Multi-lumen polymer catheter with selectively patterned distal portion

Abstract

Disclosed is a catheter, a method for operation and a method of fabrication thereof. The catheter includes a proximal section, a distal section, a main lumen, and at least one subsidiary lumen with a pattern provided along a longitudinal length of at least one portion of the distal section, the pattern being cut into at least part of a circumference of the distal section to vary bendability of the distal section.

Description

MULTI-LUMEN POLYMER CATHETER WITH SELECTIVELY PATTERNED DISTAL PORTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of and priority to U.S. Provisional Patent Application No. 63 / 672,399, filed with the U.S. Patent and Trademark Office on July 17, 2024, the entire content of which is incorporated by reference herein.BACKGROUNDField of Disclosure

[0002] The present disclosure relates generally to medical devices and, more particularly, to an apparatus and method for controlled bendability of a robotically controlled catheter.Description of Related Art

[0003] Endoscopy is a medical procedure that allows remote inspection, manipulation, and / or treatment of internal organs using flexile devices inserted through an orifice. The complexity of anatomical pathways, the limited flexibility of existing instruments, and the need to use multiple instruments may limit such procedures. Endoscopes are generally composed of a passive proximal section and an active distal section. The proximal passive section can be rigid, semi-rigid, or flexible. The active distal section may include a steerable tip that is remotely actuated by control or drive wires connected to actuation units, e.g., wheels located on a handle or hub of the device. Endoscopes are typically equipped with an imaging device, e.g., a camera, a light source, irrigation and / or suction channels, and at least one instrument channel for passing interventional tools. Endoscopic instruments may have at least three degrees of freedom to allow for insertion, rotation and grasping operations. However, confined workspaces and limited visibility of target organs further limit the usability of these systems and require one or more highly skilled endoscopists to perform dexterous tasks. For example, four hands may be required to manually control the endoscope and its instruments during certain procedures. To that end, an endoscopist may need to master a combination of accurate tip angulations, shaft management, and instrument insertion procedures, while communicating with an assistant to actuate the instrument and hold the endoscopic shaft in a correct position. To alleviate the complexity of such procedures, innovative techniques have been proposed and robotic endoscope systems have been developed.

[0004] Examples of manual and robotic endoscope systems are provided by US 2006 / 0200000, US 2017 / 0086652, and JP 2001-161631, each of which is incorporated by reference herein in their entirety.

[0005] US 2006 / 0200000 discusses an endoscope with an insertion section that is to be inserted from a distal end into a subject. A bendable portion is disposed between the distal end and a proximal end of the insertion section, with an actively bent region disposed in a bend portion to be bent in accordance with operator’s operation. A passively bent region disposed in the bend portion may be a flex member that is bendable under an external force, such as a material obtained by covering a spirally wound flex coil member with a braid.

[0006] US 2017 / 0086652 discusses an endoscope insertion portion that includes first and second bending portions disposed on a distal end side and connected to a proximal end of the first bending portion, respectively, with the second bending portions provided with flexural rigidity higher than flexural rigidity of the first bending portion: and a tubular member formed with bendability so as to be passively flexible, with the first bending portion being configured to be bendable in the first direction and a second direction opposite to the first direction.

[0007] JP 2001-161631 discusses an endoscope shaft with a frame having a super-elastic alloy tube with slots disposed therethrough. Properties of the super-elastic alloy allow the tube to bend an adjacent slot without substantial permanent deformation.

[0008] Conventional systems and methods require wire guides, which are small components that must be individually placed within and attached to the catheter body, adding to the costs to manufacture the catheter. Due to the need to balance small component size with the great mechanical needs, wire guides may lack sufficient structural robustness. In addition, wire guides require other mechanisms, e.g., adhesives, thermal processes, or laser welding processes, for integration with the catheter body or for bending action during movement of the device, again adding to the complexity of the catheter system. Thus, conventional systems and methods provide a bendable structure for a catheter in a complicated and costly manner.SUMMARY

[0009] Provided herein are devices and methods for manufacture of a catheter utilizing a polymer based on the polymer’s unique advantage(s) while maintaining flexibility necessary for targeted minimally invasive surgical (MIS) procedure(s).

[0010] An aspect of the present disclosure provides a catheter that includes a proximal section, a distal section, a main lumen, and at least one subsidiary lumen, with a pattern provided along a longitudinal length of at least one portion of the distal section.

[0011] Another aspect of the present disclosure provides a catheter that includes a plurality of segments, with each segment of the plurality of segments including a main lumen, a subsidiary lumen, an anchor formed at a distal end of the subsidiary lumen, and a drive wiresecured to the anchor and extending through the subsidiary lumen. A distal section of the catheter is formed by joining a proximal end of a first section of the plurality of segments with a distal end of a second section of the plurality of segments and aligning the respective main and subsidiary lumens. A proximal section of the catheter is formed by joining a distal end of a third section of the plurality of segments with a proximal end of the second section of the plurality of segments and aligning the respective main and subsidiary lumens. The drive wire of the first section is extended through the second section and the third section; the drive wire of the second section is extended through the third section; and the first section and the second section are steerable by application of one of a push force and a pull force on a proximal end of at least one drive wire of the first section or the second section.

[0012] A further aspect of the present disclosure provides a method of manufacture of a catheter that includes a plurality of segments with each segment of the plurality of segments including a main lumen, a subsidiary lumen, an anchor formed at a distal end of the subsidiary lumen, and a drive wire secured to the anchor and extending through the subsidiary lumen, with the method including forming a distal section of the catheter by joining a proximal end of a first section of the plurality of segments with a distal end of a second section of the plurality of segments and aligning main and subsidiary lumens of the first and second sections; forming a proximal section of the catheter by joining a distal end of a third section of the plurality of segments with a proximal end of the second section of the plurality of segments and aligning main and subsidiary lumens of the second and third sections; extending a drive wire of the first section through the second section and the third section; and extending a drive wire of the second section through the third section, with the first section and the second section being steerable by application of one of a push force and a pull force on a proximal end of at least one drive wire of the first section or the second section.

[0013] These and other objectives, features, and advantages of the present disclosure will become apparent upon reading the following detailed description of exemplary embodiments of the present disclosure, when taken in conjunction with the appended drawings, and provided claims.BRIEF DESCRIPTION OF DRAWINGS

[0014] Further aspects will hereinafter be described in conjunction with the appended drawings, provided to illustrate and not to limit the disclosed aspects, wherein like designations denote like elements of the present disclosure.

[0015] FIG. 1 illustrates components of a steerable endoscope probe controlled by a continuum robot system.

[0016] FIG. 2 is a perspective cutaway view illustrating components of a steerable endoscope probe.

[0017] FIG. 3 provides perspective views of representative guide members.

[0018] FIG. 4 illustrates bending / steering of a bending section.

[0019] FIG. 5A is a profile view illustrating a polymer segment with a spiral pattern cut into a distal section thereof, according to an embodiment.

[0020] FIG. 5B is a cross section of the polymer segment of FIG. 5A, according to an embodiment.

[0021] FIG. 6 is a profile view illustrating a polymer segment with an interrupted pattern, according to an embodiment.

[0022] FIG. 7 is a profile view illustrating a polymer segment with a longitudinally extended, interrupted spiral pattern according to an embodiment.

[0023] FIG. 8A is a profile view illustrating a polymer segment with a first open cell pattern according to an embodiment.

[0024] FIG. 8B is a profile view illustrating a polymer segment with a second open cell pattern according to an embodiment.

[0025] FIG. 8C is a profile view illustrating a polymer segment with a third open cell pattern, according to an embodiment.

[0026] FIG. 9 is a cross sectional view of a polymer segment, according to an embodiment.

[0027] FIG. 10 is a profile view illustrating a polymer segment with one steerable section and an anchor provided on a distal end of the one steerable section, according to an embodiment.

[0028] FIG. 11 is a profile view of a polymer segment of a catheter illustrating a plurality of steerable sections and drive wires terminating within respective polymer segments, according to an embodiment.

[0029] FIG. 12 is a profile view of a polymer segment of a catheter illustrating a plurality of steerable sections and drive wires terminating within respective drive anchors, according to an embodiment.

[0030] FIG. 13A is a disassembled view of a polymer catheter illustrating multiple steerable sections and drive wires terminating in discreet lengths of polymer segments, according to an embodiment.

[0031] FIG. 13B illustrates an assembled state of the polymer catheter of FIG. 13 A.DETAILED DESCRIPTION

[0032] The exemplary embodiments disclosed herein are based on an objective of providing a controller interface applicable to interchangeable manual and robotic control for an articulated steerable medical device having manual insertion mode and robotically controlled navigation mode to guide interventional tools and instruments, such as endoscopes and catheters, through intraluminal tortuous paths.

[0033] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. In addition, while the subject disclosure is described in detail with reference to the enclosed figures, it is done so in connection with illustrative exemplary embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended claims. Although the drawings represent some possible configurations and approaches, the drawings are not necessarily to scale and certain features may be exaggerated, removed, or partially sectioned to better illustrate and explain certain aspects of the present disclosure. The descriptions set forth herein are not intended to be exhaustive or otherwise limit or restrict the claims to the precise forms and configurations shown in the drawings and disclosed in the following detailed description.

[0034] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached", "coupled" or the like to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown in one embodiment can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0035] The terms first, second, third, etc. may be used herein to describe various elements, components, regions, parts and / or sections. It should be understood that these elements,components, regions, parts and / or sections are not limited by these terms of designation. These terms of designation have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed a second element, component, region, part, or section merely for purposes of distinction but without limitation and without departing from structural or functional meaning.

[0036] As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "includes" and / or "including", “comprises” and / or “comprising”, “consists” and / or “consisting” when used in the present specification and claims, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof not explicitly stated. Further, in the present disclosure, the transitional phrase “consisting of’ excludes any element, step, or component not specified in the claim. It is further noted that some claims or some features of a claim may be drafted to exclude any optional element; such claims may use exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or it may use of a "negative" limitation.

[0037] The term “about” or “approximately”, as used herein, means, for example, within 10%, within 5%, or less. In some embodiments, the term “about” may mean within measurement error. In this regard, where described or claimed, all numbers may be read as if prefaced by the word "about" or "approximately," even if the term does not expressly appear. The phrase "about" or "approximately" may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1 % of the stated value (or range of values), + / - 1 % of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical range, if recited herein, is intended to include all sub-ranges subsumed therein. As used herein, the term “substantially” is meant to allow for deviations from the descriptor that do not negatively affect the intended purpose. For example, deviations that are from limitations in measurements, differences within manufacture tolerance, or variations of less than 5% can be considered within the scope of substantially the same. The specified descriptor can be an absolute value (e.g. substantially spherical, substantially perpendicular, substantially concentric, etc.) or a relative term (e.g.substantially similar, substantially the same, etc.).

[0038] The present disclosure generally relates to medical devices, and it exemplifies embodiments of an optical probe which may be applicable to a spectroscopic apparatus (e.g., an endoscope), an optical coherence tomographic (OCT) apparatus, or a combination of such apparatuses (e.g., a multi-modality optical probe). The embodiments of the optical probe and portions thereof are described in terms of their position / orientation in a three-dimensional (3D) space. As used herein, the term “position” refers to the location of an object or a portion of an object in the 3D space (e.g., translational freedom along Cartesian X, Y, Z coordinates); the term “orientation” refers to the rotational placement of an object or a portion of an object (three degrees of rotational freedom— e.g., roll, pitch, and yaw); the term “posture” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of object in at least one degree of rotational freedom (up to a total six degrees of freedom); the term "shape" refers to a set of posture, positions, and / or orientations measured along the elongated body of the object. As known in the field of medical devices, the terms “proximal” and “distal” are used with reference to the manipulation of an end of an instrument extending from the user to a surgical or diagnostic site. In this regard, the term “proximal” refers to the portion of the instrument closer to the user, and the term “distal” refers to the portion of the instrument further away from the user and closer to a surgical or diagnostic site.

[0039] As used herein, the term “catheter” generally refers to a flexible and thin tubular instrument made of medical grade material designed to be inserted through a narrow opening into a bodily lumen (e.g., a vessel) to perform a broad range of medical functions. The more specific term “optical catheter” refers to a medical instrument comprising an elongated bundle of one or more flexible light conducting fibers disposed inside a protective sheath made of medical grade material and having an optical imaging function. A particular example of an optical catheter is fiber optic catheter which comprises a sheath, a coil, a protector and an optical probe. In some applications a catheter may include a “guide catheter” which functions similarly to a sheath.

[0040] As used herein, the term “endoscope” refers to a rigid or flexible medical instrument which uses light guided by an optical probe to look inside a body cavity or organ. A medical procedure, in which an endoscope is inserted through a natural opening, is called an endoscopy. Specialized endoscopes are generally named for how or where the endoscope is intended to be used, such as the bronchoscope (mouth), sigmoidoscope (rectum), cystoscope (bladder), nephroscope (kidney / uro logy), bronchoscope (bronchi), laryngoscope (larynx),otoscope (ear), arthroscope (joint), laparoscope (abdomen), and gastrointestinal endoscopes. Endoscopes also find applications in cardiology, exploratory surgeries, and multi-functional tools.

[0041] In the present disclosure, the terms “optical fiber”, “fiber optic”, or simply “fiber” refers to an elongated, flexible, light conducting conduit capable of conducting light from one end to another end due to the effect known as total internal reflection. The terms “light guiding component” or “waveguide” may also refer to, or may have the functionality of, an optical fiber. The term “fiber” may refer to one or more light conducting fibers. An optical fiber has a generally transparent, homogenous core, through which the light is guided, and the core is surrounded by a homogenous cladding. The refraction index of the core is larger than the refraction index of the cladding. Depending on design choice, some fibers may have multiple claddings surrounding the core.

[0042] Specific embodiments of the present disclosure are directed to improving robotically controllable endoscopes or catheters applicable to MIS procedures. MIS procedures involve the use of long rigid or flexible surgical instruments that are inserted into the body of a patient through small incisions or natural orifices. There is wide range of well-known endoscopic procedures. An important aspect of MIS endoscopy is the ability to “see” inside the body of the patient by directly inserting an imaging device into the area of interest. As the imaging device, most endoscopes use a high-resolution camera and a light source at the endoscope tip. The endoscope tip can be actively steered either manually by two thumb- controlled dials, or by a robotic actuator at the proximal end. Insertion and retraction of the endoscope into the patient body can also be performed either manually or robotically. The application of such endoscopic devices includes procedures for both diagnostic and therapeutic purposes.

[0043] FIG. 1 illustrates components of a steerable endoscope probe 100 controlled by a continuum robot system 300.

[0044] The system 300 is configured to control a steerable endoscopic probe 100 either in manual mode or robotic mode. The probe 100 has at least one bendable / steerable section applicable to catheter- assisted or endoscope-assisted MIS procedures. FIG. 1 shows the probe 100 (also referred to as catheter or endoscope herein) having a steerable distal section 101 with N number of individual steerable sections and a non-steerable proximal section 102 arranged along a longitudinal axis (Ax). The non-steerable proximal section 102 is a tubular body (extrusion body) that may be made of extruded or 3D printed polymer material. The steerable distal section 101 may be made of a plurality of actuatable segments or disks. The probe 100is controlled by the robotic control system 300, which is connected to the probe 100 via a handle or hub 200. The control system 300 generally includes a controller 302, e.g., a proportional-integral-derivative (PID) controller or other digital signal processor (DSP) along with suitable software, firmware, and peripheral hardware, which are known to persons of skill in the art. DSPs are generally dedicated integrated circuits. However, DSP functionality can also be produced by using field-programmable gate array chips (FPGAs). The control system 300 can be part of, or is connected to, a computer system 400 including, e.g., a system console, operated by a processor or central processing unit (CPU) 410. The computer system 400, the robotic control system 300 and the handle 200 may be operably connected to each other by a network and / or a cable bundle 425. Among other functions, the computer system 400 can provide a surgeon or other user with an image display device 420 and a graphical user interface (GUI) 422 to interact and remotely operate the probe 100.

[0045] The robotic control system 300 may include a plurality of actuating motors (or actuators) Motor 1 through Motor M, where M is an integer greater than zero and equal to a number of control wires 110 necessary for steering the probe 100. The robotic control system 300 also includes one or more sensors 304, which may include a strain sensor and / or a position sensor. A strain sensor can be implemented by, for example, a strain gauge or a piezo resistor. A strain sensor may serve to detect and / or measure compressive or tensile forces (F) exerted on the driven control wire 110, and the strain sensor may output one or more signals 305 corresponding to the amount of compressive or tensile force (an amount of strain) being applied to each control wire 110 during actuation of the steerable probe 100. The sensors 304 may also output signals 305 corresponding to an amount of movement (a distance) of displacement for each actuated control wire 110, during a procedure. A sensor that measures the amount of displacement of the control wire may be implemented by a Hall-effect sensor. The sensor 304 may also be implemented by an electromagnetic (EM) sensor configured to measure and / or detect the position and orientation of the steerable probe 100. Signals 305 from the sensors 304 (strain sensor, displacement sensor, and / or position sensor) for each control wire 110 may be fed into the controller 302 to control each motor or actuator individually. In this manner, each control wire 110 may be actively controlled to implement appropriate shaft guidance for navigating the probe 100 through intraluminal cavities of a patient’s anatomy. Each electromechanical connection of a control wire 110 with a corresponding motor or actuator is in operative connection with the one or more sensors 304 to create a feedback loop based on signals 305 for the controller 302. The controller 302 may be used to electronically control the operation (movement) of each control wire 110 based on one or more of tensional, compressive,and / or torsional forces applied to each control wire 110.

[0046] The handle 200 may provide an electromechanical interface between the probe 100 and the control system 300. For example, the handle 200 may provide mechanical, electrical, magnetic, and / or optical connections, and other data / digital connections for interfacing the probe 100 with the control system 300. The handle 200 may also provide an input port 250 for a surgeon or operator to use to insert an instrument or an end effector. For example, the input port 250 can be used to insert small instruments, such as small forceps, needles, or electrocautery instruments and the like.

[0047] The steerable distal section 101 is bent / straightened by operating an operation member to pull / slacken one or more wires via a hand-side operation by an operation member, with the operation member including one or more of an operation lever, an operation knob, a dial and / or control wheel 252.

[0048] The probe 100 may include a cylindrical tubular shaft which has one or more tool channels and a plurality of wire conduits extending from the proximal end to the distal end of the probe. Among the tool channels, the probe 100 may include at least one tool channel extending along (typically inside) the tubular shaft. Among the wire conduits, the probe may include a plurality of wire conduits extending along (typically within) the wall of the tubular shaft (sheath). The one or more tool channels provide access to end effectors located at the distal end of the probe 100. The one or more tool channels may also be used for sending or retrieving liquid or gaseous substances (e.g., air, water) to a target area. The tool channels may also be used for passing imaging components such as optical fibers, miniature cameras, and / or sensors powered by electrical wires. The wire conduits formed within the wall of the sheath allow passage of control wires and / or support wires used for steering (or bending) the distal section 101 of the sheath. At the proximal end of the probe 100, the handle 200 with the access port 250 and one or more dials / control wheels 252 may be used to manually bend the distal (steerable) section 101 in one or more directions.

[0049] The probe 100 is configured to provide flexible access to intraluminal target areas with one or more than one bending curves to reach the intended target area near the distal end of the probe, while retaining torsional and longitudinal rigidity so that physicians can control the end effectors located at the distal end of the sheath by maneuvering the handle 200, or by kinematic operation of control system 300. In order to provide such steerable functionality, the probe 100 is equipped with one or more than one support wires (a backbone or tendon), and a plurality of control wires 110 which are arranged inside the wire conduits along (typically inside) the wall of the sheath along the length of the probe 100.-1O-

[0050] FIG. 2 is a perspective cutaway view illustrating components of a steerable endoscope probe.

[0051] The probe 100 may include the proximal section 102, which may be made of a solid sheath, and the distal section 101, which may be made of a plurality of disks or guide members grouped into bending sections 106a and 106b with at least one inflection point 107. In the probe 100, a plurality of control wires 110 extend from the proximal end to the distal end thereof, passing through respective guide holes 104a, 104b, 104c, 104d, 104e, 104f (FIG. 3) along the wall of the sheath, and through a plurality of guide members 108a, 108b, and anchor members 103a, 103b. The sheath of the proximal section 102 and wire-guiding disks of the distal section 101 are arranged along the longitudinal probe axis Ax to form at least one tool channel 105.

[0052] The control wires 110 are arranged in a lengthwise direction parallel to the Z-axis, with some control wires 110 coupled at the inflection point 107 to a first anchor member 103 a and other control wires 110 coupled to a second anchor member 103b. All of the control wires 110 are coupled, at the proximal end of the probe 100, to respective individual motors or actuators in the control system 300 (FIG. 1) via the handle / hub 200. The control wires 110 may be metal wires, for example, piano-type wires, stainless-steel wires, or nickel-titanium-alloy wires. The anchor members 103a and 103b may have an annular shape with the center axis thereof extending along the Z-axis direction. The plurality of control wires 110 are fixedly coupled to the anchor members 103a, 103b, for example, by bonding, pinning, welding, pressure fitting, or screw sets.

[0053] The proximal section 102 of the probe 100 may have a tubular shape with the center axis thereof extending along the Z-axis direction and a plurality of conduits 104 (through holes) extending within the wall of the sheath. The proximal section 102 may function as a support section, which can be flexible (but non-bendable), and thus function to transmit a force from the actuators / motors to the one or more bending sections when the control wires passing along the through holes of the sheath are driven in the Z-axis direction, without any buckling or slack of the control wires.

[0054] FIG. 3 provides perspective views of representative guide members. The representative guide members illustrated in FIG. 3 correspond to distal steering section 101, illustrating through (guide) holes for control wires 110.

[0055] As illustrated in FIG. 3, each guide member 108a, 108b may have an annular shape with an opening concentric with the probe axis Ax extending along the Z-axis direction. When the guide members 108a, 108b are combined in a lengthwise direction, as shown in FIG.2, a central opening in the guide members 108a, 108b forms the tool channel 105. As illustrated in FIG. 3, guide member 108b may have guide holes 104a, 104b, 104c extending along the longitudinal probe axis Ax. The guide holes 104a, 104b, 104c are configured to allow respective control wires 110 to pass / slide therethrough during a navigation operation (steering) of the probe 100. Among the control wires 110, one wire can be fixed to the guide member at the guide hole by, for example, bonding, and the other two control wires are slidable with respect to the guide holes. Since each guide member 108b contacts the control wires 110 through the guide holes, the guide members may include material such as resin with a low coefficient of friction.

[0056] As also illustrated in FIG. 3, guide member 108a has at least one guide hole (104a- 104f) for passage of control wires 110 of bending sections 106a and 106b. Similar to bending section 106b, bending section 106a has a plurality of guide members 108a with guide holes arranged to allow the control wires 110, which are respectively coupled at one end to anchor member 103a or anchor member 103b, to pass through respective guide holes. As illustrated, one of the three control wires coupled to the anchor member 103 a is fixed to a guide hole in each guide member, and the remaining two control wires are slidable with respect to the respective guide holes.

[0057] FIG. 4 illustrates bending / steering of a bending section. For simplicity, bending of a single section is explained. As illustrated in FIG. 4, a single bending section 106 of probe 100 includes, from the distal end thereof, an anchor member 103, a plurality of guide members 108, and a non-steerable support section 102 with a plurality of guide holes. Control wires 110a, 110b, 110c extend from the proximal end to the distal end along respective guide holes. The control wires 110 are fixedly coupled at the distal end thereof to the anchor member 103. The control wires 110 coupled at the distal thereof to anchor member 103 are slidable with respect to the guide members 108 by the action of an actuator or motor connected at the proximal end of each control wire. One of the three control wires 110 (e.g., control wire 110b in FIG. 4) is fixed (or mechanically grounded) with respect to guide members 108, and the remaining two control wires 110 (e.g., control wires 110a, 110c) are slidable with respect to the guide holes of the guide member 108.

[0058] To bend the distal section of probe 100, a control wire 110 is controlled by a respective actuator / motor. For example, in FIG. 4, while control wire 110b may be fixed or anchored to anchor member 103, a control wire 110a is pulled with a control force Fl, and a control wire 110c is pulled with a control force F2 (control force F2 is lower than control force Fl, in this example). Thus, the bending section 106 may be bent in a desired direction, inaccordance with a combination of the driving amounts of linear displacement of control wires 110a and 110c. To control a posture of the distal end of probe 100, driving two of the three control wires is sufficient. However, to bend more than one section of the probe 100, each bendable section needs to be controlled by actuating one or more control wires 110.

[0059] While driving the control wires anchored at the distal end of a single bending section has been described above with respect to FIG. 4, if control wires of all bending sections of FIG. 1 are driven, the postures of each bending section may be independently controlled in accordance with the driving amounts of the individual control wires.

[0060] In contrast to the probes in FIGS. 1 -4, catheters may be constructed from a variety of polymers, including polyurethane, silicone, latex, nylon, polyethylene, polyethylene terephthalate (PET), thermoplastic elastomers, and polyvinyl chloride, each having unique properties, advantages, and flexibility (bendability). However, use of one polymer based on the polymer’s unique advantages may result in a catheter that lacks flexibility that is necessary for desired MIS procedure(s). Thus, provided herein are devices and methods for manufacture of catheters that allow for selection of a polymer based on the polymer’s unique advantage(s) without compromise of flexibility necessary for the targeted MIS procedure(s).

[0061] FIG. 5A is a profile view illustrating a polymer segment with a spiral pattern that is cut into a distal section thereof, according to an embodiment. As illustrated in FIG. 5A, an elongated, continuous polymer segment 500 is provided, and the polymer segment 500 has a predetermined shape memory. The polymer segment 500 includes a main lumen 550 that extends substantially along a longitudinal center thereof. The polymer segment 500 includes a passive proximal section 502 and a steerable distal section 501, with a pattern 530 that is provided on an outer circumference of the distal section 501 of the main lumen 550. The pattern 530 may be applied by laser cutting, kerf cutting, molding or similar process performed on an outer circumference of the distal section 501 of the polymer segment 500. Applying the pattern 530 into the distal section 501 varies a predetermined shape memory of the distal section 501, thus improving bendability thereof, as compared to bendability of the proximal section 502.

[0062] The pattern 530 that is cut / molded into the outer circumference may be a spiral or helical pattern formed in a circumference of the distal section 501 along a longitudinal length that substantially corresponds to a length of the distal section 501.

[0063] The pattern 530 may be cut to a uniform depth along the distal section 501, to provide a predetermined bend radii that matches a target deformation change. Alternatively, the depth of the helical pattern may vary along the distal section 501, with the pattern 530 being cut deeper along at least one predetermined longitudinal length, to provide improvedbendability of the distal bendable section 501 in at least direction that is opposite to the deeper cut made along the at least one predetermined longitudinal length. The pattern 530 may be provided by varying a depth of the cut based on degree of rotation. For example, considering the outer circumference of the distal bendable section being 360°, for a four-part pattern, a section of deep cut may be made from 0° to 90°, a section of shallow cut made from 90° to 180°, a section of deep cut may be made from 180° to 270°, and a section of shallow cut may be made from 270° to 0°. In the four-part pattern, the shallow cut may be a depth of substantially zero millimeters and the deep cut may extend to a maximum wall thickness of the material forming the extrusion body, e.g., to a depth of 1.2 millimeters. Other embodiments are available. For example, a six-part pattern may vary shallow and deep cuts every 60°, and an eight-part pattern may vary between shallow and deep cuts every 45°.

[0064] In addition or alternatively, a distance between each cut of the pattern 530 may vary along the distal section 501, to provide greater bendability in sections of the distal bendable section 501.

[0065] FIG. 5B is a cross section of the polymer segment of FIG. 5A, according to an embodiment. As illustrated in FIG. 5B, at least one subsidiary lumen 560 extends through the polymer segment 500. The at least one subsidiary lumen 560 is configured to enclose at least one drive wire 565 therein. The at least one subsidiary lumen 560 extends in a longitudinal direction through the proximal section 502 and the distal section 501, with the at least one subsidiary lumen 560 being positioned outside of an outer circumference of the main lumen 550.

[0066] FIG. 6 is a profile view illustrating a polymer segment with an interrupted pattern, according to an embodiment. As illustrated in FIG. 6, a pattern 530 is provided into the outer circumference of the distal section 101, with the pattern 530 being interrupted due to the spiral not being continuous from the distal end to the proximal end of the distal section 510.

[0067] FIG. 7 is a profile view illustrating a polymer segment with a longitudinally extended, interrupted spiral pattern according to an embodiment. As illustrated in FIG. 7, a slotted, interrupted pattern is provided. The slots of the interrupted pattern of FIG. 7 are wider and deeper than the openings in pattern 530 (FIG. 6), thereby providing increased bendability of the distal section 501. The larger slots of the interrupted pattern of FIG. 7 extend from the outer circumference toward the center of the main lumen 550, exposing the region of travel of the drive wire 565 and associated subsidiary lumen 560.

[0068] FIG. 8A is a profile view illustrating a polymer segment with a first open cell pattern, according to an embodiment. As illustrated in FIG. 8 A, a lattice- work pattern of circlesis provided, with the circles being stacked circumferentially around the circumference of the distal segment 501.

[0069] FIG. 8B is a profile view illustrating a polymer segment with a second open cell pattern, according to an embodiment. As illustrated in FIG. 8B, a lattice- work pattern of ovals is provided, with the ovals being stacked circumferentially around the circumference of the distal segment 501.

[0070] FIG. 8C is a profile view illustrating a polymer segment with a third open cell pattern, according to an embodiment. As illustrated in FIG. 8C, a lattice-work pattern of rounded squares is provided, with the rounded squares being stacked circumferentially around circumference of the distal segment 501.

[0071] Similar to FIG. 7, the first to third open cell patters of FIGS. 8 A to 8C extend from the outer circumference toward the center of the main lumen 550, exposing the region of travel of a conventional guide wire.

[0072] FIG. 9 is a cross sectional view of a polymer segment, according to an embodiment.

[0073] The probe 500, the main lumen 550, the subsidiary lumen 560, and the drive wire 565 illustrated in FIG. 9 correspond to the similar components of FIG. 5B. For conciseness, the description of these components is not repeated here. Also shown in FIG. 9 is a liner 580, i.e. secondary inner tube, that extends along a longitudinal direction within an inner circumference of the polymer segment 500, through the distal section 501 and the proximal section 502. An outer circumference of the liner 580 may be bonded or affixed to the inner wall of the polymer segment 500, e.g., by thermal process or adhesive process. When bonded or affixed to the inner wall of the distal section 501, the liner 580 reinforces the distal section 501 and enhances predictability of bending. The liner 580 may be formed of at least one of an extruded polymer, a polymer-jacketed flexible metal tube (e.g., stainless steel or super-elastic alloy such as Nickel-Titanium (NiTi)), or Polytetrafluoroethylene (PTFE).

[0074] FIG. 10 is a profile view illustrating a polymer segment with one steerable section and an anchor provided on a distal end of the one steerable section, according to an embodiment.

[0075] As disclosed herein, the drive wire 565 extends from the proximal section 502 through the subsidiary lumen 560 to an anchor 590. The anchor 590 is configured to secure a distal end of drive wire 565 and, as illustrated in FIG. 10, the anchor 590 is provided on a distal end of the distal section 501.

[0076] As described above, the catheter may be formed from a single, continuous polymer segment that is divided into the passive proximal section 502 and at least one distalsection 501. An area along a longitudinal length of the polymer segment into which at least one pattern is cut defines the at least one distal section 501.

[0077] The polymer segment and anchors described herein regarding FIGS. 5 A to 10 provide a catheter having a bendable, flexible shaft with improved structural integrity that is better able to withstand external forces imposed on the catheter by anatomical variations or by the operator. The continuous structure of the polymer segment 500 disperses bending forces within the distal bending section, thus providing a smooth bend radius along the bending section without kinking or ovalization of the main lumen 550 of the catheter. In addition, forces applied by at least one control wire are easily and continuously transmitted to the distal end to modify orientation and / or pose of the catheter. Thus, the catheter may be constructed with a fewer number of components, and save labor costs.

[0078] FIG. 11 is a profile view of a polymer segment of a catheter illustrating a plurality of steerable sections and drive wires terminating within respective polymer segments, according to an embodiment.

[0079] As illustrated in FIG. 11, the distal section 501 is divided into a plurality of distal sections 501a, 501b, 501c that are individually steerable by push / pull force(s) applied on a proximal end of respective drive wires 565. A plurality of polymer anchors 595, 597, 599 are provided to secure a respective plurality of drive wires 565a, 565b and 565c. Adjacent steerable sections of the plurality of steerable sections 501a, 501b, 501c are separated by polymer anchors 597 and 599.

[0080] Each steerable section of the plurality of steerable sections 501a, 501b, 501c is formed along a respective longitudinal length of the distal section 501. A pattern 530 is cut, molded, or otherwise formed substantially along the longitudinal length of the plurality of steerable sections 501a, 501b, 501c. That is, a specific bend radii may be predetermined by variation of the pattern cut for each steerable section of the plurality of distal sections 501a, 501b, 501c. Multiple bend sections can be designed based on a predetermined catheter purpose, with the pattern 530 being customized to suit the mechanical need of each bending section.

[0081] As shown in FIG. 11, to ensure sufficient polymer to bond to anchor of a respective drive wire, a pattern 530 is not cut into longitudinal lengths between the adjacent steerable sections of the plurality of steerable sections 501a, 501b, 501c.

[0082] Drive wire 565 a is secured by polymer anchor 599 positioned at a first uncut area between proximal steering section 501c and middle steering section 501b. Drive wire 565b is secured by polymer anchor 597 positioned at a second uncut area between middle steering section 501b and distal section 501a. Drive wire 565c is secured by polymer anchor 595positioned at a third uncut area at a distal end of distal section 501a.

[0083] Distal ends of drive wires 565a, 565b and 565c may be secured to polymer anchor 595, 597 and 599, respectively, by one or more of a thermal process, an adhesive process, and a mechanical process. The thermal process may include one or more of ultrasonic metal-to- polymer welding and thermal reflow processes, where the plastic is locally melted, re-flown, then cooled to set the components into place. The adhesive process may include one or more of a moisture-cure, ultraviolet (UV) light cure. The mechanical process may include clamping the drive wire to the polymer anchor using screws, rivets, or other mechanical components.

[0084] In addition to the improvements described above regarding the polymer segment illustrated in FIG. 5 A to FIG. 10, the catheter having multiple bending sections and the pattern cut disclosed in FIG. 11 provide a catheter that is configured to actuate across multiple planes thereby providing improved navigation performance of catheter within target anatomy. Also, terminating the drive wires 565 within respective drive anchors and integrating the drive wires 565 directly into polymer segment protects the drive wires 565 within the structure of the laser cut pattern on the polymer segment. Thus, the number of components and complexity of assembly are reduced, reducing component and labor costs.

[0085] FIG. 12 is a profile view of a polymer segment of a catheter illustrating a plurality of steerable sections and drive wires terminating within respective drive anchors, according to an embodiment.

[0086] Similar to FIG. 11 , the distal section 501 of the embodiment of FIG. 12 is divided into a plurality of elongate steerable sections 501a, 501b, 501c. In FIG. 12, adjacent elongate steerable sections of the plurality of steerable sections 501a, 501b, 501c are separated by an anchor of a plurality of anchors 590a, 590b, 590c. Each steerable section of the plurality of steerable sections 501a, 501b, 501c is formed along a respective longitudinal length of the distal section 501.

[0087] The plurality of anchors 590a, 590b, 590c may be formed of a different material than the material that forms the plurality of elongate steerable sections, and the plurality of anchors may have a design that differs from polymer segment, thereby providing mechanical or manufacturing benefits, to enable the push-pull operation of the distal end by push-pull on at least one proximal end of the drive wires, for improved catheter actuation and angle output. As disclosed above, a strain sensor may serve to detect and / or measure compressive or tensile forces (F) exerted on the driven control wire 110, and the strain sensor may detect strain relief required to protect the anchor. The pattern may be customized to a desired bending radii of a catheter surrounding the anchor, while maintaining space for the anchor, thereby improvingrobustness of catheter mechanical performance.

[0088] As shown in FIG. 12, drive wire 565a is secured by anchor 590a, drive wire 565b is secured by anchor 590b, and drive wire 565c is secured by polymer anchor 590c. A longitudinal length between steerable section 501b and steerable section 501c is occupied by an area corresponding to anchor 590b and a longitudinal length between steerable section 501b and steerable section 501c is occupied by an area corresponding to anchor 590c.

[0089] A pattern 530 is cut, molded, or otherwise formed substantially along the longitudinal length of the plurality of steerable sections 501 a, 501b, 501c. For enhanced rigidity, the pattern need not be cut on a circumference of the plurality of anchors 590a, 590b, 590c, and space is maintained for adhesive placement or local thermal reflow / melting / welding.

[0090] The embodiment described in FIG. 11 may be manufactured from a single, continuous, elongate polymer segment. In contrast, the embodiment described in FIG. 12 is manufactured from a separate polymer segment for each steerable section of the plurality of steerable sections 501a, 501b, 501c.

[0091] FIG. 13A is a disassembled view of a polymer catheter illustrating multiple steerable sections and drive wires terminating in discreet lengths of polymer segments, according to an embodiment.

[0092] The polymer catheter may be laser cut to provide a flexible catheter with a plurality of steerable distal sections 501a, 501b, 501c, as well as a plurality of drive wires, respective distal ends of which terminate within respective integrated drive anchors provided within discreet polymer segments. The respective distal ends are secured within respective discreet polymer segments by one or more of a thermal process, an adhesive process, and a mechanical process. The thermal process may include one or more of ultrasonic metal-to- polymer welding and thermal reflow processes, where the plastic is locally melted, re-flown, then cooled to set the components into place. The adhesive process may include one or more of a moisture-cure, ultraviolet (UV) light cure. The mechanical process may include clamping the drive wire to the polymer anchor using screws, rivets, or other mechanical components.

[0093] As illustrated in FIG. 13A, a polymer anchor 595, 597, 599 is only provided a respective distal end of each distal section 501a, 501b, 501c. A pattern is cut, molded, or otherwise formed substantially along the longitudinal length of each of the plurality of steerable sections 501a, 501b, 501c, other than a region corresponding to each polymer anchor 595, 597, 599.

[0094] FIG. 13B illustrates an assembled state of the polymer catheter of FIG. 13 A. In addition to the improvements described above regarding the polymer segment illustrated inFIGS. 5A to 11, the polymer catheter illustrated in FIGS. 13A and 13B provides drive wires 565 that are integrated within discreet lengths of polymer segment to reduce the number of components for assembly and reduce the complexity of assembly. That is, the catheter may be assembled piecewise with discreet segments utilizing a manufacturing line process, in which the discreet segments are manufactured in parallel and in bulk, and are then combined to provide a finished catheter.

[0095] As illustrated and described herein, to protect and fully guide the at least one drive wire and to provide enhanced functionality, at least one subsidiary lumen is provided. Each drive wire is slidably embedded within a respective subsidiary lumen, which is secured to distal section along a longitudinal length thereof. Each drive wire is also secured at the distal end thereof in a respective polymer anchor. Thus, each individual drive wire may manipulate a pose of the probe 100 by exerting a pushing force, in addition to exerting a convention pulling force. Accordingly, embodiments of the present disclosure provide single wire push-pull control.

[0096] As illustrated and described herein, a catheter is provided that includes a plurality of segments, with each segment of the plurality of segments including a main lumen, a subsidiary lumen, an anchor formed at a distal end of the subsidiary lumen, and a drive wire secured to the anchor and extending through the subsidiary lumen. A distal section of the catheter is formed by joining a proximal end of a first section of the plurality of segments with a distal end of a second section of the plurality of segments and aligning the respective main and subsidiary lumens. A proximal section of the catheter is formed by joining a distal end of a third section of the plurality of segments with a proximal end of the second section of the plurality of segments and aligning the respective main and subsidiary lumens. The drive wire of the first section is extended through the second section and the third section; the drive wire of the second section is extended through the third section; and the first section and the second section are steerable by application of one of a push force and a pull force on a proximal end of at least one drive wire of the first section or the second section. Notches on the ends of a pattern of each of the first, second and third sections. Orientation of the notches expedites alignment of the drive wires, thus providing manufacturing benefits over conventional systems and methods.

[0097] Reference Numbers

[0098] Software Related disclosure. Embodiment(s) of the present disclosure can be realized by a computer of a system or apparatus that reads out and executes computer executable instructions (e.g., one or more programs) recorded on a storage medium (which may also be referred to more fully as a 'non-transitory computer-readable storage medium') to perform the functions of one or more of the above-described embodiment(s) and / or that includes one or more circuits (e.g., application specific integrated circuit (ASIC)) for performing the functions of one or more of the above-described embodiment(s), and by a method performed by the computer of the system or apparatus by, for example, reading out and executing the computer executable instructions from the storage medium to perform the functions of one or more of the above-described embodiment(s) and / or controlling the one or more circuits to perform the functions of one or more of the above-described embodiment(s). The computer may comprise one or more processors (e.g., CPU, micro processing unit (MPU))and may include a network of separate computers or separate processors to read out and execute the computer executable instructions. The computer executable instructions may be provided to the computer, for example, from a network or the storage medium. The storage medium may include, for example, one or more of a hard disk, a random-access memory (RAM), a read only memory (ROM), a storage of distributed computing systems, an optical disk (such as a compact disc (CD), digital versatile disc (DVD), or Blu-ray™ Disc), a flash memory device, a memory card, and the like. An I / O interface can be used to provide communication interfaces to input and output devices, which may include a keyboard, a display, a mouse, a touch screen, touchless interface (e.g., a gesture recognition device) a printing device, a light pen, an optical storage device, a scanner, a microphone, a camera, a drive, communication cable and a network (either wired or wireless).

[0099] Other embodiments, modifications, combinations and / or alterations. In referring to the description, specific details are set forth in order to provide a thorough understanding of the examples disclosed. In other instances, well-known methods, procedures, components and circuits have not been described in detail as not to unnecessarily lengthen the present disclosure. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The scope of the present disclosure is not to be limited by the subject specification and drawing, but rather only by the plain meaning of the claim terms employed.

[0100] In describing example embodiments illustrated in the drawings, specific terminology is employed for the sake of clarity. However, the disclosure of this patent specification is not intended to be limited to the specific terminology so selected and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner.

[0101] While the present disclosure has been described with reference to exemplary embodiments, it is to be understood that the present disclosure is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

CLAIMS1. A catheter comprising: a proximal section; a distal section; a main lumen; and at least one subsidiary lumen, wherein a pattern is provided along a longitudinal length of at least one portion of the distal section.

2. The catheter of claim 1 , wherein the pattern is cut into at least part of a circumference of the distal section to vary bendability of the distal section.

3. The catheter of claim 1, wherein the proximal section and the distal section are formed from a single polymer segment, and wherein the pattern increases bendability of the distal section.

4. The catheter of claim 3, wherein the single polymer segment is formed from at least one of polyurethane, silicone, latex, nylon, polyethylene, polyethylene terephthalate, thermoplastic elastomers, and polyvinyl chloride.

5. The catheter of claim 1, further comprising: another pattern positioned along another longitudinal length of another portion of the distal section, wherein the pattern increases bendability of the distal section along the longitudinal length of the distal section, and wherein the another pattern increases bendability of the distal section along the another longitudinal length of the distal section.

6. The catheter of claim 5, wherein the pattern defines a first predetermined bend radii of the longitudinal length, and wherein the another pattern defines a second predetermined bend radii of the another longitudinal length.

7. The catheter of claim 5, wherein at least one of the pattern and the another pattern are one of: a helical pattern, a continuous spiral pattern, an interrupted spiral pattern, a pattern of ovals, a pattern of circles, and a pattern of rounded squares.

8. The catheter of claim 1, wherein the pattern exposes a longitudinal portion of the at least one subsidiary lumen.

9. The catheter of claim 8, wherein the proximal section and the distal section are formed of polymer, and wherein the at least one subsidiary lumen is integrated in the polymer.

10. The catheter of claim 8, further comprising: a liner affixed to an inner wall of at least a distal section of the main lumen, wherein the at least one subsidiary lumen is positioned outside of an outer circumference of the liner, and wherein the liner is configured to reinforce the distal section of the main lumen to enhance predictability of bending.

11. The catheter of claim 1 , further comprising: a drive wire provided within the at least one subsidiary lumen, wherein the drive wire is fixedly secured at a distal end of the at least one subsidiary lumen, wherein the drive wire is slidable along a length of the at least one subsidiary lumen, and wherein application of one of a push force or a pull force on a proximal end of the drive wire changes an orientation of a distal end of the catheter.

12. The catheter of claim 11, further comprising: an anchor provided at a distal end of the distal section,wherein the anchor fixedly secures a distal end of the drive wire at the distal end of the at least one subsidiary lumen.

13. The catheter of claim 12, wherein the anchor is bonded to a polymer forming the distal section.

14. The catheter of claim 12, wherein the anchor is formed of polymer and the anchor is bonded to a polymer forming the distal section.

15. A catheter comprising: a plurality of segments; wherein each segment of the plurality of segments includes: a main lumen, a subsidiary lumen, an anchor formed at a distal end of the subsidiary lumen, and a drive wire secured to the anchor and extending through the subsidiary lumen, wherein a distal section of the catheter is formed by joining a proximal end of a first section of the plurality of segments with a distal end of a second section of the plurality of segments and aligning the respective main and subsidiary lumens, wherein a proximal section of the catheter is formed by joining a distal end of a third section of the plurality of segments with a proximal end of the second section of the plurality of segments and aligning the respective main and subsidiary lumens, wherein the drive wire of the first section is extended through the second section and the third section, wherein the drive wire of the second section is extended through the third section, and wherein the first section and the second section are steerable by application of one of a push force and a pull force on a proximal end of at least one drive wire of the first section or the second section.

16. The catheter of claim 15, further comprising: at least two patterns, wherein a first pattern of the at least two patterns is cut into at least part of a circumference of the first section to vary bendability thereof, andwherein a second pattern of the at least two patterns is cut into at least part of a circumference of the second section to vary bendability thereof.

17. The catheter of claim 16, wherein the at least two patterns expose portions of the subsidiary lumen.

18. The catheter of claim 16, wherein each segment of the plurality of segments is a polymer segment, and wherein the anchor is bonded to a distal section of the respective segment.

19. The catheter of claim 18, wherein a pattern of the at least two patterns is not formed on the proximal section.

20. A method of manufacture of a catheter that includes a plurality of segments with each segment of the plurality of segments including a main lumen, a subsidiary lumen, an anchor formed at a distal end of the subsidiary lumen, and a drive wire secured to the anchor and extending through the subsidiary lumen, the method comprising: forming a distal section of the catheter by joining a proximal end of a first section of the plurality of segments with a distal end of a second section of the plurality of segments and aligning main and subsidiary lumens of the first and second sections; forming a proximal section of the catheter by joining a distal end of a third section of the plurality of segments with a proximal end of the second section of the plurality of segments and aligning main and subsidiary lumens of the second and third sections; extending a drive wire of the first section through the second section and the third section; and extending a drive wire of the second section through the third section, wherein the first section and the second section are steerable by application of one of a push force and a pull force on a proximal end of at least one drive wire of the first section or the second section.

Images