Medical devices with precise distal steering expandable distal member

Abstract

According to some embodiments, an intraluminal medical device comprises a first member, a portion of the first member at, along or near the distal end comprising at least one feature, portion or member having a spiral or helical shape, wherein the distal end of the first member comprises a preformed portion that is angled or bent relative to a longitudinal axis of the device, a second member, the first member comprising a receiving area configured to receive the at least one feature, portion or member having a spiral or helical shape of the first member when the first member is moved relative to the second member along the longitudinal axis, wherein when the at least one feature, portion or member having a spiral or helical shape of the first member is moved at least partially within the receiving area of the second member, the distal end of the first member rotates or turns along the longitudinal axis.

Description

MEDICAL DEVICES WITH PRECISE DISTAL STEERING EXPANDABLEDISTAL MEMBERCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 540055, filed September 23, 2023 and titled MEDICAL DEVICES WITH PRECISE DISTAL STEERING EXPANDABLE DISTAL MEMBER , the disclosure of which is incorporated herein by reference in its entirety7. Further, The entire contents of PCT Application PCT / US2022 / 049048, filed November 4, 2022 and published as PCT Publ. WO 2023 / 081419 on May 11, 2023, are incorporated by reference herein and made a part of the present application. Any and all applications for which a foreign or domestic priority7claims is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR §1.57.BACKGROUNDField

[0002] The disclosure of the present application is in the general field of surgical instruments and relates to, among other things, catheters, guidewires, clot retrieval / removal devices, stone retrieval / removal devices, foreign body retrieval / removal devices and surgical instruments that are used in minimally invasive procedures, such as cardiovascular and endoscopic and surgical procedures. At least in some embodiments, such devices facilitate the placement of devices within endoluminal structures within the body, such as, but not limited to, blood vessels, the gastrointestinal tract, the respiratory tract, the genitourinary tract and other bodily cavities.Background

[0003] Multiple devices, including but not limited to guidewires, vascular microcatheters, vascular catheters, vascular sheaths, endoscopes, laparoscopes, arthroscopes. intracardiac echocardiography catheters, intravascular ultrasound catheters, and electrophysiology catheters and associated endoscopic instruments have been used to diagnose and treat conditions by accessing luminal structures of the body. Luminal and cavitary7structures of the body may include, but are not limited to, blood vessels, the heart, the gastrointestinal (GI) tract, genitourinary (GU) tract, peritoneal cavity, thoracic cavity, the mediastinum, bronchial passages, subarachnoidal spaces, and the intracranial ventricular system.

[0004] Push-ability refers to the ability to move the device along the longitudinal axis of the device, resulting in translational motion. Push-ability is directly dependent on the stiffness of the device, which is largely dependent on the modulus of elasticity of the material employed within the device. Devices with a high modulus of elasticity are able to transmit force along the length of the device effectively, while devices with a low modulus of elasticity do not transmit force along the device as effectively, resulting in deformation or buckling of the device.

[0005] Track-ability refers, at least in some embodiments, to the ability’ of a device to be advanced over a guidewire, and is dependent on the modulus of rigidity (or stiffness) of the material employed within the device, the profile of the device and friction between the device and the guidewire and vessel wall.

[0006] Flexibility' refers to the ability of a device to bend and flex along its lateral axis. Flexibility' is necessary to enable the device to follow the bends and turns that are present in the human vasculature. Flexibility may be affected by the type of material and / or structural factors, such as the spacing and size of slits in the device that allow bending. However, flexibility is inversely dependent on the modulus of elasticity and modulus of rigidity and thus comes at the expense of push-ability and torque-ability. In addition, in some circumstances it is desirable for the device to have a variable stiffness along its length, which can aid the device navigating along a pathway.

[0007] In some configurations the device such as a catheter, guidewire, clot removal device or retrieval device, stone retrieval or removal device, foreign body retrieval or removal device, imaging or sensing device, will advantageously demonstrate one-to-one rotation of the distal end with respect to the proximal end. For example, if the proximal end of a device is rotated 90 degrees clockwise, the distal end of the device will also rotate 90 degrees clockwise. Unfortunately, in practice this does not typically occur, especially when the device has one or more bends or loops along its length secondary to the tortuous path of the bodily luminal structures. The inherent tortuosity of bodily structures (blood vessels, GI and GU tracts) means that portions of the device are subjected to frictional forces as the device is maneuvered within the body.

[0008] These frictional forces can impede the transmission of forces from the proximal end to the distal end of a device. One particularly problematic area is torque transmission along a device. As a result, potential energy is oftentimes stored along the length of the device as the proximal end is rotated. As this stored up potential energy’ within the device overcomes the frictional forces that are being exerted along the device, a suddenrotation of the device when the potential energy is released, also known as “whip,” can occur. This can make cannulating a desired luminal branch difficult and may cause injury to the patient. Thus, current devices, such as catheters, guidewires endoscopes and endoscopic instruments, strive for a balance between stiffness and flexibility in a variety of ways.

[0009] Current devices strive to strike a balance between the overall cross- sectional profile or size, as well as a reasonable cost of the device so as to provide value to the healthcare system. A need exists for improved apparatuses, systems, devices and methods for improved steerability of the distal end of the device both in terms of rotation about the longitudinal axis as well as angulation of the distal end of the device and stabilizing the distal end of the device in order to provide better delivery of minimally invasive devices. In addition, a need exists for low profile devices that remove unwanted objects such as clot, stones and / or foreign bodies, from the body. The various embodiments of systems, devices and methods disclosed herein provide improvements and other advantages vis-a-vis existing technologies.SUMMARY

[0010] According to some embodiments, an intraluminal medical device comprises a first member having a distal end and a longitudinal axis, a portion of the first member at, along or near the distal end comprising at least one feature, portion or member having a spiral or helical shape, wherein the distal end of the first member comprises a preformed portion that is angled or bent relative to the longitudinal axis, a second member coaxially aligned with the first member, the first member comprising a receiving area configured to receive the at least one feature, portion or member having a spiral or helical shape of the first member when the first member is moved relative to the second member along the longitudinal axis, wherein when the at least one feature, portion or member having a spiral or helical shape of the first member is moved at least partially within the receiving area of the second member, the distal end of the first member rotates or turns along the longitudinal axis, a third member coaxially aligned with the first and second members, the third member configured to be removably positioned within an interior of the preformed portion of the first member, wherein movement of the third member relative to the interior of the preformed portion changes an angle of the preformed portion relative to the longitudinal axis, and a handle configured to be grasped by a user of the device.

[0011] According to some embodiments, the handle comprises at least one controller (e.g., button, dial, knob, switch, etc.). In some embodiments, the at least onecontroller is configured to control a movement of the at least one feature, portion or member having a spiral or helical shape of the first member relative to the receiving area of the second member to rotate the distal end of the first member about the longitudinal axis. In some embodiments, the at least one controller is configured to control a movement of the third member relative to the interior of the interior of the preformed portion to bend or change the angle of the preformed portion relative to the longitudinal axis. In some embodiments, the at least one controller is positioned on, in or along the handle.

[0012] According to some embodiments, the preformed portion is curved or non-linear (e.g., to facilitate the amount of bending that is accomplished along the distal end of the first member when the third member is moved relative to the interior of the preformed portion of the first portion.

[0013] According to some embodiments, the third member is configured to pass through an interior of the at least one feature, portion or member having a spiral or helical shape.

[0014] According to some embodiments, the at least one feature, portion or member having a spiral or helical shape is located along the distal 0 to 20 percent of the first member.

[0015] According to some embodiments, the device comprises at least one of a guidewire, a microcatheter, a catheter and another intraluminal device. In other embodiments, the second member comprises a microcatheter, a catheter or another intraluminal device.

[0016] According to some embodiments, a spiral or helical portion of the at least one feature, portion or member having a spiral or helical shape is angled 1 to 80 degrees relative to the longitudinal axis.

[0017] According to some embodiments, at least one of the first member, the second member and the third member is removable relative to another of the first member, the second member and the third member.

[0018] According to some embodiments, the first member comprises at least one of nickel titanium (Nitinol), another shape memory material, another metal or alloy and a polymer. In some embodiments, the at least one feature, portion or member having a spiral or helical shape comprises at least one of nickel titanium (Nitinol), another shape memory' material, another metal or alloy and a polymer.

[0019] According to some embodiments, the first member comprises or is coupled to an elongate portion or member that extends proximal to the at least one feature,portion or member having a spiral or helical shape. In some embodiments, the elongate portion or member comprises a hypotube, a tubular member, a wire, etc. In some embodiments, the elongate portion or member comprises at least one of a thermoplastic and a metal or alloy.

[0020] According to some embodiments, the device comprises a radially expandable portion configured to be moved between a radially contracted orientation and a radially expanded position. In some embodiments, the radially expandable portion is configured to be moved between the radially contracted and radially expanded positions using a fluid-based inflation member or feature. In some embodiments, the radially expandable portion is configured to be moved between the radially contracted and radially expanded positions using a mechanical expansion member or feature.

[0021] According to some embodiments, a method of advancing an intraluminal device relative to an anatomical luminal system (e.g., vascular system, digestive system, urinary tract, respiratory system, etc.) of a subject comprises positioning a device according to any of the device embodiments disclosed herein (e.g., any of the devices illustrated in FIGS. 1 to 4B herein) relative to the anatomical luminal system of the subject. The method further comprises advancing the device through the anatomical luminal system of the subject by selectively rotating and bending the distal end of the device, wherein rotating the distal end of the device comprises manipulating a first controller of the at least controller, wherein manipulating the first controller moves the at least one feature, portion or member having a spiral or helical shape of the first member relative to the receiving area of the second member, and wherein bending the distal end of the device comprises manipulating a second controller of the at least controller, wherein manipulating the second controller moves the third member relative to the interior of the preformed portion of the first member, and removing the device from the subject.

[0022] According to some embodiments, device comprises a first member (e.g., a spiral member) with a longitudinal axis having a proximal end and a distal end wherein the spiral member forms a spiral or helical shape or feature, wherein the outer diameter or perimeter of the spiral or helical feature of the spiral member is greater than the outer diameter or perimeter of the more proximal portions of the spiral member, a second member (e.g., a force imparting element) positioned colinear to the spiral member and configured to selectively exert a force on the spiral or helical shape or feature of the spiral member along the longitudinal axis of the spiral member, wherein the spiral member distal to the spiral or helical shape or feature of the spiral member is configured to at least partiallyrotate about the longitudinal axis when the second member exerts force onto the spiral or helical shape or feature of the spiral member.

[0023] According to some embodiments, the spiral or helical shape or feature of the spiral member is formed from at least one wire or ribbon wherein at least one portion of the wire or ribbon. According to some embodiments, the spiral or helical shape or feature of the spiral member is formed from a tubular member with at least one full or partial cut.

[0024] According to some embodiments, device comprises an elongate member with a longitudinal axis having a proximal end and a distal end wherein the elongate member forms a spiral or helical shape along or near the distal aspect of the elongate member, wherein the outer diameter or perimeter of the spiral or helical shaped portion of the elongate member is greater than the outer diameter or perimeter of the more proximal portions of the elongate member, a force imparting element positioned colinear to the elongate member and configured to selectively displace the spiral or helical shaped portion of the elongate member along the longitudinal axis of the elongate member, wherein the elongate member distal to the spiral or helical shaped portion of the elongate member is configured to at least partially rotate about the longitudinal axis when the force imparting element exerts force onto the spiral or helical shaped portion of the elongate member.

[0025] According to some embodiments, the spiral or helical shaped portion of the elongate member is formed from at least one wire or ribbon wherein at least one portion of the wire or ribbon is formed so as to make a coil.

[0026] According to some embodiments, the at least one partial cut extends throughout an entire thickness of a wall of the tubular member. In some embodiments, the at least one partial cut does not extend throughout an entire thickness of a wall of the tubular member. In some embodiments, the at least one partial cut comprises a spiral or helical shape. In some embodiments, an angle of the at least one partial cut relative to the longitudinal axis is between 0 and 80 degrees (e.g., 0-5, 5-10, 10-15, 15-20, 20-25, 25-30, 30-35, 35-40, 40-45, 45-50, 50-55, 55-60, 60-65, 65-70, 70-75, 75-80 degrees, angles between the foregoing ranges, etc.) relative to the longitudinal axis of the device.

[0027] According to some embodiments, the spiral or helical shape or feature of the spiral member has a helical angle between 0 and 90 degrees.

[0028] According to some embodiments, the proximal end of the at least one wire or ribbon of the spiral member travels straight along the long axis of the device.

[0029] According to some embodiments, the force imparting element has at least one lumen wherein the spiral member can be positioned within the lumen of the force imparting element.

[0030] According to some embodiments, the outer diameter of the spiral or helical shape or feature of the spiral member in its resting state is equal to or greater than the inner diameter of the force imparting element.

[0031] According to some embodiments, the spiral or helical shape or feature of the spiral member is able to undergo elongation along the longitudinal axis of the device and a subsequent decrease in the outer diameter of the spiral or helical shape or feature of the spiral member when there is relative motion between the spiral member and the force imparting element along the longitudinal axis wherein deformation of the spiral or helical shape or feature of the spiral member by the force imparting element results in at least partial rotation of the spiral member distal to the spiral or helical shape or feature of the spiral member.

[0032] According to some embodiments, an elastic member can cover the outer surface of at least one part of the spiral member wherein the elastic member can undergo radial expansion when fluid is injected into the lumen of the force imparting element.

[0033] According to some embodiments, the portion of the spiral member proximal to the spiral or helical shape or feature forms a tubular member, and an elastic member can cover the outer surface of the spiral or helical shape or feature of the spiral member wherein the elastic member can undergo radial expansion when fluid is injected into the lumen of the tubular portion of the spiral member wherein expansion of the elastic member can aid in stabilizing the distal end of the device, which improves track-ability. In addition, expansion of the elastic member can aid in removal of unwanted objects such as clot, stones and / or foreign bodies, from the body.

[0034] According to another embodiment, device comprises a spiral member with a longitudinal axis having a proximal end and a distal end wherein the spiral member forms a spiral or helical shape or feature, wherein the outer diameter or perimeter of the spiral or helical shape or feature of the spiral member is greater than the outer diameter or perimeter of the more proximal portions of the spiral member, an inner member that is at least partially disposed within the lumen of the spiral or helical shape or feature of the spiral member wherein the inner member can undergo translation along the longitudinal axis of the device, a force imparting element positioned colinear to the spiral member, wherein the inner diameter of the force imparting member is less than the outer diameter or perimeterof the spiral or helical shape or feature of the spiral member and wherein the force imparting member is configured to selectively impart a force onto the spiral or helical shape or feature of the spiral member along the longitudinal axis of the spiral member, wherein the spiral member distal to the spiral or helical shape or feature of the spiral member is configured to at least partially rotate about the longitudinal axis when the force imparting element exerts force onto the spiral or helical shape or feature of the spiral member.

[0035] According to another embodiment, device comprises a spiral member with a longitudinal axis having a proximal end and a distal end wherein at least one spiral or helical shape or feature is located along the spiral member, an elongate tubular member, wherein the proximal portion of the spiral member is coupled to the elongate tubular member, an inner member that is at least partially disposed within the lumen of the spiral or helical shape or feature of the spiral member wherein the inner member can undergo translation along the longitudinal axis of the device, a force imparting element positioned colinear to the spiral member, wherein the outer diameter or perimeter of at least one portion of the spiral or helical shape or feature of the spiral member is greater than the inner diameter of the force imparting member and wherein the force imparting member is configured to selectively displace the spiral or helical shape or feature of the spiral member along the longitudinal axis of the spiral member, and wherein the spiral member distal to the spiral or helical shape or feature of the spiral member is configured to at least partially rotate about the longitudinal axis when the force imparting element exerts force onto the spiral or helical shape or feature of the spiral member.

[0036] According to some embodiments, the distal end of the inner member can have a tapered or non-tapered outer diameter wherein advancement of the inner member is configured to change the angle of deflection of the first member relative to the longitudinal axis (for example change in the shape of the preformed curve), wherein the change of the angle of deflection of the first member relative to the longitudinal axis and the rotation of the spiral member distal to the spiral or helical shape or feature can be controlled independent of one another.

[0037] According to some embodiments, the diameter or cross sectional profile of at least a portion in the distal aspect of the inner member is less than the inner diameter of the spiral member distal to the spiral or helical shape or feature, and the diameter or cross sectional profile of at least a more proximal portion of the inner member is greater than the inner diameter of the spiral member distal to the spiral or helical shape or feature and wherein the diameter or cross sectional profile of the more proximal portion of the innermember is less than inner diameter of the spiral or helical shape or feature of the spiral member and the spiral member proximal to the spiral or helical shape or feature, wherein the inner member can contact the spiral member just distal to the spiral or helical shape or feature of the spiral member when the inner member is advanced, and wherein the outer diameter of the spiral or helical shape or feature of the spiral member can decrease as counteracting forces are applied to the proximal and distal ends of the spiral or helical shape or feature of the spiral member, which facilitates removal and reinsertion of the elongate member and the inner member from the force imparting element.

[0038] According to some embodiments, the end of the spiral member can be sealed or capped off wherein the inner member can contact the sealed or capped end of the spiral member, and wherein the outer diameter of the spiral or helical shape or feature of the spiral member can decrease as counteracting forces are applied to the proximal and distal ends of the spiral or helical shape or feature of the spiral member, which facilitates removal and reinsertion of the spiral member and the inner member from the force imparting element. For example, tension can be applied to the proximal end of the spiral or helical shape or feature while tension is applied to the distal end of the spiral or helical shape or feature by the inner member.

[0039] According to some embodiments, the elongate tubular member may be made of one or more of the following: polyimide, polyurethane, polyether block amide, nylon, nickel titanium, stainless steel braiding, reinforced tubing, laser cut tubing, laser cut hypotube or other suitable material that would be understood by a person of ordinary skill in the art. The coupling means may include: 1) adhesive, 2) welding, 3) brazing, 4) soldering, 5) mechanical linking, or other suitable means understood by a person of ordinary skill in the art.

[0040] According to some embodiments, the device can have varying stiffness along its longitudinal axis. The varying stiffness of the device can result from one or more of the following 1) differences in cross sectional area of the spiral and / or elongate member, 2) differences in modulus of elasticity in the spiral and / or elongate member or the force imparting member. 3) differences in thickness of the force imparting member.

[0041] According to another embodiment, device comprises a spiral member with a longitudinal axis having a proximal end and a distal end wherein at least one spiral or helical shape or feature is located along the spiral member, an elongate tubular member, wherein the proximal portion of the spiral member is coupled to the elongate tubular member and wherein at least one radially expandable section is located at, along or nearthe distal end of the elongate tubular member, an inner member that is at least partially disposed within the lumen of the spiral or helical shape or feature of the spiral member wherein the inner member can undergo translation along the longitudinal axis of the device wherein at least a portion of the inner member has a diameter or cross-sectional profde that is greater than at least a portion of the inner diameter of the radially expandable section of the elongate tubular member, a force imparting element positioned colinear to the spiral member, wherein the outer diameter or perimeter of at least one portion of the spiral or helical shape or feature of the spiral member is greater than the inner diameter of the force imparting member and wherein the force imparting member is configured to selectively displace the spiral or helical shape or feature along the longitudinal axis of the spiral member, and wherein the spiral member distal to the spiral or helical shape or feature is configured to at least partially rotate about the longitudinal axis when the force imparting element exerts force onto the spiral or helical shape or feature of the spiral member, and wherein the radially expandable section of the elongate tubular member is configured to at least partially radially expand when the radially expandable section is placed under compression.

[0042] According to another embodiment, device comprises an actuating member with a longitudinal axis having a proximal end and a distal end wherein at least one spiral or helical shape or feature and at least one radially expandable feature are located along the actuating member, an elongate tubular member, wherein the proximal aspect of the actuating member is coupled to the distal aspect of the elongate tubular member, an inner member that is at least partially disposed within the lumen of the actuating member wherein the inner member can undergo translation along the longitudinal axis of the device wherein at least a portion of the inner member has a diameter or cross-sectional profile that is greater than at least a portion of the inner diameter of the radially expandable feature of the actuating member, a force imparting element positioned colinear to the actuating member, wherein the outer diameter or perimeter of at least one portion of the spiral or helical shape or feature of the actuating member is greater than the inner diameter of the force imparting member and wherein the force imparting member is configured to selectively displace the spiral or helical shape or feature along the longitudinal axis of the actuating member, and wherein the actuating member distal to the spiral or helical shape or feature is configured to at least partially rotate about the longitudinal axis when the force imparting element exerts force onto the spiral or helical shape or feature of the actuating member, and wherein the radially expandable feature of the actuating member is configuredto at least partially radially expand when the radially expandable section is placed under compression.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] For a detailed understanding of the present disclosure, reference should be made to the following detailed description of the embodiments, taken in conjunction with the accompanying drawings, in which like elements have been given like numerals, wherein:

[0044] FIG. 1 schematically illustrates one embodiment of a medical system that includes a medical device;

[0045] FIG. 2A illustrates a cross sectional view along the longitudinal axis of the device of FIG. 1, wherein a spiral or helical shape or feature of a member (e.g., spiral member) is not in the lumen or other opening or portion of the force imparting element, and the inner member is not in the lumen of the preformed distal end of the member (e.g., spiral member);

[0046] FIG. 2B is a cross sectional view along the longitudinal axis of one embodiment of a medical device wherein spiral or helical shape or feature of the member (e.g., spiral member) is positioned or otherwise engaged in the lumen or other opening or portion of the force imparting element, and the inner member is partially advanced into the lumen the preformed distal end of the spiral member, resulting in, at least according to one embodiment, rotation of the spiral member distal to the spiral or helical shape or feature, as well as partial straightening of the preformed distal end of the spiral member, wherein the rotation and partial straightening are independent of one another;

[0047] FIG. 2C illustrates a cross sectional view along the long axis of one embodiment of a medical device wherein spiral or helical shape or feature of the spiral member is engaged in the lumen of the force imparting element and the inner member is fully advanced into the lumen of the preformed distal end of the spiral member, which, in at least some embodiments, results is straightening of the preformed distal end of the spiral member;

[0048] FIG. 2D illustrates a cross sectional view along the long axis of one embodiment of a medical device wherein the inner member is fully advanced into the lumen the preformed distal end of the spiral member which results is straightening of the preformed distal end of the spiral member and wherein the inner member contacts the spiralmember just distal to the spiral or helical shape or feature resulting elongation and a decrease in the outer diameter of the spiral or helical shape or feature of the spiral member;

[0049] FIG. 2E illustrates a cross sectional view along the long axis of one embodiment of a medical device wherein the spiral member has been removed from the lumen of the force imparting element;

[0050] FIG. 2F illustrates a cross sectional view along the short axis of the proximal end of one embodiment of a medical device wherein the spiral member proximal to the spiral or helical shape or feature forms, at least partially, a tubular member;

[0051] FIG. 2G illustrates a cross sectional view along the long axis of one embodiment of a medical device wherein the elastic member is in an expanded state;

[0052] FIG. 2H illustrates a cross sectional view along the long axis of one embodiment of a medical device, wherein a proximal aspect of the spiral member is coupled to an elongate member (e.g., elongate tubular member) and the inner member is fully advanced into the lumen of the preformed distal end of the spiral member, which, in at least some embodiments, results is straightening of the preformed distal end of the spiral member;

[0053] FIG. 3 schematically illustrates another embodiment of a medical system that includes a medical device;

[0054] FIG. 4A illustrates a cross sectional view along the long axis of the device of FIG. 3. wherein the radially expandable feature is not expanded; and

[0055] FIG. 4B illustrates a cross sectional view along the long axis of the device of FIG. 3, wherein the radially expandable feature is at least partially expanded;

[0056] The figures are drawn for ease of explanation of the basic teachings of the present disclosure only; the extensions of the figures with respect to number, position, relationship, and dimensions of the parts to form the preferred embodiment will be explained or will be within the skill of the art after the following teachings of the present disclosure have been read and understood. Further, the exact dimensions and dimensional proportions to conform to specific force, weight, strength, and similar requirements will likewise be within the skill of the art after the following teachings of the present disclosures have been read and understood.DETAILED DESCRIPTION

[0057] The present application is related to medical devices employed in intraluminal structures. While the medical devices disclosed herein have application in human surgical and diagnostic procedures, the present disclosure contemplates the deviceshaving application and use in human and non-human medical procedures, as well as nonmedical applications for industrial and diagnostic procedures, such as inspections.

[0058] In some embodiments, as discussed in greater detail herein, the intraluminal device is configured to aid in delivery of a device to an intraluminal location (e.g., intravascular, other intraluminal, anatomical location (e.g., through the subject’s airways, gastroenterological system, genitourinary system, other system or structure, etc.)) via precise rotation of the distal end of the device, alteration of the angulation of the distal end of the device with respect to a plane perpendicular to the longitudinal axis of the device (bending or tip deflection) and / or stabilizing the distal end of a device via a reversibly expandable member so as to aid track-ability.

[0059] As discussed in greater detail herein, the various embodiments disclosed herein can provide advantageous devices, systems and / or methods to deliver or advance a medical device (e.g., endoscope, guidewire, catheter, microcatheter, sheath, robotically controlled device or system, other intraluminal device, etc.) within the anatomy.

[0060] According to some embodiments, a device comprises an elongated member that is covered by, at least in part, and / or comprises a first member (e.g., an elastic or flexible member), a second member (e.g. , a force imparting element or a member having at least a portion configured to help impact a force on at least a section or portion of the first member) and a third member (e.g., an inner member, a member configured to adjust a bend or angle along a distal end of the device). In some embodiments, when a spiral or helical shape, feature or portion of the first member is positioned or located at least partially within a lumen or other opening or portion of the second member (e.g., a force imparting member), rotation along the longitudinal axis of the device can selectively and advantageously occur. As the spiral shape or feature of the first member is moved within the lumen or other opening or portion of the second member (e.g., the force imparting member), linear movement of the spiral member relative to the force imparting element causes the spiral or helical shape or feature of the first member (e.g., the spiral member) to elongate. As a result of this elongation, the distal end of the spiral member rotates (e.g., via a conversion of linear to rotational forces for such spiral-shaped portions or devices). In addition and separately of the rotation along the longitudinal axis as discussed above, the third member (e.g., the inner member) can be advanced relative to the first member (e.g., the spiral member or member having a spiral distal portion) independently of the relative motion between the first member (e.g., the spiral member) and the second member (e.g., the force imparting member). This advantageously enables the angulation (e.g.,bending at an angle - not rotating - relative to the longitudinal axis) or similar alteration of the distal end of the device. Accordingly, rotation and angulation or bending can be independently adjusted for the device (e.g., even at the same time). Therefore, in some embodiments, the angulation (e.g., bending) and rotation can be independently controlled for any of the device (e.g., intraluminal devices) and corresponding methods disclosed herein, and equivalents thereof.

[0061] As discussed in greater detail herein, the embodiments disclosed herein can include (e.g., can take the form of) any one of various intraluminal devices, such as, for example, catheters, microcatheters, sheaths, other intraluminal devices and / or the like. In some embodiments, the diameter (e.g., the outer diameter) of any of the intraluminal devices disclosed herein can vary between 1 mm to 100 mm or 0.1 French to 300 French(e.g., 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47,48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62. 63, 64, 65, 66, 67, 68, 69, 70, 70-75, 75-80, 80-85, 85-90, 90-95, 95-100, 100-125, 125-150, 150-175, 175-200, 200-250, 250-300 French, French values and / or ranges between the foregoing, etc.), as desired or required. However, in other embodiments, the intraluminal device can comprise any other diameter or size, such as, for example and without limitation, a custom size that is below, above or in between the values provided above. Further, the length of the device can vary depending on the application or use. In some embodiments, the length of the device is between 10 and 500 cm (e.g., 50 to 100, 1 0 to 300, 10 to 20, 20 to 30, 30 to 40, 40 to 50, 50 to 60, 60 to 70, 70 to 80, 80 to 90, 90 to 100, 100 to 110, 110 to 120, 120 to 130, 130 to 140, 140 to 150, 150 to 160. 160 to 170, 170 to 180, 180 to 190, 190 to 200, 200 to 250, 250 to 300, 300 to 350, 350 to 400. 400 to 450, 450 to 500 cm, lengths between the foregoing, etc.).

[0062] According to some embodiments, the intraluminal devices disclosed herein can be used in a variety of applications and procedures. For example, the devices can be used to reach a particular organ or vasculature of a subject (e.g., heart or cardiac region, head and neck, liver, kidneys, hepatic vasculature, renal vasculature, extremities, etc.). Any other portion of the anatomy can also be reached and targeted using the device. The various embodiments disclosed herein can be particularly advantageous when a practitioner is attempting to reach and treat a portion of a subject's anatomy that is accessible through a tortuous vascular or other intraluminal route (e.g., one that requires the intraluminal device to make several turns and directional changes). The various devicesdisclosed herein can be used for a variety of indications and procedures, such as, for example and without limitation, ablation procedures, stimulations or neuromodulation procedures, extractions, biopsies, aspirations, delivery of medicaments, fluids, energy (e.g., radiofrequency or RF, ultrasound, cryogenic, etc.) and / or the like.

[0063] In some embodiments, radial expansion of the elastic member on the spiral or helical shape, portion or feature of the first member (e.g., the member with the spiral portion or member) can be used to remove or otherwise treat (e.g.. mechanically, chemically, electrically (e.g., ablation, stimulation, etc.) unwanted objects or portions of a subject’s anatomy, such as clot, obstructing material such as stones, and / or foreign bodies. The qualities and advantages provided by the embodiments disclosed herein can improve surgical efficiency, reduce overall time for the patient in the operating theater, reduce the time that the patient is required to be exposed to anesthesia, reduce the risk of surgical complications, reduce fatigue of the surgical staff during a medical procedure, reduce the exposure time of the patient to radiation (e.g., when a radiation source is required during the operation) and the like.

[0064] In some embodiments, radial expansion of the radially expandable member or feature can be employed or utilized to remove unwanted objects, such as clot, obstructing material such as stones, and / or foreign bodies. The embodiments disclosed herein and equivalents or variations thereof can improve surgical efficiency, reduce overall time for the patient in the operating theater, reduce the time that the patient is required to be exposed to anesthesia, reduce the risk of surgical complications, reduce fatigue of the surgical staff during a medical procedure, reduce the exposure time of the patient to radiation (e.g., when a radiation source is required during the operation) and the like. While in other embodiments, radial expansion of a radially expandable member or feature can be employed or utilized to stabilize or anchor the distal aspect of the device so as to aid in the delivery of the other devices, including but not limited to aspiration catheters, sheaths, angioplasty balloon catheters, and stent delivery systems.

[0065] The terms ‘"top,” “bottom,” “first,” “second,” “upper,” “lower,” “height,” “width.” “length,” “end.” “side.” “horizontal.” “vertical.” and similar terms are used herein, it should be understood that these terms have reference only to the structures shown in the figures and are utilized only to facilitate describing embodiments of the disclosure. Accordingly, such terms should not be used to restrict or limit the scope of any description, whether claimed or not claimed, provided herein. Features depicted someembodiments may be used in other embodiments disclosed herein as would be understood by a person of ordinary’ skill in the art.

[0066] FIG. 1 illustrates one view of a device 10 according to one embodiment. The depicted medical device 10 includes first member (e.g., a spiral member) 11. In some embodiments, the first member 11 includes an elastic member or covering that at least partially covers or surrounds a first spiral or helical member, shape, portion or feature 13 of the first member (e.g.. spiral member) and that, together with the spiral or helical member, shape, portion or feature 13, forms an elastic portion 12 of the device. With continued reference to FIG. 1, the first member 11 can further include a preformed distal end 15 (e.g., a portion along the distal end of the device 10 can include a bend or angle relative to the device's longitudinal axis). In addition to the first member 11, the medical device can further comprise a second member (e.g., a force imparting member) 14, a third member (e.g., an inner member) 19 and a handle 16. In some embodiments, the device includes one or more controls or controllers (e.g., a knob, button, etc.) 20 to control (e.g., independently) rotation and / or angulation of the distal end 15 of the device. In some embodiments, such knobs and / or other controllers are positioned or otherwise located or associated with the handle 16. However, in other embodiments, one or more controllers can be located on or near location and / or a separate device. In some embodiments, one or more of the components listed above and illustrated in FIG. 1 (and / or other drawings of the present application) may be omitted and / or replaced with one or more other components (e.g., a catheter, an electrode, a sensing device, a communication device, etc.), as desired or required.

[0067] FIG. 2A illustrates a cross sectional view along the long axis of one embodiment of an intraluminal device 10, wherein a spiral or helical shape, portion and / or feature 13 of the first member (e.g., a spiral member, a member having a spiral section or portion, etc.) 11 is not in the lumen or other opening or receiving portion of a second member (e.g., a force imparting member 14). Further, in the depicted embodiment, a third member (e.g., an inner member) 19 is not in the lumen or other opening or receiving portion of the preformed distal end 13 of the first member (e.g.. the spiral member) 11. As shown, the elastic member 12 (e g., the portion of the first member 11 that includes a spiral or helical portion, section or feature) is not expanded. Accordingly, in the illustrated configuration, the distal end 15 is curved (e.g., includes the naturel bend or curve along its distal end). In some embodiments, an elongate member (e.g., a tubular member) 18 is coupled to the proximal end 17 of the spiral or helical shape, portion or feature 13 of thefirst member (e.g., the spiral member) 11. Such an elongate member 18 can be formed separately of the spiral or helical shape, portion or feature 13 and / or any other components of the device located distally to the elongate member 18 and any covering or surrounding portion, other portion, member and / or component of the elastic member 12, the distal end (e.g., angled or bent distal end) 15 of the device, etc. However, in other embodiments, the tubular or other elongate member 18 can be made together and / or combined (e.g.. during and / or after manufacture) with one or more other components, member and / or features, including but not limited to any of the components, members and / or features listed above.

[0068] FIG. 2B illustrates a cross sectional view along the longitudinal or long axis of the device 10, wherein at least a portion of the spiral or helical shape, member, portion and / or feature 13 of the first member (e.g., the spiral member 11) is positioned within or engaged with the lumen or other opening or receiving portion of the second element (e.g., a force imparting element) 14. As the spiral or helical shape, member, portion and / or feature 13 is moved within lumen or other receiving portion of the second element, the spiral or helical shape, member, portion and / or feature 13 begins to elongate. As a result of this elongation, the spiral or helical shape, member, portion and / or feature 13 begins to rotate (e.g., turn) along the longitudinal axis, resulting in rotation of the distal end 15 of the device 10. In some embodiments, the degree of rotation of the distal end 15 depends upon, at least in part, the amount of relative displacement between the spiral or helical shape, member, portion and / or feature 13 of the first member 11 and the second member 14.

[0069] In addition to the rotation along the long or longitudinal axis described in the preceding paragraph and other portions of the present application, a third member (e.g., the inner member) 19 can be partially advanced into the lumen of the preformed distal end 15 of the first member (e.g., the spiral member) 11, resulting in at least partial straightening of the preformed distal end 15. This results in changing the angle or bend of the distal end 15 relative to the long or longitudinal axis of the device 10. In some embodiments, the degree of straightening is dependent (e.g., directly, indirectly, linearly, non-linearly. etc.) on the amount or extent of advancement of the third member (e.g.. the inner member) 19 relative to the first member (e.g., the preformed and / or pre-bent distal end 15. The resulting bending or angling of the distal end 15 can be performed independently of the rotation of the device. In some embodiments, the device 10 is configured such that rotation and bending can be done independently and simultaneously. The ability to reliably and predictably control both rotation and bending of the distal endof an intraluminal or other medical device adapted for placement and movement within the anatomy beneficially and advantageously permits surgeons, other physicians and / or other practitioners to conveniently, quickly and safely steer or otherwise advance such devices to a desired location within the anatomy. In the depicted embodiment, the elastic member or portion 12 of the first member 11 is not expanded. As discussed herein, such an elastic member or portion 12 can be radially expanded, as desired or required. As noted above, in some embodiments, an elongate member (e.g.. a tubular member) 18 is coupled to the proximal end 17 of the spiral or helical shape, member, portion and / or feature 13 of the member 11 and / or other components or features of the first member 11. For any of the embodiments disclosed herein, the elongate member 18 is part of and / or otherwise secured to the first member 11. For example, the first member 11 and the elongate member 18 can be manufactured as a single item or can be manufactured separately and joined or otherwise combined during or after manufacture or fabrication, as desired or required. Further, for any of the embodiments disclosed herein or equivalents or variations thereof, an elongate member 18 need not be included. For example, the device 10 can function and be used even if the first member 11 is located only along or near a distal of the device 10.

[0070] FIG. 2C illustrates a cross sectional view along the long or longitudinal axis of the device 10, wherein a spiral or helical shape, member, portion and / or feature 13 of the first member (e g., the spiral member) 11 is at least partially positioned within or engaged with the lumen or other opening or receiving portion of the second member (e.g., a force imparting element or member) 14. Further, in the depicted arrangement, a third member (e.g., the inner member) 19 has been fully advanced into the lumen, opening and / or other receiving area or portion of the preformed distal end 15 of the first member (e.g., the spiral member) 11. As a result of such advancement of the third member 19 relative to the distal end 15 of the first member 11, the preformed distal end 15 of the first member 11 has been straightened (e.g., is aligned or substantially aligned with the longitudinal or long axis of the device 10). As noted above, the elongate member 18 is part of and / or otherwise secured to the first member 11. For example, the first member 11 and the elongate member 18 can be manufactured as a single item or can be manufactured separately and joined or otherwise combined during or after manufacture or fabrication, as desired or required.

[0071] FIG. 2D illustrates a cross sectional view along the long axis of the device 10, wherein the inner member 19 has been fully advanced into the lumen or other receiving portion of the preformed distal end 15 of the first member (e.g., spiral member)11. As discussed above, this results is at least partial straightening of the preformed distal end 15 of the first member 11.

[0072] With continued reference to FIG. 2D, in the depicted embodiment, the third member (e.g., the inner member) 19 is contacting or is positioned against a portion of the first member (e.g., the spiral member) 11 just distal to the spiral or helical shape, member, portion and / or feature 13, resulting in elongation of the spiral or helical shape, member, portion and / or feature 13 and a decrease in the outer diameter of the spiral or helical shape, member, portion and / or feature 13 of the first member (e.g., spiral member) 11. Application of the force by the third member 19 relative to the first member 11 (e.g., at a location distal to the spiral or helical shape, member, portion and / or feature 13) can be accomplished in several ways. For example, in some embodiments, the outer diameter of the third member (e.g., the inner member) 19 includes a tapered distal portion with an outer diameter that is less than the outer diameter of a proximal portion. The diameter or cross- sectional dimension of the proximal portion of the third member 19 can be greater than the inner diameter or cross-sectional dimension of the lumen or opening of the preformed distal end 15 of the first member 1 1 (e.g., the spiral member), while the outer diameter or cross- sectional dimension of the distal tapered portion of the third member 19 is less than the inner diameter or cross-sectional dimension of the lumen or opening of the spiral member 11 distal (e.g., immediately distal) to the spiral or helical shape, member, portion and / or feature 13. This can advantageously permit the distal portion of the third member (e.g.. the inner member) 19 to pass through the lumen or other opening of to the spiral or helical shape or feature 13 of the spiral member 11. However, the proximal portion of the tapered portion of the inner member 19 cannot pass through the lumen of the preformed distal end 15 of the first member 11. Accordingly, as force is applied by the third member to the first member 11 (e.g., once the third member has been advanced distally enough so that the proximal portion of the tapered third member 19 abuts and can transfer a force (e.g., an axial force) to the first member 11, the spiral or helical shape, member, portion and / or feature 13, together with one or more other portions of the elastic portion 12 and / or other portion of the first member 11 can elongated while simultaneously decreasing in diameter or cross-sectional dimension. In other embodiments, such an elongation force can be applied from the third member 19 to the spiral or helical shape, member, portion and / or feature 13 and the first member using other configurations. For instance, in some arrangements, the preformed distal end 15 of the first member 11 is capped, and the distal end of the third member 19 can contact the capped or otherwise restricted end to impart adesired axial force to it. As counteracting forces are applied to the spiral or helical shape, member, portion and / or feature 13 (to both ends of the spiral or helical shape, member, portion and / or feature 13), the spiral or helical shape, member, portion and / or feature 13 elongates and its outer diameter decreases. In some embodiments, as the third or inner member 19 is further advanced and as tension is applied to the proximal end of the first member 11, the outer diameter or other cross-sectional dimension of the spiral or helical shape, member, portion and / or feature 13 of the first member (e.g.. the spiral member) 11 can decrease, which can facilitate removal and reinsertion of the first member 11 and the third member 19 from the second member 14. In some embodiments, the second member 14 comprises a microcatheter, catheter or other intraluminal device. The configurations and features described in this paragraph can be applied to any of the embodiments disclosed herein or variations or equivalents thereof, as desired or required.

[0073] FIG. 2E illustrates a cross sectional view along the long axis of the device, wherein the first member (e.g., the spiral member) 11 has been removed from the lumen of the second member (e.g.. force imparting element or member) 14.

[0074] FIG. 2F illustrates a cross sectional view along the short axis of the proximal end of the device , wherein the first member (e.g., the spiral member) proximal to the spiral or helical shape, member, portion and / or feature forms and / or includes an elongate member (e.g.. a tubular member, for example, a hypotube, coil, wire, etc.) 18. In some embodiments, the third member (e.g., the inner member) 19 is at least partially positioned or located in a lumen, opening or other receiving area or portion of the elongate member 18. However, in other embodiments, the third member 19 is not positioned or located in any portion of an elongate member 18. In some arrangements, the device does not include an elongate member 18.

[0075] FIG. 2G illustrates a cross sectional view along the longitudinal or long axis of the device 10, wherein fluid is injected through the lumen of the elongate member 18 (e.g., the first member 11 in arrangements where the first member and the elongate member are connected or otherwise form a unitary structure), resulting in at least partial expansion of the elastic member or portion 12. In some embodiments, the tubular member 18 forms or provides a fluid pathway between the proximal end of the device and the elastic member or portion 12 (e.g., including the spiral or helical shape, member, portion and / or feature 13). Therefore, in some embodiments, the diameter or other cross-sectional dimension of the device can be selectively enlarged (e.g., to anchor the device relative to a lumen wall, to engage a wall, etc.), as desired or required. Such a configuration can beincorporated into any of the embodiments disclosed herein and any variations or equivalents thereof.

[0076] FIG. 2H illustrates a cross sectional view along the long axis of one embodiment of a medical device 10 consistent with other configurations disclosed herein, wherein at least one proximal aspect or portion of the spiral or helical shape, member, portion and / or feature 13 is coupled or otherwise secured (e.g., permanently, removably, etc.) to an elongate member (e.g., tubular member) 18. The portions or components can be secured or coupled to one another using one or more devices, features, techniques or methods, as desired or required, such as, for example and without limitation, fasteners or other mechanical coupling, friction fit, welding, soldering, adhesive bonding, brazing and / or the like. As discussed herein, in some embodiments, the third member (e.g., the inner member) 19 being advanced into the lumen or other opening or receiving area of the preformed (e.g., pre-bent) distal end 15 of the first member (e.g., spiral member) 11 results in straightening of the preformed distal end 15.

[0077] FIG. 3 illustrates one view of an intraluminal device or other medical device 30 according to one embodiment. Relative to the device of FIG. 1, the depicted medical device 30 also includes a radially expandable member or feature 41. Therefore, the device 30 can include a first member, a second member (e.g., a force imparting member, which may be a microcatheter, catheter, etc ), a third member (e.g., an inner member), an expandable member (e.g., which can be incorporated into any other component or portion of the device), a handle and / or the like. In some embodiments an elastic member 32 covering the spiral or helical shape or feature 33 is present. In some embodiments, one or more of the components listed above and illustrated in FIG. 3 (and / or other drawings of the present application) may be omitted and / or replaced with one or more other components (e.g., a catheter, an electrode, a sensing device, a communication device, etc.), as desired or required.

[0078] FIG. 4A illustrates a cross sectional view along the long axis of the device 30, wherein the radially expandable member 41 is not expanded and the spiral or helical shape, member, portion and / or feature 33 of the first member is not positioned within the lumen of the second member (e.g., the force imparting element or member 34). At least a portion of the third member (e.g., the inner member) 39 can include a feature 42 that results in an increased diameter or cross sectional profile relative to adj acent portions of the inner member 39 the radially expandable member 41. In some embodiments, an elongate member (e.g., tubular member) 38 is coupled to and / or incorporated into aproximal end 37 of the spiral or helical shape, member, portion and / or feature 33. As shown and discussed in reference to other embodiments herein, the device can include a preformed distal end 35 that is bent or angled relative to the longitudinal axis. For any of the embodiments disclosed herein, the preformed or pre-bent distal end can include a curved configuration. Such a configuration can help the user more accurately and robustly control the level of bending or angulation of the distal end during use.

[0079] FIG. 4B illustrates a cross sectional view along the long axis of the device 30, wherein the feature 42 of the third member (e.g., the inner member) 39 contacts the radially expandable member 41 and exerts a force (e.g., an axial or tensile force) on the radially expandable member 41. In the depicted embodiment, the radially expandable member 41 is shown in an expanded configuration. In the illustrated configuration, the spiral or helical shape, member, portion and / or feature 33 is not positioned in the lumen or other opening of the second member (e.g., the force imparting element or member) 34. As discussed with reference to other embodiments herein, the device can include (but does not need to necessarily include) an elongate member (e.g.. hypotube, other tubular member, wire, coil, etc.) 38 is coupled to the proximal end 37 of the spiral or helical shape, member, portion and / or feature.

[0080] It will now be evident to those skilled in the art that there has been described herein methods and apparatuses for a device with an expandable distal member. Although the inventions hereof have been described by way of several embodiments, it will be evident that other adaptations and modifications can be employed without departing from the spirit and scope thereof. The terms and expressions employed herein have been used as terms of description and not of limitation; and thus, there is no intent of excluding equivalents, but on the contrary, it is intended to cover any and all equivalents that may be employed without departing from the spirit and scope of the inventions.

[0081] While the disclosure has been described with reference to certain embodiments, it will be understood that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications will be appreciated to adapt a particular instrument, situation, or material to the teachings of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this disclosure, but that the disclosure will include all embodiments falling within the scope of the appended claims.

[0082] Although several embodiments and examples are disclosed herein, the present application extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the inventions and modifications and equivalents thereof. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above but should be determined only by a fair reading of the claims that follow.

[0083] While the embodiments disclosed herein are susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the inventions are not to be limited to the particular forms or methods disclosed, but, to the contrary, the inventions are to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as '‘advancing a catheter or microcatheter” or ‘'advancing one portion of the device (e.g., linearly) relative to another portion of the device to rotate the distal end of the device” include instructing advancing a catheter" or “instructing advancing one portion of the device,” respectively. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as '‘up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers. For example, “about 10 mm” includes “10 mm.” Terms or phrases preceded by a term such as “substantially” include the recited term or phrase. For example, “substantially parallel” includes “parallel.”

Claims

WHAT IS CLAIMED IS:

1. An intraluminal medical device comprising: a first member having a distal end and a longitudinal axis, a portion of the first member at, along or near the distal end comprising at least one feature, portion or member having a spiral or helical shape; wherein the distal end of the first member comprises a preformed portion that is angled or bent relative to the longitudinal axis; a second member coaxially aligned with the first member, the first member comprising a receiving area configured to receive the at least one feature, portion or member having a spiral or helical shape of the first member when the first member is moved relative to the second member along the longitudinal axis; wherein when the at least one feature, portion or member having a spiral or helical shape of the first member is moved at least partially within the receiving area of the second member, the distal end of the first member rotates or turns along the longitudinal axis; a third member coaxially aligned with the first and second members, the third member configured to be removably positioned within an interior of the preformed portion of the first member, wherein movement of the third member relative to the interior of the preformed portion changes an angle of the preformed portion relative to the longitudinal axis; and a handle configured to be grasped by a user of the device.

2. The device of Claim 1, wherein the handle comprises at least one controller.

3. The device of Claim 2, wherein the at least one controller is configured to control a movement of the at least one feature, portion or member having a spiral or helical shape of the first member relative to the receiving area of the second member to rotate the distal end of the first member about the longitudinal axis.

4. The device of Claim 2, wherein the at least one controller is configured to control a movement of the third member relative to the interior of the interior of the preformed portion to bend or change the angle of the preformed portion relative to the longitudinal axis.

5. The device of Claim 2, wherein the at least one controller is positioned on, in or along the handle.

6. The device of Claim 1, wherein the preformed portion is curved or nonlinear.

7. The device of Claim 1, wherein the third member is configured to pass through an interior of the at least one feature, portion or member having a spiral or helical shape.

8. The device of Claim 1, wherein the at least one feature, portion or member having a spiral or helical shape is located along the distal 0 to 20 percent of the first member.

9. The device of Claim 1, wherein the device comprises at least one of a guidewire, a microcatheter, a catheter and another intraluminal device.

10. The device of Claim 1, wherein the second member comprises a microcatheter, a catheter or another intraluminal device.

11. The device of Claim 1, wherein a spiral or helical portion of the at least one feature, portion or member having a spiral or helical shape is angled 1 to 80 degrees relative to the longitudinal axis.

12. The device of Claim 1, wherein at least one of the first member, the second member and the third member is removable relative to another of the first member, the second member and the third member.

13. The device of Claim 1, wherein the first member comprises at least one of nickel titanium (Nitinol), another shape memory' material, another metal or alloy and a polymer.

14. The device of Claim 1. wherein the at least one feature, portion or member having a spiral or helical shape comprises at least one of nickel titanium (Nitinol), another shape memoiv material, another metal or alloy and a polymer.

15. The device of Claim 1, wherein the first member comprises or is coupled to an elongate portion or member that extends proximal to the at least one feature, portion or member having a spiral or helical shape.

16. The device of Claim 15, wherein the elongate portion or member comprises a hypotube.

17. The device of Claim 15, wherein the elongate portion or member comprises at least one of a thermoplastic and a metal or alloy.

18. The device of Claim 1, wherein the device comprises a radially expandable portion configured to be moved between a radially contracted orientation and a radially expanded position.

19. The device of Claim 18. wherein the radially expandable portion is configured to be moved between the radially contracted and radially expanded positions using a fluid-based inflation member or feature.

20. The device of Claim 18, wherein the radially expandable portion is configured to be moved between the radially contracted and radially expanded positions using a mechanical expansion member or feature.

21. A method of advancing an intraluminal device relative to an anatomical luminal system of a subject, the method comprising: positioning a device according to Claim 1 within the anatomical luminal system of the subj ect; advancing the device through the anatomical luminal system of the subject by selectively rotating and bending the distal end of the device; wherein rotating the distal end of the device comprises manipulating a first controller of the at least controller, wherein manipulating the first controller moves the at least one feature, portion or member having a spiral or helical shape of the first member relative to the receiving area of the second member; and wherein bending the distal end of the device comprises manipulating a second controller of the at least controller, wherein manipulating the second controller moves the third member relative to the interior of the preformed portion of the first member; and removing the device from the subject.

22. The method of Claim 21, wherein the anatomical luminal system of the subject comprises a vascular system.

23. A device comprising: a first member having a distal end and a longitudinal axis, a portion of the first member at, along or near the distal end comprising at least one feature having a spiral or helical shape; wherein a length of the at least one feature is configured to change along the longitudinal axis;a second member configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the second member relative to the first member is configured to impart a force along and change the length of the at least one feature of the first member, wherein a change in the length of the at least one feature is configured to rotate the first member about the longitudinal axis. a third member with a longitudinal axis having a proximal end and a distal end configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the third member relative to the first member is configured to change the angle of deflection of the first member relative to the longitudinal axis.

24. The device of Claim 23, wherein the outer diameter of the portion comprising the at least one feature is equal to or greater than the inner diameter of the second member.

25. The device of Claim 23, wherein rotation of the first member about the longitudinal axis is independent of the change of the angle of deflection of the first member about the longitudinal axis.

26. The device of Claim 23, wherein the portion comprising the at least one feature is located along the distal 0 to 20 percent of the first member.

27. The device of Claim 23, wherein the device comprises at least one of a guidewire, a microcatheter or other catheter and another intraluminal device.

28. The device of Claim 23, wherein the at least one feature comprises a helical angle of 1 to 80 degrees relative to the longitudinal axis.

29. The device of Claim 23, wherein a third member configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the third member relative to the first member is configured to impart a force along and change the length of the at least one feature of the first member, wherein a change in the length of the at least one feature is configured to decrease the outer diameter of the portion comprising the at least one feature of the first member.

30. The device of Claim 23, wherein the first member is at least partially removable relative to the second member.

31. The device of Claim 23, wherein the first member comprises at least one of nickel titanium (Nitinol), another shape memory material, another metal or alloy and a polymer.

32. A device comprising: a first member having a distal end and a longitudinal axis, a portion of the first member at, along or near the distal end comprising at least one feature having a spiral or helical shape and a portion of the first member at, along or near the distal end comprising at least one feature configured to undergo radial expansion; wherein a length of the at least one feature having a spiral or helical shape and a length of the at least one feature configured to undergo radial expansion are configured to change along the longitudinal axis; a second member configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the second member relative to the first member is configured to change the length of the at least one feature having a spiral or helical shape of the first member and cause the first member to rotate about the longitudinal axis; and a third member with a longitudinal axis having a proximal end and a distal end configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the third member relative to the first member is configured to change the angle of deflection of the first member relative to the longitudinal axis.

33. The device of Claim 32, wherein a third member configured to be moved relative to the first member, wherein linear movement along the longitudinal axis of the third member relative to the first member is configured to impart a force along and change the length of the at least one feature having a spiral or helical shape of the first member, wherein a change in the length of the at least one feature is configured to decrease the outer diameter of the portion comprising the at least one feature of the first member.

34. The device of Claim 32, wherein a third member configured to be moved relative to the first member, wherein proximal displacement along the longitudinal axis of the third member relative to the first member is configured to impart a force along and change the length of the at least one portion configured to undergo radial expansion, wherein a change in the length of the at least one portion configured to undergo radial expansion is configured to increase the outer diameter of the at least one portion configured to undergo radial expansion.

35. The device of Claim 32, wherein the first member comprises at least one of nickel titanium (Nitinol), another shape memory material, another metal or alloy and polymer.

36. The device of Claim 32. wherein the device comprises at least one of a guidewire, a microcatheter or other catheter and another intraluminal device.

37. The device of Claim 32, wherein the first member is at least partially removable relative to the second member.

38. The device of Claim 32, wherein a pitch or spacing of the at least one feature can vary along the portion of the first member.

39. The device of Claim 32, wherein the first member is positioned within an interior of the second member.

40. The device of Claim 32, wherein the third member is positioned within an interior of the second member.

41. The device of Claim 32, wherein the at least one feature comprises a helical angle of 1 to 80 degrees relative to the longitudinal axis.

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