holes or grooves on the inner surface of the hypotube, providing additional stability and securing the connection between the plug and the hypotube.

[0098] In some embodiments, the plug can be threaded, with a thread shape such as helical to facilitate engagement with the inner surface of the hypotube. The size of the threads may vary, with a common pitch ranging from about 0.5 mm to 2 mm, with example intermediate sizes including about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, or about 1.7 mm, depending on the specific application requirements. The features of the threads can include a rounded or flat crest to enhance the grip and minimize wear on the hypotube material during assembly and disassembly.

[0099] In some embodiments, the plug component, as shown in FIG. 13C, can have distal and proximal retention features configured to secure the plug within the hypotube. In some embodiments, the plug can have distal or proximal retention features configured to secure the plug within the hypotube. In some cases, the retention features may take the form of barbs or ridges that extend outward from the plug, providing a mechanical interlock with the inner surface of the hypotube. The size of the retention features can vary, ranging from about 0.5 mm to 3 mm in height, with example intermediate sizes including about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, or about 2.8 mm, allowing for effective engagement without compromising the integrity of the hypotube.Atorney Docket No. 55441-740601

[0100] In some embodiments, the retention features are configured such that the plug can be inserted with an insertion force of about 1 N to about 30 N and requires a withdrawal force of about 5 N to about 100 N to remove, providing a directionally asymmetric engagement that prevents unintentional pull-out during secondary processing while permitting deliberate removal after plug-segment cutting. In some embodiments, the retention features are resiliently deformable such that, upon application of sufficient axial withdrawal force after cutting the plug middle segment, the features compress inward and allow the plug remnant to be extracted without specialized tooling.

[0101] In some embodiments, the plug retention features can interact with eyelets 1160 on the hypotube. The hypotube may have at least one eyelet, two eyelets, three eyelets, four eyelets, five eyelets, six eyelets, seven eyelets, eight eyelets, nine eyelets, ten eyelets, eleven eyelets, twelve eyelets, thirteen eyelets, fourteen eyelets, fifteen eyelets, or sixteen eyelets. The eyelets can serve as anchoring points for the retention features of the plug, enhancing the stability of the connection and preventing unintended disconnection during use. In some embodiments, the laser-cut hypotube can be linked to a coil or other non-laser cut hypotube reinforcement layer. In some embodiments, a laser-cut distal segment can be laser welded to a proximal coil, and then the proximal coil can be connected to the next laser-cut segment via the plug. In some embodiments, eyelets 1160 have a diameter of about 0.2 mm to about 2.0 mm and are formed as through-holes in the tube wall by the laser cutting process, requiring no additional machining. The eyelet diameter may be selected to match the corresponding retention feature so that the retention feature snap-fits into the eyelet with a tactile confirmation of complete plug seating. Eyelets may be arranged in pairs at 180° intervals or in sets of four at 90° intervals around the tube circumference, distributing retention load symmetrically and preventing plug tilting under asymmetric loading. The positional tolerance of the eyelets may be about ±0.05 mm to about ±0.25 mm, enabling consistent engagement across all produced LCTs.

[0102] In some embodiments, a laser-cut shaft 1410 can comprise a separable and sacrificial distal or proximal geometry 1420, as shown in FIG. 14A. Following the over-extrusion process, the plugs can be cut and removed along with the sacrificial portion of the laser-cut shaft, as shown in FIG. 14B. The removal of the sacrificial portion may reveal keying geometry that can be used to set the depth for jacket 1440 removal and / or tip installation. For example, after the sacrificial portion of the laser-cut shaft is removed, the jacket 1440 may extend beyond the keying feature. The laser-cut shaft can then be seated onto a jacket 1440 cutting fixture, where the fixture keys on the internal diameter (ID) and the keying featuresAttomey Docket No. 55441-740601that may be revealed by the removal of the sacrificial segment. This arrangement may allow the cutting operation to cut the jacket 1440 at a known, fixed length from the keying feature, facilitating downstream assembly. In some embodiments, the removal of the jacket 1440 may reveal locations for pull wire welding. Following the welding of the pull wires, the welding area can be covered by the application of, for example, a bronchoscope tip. The laser cut pattern may include a sacrificial tip for plug engagement and a frangible cylinder to reveal tip alignment features at a known distance from the joints. After the over-extrusion process, the sacrificial tip can be removed through cutting or twisting off. The jacket 1440 or braid may be relieved a specified distance from the tip alignment features. Pull tendons 1430 can be inserted through the assembly, using the plug remnant as a wire feeding aid. The pull tendons 1430 can then be welded, either by laser or resistance methods, to the laser-cut tube. Removal of the sacrificial geometry 1420 exposes a keying geometry on the laser cut shaft that serves as a reference feature for downstream assembly. For example, the keying geometry may comprise a circumferential step, a set of holes, or a distinctive cut pattern element at a precisely defined distance from the distal tip joint of the catheter. A jacket cutting fixture may engage the keying geometry to locate the tube, and an automated cutting blade then trims the outer jacket 1440 to a known length relative to the keying feature, ensuring consistent assembly dimensions across all produced catheters. As shown in FIG. 14C, the tip can be assembled by feeding the working channel 1450 and electronics 1460 through the overextrusion, aligning the tip to the laser-cut tube, and joining via potting, snap fitting, or induction welding. After jacket trimming, pull tendons 1430 are routed through the inner diameter of the assembly using the remnant of the plug as a threading aid. The pull tendons 1430 are then laser welded or resistance welded to the laser cut tube at the designated pull wire attachment point. The working channel 1450 and camera electronics 1460 are inserted and the catheter tip is assembled by potting, snap fitting, or induction welding.

[0103] In some embodiments, the keying geometry exposed by removal of the sacrificial portion comprises a circumferential shoulder, a set of radial holes, or a distinctive laser-cut pattern transition located at a defined axial distance of about 1 mm to about 30 mm from the most proximal pull wire attachment joint, encoded in the laser cut pattern design file to ensure reproducibility. A jacket-cutting fixture engages the keying geometry on the LCT ID and positions the assembly so that a cutting blade trims the over-extruded jacket at a known setback distance with a cutting tolerance of about ±0.1 mm to about ±0.5 mm, enabling high-volume automated assembly with reduced reliance on manual measurement. In some embodiments, the sacrificial geometry 1420 also serves as a handling feature duringAtorney Docket No. 55441-740601secondary processing, providing a reinforced grip region that can be clamped by processing machinery feed rollers without risk of damaging the functional laser cut pattern.

[0104] In some embodiments, a fabrication line may integrate a spooling station, a braider, an extruder, and an automated cutting station in a continuous in-line configuration. The cutting station may comprise sensors — such as machine vision cameras or laser micrometers — that detect the reduced-OD region of each plug and trigger a cutting actuator to execute precise separation at the plug middle segment. A line controller coordinates feed-spool rotation speed, dancer-roller position, braider carrier speed, extruder screw speed, die temperature, and cutting station actuation to maintain consistent product quality across the full length of the connected LCT assembly. Dimensional data captured by the cutting station sensors may be logged and linked to position along the continuous tube assembly using the plug locations as segmentation markers, enabling selective rejection of out-of-specification sections without discarding the entire assembly. The method is compatible with LCT cut patterns including ball-and-socket, spiral, hexagonal cell, and lattice patterns, and with hybrid tube assemblies in which an LCT is temporarily connected to a metallic coil reinforcement segment via the same plug concept to serve as a processing aid for the coil segment during secondary operations.

[0105] In some embodiments, the fabrication and processing of steerable catheters may require a computer. The process of laser cutting may comprise precise control of the laser to cut the hypotubes or other materials according to specific designs, which may require computer-aided design (CAD) software and / or computer numerical control (CNC) systems. A fabrication process using a Wire Electrical Discharge Machine (EDM) may comprise computer-controlled electrical discharges to shape materials, requiring programming and / or monitoring through a computer interface. The operation of braiding machines, such as Steeger braiding machines, may require computer control to manage the braiding patterns and ensure consistent application over the catheter shaft. The over-extrusion process may involve computer-controlled machinery to regulate the temperature, pressure, and speed of the extrusion, ensuring uniform application of the outer polymer jacket. Automated cutting processes, especially those that rely on precise measurements from keying features, may require computer systems to ensure accurate cuts based on predefined parameters. The assembly operations may involve automated systems or robotics, wherein computers may be used to control these systems for precise placement and integration of parts. Computer-aided design (CAD) software may be used for designing the components of the catheter, simulating their performance, and optimizing the design before manufacturing.Atorney Docket No. 55441-740601

[0106] FIG. 15 is a diagrammatic representation of a machine in the example form of a computer system within which a set of instructions, for causing the machine to perform any one or more of the methodologies or modules discussed herein, may be executed. In the example of FIG. 15, the computer system may include a processor 1530, memory 1525, nonvolatile memory 1520, and a network interface device 1515 in communications with a network 1510. Various common components (e.g., cache memory) are omitted for illustrative simplicity. The computer system is intended to illustrate a hardware device on which any of the components described in the example of FIGS. 1-15 (and any other components described in this specification) can be implemented. The computer system can be of any applicable known or convenient type. The components of the computer system can be coupled together via a bus 1535 or through some other known or convenient device. In some embodiments, the computer system may include a video display 1560, an alpha-numeric device 1555, a control device 1550, a drive unit 1545, and a signal generation device 1540.

[0107] This disclosure may contemplate the computer system taking any suitable physical form. As example and not by way of limitation, computer system may be an embedded computer system, a system-on-chip (SOC), a single-board computer system (SBC) (such as, for example, a computer-on-module (COM) or system-on-module (SOM)), a desktop computer system, a laptop or notebook computer system, an interactive kiosk, a mainframe, a mesh of computer systems, a mobile telephone, a personal digital assistant (PDA), a server, or a combination of two or more of these. Where appropriate, computer system may include one or more computer systems; be unitary or distributed; span multiple locations; span multiple machines; or reside in a cloud, which may include one or more cloud components in one or more networks. Where appropriate, one or more computer systems may perform without substantial spatial or temporal limitation one or more steps of one or more methods described or illustrated herein. As an example, and not by way of limitation, one or more computer systems may perform in real time or in batch mode one or more steps of one or more methods described or illustrated herein. One or more computer systems may perform at different times or at different locations one or more steps of one or more methods described or illustrated herein, where appropriate.

[0108] The processor may be, for example, a conventional microprocessor such as an Intel Pentium microprocessor or Motorola power PC microprocessor. One of skill in the relevant art will recognize that the terms "machine-readable (storage) medium" or "computer-readable (storage) medium" include any type of device that is accessible by the processor.Atorney Docket No. 55441-740601

[0109] The memory is coupled to the processor by, for example, a bus. The memory can include, by way of example but not limitation, random access memory (RAM), such as dynamic RAM (DRAM) and static RAM (SRAM). The memory can be local, remote, or distributed.

[0110] The bus also couples the processor to the non-volatile memory and drive unit. The non-volatile memory may be a magnetic floppy or hard disk, a magnetic-optical disk, an optical disk, a read-only memory (ROM), such as a CD-ROM, EPROM, or EEPROM, a magnetic or optical card, or another form of storage for large amounts of data. Some of this data may be written, by a direct memory access process, into memory during execution of software in the computer. The non-volatile storage can be local, remote, or distributed. The non-volatile memory may be optional because systems can be created with all applicable data available in memory. A typical computer system will usually include at least a processor, memory, and a device (e.g., a bus) coupling the memory to the processor.[oni] Software is typically stored in the non-volatile memory and / or the drive unit. Indeed, storing and entire large program in memory may not even be possible. Nevertheless, it should be understood that for software to run, if necessary, it is moved to a computer readable location appropriate for processing, and for illustrative purposes, that location is referred to as the memory in this paper. Even when software is moved to the memory for execution, the processor will typically make use of hardware registers to store values associated with the software, and local cache that, ideally, serves to speed up execution. As used herein, a software program is assumed to be stored at any known or convenient location (from nonvolatile storage to hardware registers) when the software program is referred to as "implemented in a computer-readable medium." A processor is considered to be "configured to execute a program" when at least one value associated with the program is stored in a register readable by the processor.

[0112] The bus also couples the processor to the network interface device. The interface can include one or more of a modem or network interface. It will be appreciated that a modem or network interface can be considered to be part of the computer system. The interface can include an analog modem, isdn modem, cable modem, token ring interface, satellite transmission interface (e.g. "direct PC"), or other interfaces for coupling a computer system to other computer systems. The interface can include one or more input and / or output devices. The V0 devices can include, by way of example but not limitation, a keyboard, a mouse or other pointing device, disk drives, printers, a scanner, and other input and / or output devices, including a display device. The display device can include, by way of example butAtorney Docket No. 55441-740601not limitation, a cathode ray tube (CRT), liquid crystal display (LCD), or some other applicable known or convenient display device. For simplicity, it is assumed that controllers of any devices not depicted in the example of FIG. 9 reside in the interface.

[0113] In operation, the computer system can be controlled by operating system software that may include a file management system, such as a disk operating system. One example of operating system software with associated file management system software is the family of operating systems known as Windows® from Microsoft Corporation of Redmond, Washington, and their associated file management systems. Another example of operating system software with its associated file management system software is the LinuxTM operating system and its associated file management system. The file management system is typically stored in the non-volatile memory and / or drive unit and may cause the processor to execute the various acts required by the operating system to input and output data and to store data in the memory, including storing files on the non-volatile memory and / or drive unit.

[0114] Some portions of the detailed description may be presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consi stent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like.

[0115] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the following discussion, it is appreciated that throughout the description, discussions utilizing terms such as "processing" or "computing" or "calculating" or "determining" or "displaying" or "generating" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.Atorney Docket No. 55441-740601

[0116] The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the methods of some embodiments. The required structure for a variety of these systems will appear from the description below. In addition, the techniques are not described with reference to any particular programming language, and various embodiments may thus be implemented using a variety of programming languages.

[0117] In alternative embodiments, the machine may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine may operate in the capacity of a server or a client machine in a client-server network environment, or as a peer machine in a peer-to-peer (or distributed) network environment.

[0118] The machine may be a server computer, a client computer, a personal computer (PC), a tablet PC, a laptop computer, a set-top box (STB), a personal digital assistant (PDA), a cellular telephone, an iPhone, a Blackberry, a processor, a telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine.

[0119] While the machine-readable medium or machine-readable storage medium is shown in an exemplary embodiment to be a single medium, the term "machine-readable medium" and "machine-readable storage medium" should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) that store the one or more sets of instructions. The term "machine-readable medium" and "machine-readable storage medium" shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies or modules of the presently disclosed technique and innovation.

[0120] In general, the routines executed to implement the embodiments of the disclosure, may be implemented as part of an operating system or a specific application, component, program, object, module or sequence of instructions referred to as "computer programs." The computer programs typically comprise one or more instructions set at various times in various memory and storage devices in a computer, and that, when read and executed by one or more processing units or processors in a computer, cause the computer to perform operations to execute elements involving the various aspects of the disclosure.

[0121] Moreover, while embodiments have been described in the context of fully functioning computers and computer systems, those skilled in the art will appreciate that theAtorney Docket No. 55441-740601various embodiments are capable of being distributed as a program product in a variety of forms, and that the disclosure applies equally regardless of the particular type of machine or computer-readable media used to actually effect the distribution.

[0122] Further examples of machine-readable storage media, machine-readable media, or computer-readable (storage) media include but are not limited to recordable type media such as volatile and non-volatile memory devices, floppy and other removable disks, hard disk drives, optical disks (e.g., Compact Disk Read-Only Memory (CD ROMS), Digital Versatile Disks, (DVDs).), among others, and transmission type media such as digital and analog communication links.

[0123] In some circumstances, operation of a memory device, such as a change in state from a binary one to a binary zero or vice-versa, for example, may comprise a transformation, such as a physical transformation. With particular types of memory devices, such a physical transformation may comprise a physical transformation of an article to a different state or thing. For example, but without limitation, for some types of memory devices, a change in state may involve an accumulation and storage of charge or a release of stored charge.Likewise, in other memory devices, a change of state may comprise a physical change or transformation in magnetic orientation or a physical change or transformation in molecular structure, such as from crystalline to amorphous or vice versa. The foregoing is not intended to be an exhaustive list of all exam page on pies in which a change in state for a binary one to a binary zero or vice-versa in a memory device may comprise a transformation, such as a physical transformation. Rather, the foregoing is intended as illustrative examples.

[0124] A storage medium typically may be non-transitory or comprise a non-transitory device. In this context, a non-transitory storage medium may include a device that is tangible, meaning that the device has a concrete physical form, although the device may change its physical state. Thus, for example, non-transitory refers to a device remaining tangible despite this change in state.

[0125] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the invention be limited by the specific examples provided within the specification. While the invention has been described with reference to the aforementioned specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Furthermore, it shall be understood that all aspects of the invention are notAtorney Docket No. 55441-740601limited to the specific depictions, configurations or relative proportions set forth herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is therefore contemplated that the invention shall also cover any such alternatives, modifications, variations or equivalents. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

Atorney Docket No. 55441-740601CLAIMS WHAT IS CLAIMED IS:

1. A method of fabricating a catheter shaft for an endoscopic apparatus, the method comprising:(a) connecting a first end of a first laser cut tube with a second end of a second laser cut tube with a plug component, wherein the plug component comprises a middle segment having a smaller outer diameter than the first and second laser-cut tubes;(b) performing a subsequent operation on the connected first and second laser cut tubes, wherein the subsequent operation comprises at least one of over-braiding, over-coiling and over-extrusion; and(c) separating the first and second laser cut tubes by cutting the plug component at the middle segment.

2. The method of claim 1, wherein the plug component has flaps to form the connection with the ends of the first and second laser cut tubes.

3. The method of claim 1, wherein the plug component has a tapered tubular body that determines an insertion depth between the first or second end of the first or second laser cut tubes and the plug component.

4. The method of claim 3, wherein the tapered tubular body adapts to the middle segment for separating the first and second laser cut tubes.

5. The method of claim 1, wherein at the first or the second laser cut tube has a pattern to provide a desired stiffness to the catheter shaft.

6. The method of claim 5, wherein the pattern is a ball and socket pattern and wherein the plug component has a pin feature to provide reinforcement to the ball and socket pattern.

7. The method of claim 1, wherein the plug comprises pre-tensioned flaps that frictionally engage the inner diameter (ID) of the first or the second laser cut tube to establish an interference, press, snag, or friction fit.

8. The method of claim 1, wherein (b) comprises winding the connected first and second laser cut tubes over a spool prior to performing the subsequent operation.

9. The method of claim 8, wherein the spool has a diameter selected to avoid plastic deformation of the first or the second laser cut tube.

10. The method of claim 9, wherein the diameter is about 50 mm to about 500 mm.Atorney Docket No. 55441-74060111. The method of claim 1, wherein (b) comprises over-braiding on a braider and subsequently over-extruding a polymer jacket, followed by cutting to an original length of the first or the second laser cut tube using the middle segment as a visual marker.

12. The method of claim 1, further comprising, after step (c), using a remaining portion of the cut plug component as a wire feeding aid for threading pull wires or a working channel through an inner diameter of separated first or second laser cut tube.

13. The method of claim 1, wherein the plug component comprises threads on an outer surface configured to engage with corresponding grooves or holes on an inner surface of the first and second laser cut tubes.

14. The method of claim 1, wherein the plug component comprises retention features on a distal portion and a proximal portion, the retention features being configured to engage with eyelets defined in the first and second laser cut tubes to prevent axial displacement of the plug component during the subsequent operation.

15. The method of claim 1, wherein the plug is formed from polypropylene, polyethylene, PVC, silicone, stainless steel, Nitinol, acrylic, or polyurethane.

16. The method of claim 1, wherein the smaller outer diameter of the middle segment provides a visual and dimensional indicator for locating a cutting site during step (c).

17. The method of claim 1, wherein the subsequent operation comprises over-braiding the connected laser cut tubes using a braiding machine to apply a braided layer around the connected first and second laser cut tubes.

18. The method of claim 1, wherein the subsequent operation comprises over-extruding a polymer jacket over the connected first and second laser cut tubes, and wherein the polymer jacket comprises at least one of poly ether block amide (Pebax), polyurethane, nylon, or polytetrafluoroethylene (PTFE).

19. The method of claim 1, wherein the plug component comprises a flexible pin configured to extend through a joint of a ball and socket laser cut pattern of the first or second laser cut tube to inhibit high tensile or torsional forces on the ball and socket joint during the subsequent operation.

20. The method of claim 1, wherein the first or the second the laser cut tube comprises a sacrificial distal or proximal geometry that is removable after step (c) to reveal a keying geometry for a downstream assembly operation, the keying geometry establishing a fixed reference distance for cutting a polymer jacket to a predetermined length from the keying geometry.

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