Intravascular system including variable stiffness catheter with bending adjustability

Abstract

A system is provided that includes an elongate member and a bend adjustment assembly connected to the elongate member and configured to facilitate reconfiguration of the elongate member. The elongate member includes a first section and a second section distal to the first section, wherein the second section has a stiffness that can be increased or decreased via movement of a reinforcing member to reconfigure the elongate member.

Description

[0001] background This application claims priority to provisional application serial number 63 / 538,095, filed September 13, 2023; provisional application serial number 63 / 690,364, filed September 4, 2024; and provisional application serial number 63 / 691,442, filed September 6, 2024. The entire contents of each of these applications are incorporated herein by reference. Technical Field

[0002] This invention relates to catheter-based systems and methods, and more specifically to an adjustable-bend catheter having variable stiffness to allow controlled bending of the catheter during surgery. Background Technology

[0003] For various medical, diagnostic, and therapeutic purposes, access to the patient's blood vessels (which often involves taking a long and winding route) is necessary.

[0004] While various catheters have been developed to improve vascular access, there remains a need for a catheter that provides high precision and control during placement and use. Adjustable-bend catheters are known. In these adjustable-bend catheters, the length of the bending zone and its bending radius are fixed by their design, because when the bending mechanism, such as a cable or guidewire, is actuated, the catheter will bend in a predetermined shape and with a predetermined radius of curvature at a predetermined area.

[0005] It will be beneficial to provide adjustable bendable catheters with improved versatility, which will not only facilitate surgical procedures but also provide opportunities for use in a wider range of procedures. Summary of the Invention

[0006] This invention provides an adjustable-bend conduit that overcomes the problems and shortcomings of the prior art. Generally, this invention provides a conduit with adjustable stiffness, which is used to adjust the length of the bending zone and the bending radius of the conduit. Various embodiments of the conduit of this invention are discussed in detail below. In some embodiments, the conduit may include an integrated video camera.

[0007] In one aspect of the invention, a system is provided, and in some embodiments an endovascular system is provided, configured for use during surgical procedures such as endovascular surgery. The system includes: a catheter configured in one embodiment for insertion into a patient's blood vessel; an articulation (bending) assembly connected to the catheter and configured to facilitate catheter reconfiguration; and a reinforcement assembly. The catheter includes: a proximal segment and at least one adjustable-bend segment located distal to the proximal segment, wherein the proximal segment has a first stiffness, and the adjustable-bend segment has a second stiffness less than the first stiffness to facilitate bending of the adjustable-bend segment during catheter reconfiguration and prevent bending of the proximal segment. The reinforcement assembly is configured to move relative to the adjustable-bend segment to change (e.g., increase or decrease) the second stiffness and adjust (e.g., restrict) the bending of the adjustable-bend segment.

[0008] In some embodiments, the reinforcing component may be configured to move within the adjustable bending segment to increase the stiffness of a section of the adjustable bending segment and limit the bending of the adjustable bending segment. This movement may be relative to the adjustable bending segment, either inside or outside.

[0009] In some embodiments, the articulated motion (bending) assembly may include at least one articulated motion (bending member) and a tensioning mechanism. The at least one articulated motion member extends within and is secured to the conduit, and the tensioning mechanism is connected to the at least one articulated motion member such that, when the tensioning mechanism is actuated, a force is applied to the conduit via the at least one articulated motion member to facilitate reconfiguration of the conduit.

[0010] The tensioning mechanism in the embodiments disclosed herein may include one or both of a pushing mechanism (moving distally to achieve catheter bending) or a pulling mechanism (moving proximally to achieve catheter bending).

[0011] In a preferred embodiment, the catheter has a continuous and smooth outer surface without individual nodes for articulation relative to each other.

[0012] In some embodiments, at least one articulated motion member may extend substantially within the outer wall of the conduit.

[0013] In some embodiments, at least one articulated motion member may extend within a channel defined by the outer wall of the conduit.

[0014] In some embodiments, at least one articulated motion member may include: a) a first articulated motion member fastened to the conduit such that, upon actuation of the tensioning mechanism, the first articulated motion member causes deflection of the conduit in a first direction; and b) a second articulated motion member fastened to the conduit such that, upon actuation of the tensioning mechanism, the second articulated motion member causes deflection of the conduit in a second direction.

[0015] In some embodiments, the second direction may be substantially opposite to the first direction. Alternatively, the second direction may be in the same or other directions.

[0016] In some embodiments, the conduit may be configured such that the second stiffness of the adjustable bend segment is less than or equal to the first stiffness.

[0017] In some embodiments, the proximal segment may comprise a first material having a first hardness, and the adjustable bending segment may comprise a second material having a second hardness less than the first hardness.

[0018] In some embodiments, the first segment and the second segment are made of different materials to produce different stiffnesses. In some embodiments, the first segment and the second segment have different layers to produce different stiffnesses.

[0019] In some embodiments, the reinforcing assembly may include a pushing member (e.g., an elongated member, such as a push rod, a push guide wire, a hypotube, etc.) and a reinforcing member fastened to the pushing member such that movement of the pushing member causes a corresponding movement of the reinforcing member. In other embodiments, the reinforcing assembly may include a pulling member that is pulled to move the reinforcing member.

[0020] In some embodiments, the reinforcing component may be pulled and / or pushed.

[0021] In some embodiments, the reinforcing component may include more than one member that can move together or separately and can extend along the same length of the conduit, can extend along different (e.g., different) lengths of the conduit, and / or can partially overlap.

[0022] In some embodiments, the intravascular system may further include a controller connected to the actuating component and configured to cause axial movement of the reinforcing component within the adjustable bend segment, thereby adjusting the length of the adjustable bend segment.

[0023] In some embodiments, the articulated motion component may be connected to a controller.

[0024] In some embodiments, the adjustable bending segment may include at least one shape memory material such that the adjustable bending segment presents a predetermined configuration when exposed to external stimuli or when external constraints are removed.

[0025] In another aspect of the invention, a system is provided configured for use during surgery. The system includes an elongated member and an articulated motion (bending) assembly connected to the elongated member and configured to facilitate reconfiguration of the elongated member. The elongated member includes a first segment and a second segment located distal to the first segment, wherein the second segment has variable stiffness that can be changed, i.e., increased or decreased, to affect the reconfiguration of the elongated member. The stiffness is increased or decreased to increase or decrease bending, thereby affecting the bending radius of the second segment.

[0026] In some embodiments, the second segment may comprise at least one shape memory material. In some embodiments, the at least one shape memory material may respond to external stimuli such that the variable stiffness of the second segment increases upon exposure to the external stimulus or removal of the external constraint.

[0027] In some embodiments, the shape memory material can cause the second segment to form a certain configuration (e.g., a bend with a specific shape) when the elongated member is reconfigured.

[0028] In some embodiments, different laser cutting techniques can be used to cut the sodium hypochlorite tube. The sodium hypochlorite tube can have different cutting patterns. The sodium hypochlorite tube can be incorporated into the wall of the device. The sodium hypochlorite tube can be fully circumferential or partially circumferential.

[0029] In some embodiments, the elongated member may include at least one chamber located within the second segment and configured to receive fluid (or other suitable substance) from a source such that the second segment changes (i.e., increases or decreases) in stiffness as fluid (substance) is delivered into the at least one chamber.

[0030] In some embodiments, at least one chamber may include a plurality of chambers that may be along the same length of the elongated member, along different lengths of the elongated member, and / or may partially overlap. In such embodiments, fluid (substance) may be delivered to and / or removed from one or more of the plurality of chambers to further increase control over the stiffness of the second segment.

[0031] In some embodiments, the first segment may comprise a first material having a first hardness, and the second segment may comprise a second material having a second hardness less than the first hardness, such that the second segment has a stiffness less than that of the first segment. Variations in stiffness within a segment may further affect bending and straightening, as well as shape.

[0032] In some embodiments, the elongated member is a catheter; in other embodiments, the elongated member is an endoscope.

[0033] In some embodiments, the system may further include at least one reinforcing component that is axially movable within the second segment to increase or decrease the stiffness of the second segment.

[0034] In another aspect of the invention, a method for performing surgery such as endovascular surgery is provided. The method includes: a) inserting a catheter (or endoscope) into a blood vessel or luminal organ in a first configuration, wherein the catheter includes: a first segment and a second segment located distal to the first segment; b) advancing the catheter toward a target site; c) actuating an articulated motion (bending) assembly connected to the catheter to thereby reconfigure the catheter from the first configuration to a second configuration via bending of the second segment; and d) increasing the stiffness of the second segment before or after step (c) to alter (e.g., reduce) the bending of the second segment.

[0035] In some embodiments, increasing the stiffness of the second segment may include axially advancing the reinforcing component within the second segment (e.g., within a region of the second segment, inside or outside the second segment).

[0036] In some embodiments, increasing the stiffness of the second segment may include exposing the second segment to external stimuli.

[0037] In some embodiments, increasing the stiffness of the second segment may include delivering fluid (or other suitable substance) into at least one chamber located within the second segment. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of an intravascular system according to the principles of the present invention, which includes: a catheter; an articulated motion (bending) assembly; and a reinforcement assembly.

[0039] Figure 2 For along Figure 1 The horizontal cross-section diagram taken from line 2-2 in the figure.

[0040] Figure 3 for Figure 1 A schematic diagram of an alternative embodiment of the catheter (which includes a side hole).

[0041] Figure 4 for Figure 1 A schematic diagram of an alternative embodiment of the intravascular system, in which the articulated motion component includes a pair of articulated motion (bending) members.

[0042] Figure 5 For along Figure 4 The horizontal cross-section diagram taken from line 5-5 in the figure.

[0043] Figure 6This is a schematic diagram of an alternative embodiment of an intravascular system in which the catheter includes a retaining member (ring) fastened (connected) to an articulated motion assembly.

[0044] Figure 7 For along Figure 6 The horizontal cross-section diagram taken from line 7-7.

[0045] Figure 8 This is a schematic diagram of an alternative embodiment of an intravascular system (which includes a controller).

[0046] Figure 9A for Figure 1 A schematic diagram of a catheter shown in a deflected configuration and exhibiting a curvature of (approximately) 90 degrees.

[0047] Figure 9B for Figure 1 A schematic diagram of a catheter shown in a deflected configuration and exhibiting a curvature of (approximately) 180 degrees with a first radius of curvature.

[0048] Figure 9C for Figure 1 A schematic diagram of the catheter, shown in a deflected configuration and exhibiting a curvature of (approximately) 180 degrees with a second reduced radius of curvature.

[0049] Figure 10 for Figure 1 A schematic diagram of the conduit, shown in a deflected configuration, wherein the bending assembly is advanced to a first (axial) position.

[0050] Figure 11A for Figure 1 A schematic diagram of the conduit, shown in a deflected configuration, in which the bending assembly is advanced to a second (axial) position.

[0051] Figure 11B for Figure 1 A schematic diagram of the conduit, shown in a deflected configuration, in which the bending assembly is advanced to the third (axial) position.

[0052] Figure 12 for Figure 1 A schematic diagram of a catheter, shown as an alternative embodiment with reinforcing components.

[0053] Figure 13 for Figure 12 The side perspective view of the enhanced component.

[0054] Figure 14 for Figure 1 A schematic diagram of an alternative embodiment of a conduit containing at least one or more shape memory materials.

[0055] Figure 15 This is a schematic diagram of an alternative embodiment of an intravascular system in which the catheter includes at least one (internal) chamber in (fluid) communication with the source.

[0056] Figure 16 This is a transverse (horizontal) cross-sectional view taken along line 16-16. Detailed Implementation

[0057] This invention provides a system configured for use during procedures in which one or more blood vessels or luminal organs or similar structures are accessed and treated (e.g., to remove blockages, administer therapeutic compounds, perform biopsies, etc.). The system, such as an endovascular system, includes: a variable-stiffness, bendable (articulated) catheter configured for insertion into a patient's blood vessel (or other body region); and an articulated (bending) component fastened (connected) to the catheter and configured to facilitate bendable (articulated) catheter movement via reconfiguration (e.g., bending). The catheter includes: a proximal segment; a distal segment; and at least one bendable segment located between the proximal and distal segments. Multiple bendable segments are also contemplated, optionally separated from and / or partially or completely overlapping with non-bendable segments of various lengths. The stiffness of the adjustable bending segment (in whole or in part) can be increased or decreased during the use of the system (i.e., during the procedure of surgery, for example, before or after insertion into the body). This allows for a high degree of precision and control during the placement and orientation of the system, as it allows for changes in the length of the "bending zone" and alteration of the radius and / or shape of the bend.

[0058] In one embodiment, the system further includes a reinforcing component movable within the adjustable bend segment to alter the stiffness of the adjustable bend segment and thus facilitate or limit its bending. In such embodiments, to reduce (e.g., relative to the proximal segment) the stiffness of the adjustable bend segment and thus facilitate catheter bending during reconfiguration, it is conceivable that the catheter may include an outer wall having a reduced radial thickness within the adjustable bend segment. Alternatively or additionally, it is conceivable that the adjustable bend segment may have lower stiffness than the proximal segment (e.g., by incorporating a different construction material).

[0059] In another embodiment, the variable stiffness of the adjustable bending segment is achieved by incorporating one or more of at least one shape memory material that is responsive to external stimuli, such that the stiffness of the adjustable bending segment increases or decreases upon exposure to the external stimulus. It is conceivable that the shape memory material may allow the adjustable bending segment to form a certain configuration (e.g., a bend with a specific shape). In such embodiments, a mechanism may be incorporated to adjust the length of the adjustable bending segment, thereby adjusting the radius of curvature of the bend. In some embodiments, at least one thallium tube with various cut patterns incorporated into the device wall may be used to facilitate bends of a specific radius and / or shape.

[0060] In some embodiments, shape memory materials can induce the second segment to form a certain configuration (e.g., a bend with a specific shape) during reconfiguration of the catheter.

[0061] In another embodiment, the variable stiffness of the adjustable bending segment is achieved by including at least one recess or chamber within the adjustable bending segment and the at least one recess or chamber being configured to receive fluid (substance) from a source such that the stiffness of the adjustable bending segment increases and decreases accordingly as fluid (substance) is delivered into and out of the at least one recess.

[0062] In some embodiments described herein, featuring a movable reinforcing member preferably located substantially within the wall of the device, the reinforcing member, through the conduit, moves distally into the bend, increasing resistance to bending in that area, thereby reducing the length of the bend and producing a smaller radius bend. If the reinforcing member moves proximally, this increases the length of the bend, producing a larger radius bend. Various forms of reinforcing members can be provided, such as, for example, one or more guidewires, one or more full-circumferential or partial-circumferential hypotubes, etc. The reinforcing element is preferably attached at least one connector, such as a guidewire or post, at least at its proximal end, which can be adjusted by pulling or pushing to adjust the position of the reinforcing member. The connector is preferably attached to a mechanism on a handle near one end of the device, which further incorporates a mechanism for moving the connector.

[0063] Although the systems and methods described herein are generally discussed in the context of catheters, the principles of this disclosure can be applied to monitors, instruments or other such medical devices.

[0064] As used herein, the term "proximal" refers to the section, part, component, etc., closer to the user, and the term "distal" refers to the section, part, component, etc., farther from the user. The terms "articular motion" and "bending" are used interchangeably in this document.

[0065] Turning now to the accompanying drawings (where the same reference numerals identify similar structural features of the devices and systems disclosed herein) and initial reference... Figure 1 The image illustrates an endovascular system 10 configured for use during endovascular surgery. More specifically, the endovascular system 10 includes: a catheter (elongated member) 100; an articulated movement (bending) assembly 200 operatively fastened (operatively connected) to the catheter 100 and configured to facilitate bending (articulated movement) of the catheter via reconfiguration (e.g., bending) of the catheter 100; and a reinforcement assembly 300.

[0066] It should be noted that the term articulated motion component can also be called a bending component or a bending adjustment component.

[0067] The catheter 100 is configured for insertion into a patient's blood vessels or other body spaces or cavities and may contain any suitable material or combination of materials. For example, it is conceivable that the catheter 100 may contain, alone or in combination, at least one metallic material (e.g., stainless steel, titanium, etc.) or at least one non-metallic material (e.g., plastic material, polymer material, composite material, etc.). Coils and / or braids with optional cut patterns and / or thiourea tubes may optionally be included along the entire length of the catheter 100 or along a portion of the length of the catheter 100.

[0068] The catheter 100 includes a body 102 defining a longitudinal axis X. More specifically, the body 102 includes an outer wall 104 defining a main (working) lumen 106 extending in a relationship generally parallel to the longitudinal axis X. Figure 2 The proximal (first) segment (region) 108 defines a proximal end hole 110; the distal (second) segment (region) 112 defines a distal end hole 114; and the adjustable bend (third, deflectable, intermediate) segment (region) 116 is located between the respective proximal segment 108 and distal segment 112, such that in this embodiment the adjustable bend segment 116 is located distal to the proximal segment 108, and the distal segment 112 is located distal to the adjustable bend segment 116. Figure 1 The dashed lines in (and other figures) provide an example of the boundaries of segments 112, 116, and 108. It should be understood that these boundaries provide an example, as segments of different lengths beyond those shown are also conceivable. As discussed below, these various segments can be formed from single conduits of different materials (different stiffnesses) (in some embodiments) or from separate conduit segments of different materials or stiffnesses fastened together. Variations can exist along length and / or circumference and / or combinations thereof.

[0069] Although generally shown and described as including a proximal segment 108, a distal segment 112, and an adjustable bend segment 116, embodiments of the catheter 100 without the distal segment 112 are also contemplated herein (e.g., embodiments where the adjustable bend segment 116 includes a distal end port 114), however, and these embodiments do not exceed the scope of this disclosure. The distal segment 112 is therefore an optional component of the catheter 100 and may be omitted in some embodiments. Additionally, multiple adjustable bend segments may be present along different lengths of the catheter. These may be along overlapping, non-overlapping, and / or partially overlapping lengths. The bend direction may also be optionally varied.

[0070] Although the main lumen 106 is shown to include a generally annular (i.e., circular) configuration, it should be understood that the specific configuration of the main lumen 106 and / or the external configuration of the catheter body (i.e., the configuration of the outer wall 104) may be varied in various embodiments of the catheter 100 without departing from the scope of this disclosure; for example, it may be oval, rectangular, etc.

[0071] In some embodiments such as Figure 3 In the illustrated embodiment, the catheter 100 may further include at least one or more side holes 118 that extend through the outer wall 104 to provide access to the main lumen 106. Figure 2 The passageway is described. For example, it is conceivable that the side port 118 may be configured to receive surgical instruments (e.g., a second catheter), allow fluid flow through it, or facilitate any other therapeutic effect. Although shown as including a single side port 118 located within the distal segment 112, it should be understood that the specific number, size, and shape of the side ports 118 and / or their location may be varied in alternative embodiments without departing from the scope of this disclosure, and the side ports 118 may be incorporated into any and / or all segments of the catheter 100. For example, embodiments in which the side ports 118 may be located within the proximal segment 108 or the adjustable segment 116 are conceivable, as are embodiments in which the catheter 100 may include multiple side ports 118 located in one or more (at least one) of the proximal segment 108, the distal segment 112, and / or the adjustable segment 116. In such embodiments, it is conceivable that the side ports 118 may be oriented at an angle (circumferential) alignment such that they are axially aligned, or that the side ports 118 may be offset at an angle (circumferential) from each other.

[0072] As described in further detail below, the stiffness of the conduit 100 is along the longitudinal axis X ( Figure 1The stiffness is altered, and preferably non-uniform, which improves access to the target site in the patient's body by increasing control over the configuration of the catheter 100 and thus its more precise placement and orientation. More specifically, the proximal segment 108 has a first stiffness, the adjustable-bend segment 116 has a second stiffness generally less than the first stiffness, which facilitates bending of the adjustable-bend segment 116 during reconfiguration of the catheter 100, and the distal segment 112 has a third stiffness, which is preferably greater than the second stiffness. Embodiments in which the third stiffness of the catheter in the various embodiments disclosed herein may be less than or equal to the second stiffness and / or greater than or less than the first stiffness are also contemplated herein. Within each segment, regional variations in stiffness are contemplated, and optionally may also exist.

[0073] In some embodiments, the catheter 100 may be integrally constructed (e.g., monolithically), such that the proximal segment 108, the distal segment 112, and the adjustable bend segment 116 each comprise the same material (e.g., formed of the same material). In such embodiments, the stiffness of the catheter 100 can be increased by reducing the radial thickness T of the outer wall 104 at one or more locations. Figure 2 This can be modified. For example, the conduit 100 can be configured such that the outer wall 104 defines a (first) radial thickness in the proximal segment 108, a (second) radial thickness in the adjustable bend segment 116 that is less than the radial thickness of the proximal segment 108, and a (third) radial thickness in the distal segment 112 (which may be less than or equal to the radial thickness of the proximal segment 108, but greater than the radial thickness of the adjustable bend segment 116). Variations in the braiding pattern of additional braided layers in the wall and / or changes in the cutting pattern of additional thiopanel tubes within the wall, as well as similar modifications to stiffness, are also conceivable.

[0074] Alternatively, the catheter 100 may have a multi-material construction, such that the stiffness of the catheter 100 can be varied by incorporating different construction materials in the proximal segment 108, the adjustable bend segment 116, and / or the distal segment 112. For example, the catheter 100 may be configured such that the proximal segment 108 comprises a first material having a first hardness (e.g., formed therefrom), the adjustable bend segment 116 comprises a second material having a second hardness less than the first hardness (e.g., formed therefrom), and the distal segment 112 comprises either the first material or a third material having a third hardness (e.g., formed of the first or third material), the third hardness being less than or equal to the first hardness but greater than the second hardness. In such embodiments, the proximal segment 108, the distal segment 112, and the adjustable bend segment 116 may be formed as discrete components of the catheter 100, which may be fastened (joined) together in any suitable manner (e.g., via adhesive, via ultrasonic welding, thermal welding, melting, laser welding, etc.). Liners, coils, fabrics, and / or combinations thereof and / or other components can be used alternatively to form segments with different stiffnesses. It is also conceivable that the conduit 100 may further include one or more (optional) transition zones in which a more gradual change in stiffness occurs. It is conceivable that, in some embodiments, the first and second segments are made of different materials to produce different stiffnesses. It is also conceivable that, in some embodiments, the first and second segments have different layers to produce different stiffnesses.

[0075] The articulated motion assembly 200 is fastened (connected) to the distal segment 112 and configured to apply force thereto to facilitate the reconfiguration of the conduit 100, i.e., bending. More specifically, upon actuation of the articulated motion assembly 200, the force applied to the conduit 100 (e.g., the distal segment 112) causes the adjustable bending segment 116 to bend (bend, deflect) (as described in further detail below), facilitated by its reduced stiffness (e.g., relative to the proximal segment 108). This bending region is referred to herein as the bending zone.

[0076] The articulated motion assembly 200 includes: at least one articulated motion (bending) member 202 having a proximal end 204 and a distal end 206, fastened to the catheter 100; and at least one tensioning mechanism 208 fastened to the proximal end 204 of the articulated motion member 202. Although shown in the illustrated embodiment as fastened to the distal segment 112, it is contemplated that the articulated motion member 202 may be fastened to the catheter 100 at any location suitable for facilitating the reconfiguration of the catheter 100 in the manner described herein. For example, embodiments of the endovascular system 10 including at least one articulated motion member 202 fastened to an adjustable bending segment 116 are also contemplated herein. In a preferred embodiment, the articulated motion member is fastened to a thiopancreatogram tube embedded in the catheter, preferably near the distal end of the bending region. This thiopancreatogram tube is sometimes referred to as a loop in some embodiments and may have various shapes, circumferences, etc.

[0077] In some embodiments, the articulated motion member 202 may be aligned with the conduit 100 and / or other devices. In other embodiments, the articulated motion member 202 may be offset (e.g., located in a branch-side position), and may be located within the proximal segment 108 (e.g., in close proximity to or adjacent to the proximal end hole 110).

[0078] In various embodiments of this disclosure, the articulated motion member 202 may be constructed to be flexible or rigid. For example, the articulated motion member 202 may be configured as a pulling member, such as pulling the guide wire 210 ( Figure 1 This allows for the application of a proximal traction force to the catheter 100 (e.g., distal segment 112). Alternatively, it is conceivable that the articulated motion member 202 may be configured as a push member, such as a push rod, cable, and / or guidewire, which allows for the application of both a proximal traction force and a distal push force to the catheter 100 (e.g., distal segment 112) simultaneously.

[0079] In some embodiments, it is conceivable that pushing and pulling forces can be applied to the same articulated motion member 202, while in other embodiments, it is conceivable that pushing and pulling forces can be applied to different articulated motion members 202. At the proximal end, the pushing / pulling member optionally branches off from the wall of the conduit and is attached to a mechanism capable of moving the pushing / pulling member longitudinally along the conduit by applying pushing and / or pulling forces. This mechanism may incorporate at least one wheel and / or lever and / or similar mechanisms. These may be aligned with the conduit in a straight line and / or branch at an angle. Gear mechanisms may also be optionally incorporated. Similar devices and mechanisms may also be used to control the positioning of the reinforcing member.

[0080] In some embodiments, such as those shown throughout the figures, the articulated motion member 202 may be radially spaced from the main lumen 106 and may extend substantially within the outer wall 104 of the conduit 100. More specifically, the articulated motion member 202 extends within a corresponding channel 120 defined by the outer wall 104, and this corresponding channel is preferably aligned with the longitudinal axis X ( Figure 1 The relationship between the main cavity 106 and the main tube extends roughly parallel.

[0081] exist Figure 1 and Figure 2 In the illustrated embodiment, the articulated motion assembly 200 includes a single articulated motion member 202 received within a corresponding channel 120, which allows the conduit 100 (e.g., the distal segment 112) to deflect only in a single direction (e.g., when configured to specifically apply a pushing or pulling force). However, it should be understood that the specific number of articulated motion members 202 and channels 120 may be increased in alternative embodiments to facilitate deflection of the conduit 100 (e.g., the distal segment 112) in multiple directions (e.g., when configured to apply pushing and pulling forces to facilitate deflection (bending) in opposite directions). For example, Figure 4 and Figure 5 An embodiment is shown in which the articulated motion assembly 200 includes a pair (e.g., a first (primary) and a second (secondary)) articulated motion members 202i, 202ii, which can be configured to extend pull guide wires, such as pull guide wires 210i, 210ii, through corresponding (first and second) channels 120i, 120ii in the outer wall 104. More specifically, a (first) articulated motion member 202i is fastened (connected) to conduit 100 (e.g., distal segment 112) such that, upon actuation of tensioning mechanism 208, the (first) articulated motion member 202i causes deflection of conduit 100 in a first direction, and a (second) articulated motion member 202ii is fastened (connected) to conduit 100 (e.g., distal segment 112) such that, upon actuation of tensioning mechanism 208, the (second) articulated motion member 202ii causes deflection of conduit 100 in a second direction substantially opposite to the first direction (e.g., when a pulling or pushing force is applied in the same direction to each of the articulated motion members 202). A single conduit may alternatively be configured in various different directions. Embodiments comprising three or more articulated motion members 202 and corresponding channels 120 are also contemplated herein.

[0082] The distal end 206 of the articulated motion component 202 can be fastened (connected) to the conduit 100 (e.g., distal segment 112) in any suitable manner. For example, the distal end 206 of the articulated motion component 202 can be directly fastened (connected) to the body 102 (e.g., within the channel 120) such as, for example, via adhesive, via ultrasonic welding, thermal welding, laser welding, etc. Figure 1 As shown. Alternatively, the distal end 206 of the articulated motion member 202 can be indirectly fastened (connected) to the body 102. For example, in Figure 6 and Figure 7 In the illustrated embodiment, the conduit 100 includes a retaining member 122 fastened (connected) to the body 102 and the distal end 206 of the articulated motion member 202. Although in Figure 6 and Figure 7 The retaining ring 124 is shown as being configured as a generally annular ring; however, it should be understood that the specific configuration of the retaining member 122 may be varied in alternative embodiments. For example, embodiments in which the retaining member 122 may be configured as crescent-shaped (e.g., semi-circular) are also contemplated herein, and such embodiments do not exceed the scope of this disclosure. In one embodiment, the retaining member includes a submersible tube or other generally cylindrical member substantially embedded in the wall of a conduit.

[0083] Despite Figure 6 and Figure 7 While shown as including a single retaining member 122, it should be understood that the specific number of retaining members 122 may be increased in alternative embodiments of this disclosure. Additionally, embodiments in which the conduit 100 may include multiple retaining members 122 associated with (e.g., fastened to) multiple (different) adjustable bend segments 116 are contemplated. Each retaining member may also be connected to multiple independent articulated motion members.

[0084] Tensioning mechanism 208 may include any means, structure, etc., suitable for the intended purpose of applying force to the proximal end 204 of articulated motion member 202, such that when tensioning mechanism 208 is actuated, force is applied to conduit 100 (e.g., distal segment 112) via articulated motion member 202 to facilitate bending of adjustable bending segment 116 and reconfiguration of conduit 100. For example, tensioning mechanism 208 may include a rotating wheel, pulley system, ratchet, lever, etc.

[0085] The articulated motion component may also include a cone with a helical channel and / or pulley to increase the distance traveled by the articulated motion component 202 over a given linear length of the component. Combinations of the above are also conceivable.

[0086] Despite Figure 1While illustrated as including a single tensioning member 208, it should be understood that the specific number of tensioning mechanisms 208 may be increased in alternative embodiments of this disclosure. For example, in embodiments of the endovascular system 10 including multiple articulated motion members 202, it is contemplated that each articulated motion member 202 may optionally be fastened (connected) to a corresponding tensioning mechanism 208 (e.g., such that the number of articulated motion members 202 corresponds to the number of tensioning mechanisms 208). However, embodiments in which multiple articulated motion members 202 may be fastened (connected) to a single tensioning mechanism 208 are also contemplated herein, as are embodiments in which the tensioning mechanism 208 may be omitted entirely. In those embodiments without any tensioning mechanism 208, it is contemplated that force may be applied manually, electronically, magnetically, or otherwise to the articulated motion member 202 to reconfigure the catheter 100.

[0087] refer to Figure 1 The reinforcing component 300 includes a corresponding proximal end 302 and a distal end 304, and is configured to move axially within the adjustable bending segment 116 (e.g., to be aligned with the longitudinal axis X). Figure 1 (Generally parallel relationship) to change its stiffness and thereby affect the reconfiguration of catheter 100. In other words, the adjustable bend segment 116 has variable stiffness, which can be changed by advancing and retracting the reinforcing component 300, i.e., increasing and decreasing, to facilitate or limit the bending of the adjustable bend segment 116 and select the length of the bending zone and the resulting radius of bending for the catheter. Thus, the length of the catheter 100 to be bent can be selectively determined by the clinician to provide different bending radii (e.g., radius of curvature) and / or bend shapes. Thus, the catheter resists bending where the rigid component is located.

[0088] In some embodiments, the axial advancement (distal movement) of the reinforcing component 300 through the adjustable bend segment 116 (which increases the stiffness of the adjustable bend segment) can be used to suppress (and in some embodiments completely prevent) bending of a segment of the adjustable bend segment 116, while the axial retraction (proximal movement) of the reinforcing component 300 through the adjustable bend segment 116 can be used to reduce its stiffness, which promotes bending over a longer length of the adjustable bend segment 116. Bending over a longer length typically also results in bending with a larger radius of curvature.

[0089] The reinforcing component 300 includes: a pushing member 306, such as a push rod or pushing guide wire (or alternatively, a pulling guide wire or pull rod; and / or a dual-function component); and a reinforcing member 308 (e.g., a pin 310 having a generally linear configuration), which is preferably fastened (connected) to the pushing member 306 at its distal end such that movement of the pushing member 306 (e.g., axial advancement and retraction) causes a corresponding movement (axial advancement and retraction) of the reinforcing member 308. In the illustrated embodiment, the reinforcing component 300 is constructed integrally (e.g., monolithically), wherein the pushing member 306 and the reinforcing member 308 are integrally formed from a single piece of material, which is metallic (e.g., stainless steel, titanium, etc.) or non-metallic (e.g., plastic material, polymer material, composite material) or a combination thereof. Various combinations of materials may also be used. However, it is also conceivable that the pusher 306 and the reinforcing member 308 can be configured as separate components of the reinforcing assembly 300, which can be fastened (connected) together in any suitable manner, such as, for example, by welding, by adhesive, by (one or more) at least one mechanical fastener (e.g., pin, screw, clip, etc.).

[0090] Although shown in the illustrated embodiment as including a single actuating member 306 and a single reinforcing member 308, it should be understood that the specific number of actuating members 306 and reinforcing members 308 may be increased in alternative embodiments of this disclosure. In such embodiments, it is contemplated that the actuating member 306 and reinforcing member 308 may function along the same length (e.g., segment) or along different lengths (e.g., segments) of the conduit 100, or may overlap along partial segments. They may function along the lengths of the same and / or different bending segments.

[0091] In the illustrated embodiment, the actuating member 306 and the reinforcing member 308 each have a generally annular transverse cross-sectional configuration. More specifically, the actuating member 306 defines a (first) transverse cross-sectional dimension (e.g., diameter) D1. Figure 1The reinforcing member 308 defines a (second) transverse cross-sectional dimension (e.g., diameter) D2 that is larger than the transverse cross-sectional dimension D1. However, embodiments in which the actuating member 306 and / or the reinforcing member 308 may have a generally non-annular transverse cross-sectional configuration (e.g., oval, square, rectangular, triangular, trapezoidal, rhomboid, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.) are also conceivable. In such embodiments, the transverse cross-sectional dimensions D1 and D2 defined by the actuating member 306 and the reinforcing member 308, respectively, can be substantially equivalent, such that the reinforcing assembly 300 includes a generally cylindrical (tubular) configuration that defines a generally uniform transverse cross-sectional dimension (e.g., diameter) between its respective proximal end 302 and distal end 304. The reinforcing member is preferably configured to be substantially retained within the wall of the conduit. In embodiments where the reinforcing member is cylindrical, it is preferably retained substantially within the wall of the conduit along its circumference as a closed loop or partial loop.

[0092] In some embodiments, the reinforcing component 300 is radially spaced from the main cavity 106 and angularly (circumferentially) spaced from the channel 120. More specifically, in some embodiments, the reinforcing component 300 is located in the channel 126 ( Figure 2 Within the space, the channel is defined by the outer wall 104, and the channel is aligned with the longitudinal axis X ( Figure 1 Orientation is achieved by the generally parallel relationship between the main cavity 106 and the channel 120.

[0093] In some embodiments, the reinforcement component 300 can be configured for manual manipulation (e.g., axial movement). Alternatively, the intravascular system 10 may include a controller 400. Figure 8 The controller is fastened (connected) to the reinforcing component 300 (e.g., the push member 306) such that the axial advance and retraction of the reinforcing component 300 are regulated (controlled) by the controller 400. In such embodiments, it is conceivable that the controller 400 may also be fastened (connected) to the articulated motion component 200 such that the force applied to the articulated motion component 202 is also regulated (controlled) by the controller 400. Multiple controllers are also conceivable. Additionally, it is conceivable that a pulling force, rather than a pushing force, or a combination thereof may be used for the reinforcing component.

[0094] The controller 400 can be positioned in any suitable location. For example, it is conceivable that the controller 400 may define a handle of the catheter 100, or may be included on the handle of the catheter. In such embodiments, it is conceivable that the handle may include (optionally) pulleys, screws, levers, wheels and / or other such mechanisms to increase the distance traveled by the articulated motion member 202 and / or the actuating member 306 over a given distance, which allows for a reduction in the overall length of the handle.

[0095] Now for reference Figure 1 , Figure 2 and Figures 9A to 1 1. A method for performing endovascular surgery using the endovascular system 10 will be discussed, with additional details provided in U.S. Patent Application Serial No. 16 / 602,469, Publication No. 2020 / 0078554 and U.S. Patent Application Serial No. 17 / 423,502, Publication No. 2022 / 0118219, the entire contents of which are incorporated herein by reference. Initially, with catheter 100 in (first, initial) normal configuration ( Figure 1 In this configuration, catheter 100 is inserted into the patient's blood vessel, where it is generally linearly positioned. Catheter 100 is then advanced through the vessel to a target site (e.g., occlusion), and, if necessary or desired, articulated motion assembly 200 is actuated to reconfigure catheter 100 from its initial configuration to a (second, subsequent) deflected configuration. Figure 9A In this deflection configuration, the conduit 100 is substantially non-linear in configuration (e.g., curved). More specifically, when the articulated motion assembly 200 is actuated, force is applied manually or via the tensioning mechanism 208 through the articulated motion member 202. Figure 1 An application is made to catheter 100 (e.g., distal segment 112), which causes the adjustable bending segment 116 to bend.

[0096] Although catheter 100 (e.g., adjustable bend segment 116) is shown as in Figure 9A The deflection configuration in the conduit 100 has a curvature of (approximately) 90 degrees; however, it should be understood that the curvature exhibited by the conduit 100 can be increased or decreased by adjusting the force applied to it via the articulated motion component 200. For example, curvatures less than 90 degrees (e.g., approximately 15 degrees to approximately 75 degrees) and greater than 90 degrees (e.g., approximately 105 degrees to approximately 180 degrees or greater) are also contemplated herein. Figure 9B and Figure 9C As seen in the present disclosure, and this curvature will not exceed the scope of this disclosure. More specifically, Figure 9B The diagram illustrates a deflected configuration of the conduit 100, where the adjustable bend segment 116 is bent (approximately) 180 degrees and the reinforcing assembly 300 is removed from it (e.g., spaced proximally from it). That is, the reinforcing assembly is entirely outside the "bending zone" (and exhibits an optional maximum 180-degree bend diameter). Similarly, Figure 9C The catheter 100 is shown in a deflected configuration, where the adjustable bend segment 116 is bent (approximately) 180 degrees. Figure 9B The illustration provided (where the adjustable bending segment 116 defines the first radius of curvature) is the opposite of the one shown in the diagram. Figure 9CIn the middle, the reinforcing component 300 is partially advanced into the adjustable bending segment 116, and the articulated motion component 202 retracts by different amounts (when...). Figure 9B Compared to the amount of retraction in the middle), this produces a second reduced radius of curvature. Therefore, compared to Figure 9B In comparison, Figure 9C In this configuration, the reinforcing member partially enters the bending zone, and the pulling mechanism is pulled (or the pushing mechanism is pushed) by varying amounts, but also pulled until the turn is approximately 180 degrees, thus producing a smaller "turning diameter" bend. Bends of any degree and / or shape can also be envisioned.

[0097] In some embodiments of this disclosure, it is conceivable that the catheter 100 may include a locking mechanism that can be actuated manually or automatically (e.g., via controller 400). Figure 8 ()) so as to fix the curvature of the conduit 100 in the desired deflection configuration.

[0098] Depending on the specific surgical procedure performed, the location of the pathology, etc., after reconfiguration of catheter 100, it may be necessary or desirable to change the catheter configuration by manipulating the reinforcing component 300 to reduce the curvature of the deflection configuration. More specifically, the reinforcing component 300 is positioned in access 126 ( Figure 2 The axial advancement within the conduit increases the stiffness of the adjustable bending segment 116, which reduces the bending of the conduit 100 (e.g., the length and / or radius of curvature of the conduit being bent), and allows the distal segment 112 (e.g., distal end hole 114 and / or side hole 118) to be advanced. Figure 3 The bending of the catheter 100 not only increases control over its specific position but also increases the accuracy of its placement. For example, Figure 10 This demonstrates advancing the reinforcing component 300 within the adjustable bend segment 116 to the (first) axial position L1 (reference numeral 310a indicates the farthest end of the reinforcing component 310) to reduce the curvature of the conduit 100 in the deflected configuration to (approximately) 45 degrees (and reduce the bend area), and Figure 11A It is shown that the reinforcing component 300 is advanced within the adjustable bend segment 116 to the (second) axial position L2 in order to reduce the curvature of the conduit 100 in the deflected configuration to (approximately) 15 degrees (and further reduce the bend area). Figure 11BThe diagram illustrates the positioning of the reinforcing member 310 of the reinforcing assembly 300 to a (third) axial position within the adjustable bending segment 116 to achieve a greater curvature. It should be noted that these various positions of the reinforcing member are shown as examples in the figures, as other positions to achieve other curvatures are also conceivable. That is, it is conceivable that any desired curvature for the conduit 100 can be achieved (e.g., from (approximately) 180 degrees to (approximately) 0 degrees) by manipulating the articulated motion assembly 200 and the reinforcing assembly 300. Therefore, the bending diameter / turning radius can be changed (increased or decreased) by moving the reinforcing member to a variable length within a given "adjustable" zone to effectively further reinforce the segment to which the reinforcing member is moved to resist bending. The reinforcing member is optimally positioned before bending the conduit, but alternative methods such as those described above, where the reinforcing member is positioned after bending the conduit, are also conceivable.

[0099] Now for reference Figure 12 and Figure 13 Alternative embodiments of the reinforcing component 300, identified by reference numeral 500, will be discussed. The reinforcing component 500 is structurally and functionally similar to the aforementioned reinforcing component 300. Figure 1 They are essentially similar, and therefore, for the sake of brevity, only the differences between them will be discussed. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc., common to reinforcing components 300 and 500.

[0100] The reinforcing component 500 includes: a pair (first and second) elongated members, such as actuating members 306i, 306ii; and an alternative embodiment of the reinforcing member 308, identified by reference numeral 508. In contrast to the reinforcing member 308, the reinforcing member 508 has a generally non-linear configuration. More specifically, the reinforcing member 508 has an arcuate (bent) configuration and is configured as a reinforcing ring 512 with a generally annular configuration. Embodiments in which the reinforcing member 508 can be configured as crescent-shaped (e.g., semi-circular), cylindrical, or other configurations are also contemplated herein.

[0101] Despite Figure 12 and Figure 13 The illustrated embodiments are shown to include a pair of actuating members 306 extending proximally from the reinforcing member 508, but embodiments in which the reinforcing member 500 may include a single actuating member 306 are also contemplated herein.

[0102] Although generally described as a pushing member 306, it should be understood that the reinforcing member 500 can also be used as a pulling member or configured for pulling. Any pushing or pulling member can optionally be configured to push and / or pull both as desired by the operator. Additionally, it is conceivable that one or more guide wires and / or other such elongated control members can be incorporated.

[0103] As mentioned above, in conjunction with reinforcement component 300 ( Figure 1 As discussed, the reinforcing component 500 can be configured for manual operation, or the reinforcing component 500 (e.g., the push member 306) can be fastened (connected) to the controller 400. Figure 8 This allows the axial advance and retraction of the reinforcing component 500 to be regulated (controlled) by the controller 400.

[0104] In the illustrated embodiment, the reinforcing ring 512 includes a hollow structure that is substantially cylindrical in configuration and is configured to define an internal lumen for the sub-tube 514. Embodiments in which the configuration of the reinforcing ring / sub-tube 512 can be varied are also contemplated. For example, embodiments in which the reinforcing ring 512 may comprise a solid construction (e.g., embodiments in which the reinforcing ring 512 has no internal lumen) are also contemplated, as are embodiments in which the reinforcing ring 512 may comprise at least one or more weakened sections (e.g., etched, laser-cut, etc.) to increase its flexibility. In such embodiments, the reinforcing ring 512 may have stiffness greater than that of the adjustable bending segment 116 but less than that of the proximal segment 108. It may also facilitate alternative bending shapes. Additionally or alternatively, it is contemplated that the conduit 100 (e.g., outer wall 104) in some embodiments may include at least one or more weakened sections (e.g., etched, laser-cut, etc.) to facilitate deflection of the conduit 100, thereby achieving a bend (e.g., a kink) with a specific configuration and / or size.

[0105] When a laser-cut thiocyanate tube is incorporated to aid in influencing the bending segment and shape, the thiocyanate tube can optionally slide above or below the laser-cut thiocyanate tube. That is, in some embodiments, the adjustable bending segment may include at least one fixed thiocyanate tube embedded in the conduit wall, the at least one fixed thiocyanate tube having a first laser-cut pattern to facilitate bending in a first predetermined shape, wherein, when the bending force is activated, the adjustable bending segment presents at least one predetermined configuration. In some embodiments, the thiocyanate tube may further have a second cut pattern to facilitate bending in a second predetermined shape, such that the adjustable bending segment presents a different predetermined configuration. The first and second patterns may be on opposite sides in some embodiments.

[0106] Although the reinforcing member 508 is shown as being located inside the conduit 100 (e.g., shown as extending within or substantially within the outer wall 104), embodiments in which the reinforcing member 508 may be located entirely outside or partially outside the conduit 100 are also contemplated herein. For example, embodiments in which the reinforcing member 508 may (partially or completely) surround the outer wall 104 of the conduit 100, embodiments in which the reinforcing member 508 may be completely located within the outer wall 104, and embodiments in which the reinforcing member 508 may be partially located within and partially exposed from the outer wall 104 are also contemplated herein.

[0107] The reinforcing ring 512 may have a length different from the length shown. Alternatively, it is conceivable that the reinforcing ring 512 may be configured to have a length similar to... Figure 13 The diagram shows slender thallium tubes or rods of varying lengths. Additionally, ring 512 may have one or more push / pull members (although...). Figure 13 Two are shown in the image.

[0108] Now for reference Figure 14 Alternative embodiments of the intravascular system 10, identified by reference numeral 20, will be discussed, and these alternative embodiments include a catheter 600 and an articulated motion assembly 200. The intravascular system 20 and catheter 600 are structurally and functionally similar to the intravascular system 10 and catheter 100 discussed above. Figure 1 They are basically similar, and therefore, for the sake of brevity, only the differences between them will be discussed. Therefore, the same reference numerals will be used to refer to elements, structures, features, etc., common to the intravascular systems 10, 20 and catheters 100, 600.

[0109] In contrast to the endovascular system 10, where the stiffness of the adjustable bend segment 116 is mechanically altered via a manipulating reinforcement component 300, the endovascular system 20 lacks a reinforcement component 300 and instead utilizes at least one shape memory material 628 (one or more) that can respond to external stimuli to change the stiffness of the adjustable bend segment 116. More specifically, the shape memory material is incorporated into the adjustable bend segment 116 such that the stiffness of the adjustable bend segment 116 changes upon exposure to external stimuli, i.e., increases or decreases. The catheter 600 thus comprises a first structural material in the proximal segment 108 and a second, different structural material (e.g., a shape memory material) in the adjustable bend segment 116. As described above in conjunction with catheter 100 ( Figure 1 As discussed, the structural material in the distal segment 112 may be the same as or different from the structural material in the proximal segment 108. Alternatively, the stiffness of this segment may be altered by adding or subtracting additional material having recesses therein to receive material that can change the stiffness of a portion of the bending zone.

[0110] In some embodiments, it is conceivable that shape memory material may be incorporated into the conduit 100 such that the adjustable bending segment 116 presents a (predetermined) configuration upon exposure to external stimuli. For example, it is conceivable that external stimuli may cause the adjustable bending segment 116 to present a bend with a certain length and / or radius of curvature.

[0111] In the illustrated embodiment, the catheter 600 is configured such that the shape memory material is responsive to electrical stimulation (e.g., electric current), which is delivered from a power source 700 to an adjustable bend segment 116 via at least one transmission member 702 (e.g., wire 704). However, embodiments in which the shape memory material is responsive to thermal stimulation (e.g., internal heat from the patient) are also contemplated herein, which would allow the power source 700 and transmission member 702 to be omitted. Embodiments in which the catheter 600 may include robotic and / or automated components and / or can be configured for use with them are also contemplated.

[0112] Depending on the specific surgical procedure employing the endovascular system 20 and the specific memory material used in constructing the catheter 600, the catheter 600 can be configured such that the stiffness of the adjustable bending segment 116 increases upon exposure to external stimuli, thereby reducing the curvature of the catheter 600 in a deflected configuration. Figures 9A to 1 1) Alternatively, catheter 600 can be configured such that the stiffness of the adjustable bend segment 116 decreases upon exposure to external stimuli, thereby increasing the curvature of catheter 600 in a deflected configuration. Catheter 600 thus allows the operating clinician to selectively reinforce and / or soften various regions of catheter 600 as needed. Transmission members can be provided to communicate with different regions of the adjustable bend segment 116 to selectively reinforce selected regions of the adjustable bend segment to create various flexural resistance zones. Multiple transmission members can optionally be powered by a single power supply 700 or by separate power supplies for one or more transmission members.

[0113] Continue to refer to Figure 14 The method of performing endovascular surgery using the endovascular system 20 will be discussed. After the catheter 600 is inserted into the patient's blood vessel (e.g., where the catheter 600 is in normal configuration ( Figure 14 The catheter 600 is advanced to the target site, during or after which the articulated motion component 200 can be actuated to reconfigure the catheter 600 via the bending of the adjustable bending segment 116. If necessary or desired, the configuration of the catheter 600 can be altered during the endovascular procedure by changing the stiffness of the adjustable bending segment 116 through exposure to external stimuli. More specifically, the catheter 600 can be exposed to external stimuli to thereby increase the stiffness of the adjustable bending segment 116 and thus reduce the bending (e.g., radius of curvature) of the catheter 600.

[0114] Now for reference Figure 15 and Figure 16 Alternative embodiments of the intravascular system 10, identified by reference numeral 30, will be discussed, and these alternative embodiments include a catheter 800 and an articulated motion assembly 200. The intravascular system 30 and catheter 800 are structurally and functionally similar to the intravascular system 10 and catheter 100 discussed above. Figure 1 They are basically similar, and therefore, for the sake of brevity, only the differences between them will be discussed. Therefore, the same reference numerals will be used to refer to common elements, structures, features, etc., of the intravascular systems 10, 30 and catheters 100, 800.

[0115] The catheter 800 includes at least one (internal) chamber 830 (e.g., cavity, recess, etc.) defined by an outer wall 104. The chamber 830 is located within an adjustable bend segment 116 and is configured to receive fluid (e.g., air, water, saline solution, or other suitable substance) from a source 900 (e.g., a fluid pump 902), which allows for alteration of the stiffness of the adjustable bend segment 116. More specifically, fluid (substance) delivery (e.g., from source 900) into the chamber 830 causes an increase in the stiffness of the adjustable bend segment 116, while fluid (substance) delivery from the chamber 830 (e.g., to source 900) causes a decrease in the stiffness of the adjustable bend segment 116. The degree of chamber filling can be used to adjust catheter bends by selecting a desired, more rigid segment based on the location where the reinforcing fluid (substance) terminates within the catheter.

[0116] In various embodiments, it is conceivable that a single chamber 830 may be used to increase the stiffness of the catheter 800 when it is filled with a certain substance, or to reduce the stiffness of the catheter 800 when the substance is removed.

[0117] It is also conceivable that a single chamber 830 could be used to reduce the stiffness of the catheter 800 when it is filled with a certain substance, or to increase the stiffness of the catheter 800 when the substance is removed.

[0118] This article may also envision embodiments in which the stiffness of the conduit 800 can be altered by adding and / or removing different substances.

[0119] Although shown as comprising a pair (first and second) chambers 830i, 830ii positioned generally radially opposite each other, it should be understood that the specific number of chambers 830 may be increased or decreased in alternative embodiments without departing from the scope of this disclosure. For example, embodiments in which the catheter 800 may comprise a single chamber 830 are contemplated, as are embodiments in which the catheter 800 may comprise three or more chambers 830. Various shapes, numbers, and locations of chambers are contemplated, including cylindrical chambers within the circumference of the device wall. By filling different chambers, catheter stiffness can be varied; that is, a clinician can decide which segment of the catheter to reinforce to adjust its bends, and / or the stiffness of different regions of the catheter 800 can be altered. Multiple chambers may be circumferentially aligned and / or axially spaced, and may receive fluid simultaneously or selectively.

[0120] The chamber 830 is in communication with a fluid (liquid or gas) source 900 via at least one conduit 904 (e.g., tube 906) configured for connection to the conduit 800. For example, it is contemplated that the conduit 904 may extend from a point near its proximal end within or substantially within the outer wall 104 of the conduit 800. The fluid (substance) may be delivered from the source 900 to the chamber 830 in any suitable manner, such as, for example, through at least one port, opening, seal, etc., in the body 102 of the conduit 800. Fluid may be propelled into the chamber using a fluid pump, injection device, or other means / mechanism, and liquid may be withdrawn from the chamber using a suction device or other means / mechanism for removing fluid.

[0121] Continue to refer to Figure 15 and Figure 16 The method of performing endovascular surgery using the endovascular system 30 will be discussed. After the catheter 800 is inserted into the patient's blood vessel (e.g., where the catheter 800 is in normal configuration ( Figure 15The catheter 800 is advanced to the target site, during or after which the articulated motion component 200 can be actuated to reconfigure the catheter 800 via bending of the adjustable bending segment 116. If necessary or desired, during the procedure of endovascular surgery, before or after catheter insertion into the body, the configuration of the catheter 800 can be altered by changing the stiffness of the adjustable bending segment 116 by delivering fluid (substance) into chamber 830 (e.g., from 900) and out of chamber 830 (e.g., to source 900). More specifically, delivering fluid (substance) into chamber 830 increases the stiffness of the adjustable bend segment 116, thereby reducing the bending of catheter 800 (e.g., and / or the length by which the adjustable bend segment 116 bends), and delivering fluid (substance) from chamber 830 (e.g., to source 900) further reduces the stiffness of the adjustable bend segment 116, thereby promoting the bending of catheter 800 (e.g., increasing the radius of curvature). Therefore, by changing the volume of fluid (substance) within chamber 830, the stiffness of the adjustable bend segment 116 can be controlled (adjusted) with increased precision, and thus the bending length and / or curvature of catheter 800 in a deflected configuration can be controlled (adjusted).

[0122] In embodiments of the conduit 800 that include multiple chambers 830, the chambers 830 may be interconnected to allow fluid (substance) to be delivered from a source 900 via a single conduit 904 into the chamber 830, resulting in uniform stiffness of the adjustable bend segment 116. Alternatively, the chambers 830 may not be interconnected (i.e., independent of each other), allowing the chambers 830 to be filled independently from sources 900 (or multiple sources 900) via corresponding conduits 904, resulting in non-uniform stiffness and / or selective segment reinforcement of the adjustable bend segment 116. For example, in such embodiments, chamber 830i may receive a (first) volume of fluid (substance), and chamber 830ii may receive a (second) volume of fluid (substance) that may be less than, equal to, or greater than the first volume, thereby facilitating additional control over the configuration of the conduit 800. Axially aligned chambers can select the axial position of the reinforcement via filling to select a desired bend radius or bending zone.

[0123] In a preferred embodiment, the reinforcing component disclosed herein will have a minimal impact on the degree of bend, although it may sometimes do so to an unpredictable degree. The primary purpose of the reinforcing component is to reduce the length of the conduit that will bend. By reducing the length of the conduit bend, many configurations will result in a reduction in the bending radius produced by the bend adjustment.

[0124] The foregoing description outlines an adjustable bending system for bending catheters in endovascular procedures. However, it should be understood that the adjustable bending system of the present invention for adjusting stiffness can also be used in catheters for other procedures, and for bending endoscopes for various applications, such as gastrointestinal, genitourinary, pulmonary, enterology, etc. In some of these applications / examples, an incorporated imaging system, such as a camera and / or illumination system, may also be included in the catheter (or endoscope).

[0125] In a preferred embodiment, the catheter has a central working lumen, but in some embodiments, it may have multiple "working" lumens in addition to those in the wall. One of the lumens may be used for an imaging system.

[0126] The adjustable bending system described above is manually activated; however, it should be understood that it can alternatively be robot-activated, computer-driven, hydraulically driven, motor-driven, etc. Automated, artificial intelligence-driven bending is also conceivable.

[0127] Adjustable bending systems, such as those described in U.S. Application Serial No. 18 / 668,492, filed May 20, 2024, the entire contents of which are incorporated herein by reference.

[0128] Although the apparatus and methods of this disclosure have been described with respect to preferred embodiments, it will be readily understood by those skilled in the art that changes and modifications can be made thereto without departing from the spirit and scope of this disclosure as defined by the appended claims.

[0129] Those skilled in the art will understand that the various embodiments of this disclosure described herein and illustrated in the accompanying drawings constitute non-limiting examples. Furthermore, those skilled in the art will understand that elements and features shown or described in connection with one embodiment may be combined with elements and features of another embodiment without departing from the scope of this disclosure, and that further features and advantages of the subject matter disclosed herein will be understood based on the provided description.

[0130] In the foregoing description, reference may be made to the spatial relationships between the various structures illustrated in the accompanying drawings and the spatial orientations of these structures. However, as will be appreciated by those skilled in the art upon a complete reading of this disclosure, the structures described herein can be positioned and oriented in any manner suitable for their intended purpose. Therefore, the use of terms such as “above,” “below,” “up,” “down,” “inner,” “outer,” “left,” “right,” “upward,” “downward,” “inward,” “outward,” etc., should be understood to describe the relative relationships between structures and / or the spatial orientations of the structures. Those skilled in the art will also recognize that the use of such terms may be provided in the context of the illustrations provided in the corresponding drawings.

[0131] Additionally, terms such as “approximately,” “generally,” and “substantially” should be understood to allow for variation within any numerical range or concept associated with them, and to cover variations on the order of 25% (e.g., to allow for manufacturing tolerances and / or design deviations).

[0132] Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and / or sections, these operations, elements, components, regions, and / or sections should not be limited by the use of these terms, as these terms are used to distinguish one operation, element, component, region, or section from another. Therefore, unless expressly stated otherwise, without departing from the scope of this disclosure, the first operation, element, component, region, or section 10 may be referred to as the second operation, element, component, region, or section.

[0133] Each claim is incorporated herein by reference as a further disclosure and represents an embodiment of the present disclosure. Furthermore, the phrases “at least one of A, B, and C” and “A and / or B and / or C” should each be interpreted as including only A, only B, only C, or any combination of A, B, and C.

Claims

1. A system configured for use during endovascular surgery, the system comprising: A catheter configured for insertion into a patient's blood vessel, the catheter comprising: Proximal segment; and At least one adjustable bending segment is located distal to the proximal segment; A bending assembly, operatively connected to the catheter and configured to facilitate catheter reconfiguration, wherein the proximal segment has a first stiffness and the adjustable bending segment has a second stiffness less than the first stiffness to facilitate bending of the adjustable bending segment during catheter reconfiguration; and A reinforcing component is configured to move relative to the adjustable bending segment to increase the second stiffness and limit the bending of the adjustable bending segment.

2. The system according to claim 1, wherein the bending adjustment component comprises: At least one bending member extends within the conduit and is fastened to the conduit; as well as A tensioning mechanism, connected to the at least one bending member, such that when the tensioning mechanism is actuated, a force is applied to the conduit via the at least one bending member to facilitate the reconfiguration of the conduit.

3. The system of claim 2, wherein the at least one bending member extends substantially within the outer wall of the conduit.

4. The system of claim 2, wherein the at least one bending member extends within a channel defined by the outer wall of the conduit.

5. The system according to claim 2, wherein the at least one bending member comprises: A first bending member is fastened to the conduit such that when the tensioning mechanism is actuated, the first bending member causes the conduit to deflect in a first direction; as well as A second bending member, which is fastened to the conduit, causes the conduit to deflect in a second direction when the tensioning mechanism is actuated.

6. The system of claim 1, wherein the catheter includes a distal segment distal to the bending segment.

7. The system of claim 6, wherein the distal segment has a third stiffness greater than the second stiffness.

8. The system of claim 1, wherein the proximal segment comprises a first material having a first hardness, and the adjustable bending segment comprises a second material having a second hardness.

9. The system according to claim 8, wherein the second hardness is less than the first hardness.

10. The system of claim 1, wherein the reinforcing component comprises: Propulsion components; as well as A reinforcing member is fastened to the pushing member such that movement of the pushing member causes a corresponding movement of the reinforcing member.

11. The system of claim 1, wherein the bending assembly includes a bending member, and the system further includes a controller connected to the bending member and configured to cause axial movement of the bending member to cause axial movement of the reinforcing assembly within the adjustable bending segment.

12. The system of claim 1, wherein the reinforcing component comprises at least one thiopancreatic tube, the at least one thiopancreatic tube being substantially within the wall of the conduit and movable within the wall.

13. The system of claim 1, wherein the reinforcing component comprises at least one substantially cylindrical member, the at least one substantially cylindrical member being substantially within the wall of the conduit and movable within the wall.

14. The system of claim 1, wherein moving the reinforcing component changes the length of the bending segment.

15. The system of claim 14, wherein the turning radius is reduced when the bending segment is shortened by positioning the reinforcing component.

16. The system of claim 13, wherein the reinforcing component further comprises at least one bending member attached to the substantially cylindrical member to cause movement of the substantially cylindrical member.

17. The system of claim 1, wherein the adjustable bending segment comprises at least one shape memory material such that the adjustable bending segment presents a predetermined configuration upon exposure to an external stimulus.

18. The system of claim 16, wherein the adjustable bending segment comprises at least one shape memory material such that the adjustable bending segment presents a predetermined configuration upon exposure to an external stimulus.

19. The system of claim 1, wherein the adjustable bending segment comprises at least one fixed thiocyanate tube embedded in the conduit wall, the at least one fixed thiocyanate tube having a first cut pattern to facilitate bending in a first predetermined shape, wherein the adjustable bending segment presents at least one predetermined configuration when the bending force is activated.

20. The system of claim 19, wherein the hyaluronic acid tube has a second cut pattern to facilitate bending in a second predetermined shape, such that the adjustable bending segments present different predetermined configurations.

21. A system configured for use during surgery, the system comprising: The slender member includes: First section; and The second segment located distal to the first segment; and A bending adjustment assembly, which is connected to the elongated member and configured to facilitate the reconfiguration of the elongated member, wherein the stiffness of the second segment can be increased or decreased to increase or decrease resistance to bending, thereby affecting the bending radius of the second segment.

22. The system of claim 21, wherein the second segment comprises at least one shape memory material, wherein the at least one shape memory material is responsive to an external stimulus such that the stiffness of the second segment increases upon exposure to the external stimulus.

23. The system of claim 21, wherein the adjustable bending segment includes at least one fixed thiocyanate tube embedded in the conduit wall, the at least one fixed thiocyanate tube having a first cut pattern to facilitate bending in a first predetermined shape, wherein the adjustable bending segment presents at least one predetermined configuration when the bending force is activated.

24. The system of claim 23, wherein the hyaluronic acid tube has a second cut pattern to facilitate bending in a second predetermined shape, such that the adjustable bending segments present different predetermined configurations.

25. The system of claim 21, wherein the elongated member comprises an imaging system.

26. The system of claim 25, wherein the catheter has a plurality of working lumens.

27. The system of claim 21, wherein the elongated member includes at least one chamber located within the second segment and configured to receive material from a source such that the second segment changes in stiffness as the material is delivered into the at least one chamber.

28. The system of claim 21, wherein the first segment has a first hardness and the second segment has a second hardness less than the first hardness, such that the second segment has a stiffness less than that of the first segment.

29. The system of claim 21, wherein the first segment and the second segment are made of different materials to produce different stiffnesses 30.

30. The system of claim 21, wherein the first segment and the second segment have different layers to produce different stiffnesses.

31. The system of claim 21, further comprising a reinforcing component axially movable relative to the second segment to increase and decrease the stiffness of the second segment.

32. The system of claim 21, further comprising a reinforcing component, wherein the reinforcing component includes at least one substantially cylindrical member substantially within the wall of the conduit and movable within the wall to change the length of at least one bend segment.

33. The system of claim 21, wherein the turning radius decreases when the bending segment is shortened.

34. The system of claim 32, wherein the reinforcing component further comprises at least one bending member attached to the substantially cylindrical member to cause movement of the substantially cylindrical member.

35. A method for performing endovascular surgery, the method comprising: a) Inserting a catheter into a blood vessel in a first configuration, wherein the catheter comprises: First section; and The second segment located distal to the first segment; b) Advance the catheter toward the target site; c) Actuate the bending assembly connected to the conduit to reconfigure the conduit from the first configuration to the second configuration via bending the second segment; and d) Before or after step (c), change the stiffness of the second segment to change the bending of the second segment.

36. The method of claim 35, wherein increasing the stiffness of the second segment comprises axially advancing the reinforcing component within the second segment.

37. The method of claim 35, wherein increasing the stiffness comprises moving a substantially cylindrical member positioned substantially in the wall of the conduit to a selected region of the second segment via an elongated member attached to the substantially cylindrical member.

38. The method of claim 35, wherein increasing the stiffness of the second segment comprises exposing the second segment to an external stimulus.

39. The method of claim 35, wherein increasing the stiffness of the second segment comprises delivering material into at least one chamber located within the second segment.

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