Single-component deflectable catheter device and method for manufacturing the same

Abstract

Provided are catheters, sheaths, or other tubular devices, such as steerable tubular devices, and / or methods for manufacturing such catheters, sheaths, or other tubular devices, which include braids or other reinforcing structures and / or one or more steering elements for deflecting the distal portion. The devices and methods described herein may utilize a simplified, for example, single-piece catheter shaft, thereby saving space compared to conventional manufacturing methods and / or providing a more robust structure for the resulting device.

Description

Technical Field

[0001] This application generally relates to catheters, sheaths or other tubular devices, and more specifically to a tubular body for a catheter, sheath or other tubular device that includes a braided or other reinforcing configuration and / or one or more steering elements for deflecting a distal portion of the tubular device, and a method of manufacturing such tubular bodies and devices.

[0002] This application claims the benefit of co-pending U.S. Provisional Application Nos. 63 / 463,284 and 63 / 463,285, filed on May 1, 2023, the disclosures of which are hereby incorporated by reference in their entirety.

Background Art

[0003] Elongated tubular devices such as diagnostic or therapeutic catheters and sheaths may be used to introduce into a patient's body, such as the patient's vasculature or other body cavities. For example, a catheter can have a distal portion configured to be introduced into a body cavity and advanced to one or more desired locations within the patient's body by manipulating the proximal end of the catheter.

[0004] To facilitate the introduction of such a catheter, one or more wires, cables, or other steering elements can be provided within the catheter. They can deflect the distal portion, for example, by being connected to the distal portion and pulled or pushed from the proximal end side. For example, steering elements may be used to deflect the distal portion within a preset plane and / or into a desired curved shape.

[0005] Pull wires are a common method for imparting deflection functionality to such catheters. However, such pull wires have many drawbacks. For example, pull wires occupy a considerable amount of space within the catheter body. Furthermore, to prevent "pull-out" or loosening when the pull wire is manipulated by pushing or pulling, it is often necessary to reinforce the inside and outside of the catheter's braid or other reinforcing materials. If pull-out occurs, the resulting bending moment can cause the pull wire to separate or at least partially tear the layers of the catheter wall, potentially tearing the catheter or reducing the mechanical performance of the pull wire. In addition, pull wires can make the catheter's torque characteristics uneven, and when the pull wire is in operation, for example, under tension in a meandering path, it may become difficult or impossible to torque the catheter. Furthermore, auxiliary lumens, especially those located in the walls of large-diameter sheaths, can be difficult to manufacture reproducibly due to difficulties in alignment and manual assembly.

[0006] Furthermore, deflection mechanisms based on pull and push wires in catheters present numerous design and performance challenges. These challenges include, but are not limited to, 1) avoiding undesirable bending / deflection / wavy movement outside the desired deflection region, 2) preventing the catheter from becoming excessively rigid, 3) avoiding limitations in torque transmission to the distal portion of the device, 4) avoiding the generation of high deflection forces, and / or 5) achieving manufacturing flexibility regarding the position of the deflection segment.

[0007] Deflectable electrophysiology ("EP") catheter shafts and other catheter shafts are almost without exception composed of at least two separate sections, and sometimes more. The ultimate goal of the shaft assembly is to create a single-lumen proximal shaft section that is highly torque-responsive (smooth and responsive even at bends) and a multi-lumen distal section that allows deflection through interaction with compression coils and pull wires in one or more central lumens through which peripheral lumens and other elements (conductors, perfusion, sensors, actuating wires, etc.) also need to pass. To maximize the torque characteristics of the proximal shaft, a single-lumen structure that provides uniform walls (and thus isotropic bending and rotational characteristics) is preferred over a multi-lumen structure along its entire length. To achieve this, EP catheter shafts have two representative modern technology structures: 1) in which a multi-lumen segment is joined to the end of a single-lumen section by various joining mechanisms, and 2) in which a multi-lumen segment slides inside the distal section of a single-lumen shaft. Both structures terminate at the distal end with elements customized for the specific application of the catheter, such as mapping, ablation, injection, sensing, or a combination of all or some of these. With or without such customization, almost all types of actually deflectable EP catheters employ the same core-shaft structure described here in almost common.

[0008] Issues concerning shafts for steerable devices generally fall into two main categories: manufacturing and design / performance. Multi-part structures are more complex and require additional processes. This presents not only additional labor but also yield problems. For example, braided wire at the end of a single-lumen section of a shaft is difficult to prevent from coming loose when attaching multi-lumen sections during heat welding (which is preferred over adhesive bonding despite yield issues and additional manufacturing processes). Furthermore, discontinuities in the braid itself impair torque transmission, kink resistance, and the overall integrity of the device, thus creating performance issues. Additionally, a certain amount of total wall thickness and cross-sectional area must be allocated to the joint section to ensure its rigidity, consequently limiting the amount of remaining space available to allow passage of other critical elements. As EP catheters and other catheters continue to evolve with an increasing number of sensors, effectors, and other mechanisms, wasted space can lead to higher costs.

[0009] Similarly, structures in which a multi-lumen section slides within the distal section of a single-lumen shaft present similar, though slightly different, problems. This also requires additional steps and processes that worsen manufacturability, and creates a discontinuity in the shaft at the proximal end of the insert (where kinking can occur). In some cases, the walls of the single-lumen shaft can be thinned to reduce wasted space created by the insert and its allocated space, for example, by reducing the amount of overlapping wall resulting from the insertion of a multi-lumen extruder. Even in this case, some space is still lost (though less), impairing the performance of the proximal shaft and potentially resulting in suboptimal kink resistance of the distal deflection section. For example, a section of two thick walls overlapping each other is significantly less kink-resistant than a single wall of equal or lesser total wall thickness.

[0010] In other advanced design technologies, the shaft remains nearly optimized in terms of torque, but the multi-lumen walls occupy far more cross-sectional area than ideal, potentially leading to wasted space and performance limitations (stiffness) in the deflection section. Yet another design involves removing the outer walls of the peripheral lumens to create space (reducing volume and stiffness) by machining the multi-lumen extruder in specific areas, but this process is even more labor-intensive and lacks performance consistency.

[0011] Furthermore, problems arise when incorporating compression coil stops. EP catheters use a compression coil to hold the working wire, thereby allowing deflection without applying a compressive load to the proximal portion of the shaft. If a compressive load is applied, it would significantly negatively impact torque transmission through the anatomically relevant bends of the shaft. The compression coil passes through a single-lumen section of the shaft and terminates at a "compression coil stop." This stop must resist the entire maximum deflection force of the distal deflection section, plus friction and a buffer / safety factor. Because such a large force acts on a small cross-sectional area, this stop needs to be reinforced with a higher strength than the generally softer polymers used to construct the catheter. Such stop elements also need to be added to one of the two structures described above, increasing complexity and leading to a reduction in cross-sectional area (e.g., the cross-sectional area that needs to be used for the stop / junction / joint). These structures may also introduce new failure modes, such as breakage of the stop junction.

[0012] Incorporating asymmetric deflection presents further challenges. The same complexity described above is amplified when creating two offset / shifted compression coil stops or two offset / shifted pull wiring positions to create deflection sections of different lengths (flexible deflection sections of different lengths allowing for different bending radii / asymmetric deflection in each deflection direction). Both of these methods for incorporating asymmetric deflection are difficult from a manufacturing standpoint and add further discontinuity to the deflection sections.

[0013] If electrodes or other sensing elements need to be added to the outer surface of the shaft or deflection section, further manufacturing and performance issues may arise.

[0014] Therefore, there is a need for improved catheters, sheaths, and other tubular devices, as well as for their manufacturing methods. [Overview of the project]

[0015] This application relates to catheters, sheaths or other tubular devices, and methods for manufacturing such devices. More specifically, this application relates to catheters, sheaths or other tubular devices, e.g., steerable tubular devices, and / or methods for manufacturing such catheters, sheaths or other tubular devices, which include braids or other reinforcing structures and / or one or more steering elements for deflecting the distal portion. The devices and methods described herein may include simplified structures of tubular bodies for catheter shafts, e.g., single-piece or integral structures, which can save space and / or provide a more robust structure of the resulting device compared to conventional manufacturing methods.

[0016] For example, the methods described herein can provide the functionality of a complete EP or other deflectable catheter shaft in a single-piece structure, which may, for example, have a fully continuous braid between sections of the shaft. Optionally, the devices and methods herein can also provide the ability to easily augment the shaft with asymmetric deflection capabilities, integrated compression coil stops, integrated pull-wire shoulders and braided ends, and / or additional sensing elements. Similar to shafts of current state technology, single-piece shaft structures can be augmented with additional components, such as distal tips, electrodes, sensors, balloons, injection / aspiration channels, optical elements, and / or other elements that serve a specific clinical purpose of the finished product, while utilizing a standardized shaft useful across a wide range of catheter sizes and applications. Such structures and methods can also achieve optimization of the performance, profile, and / or manufacturability of each of the two main sections of the catheter shaft.

[0017] For example, a device is provided for performing a procedure inside a patient's body, the device comprising: a tubular member including a proximal end, a distal end sized for introduction into the patient's body, a longitudinal axis extending between the proximal and distal ends, an intermediate portion partially extending between the proximal and distal ends, and a distal portion extending distally from a transition with the intermediate portion to the distal end; a main lumen extending between the proximal and distal ends; an auxiliary lumen extending adjacent to the main lumen along the distal portion from an opening in the transition communicating with the main lumen to the distal end; and a first end slidably positioned within the auxiliary lumen and fixed to the distal end distal to the auxiliary lumen. A steering element comprising a first end portion and a second portion that passes proximal through the opening into the main lumen and extends to a second end adjacent to the proximal end; an actuator provided at the proximal end and connected to the second end of the steering element, which, upon operation of the actuator, applies axial tension or compression to the first portion of the steering element, thereby curving the distal portion; and a compression resistance member positioned around the first portion of the steering element in the main lumen between the transition portion and the proximal end, for preventing forces from the steering element from being transmitted to the tubular member proximal to the distal portion.

[0018] In another example, a device is provided for performing a procedure inside a patient's body, the device comprising: a tubular member including a proximal end, a distal end sized for introduction into the patient's body, a longitudinal axis extending between the proximal and distal ends, an intermediate portion partially extending between the proximal and distal ends, and a distal portion extending distally from a transition with the intermediate portion to the distal end; a main lumen extending between the proximal and distal ends, having a first segment along the intermediate portion defining a first internal diameter or cross-sectional dimension, and a second segment along the distal portion defining a second internal diameter or cross-sectional dimension smaller than the first segment; an auxiliary lumen extending adjacent to the main lumen along the distal portion from an opening in the transition that communicates with the main lumen at the transition to the distal end; a first portion slidably positioned within the auxiliary lumen and terminating at a first end fixed to the distal end distal to the auxiliary lumen, and passing proximal through the opening A steering element including a second portion that enters into the main lumen and extends to a second end adjacent to the proximal end; an actuator provided at the proximal end and connected to the second end of the steering element, which, upon operation of the actuator, applies axial tension or compression to the first portion of the steering element, thereby curving the distal portion; a compression resistance member positioned around the first portion of the steering element in the main lumen between the transition and the proximal end to prevent forces from the steering element from being transmitted to the tubular member proximal to the distal portion; and a plurality of reinforcing members continuously braided along the intermediate and distal portions, wherein the plurality of reinforcing members include a winding that is spirally wound within the wall of the distal portion along the distal portion, with at least a portion of the winding passing between the main lumen and the auxiliary lumen, and at least a portion of the winding surrounding both the main lumen and the auxiliary lumen.

[0019] In yet another example, a single-piece tubular structure for medical use is provided, the tubular structure comprising: a first part including a first main lumen segment, the first main lumen segment extending from a first end of the tubular structure along the longitudinal axis of the first part; a second part adjacent to the first part, comprising a second main lumen segment communicating with the first main lumen segment and extending along the longitudinal axis toward a second end of the tubular structure, and an auxiliary lumen extending along the second part adjacent to the second main lumen segment toward the second end from an opening in the transition between the first and second parts; and a plurality of reinforcing members continuously braided along the first and second parts. Optionally, the tubular structure may include two or more auxiliary lumens, which may be axially offset from one another.

[0020] In yet another example, a method for manufacturing a tubular body is provided, the method comprising the steps of: providing a primary mandrel including a first section defining a first cross-sectional dimension and a second section defining a second cross-sectional dimension smaller than the first cross-sectional dimension; braiding a reinforcing member around a liner along the first section toward the second section; positioning a secondary mandrel outside the primary mandrel at a position adjacent to the second section; and braiding the reinforcing member along the second section such that the secondary mandrel is included within the braid of the reinforcing member, thereby providing an auxiliary The steps include: defining a lumen; applying an outer jacket around a primary mandrel after braiding reinforcing members around first and second sections; removing the primary mandrel to define a main lumen, wherein the main lumen includes a first segment corresponding to a first section of the primary mandrel and defining a first portion of a tubular body, and a second segment corresponding to a second section of the primary mandrel and defining a second portion of a tubular body, and an auxiliary lumen extending along the second portion adjacent to the second segment.

[0021] Other aspects and features of the present invention will become apparent from the following description in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0022] The present invention is expected to be better understood from the following description of specific examples in conjunction with the accompanying drawings. In the figures, similar reference numerals indicate the same elements. [Figure 1] Figure 1A is a perspective view of an example catheter, which includes a main lumen extending between the proximal and distal ends and a steerable distal portion. Figure 1B is a longitudinal cross-sectional side view of the catheter of Figure 1A along line segment 1B-1B, showing the steering element extending between the distal end and the catheter handle. [Figure 2] Figure 2A is a cross-sectional side view of the catheter from Figures 1A and 1B along line segment 2A-2A, showing the reinforcing members positioned around the main lumen along the middle portion of the catheter. Figure 2B is a cross-sectional side view of the catheter from Figure 1A along line segment 2B-2B, showing the braided reinforcing members around the main and auxiliary lumens of the catheter along the distal portion. [Figure 3] Figure 3 is a detailed view of exemplary internal components included in the catheter shown in Figures 1A and 1B, illustrating the transition between the intermediate and distal portions. [Figure 4] Figure 4 shows an example of a braided assembly that may be used to manufacture the catheters shown in Figures 1A and 1B. Figures 4A–4C are cross-sectional views of the braided assembly shown in Figure 4, along line segments 4A–4A, 4B–4B, and 4C–4C, respectively. [Figure 5] Figure 5A is a schematic diagram of an example of a braiding apparatus for manufacturing a reinforced tubular member including multiple mandrels supported by reinforcing members. Figure 5B is a front view of the arrangement of horn gear for creating a braided configuration of the reinforcing member, which can be included in the braiding apparatus of Figure 5A and include various positions for the mandrel supply source. Figure 5C is a cross-sectional view of a catheter showing the positions of mandrels corresponding to the various positions for the mandrel supply source shown in Figure 5B. [Figure 6]FIG. 6 is a side view of an exemplary method for manufacturing a tubular body for a catheter or other device, including a primary mandrel and a secondary mandrel. FIG. 6A is a cross-sectional view of the mandrel shown in FIG. 6, including a transition portion having a pair of channels within the primary mandrel for receiving the secondary mandrel. FIG. 6B is a cross-sectional view of an alternative primary mandrel, including a transition portion having only a single channel for receiving the secondary mandrel. [Figure 7] FIG. 7 is a side view of another example of a tubular body of a single-piece construction. FIGS. 7A-7C are cross-sectional views of the tubular body shown in FIG. 7 taken along line segments 7A-7A, 7B-7B, 7C-7C, respectively. FIG. 7D is a cross-sectional view of the tubular body shown in FIG. 7, including a pair of steering elements received within an auxiliary lumen and attached to a tension ring, and a compression resistance member disposed over the steering elements. [Figure 8] FIGS. 8A and 8B are cross-sectional views of another example of a tubular device, including two auxiliary lumens axially offset from each other along a steerable portion of the tubular body. [Figure 9] FIGS. 9A and 9B are cross-sectional views of another example of a tubular device, including two auxiliary lumens axially offset from each other along a steerable portion of the tubular body. [Figure 10] FIGS. 10A and 10B are cross-sectional views of another example of a tubular device, including two auxiliary lumens axially offset from each other along a steerable portion of the tubular body. [Figure 11] FIGS. 11A and 11B are cross-sectional views of another example of a tubular device, including two auxiliary lumens axially offset from each other along a steerable portion of the tubular body. [Figure 12] FIG. 12 is a cross-sectional view of an alternative example of a distal portion, including a stabilization element embedded adjacent to the auxiliary lumen. [Figure 13] FIG. 13 is a cross-sectional view of another alternative example of a distal portion, including a softer core surrounded by a relatively hard outer layer. [Figure 14]Figures 14A to 14C show an example of a tension ring that can be connected to a pair of steering elements.

[0023] The drawings are not intended to limit anything in any sense, and it is assumed that various examples of the present invention may be carried out in various other ways, including those not necessarily shown in the drawings. The accompanying drawings incorporated herein and forming part thereof illustrate some aspects of the present invention and, together with the detailed description, serve to illustrate the principles of the present invention. However, it should be understood that the present invention is not limited to the exact arrangement configurations shown. [Modes for carrying out the invention]

[0024] The following description relating to specific examples of the present invention should not be used to limit the scope of the invention. Other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art from the following description. The following description illustrates one of the best modes intended to carry out the present invention. It will be understood that various other obvious embodiments are possible, none of which will depart from the present invention. Accordingly, the drawings and description are illustrative and should not be considered limiting.

[0025] Before describing the examples, it should be understood that the present invention is not limited to the specific examples described and is, of course, subject to change. Furthermore, since the scope of the present invention is limited only by the appended claims, it should be understood that the terms used herein are for the sole purpose of describing specific examples and are not intended to limit them.

[0026] Where a range of values ​​is given, unless the context explicitly indicates otherwise, each intermediate value between the upper and lower limits of that range, up to one-tenth of the lower limit, should be understood to be specifically disclosed. Each small range between any stated value or intermediate value within the stated range and any other stated value or intermediate value within the stated range is included in the present invention. The upper and lower limits of those small ranges may be independently included in or excluded from the range, and whether both or one of them are included in the small range, or neither is included in the small range, each range is included in the present invention, subject to any particularly excluded limits within the stated range. If a stated range includes one or both of the limits, the range excluding one or both of the limits that they include is also included in the present invention.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in which the present invention pertains. Any methods and materials similar to or equivalent to those described herein may be used in carrying out or testing the present invention, but several possible exemplary methods and materials are described herein.

[0028] In this specification and the appended claims, the singular forms "a," "an," and "the" refer to multiple subjects unless the context clearly indicates otherwise. For example, a reference to "compound" includes multiple such compounds, and a reference to "polymer" includes one or more polymers and their equivalents known to those skilled in the art.

[0029] In this specification, certain ranges are indicated by the term “approximately” preceding a number. The term “approximately” is used herein to provide literal backing for the exact number following the term and for numbers that are close to or approximate the number following the term. When determining whether a number is close to or approximates a specifically mentioned number, the close or approximate unmentioned number may be a number that, in the context in which it is presented, provides a substantially equivalent to the specifically mentioned number.

[0030] Referring to the drawings, Figures 1A and 1B show an example of a device 8 to be introduced into a body cavity (not shown) for, for example, to perform a diagnostic and / or therapeutic procedure within a patient's body. For example, the device 8 could be a guide catheter, sheath, procedure catheter, e.g., imaging catheter, ablation and / or mapping catheter, balloon catheter, or other tubular device sized to be introduced into a body cavity such as a blood vessel in the patient's vascular system, the patient's gastrointestinal tract, urogenital tract, reproductive tract, respiratory tract, lymphatic system, etc. (not shown). In various examples, the device 8 may have a length of about 10 to 170 centimeters (10 to 170 cm) and / or an outer diameter of about 4 to 24 French (4 to 24 Fr or 1.33 to 8.0 mm). The outer diameter or non-circular cross-section of the device 8 may be substantially uniform or vary along the length of the device 8.

[0031] Overall, the device 8 includes an elongated tubular body or member 10, which includes a proximal end 12, a distal end 14 sized for insertion into a body cavity, a longitudinal axis 16 extending between the proximal end 12 and the distal end 14, and one or more lumens 18 extending at least partially between the proximal end 12 and the distal end 14. For example, as best shown in Figure 1B, the device 10 may include a central or primary lumen 18a extending from the proximal end 12 to an exit 17 at the distal end 14. The main lumen 18a is sized to accept or hold one or more instruments or devices, such as guidewires, treatment catheters, balloon catheters, ablation catheters, cardiac leads, needles, or other instruments (not shown), one or more wires or other conductors, one or more optical fibers, one or more tubes or attached lumens, one or more mechanical elements, one or more sensors, and / or may be sized to deliver and / or remove fluids or other fluid agents or substances through this main lumen.

[0032] In the examples shown in Figures 1A and 1B, the main lumen 18a can open at or communicate with the outlet 17 at the distal tip 15 of the distal end 14, allowing, for example, a guidewire or other instrument (not shown) to pass through and / or to deliver or draw fluid through it. Alternatively, the main lumen 18a can be sealed (i.e., without an outlet) and terminated, for example, inside or near the distal end 14, by an electrode, cap or other component (not shown), thereby isolating the main lumen 18a and / or the elements contained therein from the environment outside the device 8.

[0033] The tubular body 10 includes one or more auxiliary lumens 18b in addition to the main lumen 18a, which extend at least partially between the proximal end 12 and the distal end 14, for example, adjacent to the main lumen 18a. For example, as shown in Figure 1B, a single auxiliary lumen 18b may be provided extending along the distal portion 24. One or more auxiliary lumens 18b may be sized to slidably receive a pull wire or other steering element 36 to bend or otherwise deflect the distal portion 24, for example, as further described elsewhere in this specification. As shown, the auxiliary lumens 18b extend substantially parallel to the longitudinal axis 16, typically radially offset from the longitudinal axis 16 along the length of the distal portion 24. Alternatively, the radial and / or circumferential positions of one or more auxiliary lumens 18b may vary, as needed, at various positions along the length of the device 8, relative to the main lumen 18a and / or other components of the tubular body 10.

[0034] Alternatively, as shown in Figure 3, a pair of auxiliary lumens 18b can be provided along the distal portion 24 of the tubular body 10. As shown, the auxiliary lumens 18b can be provided on both sides of the tubular body 10, for example, positioned approximately 180 degrees (180°) apart from each other around the outer circumference of the tubular body 10. Optionally, if necessary, the tubular body 10 may include one or more additional lumens (not shown), such as one or more additional steering element lumens, conductor lumens, expansion lumens (for example, if the device 8 includes one or more balloons, not shown, at the distal end 14), and / or accessory lumens, for example, within the walls of the tubular body 10. For example, in some applications, it may be desirable to provide one or more lumens circumferentially offset between the auxiliary lumens 18b, for example, lumens offset approximately 90 degrees (90°) from the auxiliary lumens 18b, which can receive one or more cables, wires, or provide expansion lumens.

[0035] Optionally, one or more stabilizing elements can be provided adjacent to the auxiliary lumens. For example, as shown in Figure 12, a pair of hinges or other relatively flat stabilizing members 329 can be embedded in the distal portion 324 of the tubular body, for example, on both sides of each auxiliary lumen 318b, aligned, for example, along a plane 331. One or more stabilizing members 329 can facilitate the desired bending of the distal portion 324 when a steering element (not shown) in the auxiliary lumen 318b acts, for example, in a plane perpendicular to the plane 331 of the stabilizing member 329. Additionally or alternatively, as shown in Figure 13, the material of the steerable portion including one or more auxiliary lumens 428b adjacent to the main lumen 428a can be configured to provide a desired bending profile. For example, as shown in the figure, a relatively soft core 440a (e.g., having a durometer of about 35D) and a relatively hard outer layer 440b (e.g., having a durometer of about 55D) can be provided, thereby reducing the overall rigidity of the steerable portion and / or suppressing unexpected deflection.

[0036] Optionally, the main lumen and / or auxiliary lumen may have a variety of cross-sectional shapes and / or sizes, such as substantially circular, elliptical or egg-shaped, substantially rectangular, triangular, or a shape of two overlapping circles, as described elsewhere in this specification and as in the device disclosed in U.S. Patent Publication No. 2014 / 0323964 (all of which are expressly incorporated herein). The shape and / or size of the main lumen and / or auxiliary lumen may be substantially uniform along their longitudinal direction or vary by position, as described elsewhere in this specification.

[0037] For example, as shown in Figures 1B and 3, the main lumen 18a may comprise a first segment 18a1 defining a first diameter or cross-section D1 along at least the intermediate portion 22, and a second segment 18a2 defining a second diameter or cross-section D2 smaller than the first diameter D1 along the distal portion 24, as will be further described elsewhere in this specification. In this example, the main lumen 18a may include an end wall 21 that provides a transition between the first and second segments 18a1, 18a2, and thus a transition between the intermediate portion 22 and the distal portion 24. Also in this example, as will be further described elsewhere in this specification, an auxiliary lumen 18b communicates with an opening 19b in the end wall 21, thereby allowing the steering element 36 to pass between the main lumen 18a and the auxiliary lumen 18b. The end wall 21 may be substantially flat and, for example, substantially perpendicular to the longitudinal axis 16, as shown. Alternatively, the end wall may be a tapered or other shape (not shown) that transitions between the first and second segments 18a1 and 18a2.

[0038] Returning to Figure 1A, the distal end 14 includes a distal tip 15 that is tapered, rounded, or otherwise shaped, thereby providing, for example, a substantially non-traumatic tip and / or allowing it to easily advance or navigate through various anatomical structures. Additionally or alternatively, the distal end 14 may include one or more therapeutic and / or diagnostic elements, such as one or more balloons, stents, sensors, electrodes, ablation elements, thermocouples, steering mechanisms, imaging devices, helical anchors, needles, etc. (not shown), depending on the specific intended use of the device 8. Such elements may be provided on the distal portion 24 or on an extension beyond the distal portion 24, as needed. Furthermore, the distal end 14 and / or distal portion 24 may additionally or alternatively include one or more markers or other features that improve radiopaqueness and / or enhance visibility under ultrasound, MRI, or other imaging modalities, for example, by attaching one or more platinum components to the distal end 14, doping one or more regions of the distal end 14 with tungsten or barium sulfate, and / or by other methods known in the art.

[0039] Continuing to refer to Figures 1A and 1B, the proximal end 12 may include a handle or hub 30 configured and / or sized to, for example, hold and / or operate the device 8 from the proximal end 12. Furthermore, the handle 30 may include one or more ports, for example, a port 32a communicating with the main lumen 18a, or ports communicating with each of the other lumens (not shown). Optionally, port 32a may include one or more valves, for example, hemostatic valves (not shown), which can allow the insertion of one or more instruments or fluids into the main lumen 18a while providing a substantially fluid-tight seal. Optionally, as shown in Figure 1B, a side port 32b may also be provided on the handle 30, for example, to deliver fluid into the main lumen 18a from around an instrument inserted into the main lumen 18a via the first port 32a, and / or to draw fluid from the main lumen. Optionally, the handle 30 and / or the proximal end 12 may include one or more connectors, such as a Luer lock connector, an electrical connector, or a cable, for connecting other devices (not shown), such as a syringe, display, or controller (not shown), to the apparatus 10.

[0040] Furthermore, the handle 30 may include one or more actuators, such as sliders, buttons, switches, and rotary actuators, for example, to actuate and / or operate a component (not shown) located at the distal end 14, or to operate the device 8 in other ways. For example, as shown in Figures 1A and 1B, an actuator 34 may be provided connected to the proximal end 36a of the steering element 36 in the auxiliary lumen 18b. The actuator 34 may be movable, for example, by sliding axially or rotating about the axis 16, thereby applying axial tension to the steering element 36, for example, tension in the proximal direction, to deflect the distal portion 24, for example, as described elsewhere in this specification. For example, in a device including two side steering elements, similar to the example shown in Figure 3, the steering wheel may include a single actuator (not shown) connected to both steering elements 36, which applies or releases tension to each steering element when moved in the first and second directions, or separate actuators (not shown) may be connected to each steering element 36 so that the steering elements can be operated independently of each other as needed.

[0041] The steering element 36 can be formed from a material that can substantially transmit an axial force applied at its proximal end to the distal end 14, as is known in the art, and can be formed from, for example, a wire or other solid or hollow elongated member that is substantially incompressible or tensile in the axial direction, yet flexible enough to follow the bending of the tubular body 10. Alternatively, the steering element 36 can be formed from multiple strands, such as a braided or twisted cable or thread, thereby providing an outer surface with spiral ridges and reducing friction. Optionally, the steering element 36 can include a coating, such as PTFE, parylene, silicone or other lubricating material, or an outer sleeve formed from, for example, HDPE, PTFE, thereby reducing friction between the steering element and the wall of the auxiliary lumen 18b. Alternatively or additionally, as described elsewhere in this specification, the inner surface of the auxiliary lumen 18b may be formed from a lubricating material and / or include one or more coatings.

[0042] Furthermore, the device 8 may include one or more additional components that interact with one or more steering elements 36 to control the deflection of the distal portion 24. For example, as shown in Figure 1B, a tension ring or other anchor 38 may be provided adjacent to the distal end 14 of the tubular body 10 (for example, it may be fixed to the distal end 14), to which the distal end 36b of the steering element 36 can be attached to transmit axial tension from the steering element 36 to the distal portion 24. In addition, a compression resistance member 50 may be provided surrounding at least a portion of the steering element 36 or otherwise positioned adjacent to it, thereby preventing forces from the steering element 36 from being transmitted to the tubular body 10 proximal to the distal portion 24, for example, as described elsewhere in this specification. Optionally, one or more stops can be provided to restrict the axial movement of the compression resistance member 50, for example, a stop 58 in the handle 50 adjacent to the proximal end 52 of the compression resistance member 50, and / or stops adjacent to the end wall 21 and the distal end 54 of the compression resistance member 50, as described elsewhere in this specification.

[0043] During use, the actuator 34 can be actuated to apply an axial force to the steering element 36, for example, in a proximal or distal direction relative to the handle 50 and / or the proximal end 12. For example, moving the actuator 34 in a first direction, e.g., proximal, can pull the steering element 36 and apply tension, and moving it in a second direction, e.g., distal, can advance the steering element 36 to release tension and / or apply compression. Since the steering element 36 is slidable within the auxiliary lumen 18b, the axial force is transmitted to and applied to the distal end 36b connected to the tension ring 38. Furthermore, since the auxiliary lumen 18b is offset from the longitudinal axis 16 at least along the distal portion 24, the axial force gives a bending moment, thereby causing the distal portion 24 to bend into a desired plane or otherwise flex.

[0044] In the example shown in Figure 1B, the compression resistance member 50 surrounds a portion of the steering element 36, for example, extending from the proximal end 12 of the tubular body 10 through the intermediate portion 22 into the main lumen 18a and terminating before the distal portion 24, thereby preventing forces from the steering element 36 from being transmitted along the intermediate portion 22 and / or to the tubular body 10 proximal to the distal portion 24. For example, the compression resistance member 50 can be sized to slidably receive the steering element 36, thereby preventing bending forces from the steering element 36 from being transmitted to the material of the tubular body along one or more portions to which the compression resistance member 50 is provided, for example, along the intermediate portion 22.

[0045] In one example, the compression resistance member 50 can be a tightly wound coil, for example, in which the coils abut each other in a relaxed or low potential energy state, thereby preventing axial compression of the coil. Alternatively, the coil 50 can be formed from a metal, steel, polymer, or composite material, such as one or more stainless steel or nitinol wires having a circular or rectangular cross-section. Alternatively, the compression resistance member 50 can also be provided as another tubular or cylindrical structure that slidably receives the steering element 36. For example, the compression resistance member 50 may include a reverse-wound coil tube, a coil tube with one or more tension elements attached, a laser-cut tube, a densely braided polymer tube, etc. (all not shown).

[0046] The compression resistance member 50 is received so as to be freely movable within the main lumen 18a or otherwise slidably received, for example, so that its proximal end 52 and distal end 54 are not coupled to the tubular body 10. Alternatively, one or both ends can be fixed or stopped relative to the tubular body 10. For example, as shown in Figure 1B, a stop 58 fixed axially to the handle 50 is provided within the handle 50, and the proximal end 52 of the compression resistance member 50 is positioned on the steering element 36 immediately distal to the stop 58 (without being mechanically coupled to the stop 58) to prevent proximal movement of the proximal end 52. Similarly, the distal end 54 of the compression resistance member 50 is positioned in the main lumen 18a very close to the end wall 21 (without being mechanically coupled to the end wall 21) to prevent distal movement of the distal end 54. Optionally, a stop or other reinforcing material (not shown) may be provided on or within the end wall 21 to further support the distal end 54, thereby preventing, for example, the distal end 54 from penetrating into the material of the end wall 21.

[0047] Optionally, the compression resistance member 50 may be pre-compressed, for example, between the proximal stop 58 and the end wall 21. For example, during assembly, the stop 58 can be initially positioned within the handle 50 so that both ends 52, 54 of the compression resistance member 50 contact the stop 58 and the end wall 21. The stop 58 can then be adjusted to move distally, for example, before being fixed to the handle 50, thereby generating an axial compressive force between the ends 52, 54 of the compression resistance member 50. Such pre-compression ensures that the compression resistance member 50 remains axially compressed throughout the lifespan of the resulting device 8, even if the material of the tubular body 10 softens or stretches slightly after final assembly.

[0048] Alternatively, the distal end 54 can be embedded in the end wall 11, attached to the end wall, or otherwise fixed by one or more of the following methods: adhesive bonding, heat welding, ultrasonic welding, or the incorporation of a secondary stop element. In one example, the distal end 54 of the compression resistance member 50 can be fixed with an additional stop for reinforcement, while the proximal end 52 can be allowed to slide freely on the steering element 36 adjacent to the proximal stop 58, so that, for example, changes in the path length due to catheter manipulation do not transmit those forces to the tubular body 10.

[0049] The diameter or other cross-section of the auxiliary lumen 18b is smaller than the outer diameter or other cross-section of the distal end 54 of the compression resistance member 50, thereby preventing the distal end 54 from entering the auxiliary lumen 17b. In one example, the auxiliary lumen 18b may have a diameter of approximately 0.012 inches (0.30 mm), and the distal end 54 may have an outer diameter of approximately 0.020 inches (0.50 mm). Optionally, the radial dimension of the end wall 21 (e.g., the width perpendicular to the longitudinal axis 16) can also be smaller than the diameter of the distal end 54 of the compression resistance member 50. In this case, the distal end 54 will only partially contact the end wall 21. The steering element 36 in the compression resistance member 50 and the auxiliary lumen 18b prevents lateral movement of the distal end 54, thereby preventing distal movement of the distal end 54 of the compression resistance member 50.

[0050] Generally, as shown in Figures 2A and 2B, the tubular body 10 can be configured to include, for example, an inner liner 40 that at least partially or completely surrounds or otherwise defines the main lumen 18a, a reinforcing layer 42 surrounding the inner liner 40, and an outer jacket 44 surrounding and / or covering the reinforcing layer 42, each of which can extend at least partially between the proximal end 12 and the distal end 14 of the device 10. The reinforcing layer 42 and / or the outer jacket 44 can be permanently attached to the inner liner 40 by one or more of the following: lamination, bonding, adhesive bonding, ultrasonic welding, reflow or other heating.

[0051] In one example, as shown in Figure 2A, the main lumen 18a may include an inner liner 40a defining its inner surface 41a. The inner liner 40a can be formed from a lubricating material, such as PTFE or a fluoropolymer, thereby providing a lubricating inner surface 41a. Alternatively, the inner liner 40 may be formed from one or more layers of thermoplastic or other polymer material, including one or more coatings (e.g., hydrophilic and / or lubricating coatings) on the inner surface 41a having desired properties, similar to the liners disclosed in, for example, U.S. Patent No. 7,550,053, 7,553,387, and U.S. Patent Publication No. 2009 / 0126862 (these disclosures are expressly incorporated herein by reference). In a further alternative example, the inner surface 41a may be coated with a hydrophobic coating that does not contain perfluoroalkyl and polyfluoroalkyl substances (PFAS).

[0052] Optionally, as shown in Figure 2B, the inner liner 40b may also at least partially surround the auxiliary lumen 18b, and this inner liner may be formed from a lubricating material and / or may include one or more coatings on its inner surface 41b, similar to the inner liner 40a. The inner surface 41b of the auxiliary lumen 18b may have a substantially uniform cross-section, as shown in Figure 2B. Alternatively, the inner surface 41b of the auxiliary lumen 18b may have a texture or other variable cross-section, for example, along its longitudinal direction and / or around its outer circumference (not shown).

[0053] Optionally, any or all of the inner liner 40a, reinforcing layer 42, and / or outer jacket 44 can be formed from multiple layers (not shown) of similar or different materials to achieve desired material properties in different parts of the apparatus 10. In one example, the outer jacket 44 can be formed from PEBAX, nylon, urethane, and / or other thermoplastic materials, as described elsewhere in this specification, so that, for example, the material of the outer jacket 44 can be heated and reflowed and / or formed in other ways around the components defining the lumen 18.

[0054] One or more layers of the tubular body 10 can have a substantially uniform structure between the proximal end 12 and the distal end 14. For example, the reinforcing layer 42 can be provided substantially continuously between the proximal portion 20 and the distal portion 24 of the tubular body 10. As described elsewhere in this specification, such a single-piece structure can offer several advantages compared to forming the tubular body 10 by joining separate tubular components, for example, by eliminating discontinuities or joints that could impair device performance. Also, if necessary, the liner 41a can be extended substantially continuously and uniformly from the proximal portion 20 to the portion 24.

[0055] Alternatively, the structure of the tubular body 10 may vary along its length to provide desired properties, for example, between the proximal portion 20, the intermediate portion 22, and the distal portion 24. For example, the proximal portion 20 of the tubular body 10 adjacent to the proximal end 12 may be substantially rigid or semi-rigid, thereby providing sufficient column strength to allow, for example, the distal end 14 of the tubular body 10 to be pushed forward from the proximal end 12 or otherwise manipulated, while the distal portion 24 may be substantially flexible to allow insertion into a bending and / or meandering anatomical structure. As described elsewhere in this specification, the distal portion 24 of the tubular body 10 may be steerable, i.e., it may be bent, curved, or otherwise deflected substantially within the steering plane.

[0056] Continuing with reference to Figures 2A and 2B, the reinforcing layer 42 may include one or more reinforcing members 43, which are wound, for example, around the inner liner 40a in a braided or other helical configuration using a braiding apparatus such as those described in U.S. Patents 9,427,551, 10,071,222 and 10,065,015 (all of which are expressly incorporated herein by reference). The outer jacket 44 may include one or more tubular layers that surround the reinforcing layer 42 and / or are located between the reinforcing layer 42 and the inner liner 40a. In one example, the reinforcing layer 42 may include one or more circular or flat (e.g., rectangular, elliptical, or flattened elliptical) wires, filaments, strands or other reinforcing members 43, which are formed from, for example, metals such as stainless steel, plastics such as PEEK, glass, woven or twisted fibers such as aramid, and composite materials.

[0057] For example, multiple reinforcing members 43 can be braided around the inner liner 40a, and each reinforcing member 43 may be made of the same material and / or shape. Alternatively, the reinforcing members 43 may be of different sizes, materials and / or shapes, for example, a first size or shape extending spirally in a first direction and a second size or shape (different from the first) extending spirally in a second direction (for example, opposite to the first direction).

[0058] The reinforcing layer 42 is configured to substantially transmit torsional forces between the proximal end 12 and the distal end 14, for example, by twisting the device 10 from the proximal end 12, the distal end 14 can be rotated around the longitudinal axis 16 within the patient's body. Furthermore, the reinforcing layer 42 allows the distal end 14 of the device 10 to advance or otherwise be manipulated within the patient's body from the proximal end 12 with substantially no risk of buckling and / or kinking. Optionally, the pitch of the reinforcing layer 42 can be varied along the longitudinal direction of the device 10 as needed to optimize the mechanical properties of different segments or parts of the device 10.

[0059] Furthermore, the position of the reinforcing layer 42 may vary with respect to the main lumen 18a and / or auxiliary lumen 18b, for example, when the auxiliary lumen 18b moves to a different radial position within the wall of the tubular body 10. For example, as shown in Figures 2A and 3, the reinforcing member 43 may be braided substantially continuously around the liner 40a along the middle portion 22 of the tubular body 10. In this case, the reinforcing member is added on a mandrel using a braiding device, such as the device 60 shown in Figure 5A, and then an outer layer 44 is added to provide the finished outer surface of the tubular body 10. For example, Figure 4 shows an example of a braided assembly, which is made using a braiding device and then incorporated into the tubular body 10 and / or device 8 after an outer layer 44 is added around the braided assembly, as described in the patents otherwise referenced herein.

[0060] As a result, once the tubular body 9 is fully assembled along the intermediate portion 22, the steering element 36 and the compression resistance member 50 are comfortably positioned within the main lumen 18a surrounded by layers 40-44 of the tubular body 10, as shown, for example, in Figures 1B, 2A, and 4A. Furthermore, within the distal portion 24, the steering element 36 can enter the opening 19b and extend along the auxiliary lumen 18b.

[0061] As shown in Figures 2B and 4B, the auxiliary lumen 18b can extend along the distal portion 24 through the braid of the reinforcing layer 42, for example, as in the apparatus and method described in the patents otherwise incorporated herein by reference, for example, some reinforcing members 43a pass between the auxiliary lumen 18b and the main lumen 18a, and some reinforcing members 43b are arranged to surround both the auxiliary lumen 18b and the main lumen 18a. Such a structure minimizes the risk of the steering element 36 piercing the wall of the tubular body 10 along the distal portion 24 when tension is applied to deflect the distal portion 24. Alternatively, depending on the application, it may be desirable to position the auxiliary lumen 18b entirely inside or entirely outside the reinforcing layer along the distal portion 24.

[0062] Optionally, the auxiliary lumen 18b can be further reinforced without substantially affecting the bendability of the distal portion 24. For example, a coil (not shown) can be provided surrounding the auxiliary lumen 18b and, for example, embedded within the material of the distal portion 24. Such a coil is "open-wound," i.e., has a pitch greater than the diameter of the coil wire, thereby allowing the coil to tolerate bending of the distal portion 24. Additionally or alternatively, additional reinforcing members (not shown) can be braided around the auxiliary lumen and / or a strong liner material can be used around the auxiliary lumen.

[0063] Furthermore, as shown in Figures 3 and 4C, at the distal end of the distal portion 24 (for example, adjacent to the distal tip 15), the steering element 36 can pass outside the reinforcing layer 42, so that, for example, the reinforcing member 43 surrounds only the main lumen segment 18a2 of a smaller diameter. This transition facilitates the attachment of the distal end 36b of the steering element 36 to the tension ring 38. The tension ring can be positioned on the reinforcing layer 42 adjacent to the distal end 14 during assembly, for example, as shown in Figure 4. Alternatively, the steering element 36 can remain within the reinforcing member beyond the distal portion. In this alternative example, the distal end of the steering element can be connected to a tension ring or other tip that fits within an extension (not shown) beyond the distal portion.

[0064] Various methods can be used to manufacture and / or assemble any of the devices described herein. For example, Figures 5A and 5B show an example of an apparatus 60 for manufacturing one or more tubular bodies, such as catheters and / or components for catheters, sheaths or other tubular devices 8. Generally, the apparatus 60 includes a supply source 62, 64 for a plurality of mandrels 2 and / or liners 4, a guide 66, a supply source 70 for reinforcing members 6, a drive mechanism 80, and optionally a supply source 90 for jacket material 7.

[0065] The mandrel, liner, and / or jacket may be provided as separate segments (not shown), but the apparatus 50 can enable the substantially continuous production of the tubular body, for example, by winding liner material 4a around a primary mandrel 2a (or the primary mandrel 2a may include tubular or other liner material provided around it in a supply source 62, which is similar to the liners disclosed in literature referenced elsewhere in this specification). Optionally, the primary mandrel 2a may include variable cross-sections and / or features to facilitate the production of a one-piece tubular body 10 for the apparatus 8, thereby enabling the creation of a braided assembly, for example, as shown in Figure 4. For example, as shown in Figure 6, the primary mandrel may have a length corresponding to a desired braided assembly having one or more channels, e.g., sealed lumens, open grooves, etc., provided at desired positions along the mandrel to receive one or more secondary mandrels and / or steering elements. Furthermore, the primary mandrel may include one or more steps or changes in size and / or shape, as described elsewhere in this specification.

[0066] In this specification, “substantially continuous” means that the apparatus 60 and / or method can operate indefinitely, that is, to produce one to several hundred or several thousand tubular bodies 9 by supplying the components of the tubular bodies 9 substantially simultaneously from a supply source 62, such as a reel, through the components of the apparatus 60 until the supply source 62 is depleted, and if the supply source is depleted, a new supply source can be loaded into the apparatus 60 to continue the process. Alternatively, for example, if mandrels and / or liners are supplied in specific lengths corresponding to one or more individual tubular devices (not shown), the apparatus 60 can be used to create tubular bodies of individual lengths in a one-piece or single-piece structure. In further alternatives, some operations may be performed substantially continuously while other operations are performed on the components of one or more individual tubular devices.

[0067] Referring particularly to Figure 5A, the apparatus 60 may include one or more sources 62 of mandrel 2 and optionally one or more sources 64 of liner material 4, which are fed into the guide 66 to form the lumen of the tubular body 9. For example, the first reel 62a may include an elongated primary mandrel 2a, which is shaped and / or configured to define, for example, the main lumen (not shown) of the tubular body 9. Similarly, the second reel 62b may include an elongated auxiliary or secondary mandrel 2b, which is shaped and / or configured to define, for example, the second or auxiliary lumen (not shown) of the tubular body 9. As will be described later, the second reel 62b or other sources of secondary mandrels may be positioned in any of several positions available during operation to configure the tubular body 9 in a desired manner. Optionally, if additional lumens are needed for the tubular body 9, one or more additional secondary mandrels (not shown) may be added, and these are also movable to one or more positions.

[0068] The mandrel 2 may have a desired cross-sectional shape and / or size corresponding to a desired cross-section of the lumen, and may have a substantially circular or other shape, for example, as described elsewhere in this specification. The mandrel 2 is a solid or hollow wire or other cylindrical member having a diameter (or other cross-section) corresponding to the diameter of the lumen lined by the liner material 4a, the diameter of which may be, for example, in the range of about 0.005 to 0.300 inches (0.125 to 7.5 mm), 0.014 to 0.092 inches (0.35 to 2.3 mm), or 0.014 to 0.045 inches (0.35 to 1.15 mm). In some examples, the mandrel 2 is formed from a beading or monofilament material, such as a lubricating material, such as PTFE or other fluoropolymers, silicone-treated acetal, PTFE-coated stainless steel, parylene-coated stainless steel, silver-coated copper, etc., and has sufficient flexibility to allow the mandrel 2 to be wound onto a supply reel 62 and / or wound onto a winding reel (not shown) after being incorporated into a tubular body 9.

[0069] Optionally, a source 64 for the liner material 4 can be provided for one or both mandrels 2. For example, as shown in the figure, a source 64a for the liner material 4a is provided such that the liner material 4a is at least partially wrapped around the primary mandrel 2a as the primary mandrel 2a and the liner material 4a are fed through the guide 66. The liner material 2a can be formed from a lubricating material and / or may include one or more coatings (not shown) directed toward the primary mandrel 2a on its inner surface, thereby forming the inner liner of the main lumen of the resulting tubular body 9.

[0070] For example, the liner material may include a relatively thin-walled polymer sheet having a width corresponding to the outer circumference of the substrate, such as the corresponding mandrel, and may include thermoplastics such as polyether block amide, urethane, and nylon, fluoropolymers such as PTFE, FEP, and TFE, thermosetting plastics and thermoformable plastics such as polyimide or polyester. In some examples, the liner material may have a thickness in the range of about 0.0001 to 0.050 inches (0.0025 to 1.25 mm), 0.0001 to 0.003 inches (0.0025 to 0.076 mm), 0.0001 to 0.0015 inches (0.0025 to 0.038 mm), or 0.0005 to 0.002 inches (0.0125 to 0.05 mm).

[0071] Optionally, a source of liner material can be provided for the secondary mandrel 2b and / or other secondary mandrels (not shown for simplicity) as needed. In this case, for example, a guide (not shown) can be provided to wrap the liner material around the secondary mandrel 2b before the secondary mandrel 2b is positioned adjacent to the primary mandrel 2a. In an alternative embodiment, tubular liner material can be provided on one or both mandrels when loaded into the source 52 and / or supplied as individual segments (not shown) on the desired mandrel before passing through the guide 60 or horn gear 72 to the mandrel 2.

[0072] Referring further to Figures 5A and 5B, the source 70 for the reinforcing members 6 can provide one or more reinforcing members 6, for example, multiple reinforcing members, which are wound around the mandrel 2 when they come out of the guide 66, for example. In the example shown in Figure 5B, the reinforcing member source 70 can include an arrangement configuration of horn gears 72, which are mounted, for example, on a base or other support structure 76 in a substantially circular configuration around the guide 66. The horn gears 72 can rotate freely about their individual central axes but are substantially fixed in position to each other and to the guide 66. The horn gears 72 can cause one or more carriers 74 of the reinforcing members 6 to pass around a path 78, for example, in clockwise and / or counterclockwise directions, for example, by having at least some of the carriers move clockwise and some move counterclockwise, for example, a braided pattern can be formed. The carrier 74 can be loaded onto the horn gear to form various patterns, such as one up and one down (diamond pattern), two up and two down (herringbone pattern), one up and one down with two reinforcing members in parallel (tow), and / or other patterns known in the art.

[0073] Furthermore, the secondary mandrel 2b can be moved to various positions relative to the horn gear 72, thereby allowing, for example, the secondary mandrel 2b to be repositioned relative to the primary mandrel 2a and / or reinforcing member 6. For example, as shown in Figure 5B, during the operation of the device 60, the supply source for the secondary mandrel 2b can be positioned at, for example, a predetermined time and / or distance along the primary mandrel 2a, at positions A1, A2, A3, or A4, and can be moved to any of the other positions once or more times as needed. Thus, the position of the secondary mandrel 2b can be adjusted, thereby allowing the position of the auxiliary lumen defined by the secondary mandrel 2b to be moved to a desired position and / or omitted, for example, as shown in Figure 5C and as further described elsewhere in this specification.

[0074] For example, at position A1 shown in Figure 5A, one of the horn gears 72a may include a passage 73a that aligns, for example, with the central axis of the horn gear 72a, and the secondary mandrel 2b may pass through the passage 73a toward, for example, the primary mandrel 2a from the source 52b, and there exit the guide 60. If the liner material is to be wrapped around the secondary mandrel 2b or otherwise positioned, guides (not shown) may be provided before, after, or inside the passage 73a, thereby allowing the liner material to be wrapped around the secondary mandrel 2b or otherwise positioned. Optionally, if additional secondary lumens are provided in the tubular body 9, one or more additional horn gears may also include such passages and / or guides for guiding the corresponding secondary mandrels.

[0075] As will be further described below, at this position, the secondary mandrel 2b is at least partially woven into the reinforcing member 6 adjacent to the primary mandrel 2a, i.e., as identified by the secondary mandrel A1 shown in Figure 5C, some of the reinforcing member 6 surrounds both the primary mandrel 2a and the secondary mandrel 2b, and some of the reinforcing member 6 surrounds only the primary mandrel 2a. For example, at position A1, an auxiliary lumen 18b is formed along the distal portion 24 (e.g., in the case of the tubular body 10 shown in Figures 1A and 1B), or two auxiliary lumens 18b are formed (e.g., in the case of the tubular body 11 shown in Figure 3). As will be further described elsewhere in this specification, the secondary mandrel 2b provides a steering element for each auxiliary lumen 18b, or alternatively, during assembly, the secondary mandrel 2b is removed and replaced by a steering element inserted into the auxiliary lumen 18b.

[0076] In contrast, at position A2, i.e., when the secondary mandrel 2b is guided, for example via the guide 66, to be immediately next to the primary mandrel 2a, all the reinforcing members 6 surround both the primary mandrel 2a and the secondary mandrel 2b, thereby positioning the secondary mandrel 2b as closest to the primary mandrel 2a along the tubular device 8. At position A3, i.e., when the secondary mandrel 2b is outside the path of the horn gear 72, for example outside the path 78 shown in Figure 5B, or positioned toward the primary mandrel 2a after the braiding operation, all the reinforcing members 6 surround only the primary mandrel 2a, and the secondary mandrel 2b remains outside all the reinforcing members 6, and is closest to the outer surface of the tubular device 8, for example, as shown in Figure 5C. For example, as shown in Figure 3, distal to the distal portion 24, the secondary mandrel 2b is moved to position A3, thereby allowing the secondary mandrel 2b to exit the tubular body 10, as will be further described elsewhere in this specification, thereby facilitating attachment to, for example, the tension ring 38.

[0077] Finally, at position A4, the secondary mandrel 2b is received within the features of the primary mandrel 2a, thereby positioning the secondary mandrel 2b within the main lumen 18a, as shown in Figure 5C. For example, the primary mandrel 2a may include a sealed lumen, an open groove, or other channel 3a extending along the longitudinal direction of the primary mandrel 2a corresponding to the intermediate portion 22 of the catheter 10, and the secondary mandrel 2b is received within the channel 3a, thereby allowing the liner 40 and reinforcing member 42 to be provided around the primary mandrel 2a while the secondary mandrel 2b remains within the channel 3a, and allowing the auxiliary lumen to be omitted along that section.

[0078] Optionally, as shown in Figure 5A, a jacket supply source 90 can be provided to provide one or more layers of jacket material around the mandrel 2 around which the reinforcing material is wound. For example, a co-extruder, laminator, or other applicator can be provided to supply molten, uncured and / or untreated jacket material 7 from a hopper or other container (not shown), or a roll of jacket material 7 can be wound around the reinforcing member 43 and the mandrel 2. Exemplary materials for the jacket material 7 include, for example, plastics, thermoplastics such as polyether block amide, nylon or urethane, thermosetting plastics, metals or composite materials. Alternatively, other processes can be used to bond or otherwise attach the jacket material 7 to the liner material 4 and / or embed the reinforcing member 43 into the jacket material 7, thereby obtaining a tubular body 9 with a single structure. The resulting tubular body 9 (with or without the jacket material 7) can be collected, for example, on a collection reel or in a container (not shown).

[0079] Subsequently, the tubular body 9 may be further processed to manufacture devices such as the apparatus 8 shown in Figures 1A and 1B. Other components may also be added to individual tubular devices as needed for specific applications, as described elsewhere in this specification.

[0080] Referring to Figure 6, an exemplary method for manufacturing a single-piece tubular body, such as the tubular body 11 shown in Figure 3, is illustrated. To facilitate the manufacture of the tubular body 11, a primary mandrel 102 can be used whose cross-section changes along its longitudinal direction to correspond to various parts or sections of the tubular body 11. This variable cross-section allows for the substantially continuous braiding of reinforcing members along the longitudinal direction of the primary mandrel 102, thereby enabling, for example, the fixing of liner material (not shown) around the mandrel 102, while simultaneously allowing the addition, movement, and / or removal of one or more secondary mandrels along one or more sections of the primary mandrel 102.

[0081] For example, as shown in Figure 6, the primary mandrel 102 may have a first section 112 and a second section 114 having different dimensions. In the illustrated example, the first section 112 has a substantially uniform cross-section along its length from the first end 102a of the primary mandrel 102 to the second section 114. For example, as shown in Figure 6A, the first section 112 may define a substantially uniform diameter C1 along its length, but alternatively, the first section may have an elliptical or other non-circular cross-section (not shown) as needed. The first section 112 may have a length corresponding to the middle and / or proximal portion of the tubular body, for example, including at least the middle portion 22 of the tubular body 10 shown in Figures 1A and 1B.

[0082] The second section 114 may have a smaller cross-section than the first section 112. For example, as shown in Figure 6A, the second section 114 may have a cross-sectional dimension C2 smaller than the diameter C1 (both in directions perpendicular to the longitudinal axis 120). In the illustrated example, the second section 114 may include a pair of substantially flat surfaces 116 extending along the longitudinal direction of the second section 114, spaced apart from each other and defining dimension C2. As a result, a step or other transition area 113 is provided between the first and second sections 112, 114, and a pair of end walls 115 transitioning between the two cross-sections C1, C2 are defined. The width of the second section 114 (in the direction perpendicular to dimension C2) may be the same as or less than dimension C1.

[0083] Furthermore, one or more lumens, grooves, or other channels may be provided in the primary mandrel 102 to accommodate at least a portion of one or more secondary mandrels. For example, as shown, each end wall 115 may include an opening that communicates with a sealed lumen 118 extending substantially parallel to the longitudinal axis 120 of the primary mandrel 102. Each lumen 118 may extend axially for a relatively short distance from the end wall 115 into the first section 112, for example, along the intermediate section 113. Alternatively, each channel may extend along the entire length of the first section as needed (not shown).

[0084] During assembly, the first end 102a of the primary mandrel 102 is fed into the braiding device, for example, via a guide 66 of the braiding device 60 shown in Figure 5A, and multiple reinforcing members 43 are braided around the first section 112 of the primary mandrel 102 on a liner (not shown), or otherwise wrapped, for example, as described elsewhere in this specification. As the reinforcing members 43 approach the transition region 113, the first end 104a of the secondary mandrel 104 is inserted into each lumen 118 so that the secondary mandrel 104 extends along the second section 114, for example, as shown in Figure 6. For example, the secondary mandrel 104 can extend from a passage 73a via one of the horn gears 72a in the braiding device 60, i.e., the secondary mandrel 104 is provided at position A1 shown in Figure 5B, adjacent to the second section 114. Subsequently, as the reinforcing member 43 is wrapped around the second section 114, the secondary mandrel 104 is incorporated into the resulting braid, with some of the reinforcing member 43 passing above and below the secondary mandrel 104 along the second section 114.

[0085] As a result, the reinforcing members 43 and any liners surrounding the primary mandrel 102 (not shown in Figure 6 for clarity) are positioned along the contour of the primary mandrel 102, resulting in transitions between the first and second sections 112, 114, corresponding, for example, to the transitions between the first and second segments 18a1, 18a2 and the end wall 21 of the main lumen 18a shown in Figure 3.

[0086] If necessary, distal to the second section 114, the secondary mandrel 104 is moved to position A3 shown in Figure 5B, for example, so that the secondary mandrel 104 is located outside the braid of the reinforcing member 43 to provide the extension 27 as shown in Figure 3. This arrangement creates an opening 23 that serves as an exit from the auxiliary lumen 18b, thereby facilitating the attachment of the steering element 36 to the tension ring 38 positioned on the extension 27, for example, as shown in Figure 3 and as further described herein.

[0087] Optionally, if necessary, the apparatus 60 may be used to provide an outer layer around the braided mandrel assembly during or immediately after the braiding operation, or the braided assembly may be separated from the braiding apparatus for further processing. For example, as shown in Figure 3, an outer layer 44 can be provided around a reinforcing member (not shown), thereby forming walls for the intermediate and distal portions 22, 24. At any point, the reinforcing member 43 distal to the second section 114 of the primary mandrel 102 can be cut or otherwise severed to obtain a braided assembly that can be further processed.

[0088] In one example, to create a braided assembly similar to the example shown in Figure 4, the primary and secondary mandrels 102 and 104 are removed after the braiding process shown in Figure 6, and then the steering elements 36 are introduced into the braided assembly, for example, through the resulting main lumen 18a into each auxiliary lumen 18b. Then, a tension ring 38 is positioned adjacent to the distal portion 24, for example, on the extension portion 27, and the distal end 36b of the steering element 36 is attached to this tension ring 38. Each steering element 36 may have a length sufficient to allow its proximal end 36a to extend from the proximal end of the braided assembly for connection to an actuator in a handle (not shown), for example, as described elsewhere in this specification.

[0089] The distal end 54 of the compression resistance member 50 is inserted into the main lumen 18a from above each steering element 36 and advanced until the distal end 54 is positioned adjacent to the end wall 21 and / or other transitions. The compression resistance member 50 may have sufficient length for its proximal end 52 to extend from the proximal end of the braided assembly, for example, to be positioned adjacent to a stop in a handle (not shown), as in examples described elsewhere in this specification.

[0090] Alternatively, instead of adding steering elements after removing the secondary mandrel 104 as shown in Figure 6, the secondary mandrel is used as the steering element. In this alternative example, the primary mandrel 102 extends along the length of the first section 112 and includes channels (not shown) to receive each secondary mandrel steering element, and the secondary mandrel is positioned along the first section 112 inside the reinforcing member and liner. The secondary mandrel is positioned at position A1 at the transition to the second section, so that the secondary mandrel is woven into the reinforcing member as described above. Optionally, a tubular member (not shown) extending along the distal portion and having sufficient length to define the inner diameter of the auxiliary lumen 18b is positioned around the secondary mandrel. This tubular member can be removed at any time after assembly, thereby creating space around the secondary mandrel and allowing the secondary mandrel to slide freely within the auxiliary lumen.

[0091] The distal end of the secondary mandrel is positioned distal to the distal portion, allowing it to be attached to the tension ring, thereby providing a steering element. When the primary mandrel 102 is removed, the length portion of the secondary mandrel in the channel simply slides along the channel as the primary mandrel 102 is pulled out, resulting in the secondary mandrel being released within the main lumen 18a. The secondary mandrel is made long enough to extend from the resulting tubular member in order to reconnect to the actuator. Subsequently, the compression resistance member is advanced into the main lumen from above the secondary mandrel, which here has become the steering element, in the same manner as described above.

[0092] Figure 4 shows an example of a tubular body 9 obtained by these methods. The tubular body 9 may include an outer layer (not shown for clarity) if the outer layer is provided before the primary mandrel 102 (and secondary mandrel if a separate steering element is added). Alternatively, if the tubular body 9 is assembled without an outer layer, i.e., has a liner (not shown), a reinforcing layer 42, a steering element 36, a compression resistance member 50 and a tension ring 38, the outer layer may be provided later as needed.

[0093] The resulting tubular body 9 can be incorporated into a finished device, such as the apparatus 8 shown in Figures 1A and 1B, by adding one or more additional components for the outer layer as needed, and one or more tip segments (not shown) on, for example, the tension ring 38. Subsequently, additional components, such as a handle 50 and its components to be attached to the proximal end of the tubular body 9 as needed, can be added to the assembly. Optionally, other components, such as one or more sensing elements, electrodes, balloons, etc. (not shown), can be added to the catheter as needed.

[0094] Referring to Figure 7, another example of the tubular body 210 is shown, which is formed as a single unit and includes various parts or sections having various cross-sections and / or configurations between the first and second ends of the tubular body 210. For example, as shown, the tubular body 210 includes a first part 212 corresponding to the intermediate and / or proximal portions 22, 20 of the catheter shaft of the device 8 shown in Figures 1A and 1B, for example, and a second part 214 corresponding to the steerable distal portion 24, for example, and extending axially along the longitudinal axis 216 of the tubular body 210. The first part 212 extends axially from the first end of the tubular body 210 (not shown on the left side of Figure 7) to the first end wall or transition 221a. Along the first part 212, the tubular body 210 includes a single lumen, i.e., a first segment 218a1 of the main lumen 21a. The first segment 218a1 may have a substantially circular cross-section as shown in the figure, or any other desired cross-section, which may be substantially uniform along the length of the first portion 212, or may vary, as in other examples.

[0095] The first portion 212 can be configured in the same manner as other examples herein and may include, for example, an inner liner 240 surrounding the main lumen 18a, a reinforcing layer 242 including a plurality of reinforcing members 243 braided around the liner 240 along the longitudinal direction of the first portion 212, and an outer jacket or layer 244.

[0096] The second portion 214 includes a second segment 218a2 of the main lumen 218a, which communicates with the first segment 218a1 and extends along the longitudinal axis 216 toward the second end of the tubular body 210 (e.g., ending at an extension 227). The second portion 214 includes a first auxiliary lumen 218b1 that extends along the second portion 214 adjacent to the second segment 218a2 toward the extension 227 from a first or proximal opening 219a of the first end wall or other transition 221a between the first and second portions 212, 214. For example, the first auxiliary lumen 218b1 may extend from the proximal opening 219a to a second or distal opening 223a adjacent to the extension 227.

[0097] Furthermore, unlike the example described above, the second portion 214 includes a second auxiliary lumen 218b2 extending toward the extension 227 from a second end wall or transition 221b adjacent to the second segment 218a2, for example, to a second or distal opening 223b adjacent to the extension 227. As shown in the figure, the second end wall 221b is positioned axially spaced from the first end wall 221a, for example, closer to the extension 227 than the first portion 212. The second auxiliary lumen 218b2 is offset circumferentially from the first auxiliary lumen 218b1, for example, by about 180 degrees (180°) around the longitudinal axis 216. The second auxiliary lumen 218b2 has a shorter axial length than the first auxiliary lumen 218b1, but the second openings 223a, 223b can be positioned axially aligned adjacent to the extension 227. As a result, steering elements (not shown) introduced through auxiliary lumens 218b1 and 218b2 can be coupled to the same tension ring or other end (not shown) attached to the extension 227, as with other devices in this specification.

[0098] As best shown in Figure 7C, the main lumen 218a may include a third segment 218a3 along the distal portion 214, which includes a second auxiliary lumen 218b2, and which is smaller than the second segment 218a2 (Figure 7B), and which is smaller than the first segment 218a1 in the first portion 212 of the tubular body 210. The structure of the wall of the tubular body 210 along the second portion 214 is similar to that of other devices in this specification and may include, for example, an inner liner 240 surrounding the main lumen 218a, a reinforcing layer 242, and an outer jacket or layer 244. In the illustrated example, the auxiliary lumens 218b1 and 218b2 extend through the reinforcing layer 242 and, for example, are woven into the reinforcing layer 242, so that, as with other devices described herein and in the literature referenced herein, some reinforcing members 243a surround only the main lumen 218a, and some reinforcing members 243b surround both the auxiliary lumens 218b1 and 218b2 and the main lumen 218a.

[0099] As a result, the tubular body 210, like other tubular bodies described elsewhere in this specification, may include a continuous braid of reinforcing members 243 wound around both the first and second portions 212, 214, so that the tubular body 210 is formed as a single structure containing lumens 218a, 218b within it. As with other tubular bodies in this specification, by adding steering elements, compression resistance members, tension rings, ends and / or other components (not shown) to the tubular body 210, a finished device such as the apparatus 8 shown in Figures 1A and 1B can be obtained.

[0100] For example, as shown in Figure 7D, the steering element 236 is received into the respective auxiliary lumens 218b1, 218b2 through openings 219a, 219b via a first segment 218a1 of the main lumen 218a, and the distal end 236b of this steering element 236 is attached to a tension ring 238 mounted on an extension 227, as with other devices in this specification. Furthermore, compression resistance members 250 are positioned on each steering element 236, with their distal ends 254 abutting against or otherwise adjacent to the end walls 221a, 221b.

[0101] Optionally, the liner 240 of the tubular body 210 can electrically insulate elements or devices within the main lumen 218a from components of the tubular body 210 outside the liner 240. PTFE or FEP may be ideal materials for the liner 240 due to their excellent dielectric strength and low friction. Alternatively, in such applications, PEBAX, urethane, or other thermoplastic materials may provide better braiding integrity and encapsulation than fluoropolymers.

[0102] To manufacture the tubular body 210 shown in Figure 7, a primary mandrel having steps on both sides, i.e., a primary mandrel containing multiple steps or transition regions spaced apart from each other in the axial direction, can be used. This forms auxiliary lumens 218b1, 218b2 with axially offset proximal openings 219a, 219b, resulting in a main lumen with a "double D" shape. Such a structure allows compression coil stops, e.g., end walls 221a, 221b, to be formed and positioned at different axial locations, and allows steering elements (not shown) housed within each auxiliary lumen 218b1, 218b2 to be coupled to the same tension ring. The resulting configuration of the steering elements results in different deflection section lengths when each steering element is in operation, thereby obtaining different bending radii / diameters.

[0103] Such a configuration allows for multiple or more complex curvature shapes to be imparted to the steerable portion of the resulting device. This can be useful in many situations where the required reach and radius of curvature differ depending on the range of anatomical structures encountered and / or the relationship with the access site. Furthermore, the asymmetry allows for a longer reach and / or larger curvature (for a given deflection angle) on one side (operating one steering element) and a shorter curvature on the other side (operating the other steering element). For example, when accessing from the atrial septum, the required reach for the right pulmonary vein may differ from that for the left pulmonary vein, where a longer reach is advantageous. When accessing the left ventricle through the mitral valve, the ventricular wall is closer to the mitral valve on one side than on the other. Asymmetrical deflection allows the operating physician or other user to use one curvature and the other curvature as needed in the same case and with the same device.

[0104] Alternatively, symmetrical deflection can also be easily achieved if the end walls / stops are formed and / or positioned in the same axial direction. For example, it should be noted that it is also possible to implement three or more stop / pull wires to achieve deflection in multiple directions using the same structure and method described above.

[0105] In the example shown in Figure 7, the main lumen 218a may have a “double D” cross-section along the second portion 214. For example, the second segment 218a2 of the main lumen 218a, along the portion containing only the first auxiliary lumen 218b1 (shown in Figure 7B), may define a “D”-shaped cross-section as a whole, including a substantially straight or flat wall adjacent to the auxiliary lumen 218b1 and a semicircular or other curved wall opposite the flat wall, for example, a wall following the curve on the outside of the tubular body 210. The third segment 218a2 of the main lumen 218a, along the portion containing both the first and second auxiliary lumens 218b1, 218b (shown in Figure 7C), may include a substantially rectangular cross-section, including substantially flat walls adjacent to both auxiliary lumens 218b1, 2182 and a curved wall between the flat walls.

[0106] Figures 8A to 11B show variations in the cross-section that may be provided to a main lumen along a portion containing one or two auxiliary lumens on either side of the main lumen. For example, in Figures 9A and 9B, the main lumen includes a concave wall adjacent to one or both auxiliary lumens, while in Figures 10A and 10B, the main lumen may include a convex wall adjacent to one or both auxiliary lumens. Alternatively, in Figures 11A and 11B, the main lumen may include a "V"-shaped wall adjacent to each auxiliary lumen, allowing the shape of the main lumen to change as it passes through the portion containing one or both auxiliary lumens. This shape of the inner wall of the main lumen facilitates holding a steering element passing through the main lumen centrally and / or increases the space within the tubular body for accommodating other components of the finished device, such as one or more wires, cables, etc. (not shown).

[0107] Referring to Figures 14A–14C, an exemplary tension ring 438 is shown, which is attached to the distal end of a tubular device, such as a device described elsewhere in this specification. This tension ring can be connected to a single elongated wire or cable to provide a pair of steering elements 436. For example, the tension ring 438 is attached to or on the extension at the end of the steerable portion of the tubular body, for example, distal to the distal portion 24 of the tubular body 11 shown in Figure 3. In the illustrated example, a single cable is used for both steering elements 436, with the middle portion of this cable passing through the tension ring 438 and / or being fixed to the tension ring. The length of the cable is such that, as with the separate steering element 36 shown in Figure 3, for example, both ends pass through their respective auxiliary lumens 18b and primary lumens 18a. For example, the middle portion of the cable is received through a recess in the tension ring and then fixed by one or more of the following: crimping, adhesive bonding, welding, etc.

[0108] The various examples disclosed above are presented for illustrative and explanatory purposes only. They are not intended to be exhaustive or to limit the invention to the exact form of the disclosure. Many variations and modifications of the embodiments described herein will be apparent to those skilled in the art in light of the above disclosure.

[0109] Furthermore, in describing representative embodiments, this specification presents methods and / or processes as specific sequences of steps. However, a method or process should not be limited to a specific sequence of steps described herein unless the method or process depends on a specific order of steps described herein. Those skilled in the art will understand that other sequences of steps are also possible. Therefore, the specific order of steps described in the specification should not be construed as limiting the claims.

[0110] While the present invention is capable of various modifications and alternative forms, specific examples are shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to any particular form or method disclosed, and encompasses all modifications, equivalents, and alternatives that fall within the scope of the appended claims.

Claims

1. A device for performing procedures inside a patient's body, A tubular member comprising a proximal end, a distal end sized to be introduced into the patient's body, a longitudinal axis extending between the proximal end and the distal end, an intermediate portion partially extending between the proximal end and the distal end, and a distal portion extending distally from the transition between the intermediate portion to the distal end, A main lumen extending between the proximal end and the distal end, An auxiliary lumen extends adjacent to the main lumen along the distal portion from the opening of the transition section communicating with the main lumen to the distal end, A steering element comprising: a first portion slidably disposed within the auxiliary lumen and terminating at a first end fixed to the distal end distal to the auxiliary lumen; and a second portion passing proximal through the opening into the main lumen and extending to a second end adjacent to the proximal end; An actuator provided at the proximal end and connected to the second end of the steering element, wherein the actuator, when operated, applies axial tension or compression to the first portion of the steering element, thereby bending the distal portion, The apparatus is characterized by comprising a compression resistance member positioned around a first portion of the steering element within the main lumen between the transition portion and the proximal end, for preventing the force from the steering element from being transmitted to the tubular member proximal to the distal portion.

2. In the apparatus according to claim 1, The apparatus is characterized in that the main lumen has a first segment that defines a first inner diameter or cross-sectional dimension along the intermediate portion, and a second segment that defines a second inner diameter or cross-sectional dimension smaller than that of the first segment along the distal portion.

3. In the apparatus according to claim 2, The apparatus is characterized in that the main lumen includes an end wall in the transition section, and the transition from the first segment to the second segment occurs at this end wall.

4. In the apparatus described in claim 3, The device is characterized in that the end wall extends substantially perpendicular to the longitudinal axis.

5. In the apparatus according to claim 2, The apparatus is characterized in that the second segment communicates with the outlet at the distal tip of the distal end.

6. In the apparatus according to claim 1, The intermediate portion includes a plurality of reinforcing members, each including a winding that is spirally wound around the main lumen within the wall of the intermediate portion. The apparatus is characterized in that the distal portion includes a plurality of reinforcing members, each containing a winding spirally wound within the wall of the distal portion, at least a portion of the winding passes between the main lumen and the auxiliary lumen, and at least a portion of the winding surrounds both the main lumen and the auxiliary lumen.

7. In the apparatus according to claim 6, The apparatus is characterized in that the plurality of reinforcing members are continuously braided along the intermediate and distal portions.

8. In the apparatus according to claim 6, The apparatus is characterized in that the first end of the steering element is positioned distal to the distal portion and radially outward of the plurality of reinforcing members.

9. In the apparatus according to claim 8, The apparatus further includes a tension ring fixed to the distal end distal to the distal portion, wherein the first end of the steering element is attached to the tension ring.

10. A device for performing procedures inside a patient's body, A tubular member comprising a proximal end, a distal end sized to be introduced into the patient's body, a longitudinal axis extending between the proximal end and the distal end, an intermediate portion partially extending between the proximal end and the distal end, and a distal portion extending distally from the transition between the intermediate portion to the distal end, A main lumen extending between the proximal end and the distal end, having a first segment along the intermediate portion defining a first inner diameter or cross-sectional dimension, and a second segment along the distal portion defining a second inner diameter or cross-sectional dimension smaller than that of the first segment, An auxiliary lumen extends adjacent to the main lumen along the distal portion from the opening of the transition section that communicates with the main lumen to the distal end, A steering element comprising: a first portion slidably disposed within the auxiliary lumen and terminating at a first end fixed to the distal end distal to the auxiliary lumen; and a second portion passing proximal through the opening into the main lumen and extending to a second end adjacent to the proximal end; An actuator provided at the proximal end and connected to the second end of the steering element, wherein the actuator, when operated, applies axial tension or compression to the first portion of the steering element, thereby bending the distal portion, A compression resistance member is provided, positioned within the main lumen between the transition portion and the proximal end, to prevent the force from the steering element from being transmitted to the tubular member proximal to the distal portion. The apparatus is characterized by comprising a plurality of reinforcing members continuously braided along the intermediate and distal portions, wherein the plurality of reinforcing members include a winding that is spirally wound within the wall of the distal portion along the distal portion, at least a portion of the winding passes between the main lumen and the auxiliary lumen, and at least a portion of the winding surrounds both the main lumen and the auxiliary lumen.

11. In the apparatus according to claim 10, The apparatus is characterized in that the main lumen includes an end wall in the transition section, and the transition from the first segment to the second segment occurs at this end wall.

12. In the apparatus according to claim 11, The device is characterized in that the end wall extends substantially perpendicular to the longitudinal axis.

13. In the apparatus according to claim 10, The apparatus is characterized in that the first end of the steering element is positioned distal to the distal portion and radially outward of the plurality of reinforcing members.

14. In the apparatus according to claim 10, The apparatus is characterized in that the auxiliary lumen is a first auxiliary lumen, and the tubular body further includes a second auxiliary lumen that extends along the distal portion adjacent to the main lumen from the second opening of the second transition section toward the distal end.

15. In the apparatus according to any one of claims 3, 4, 11, or 12, The apparatus is characterized in that the distal end of the compression resistance member is in contact with the end wall.

16. In the apparatus according to claim 15, The apparatus is characterized in that the distal end of the compression resistance member is positioned on the steering element in an unrestrained state in the immediate vicinity of the end wall.

17. In the apparatus according to claim 16, The apparatus is characterized in that the radial dimension of the end wall is smaller than the diameter of the distal end of the compression resistance member, and only a portion of the distal end of the compression resistance member contacts the end wall.

18. In the apparatus according to claim 16, The apparatus further includes a stop adjacent to the proximal end of the tubular member for preventing the proximal end of the compression resistance member from moving in the proximal direction.

19. In the apparatus according to claim 18, The apparatus is characterized in that the stop is configured to apply an axial compressive force between the proximal end of the compression resistance member that contacts the stop and the distal end of the compression resistance member that abuts against the end wall.

20. In the apparatus according to any one of claims 3, 4, 11, or 12, The apparatus is characterized in that the distal end of the compression resistance member is fixed axially to the end wall.

21. In the apparatus according to any one of claims 1 to 13, The apparatus is characterized in that the compression resistance member includes a coil that surrounds the steering element between the proximal end of the tubular member and the transition portion.

22. In the apparatus according to claim 21, The apparatus is characterized in that the coil includes one of the following: a tightly wound coil, a reverse-wound coil tube, a coil tube to which a tension element is attached, and a laser-cut tube.

23. In the apparatus according to any one of claims 1 to 13, The apparatus is characterized in that the compression resistance member includes a distal end located in the immediate vicinity of the transition portion, and a distal portion is defined between the distal end of the compression resistance member and the distal end of the tubular member.

24. In the apparatus according to any one of claims 1 to 13, The device is characterized in that the compression resistance member includes a distal end fixed to the tubular member at a position adjacent to the transition portion so that the force from the steering element is transmitted to the distal portion, thereby causing the distal portion to deflect when an axial force is applied to the steering element.

25. In the apparatus according to any one of claims 1 to 13, The apparatus further includes a stop provided adjacent to the proximal end of the tubular member, for preventing the proximal end of the compression resistance member from moving in the proximal direction.

26. In the apparatus according to any one of claims 1 to 13, A handle connected to the aforementioned proximal end, An actuator provided on the handle and connected to the second end of the steering element, The apparatus further comprises a stop fixed within the handle and positioned adjacent to the proximal end of the compression resistance member, the stop being used to limit the compression of the tubular member by bending when the distal end of the compression resistance member contacts the stop.

27. In the apparatus according to any one of claims 6 to 13, The apparatus is characterized in that the tubular member includes one or more layers surrounding the plurality of reinforcing members.

28. In the apparatus according to any one of claims 1 to 13, The apparatus is characterized in that the main lumen includes a liner that defines the inner surface of the main lumen.

29. In the apparatus according to claim 28, The apparatus is characterized in that the liner includes a lubricating coating on its inner surface.

30. In the apparatus according to claim 28, The apparatus is characterized in that the liner contains PTFE or a fluoropolymer.

31. In the apparatus according to claim 28, The apparatus is characterized in that the liner has a hydrophobic coating on its inner surface that does not contain PFAS.

32. In the apparatus according to any one of claims 1 to 13, The apparatus is characterized in that the auxiliary lumen includes a liner that defines the inner surface of the auxiliary lumen.

33. A tubular body with a single-part structure for medical use, A first portion including a first main lumen segment, wherein the first main lumen segment extends from a first end of the tubular body along the longitudinal axis of the first portion, A second portion adjacent to the first portion, comprising a second main lumen segment communicating with the first main lumen segment and extending toward the second end of the tubular body along the longitudinal axis, and an auxiliary lumen extending toward the second main lumen segment and toward the second end from the opening of the transition between the first and second portions toward the second end, A tubular body characterized by comprising a plurality of reinforcing members continuously braided along the first and second portions.

34. In the tubular body according to claim 33, A tubular body characterized in that the plurality of reinforcing members include a winding that is spirally wound within the wall of the distal portion along the second portion, at least a portion of the winding passes between the second main lumen segment and the auxiliary lumen, and at least a portion of the winding surrounds both the main lumen and the auxiliary lumen.

35. In the tubular body according to claim 33, A tubular body further comprising a liner surrounding the first and second main lumen segments.

36. In the tubular body according to claim 35, A tubular body characterized in that the liner extends continuously between the first and second ends of the tubular body and includes a liner material that surrounds the first and second main lumen segments.

37. In the tubular body according to claim 33, The tubular body is characterized in that the auxiliary lumen is a first auxiliary lumen, and the tubular body further includes a second auxiliary lumen that extends along the second portion adjacent to the second main lumen from the second opening of the transition portion toward the second end.

38. In the tubular body according to claim 37, A tubular body characterized in that the second auxiliary lumen is located on the opposite side of the first auxiliary lumen around the outer circumference of the second portion.

39. In the tubular body according to claim 33, The tubular body is characterized in that the auxiliary lumen is a first auxiliary lumen, and the tubular body further includes a second auxiliary lumen that extends along the second portion adjacent to the second main lumen from the second opening of the second transition portion toward the second end.

40. In the tubular body according to claim 39, A tubular body characterized in that the second transition portion is located closer to the second end than the transition portion between the first and second sections, and the axial length of the second auxiliary lumen is shorter than that of the first auxiliary lumen.

41. In the tubular body according to claim 39 or 40, A tubular body characterized by further including an extension distal to the second portion that defines the second end of the tubular body.

42. In the tubular body according to claim 41, A tubular body characterized in that the plurality of reinforcing members are continuously braided from the second portion to the extended portion.

43. In the tubular body according to claim 41, A tubular body characterized in that the first and second auxiliary lumens define an outlet near the extension portion.

44. In the tubular body according to claim 43, A tubular body further comprising a tension ring, anchor, or tip attached to the extension near the outlet.

45. In the tubular body according to claim 44, A tubular body further comprising first and second steering elements slidably received within the first and second auxiliary lumens, respectively, wherein each steering element has a distal end connected to the tension ring, anchor or tip, and a proximal end that enters the first main lumen segment through the respective first and second openings.

46. In the tubular body according to claim 45, A tubular body characterized in that the proximal end of each steering element exits the first main lumen segment at the first end of the tubular body.

47. In the tubular body according to claim 46, A first compression resistance member slidably disposed on the first steering element, wherein the distal end of the first compression resistance member is positioned adjacent to the opening in the transition portion between the first and second parts, A tubular body further comprising a second compression resistance member slidably disposed on the second steering element, wherein the distal end of the second compression resistance member is positioned adjacent to the opening of the second transition portion.

48. In the tubular body according to any one of claims 33 to 40, A tubular body further comprising an outer jacket that surrounds the plurality of reinforcing members along the first and second portions.

49. A method for manufacturing a tubular body, A step of providing a primary mandrel including a first section defining a first cross-sectional dimension and a second section defining a second cross-sectional dimension smaller than the first cross-sectional dimension, The steps include: braiding reinforcing members around the liner along the first section toward the second section; The steps include: positioning a secondary mandrel outside the primary mandrel at a location adjacent to the second section; A step of defining an auxiliary lumen by braiding the reinforcing member along the second section such that the secondary mandrel is included in the braid of the reinforcing member, The steps include applying an outer jacket around the primary mandrel after braiding the reinforcing members around the first and second sections, A method comprising the step of removing the primary mandrel to define a main lumen, wherein the main lumen includes a first segment corresponding to a first section of the primary mandrel and defining a first portion of the tubular body, and a second segment corresponding to a second section of the primary mandrel and defining a second portion of the tubular body, and the auxiliary lumen extends adjacent to the second segment and along the second portion.

50. In the method according to claim 49, A method characterized in that the secondary mandrel is positioned adjacent to the second section such that the first end of the secondary mandrel is inserted into the channel of the primary mandrel at the transition between the first and second sections, and the second end of the secondary mandrel extends along the second section outside the primary mandrel.

51. In the method according to claim 49, The steps include removing the secondary mandrel from the auxiliary lumen, A method comprising the step of inserting a steering element through a first segment of the primary mandrel and the auxiliary lumen, wherein the first end of the steering element is positioned outside the first portion of the tubular body and the second end of the steering element is positioned outside the second portion of the tubular body.

52. In the method according to claim 51, A method further comprising the step of attaching the second end of the steering element to a tension ring disposed at the end of the tubular body adjacent to the second portion.

53. In the method according to claim 49, The primary mandrel includes a third portion that defines a third cross-sectional dimension smaller than the second cross-sectional dimension, and the method is The steps include: positioning a second secondary mandrel outside the primary mandrel at a location adjacent to the third section; A method comprising the step of defining another auxiliary lumen by braiding the reinforcing member along the third section such that the second secondary mandrel is included in the braid of the reinforcing member.

54. In the method according to claim 49, A method further comprising the step of positioning another secondary mandrel outside the primary mandrel at a location adjacent to the second section, wherein the reinforcing member is braided along the second section such that the second secondary mandrel is included in the braid of the reinforcing member, thereby defining another auxiliary lumen.

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