Distally controlled medical device

Abstract

To provide an improved device, system and method for imparting accurate and reliable rotational movement to distal aspects of medical devices.SOLUTION: A distally controlled medical device comprises: a tube 30 with a longitudinal axis 40 having a proximal end and a distal end; cuts 31 and 32 located near a distal end of the tube 30, including orientations that are inclined with respect to both the longitudinal axis 40 and an axis transverse to the longitudinal axis 40; and a pusher member disposed within the tube 30 and configured to selectively advance the distal end of the tube 30 in a longitudinal direction, the pusher member configured to at least partially rotate as the pusher member advances relative to the tube 30, thereby facilitating placement of the distal end within a particular branch of an intraluminal network of a subject, where the distal end of the tube 30 is configured to extend longitudinally along or near an area of at least one of the cuts 31 and 32.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 15 / 204,800, filed July 7, 2016, U.S. Provisional Patent Application No. 62 / 359,588, filed July 7, 2016, and U.S. Provisional Patent Application No. 62 / 467,229, filed March 5, 2017, the entire contents of each of which are incorporated herein by reference in their entirety.

[0002] The present disclosure is in the general field of surgical instruments, and more particularly, relates to catheters, guidewires, endoscopes, and endoscopic devices used in minimally invasive procedures, such as cardiovascular and endovascular procedures, to facilitate the placement of devices within intraluminal structures within the body, such as, but not limited to, blood vessels, the gastrointestinal tract, and the genitourinary tract. [Background technology]

[0003] Catheters, guidewires, endoscopes, and related endoscopic instruments have been used to diagnose and treat conditions by accessing luminal structures of the body. Luminal structures of the body may include, but are not limited to, blood vessels, the heart, the gastrointestinal (GI) tract, the genitourinary (GU) tract, the peritoneal cavity, the thoracic cavity, the diaphragm, the bronchial tract, the subarachnoid space, and the intracranial ventricular system. Catheters, guidewires, and endoscopes may be used in minimally invasive, laparoscopic, and other procedures. These devices are manipulated by transmitting force along and through the longitudinal structure of the device from the proximal end (i.e., the end of the device outside the body) to the distal end (i.e., the end of the device within the body). Precise control of the distal portion of the device is required for medical procedures to precisely cannulate desired luminal structures, such as blood vessels. To accomplish this, in some embodiments, several design criteria are considered during the design process of intraluminal devices such as guidewires and catheters. Key design criteria include pushability, torqueability, and flexibility.

[0004] Pushability refers to the ability of a device to move and result in translation along the longitudinal axis of the device. Pushability is directly dependent on the stiffness of the device, which in turn is highly dependent on the modulus of elasticity of the material employed within the device. A device with a high modulus of elasticity can efficiently transmit force along the length of the device, while a device with a low modulus of elasticity will not transmit force as efficiently, resulting in deformation or distortion of the device.

[0005] Torque capacity refers to the ability of rotational movement to be transmitted along the length of the device and is directly dependent on the stiffness (or shear modulus) of the material employed within the device: devices with high stiffness are able to transmit torque efficiently along the length of the device, while devices with low stiffness do not transmit force as efficiently.

[0006] Flexibility relates to the device's ability to bend and deflect along its transverse axis. Flexibility is necessary to allow the device to conform to the bends and curves present in the human vasculature. Flexibility can be influenced by structural factors, such as the type of material and / or the spacing and size of slits in the device that allow bending. However, flexibility is inversely dependent on the elastic and rigid moduli, which can result in sacrifices in pushability and torqueability.

[0007] Ideally, devices such as catheters, guidewires, endoscopes, or endoscopic instruments exhibit a one-to-one rotation of their distal end relative to their proximal end. For example, if the proximal end of the device rotates 90 degrees clockwise, the distal end of the device will also rotate 90 degrees clockwise. Unfortunately, in practice, this does not usually occur, especially when the device has one or more bends or loops along its length that conform to the curvature of the body's luminal structures. The inherent curvature of body structures (blood vessels, GI tract, and GU tract) means that each part of the device is subjected to frictional forces as the device moves through the body.

[0008] These frictional forces can hinder the transmission of force from the proximal end to the distal end of the device. One particularly problematic area is the transmission of torque along the device. As a result, potential energy is often stored along the length of the device as the proximal end rotates. If this stored potential energy within the device exceeds the frictional forces exerted along the device, a sudden rotation of the device, also known as "device whip," can occur when the potential energy is released. This can make it difficult to insert the cannula into the desired vessel and can cause injury to the subject. For this reason, current devices, such as catheters, guidewires, endoscopes, and endoscopic instrument devices, strive to balance stiffness and flexibility in various ways. Improved devices, systems, and methods are needed for imparting accurate and reliable rotational movement to distal aspects of medical devices. Summary of the Invention

[0009] According to some embodiments, the device comprises a tubular member with a longitudinal axis having a proximal end and a distal end; at least one partial cut located at, along, or near the distal end of the tubular member, the at least one partial cut including an orientation that is oblique with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a pusher member disposed within the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, the distal end of the tubular member being configured to at least partially rotate when the pusher member is advanced relative to the tubular member, thereby facilitating placement of the distal end within a particular branch of the network within the subject's lumen, wherein the distal end of the tubular member is configured to extend longitudinally along or near the area of ​​the at least one partial cut.

[0010] According to some embodiments, the device comprises a tubular member with a longitudinal axis having a proximal end and a distal end; at least one partial cut located at, along, or near the distal end of the tubular member, the at least one partial cut including an orientation that is oblique with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a pusher member disposed within the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, wherein movement of the pusher member relative to the tubular member converts longitudinal displacement into rotational movement, causing the distal end of the tubular member to at least partially rotate as the pusher member advances relative to the tubular member, thereby facilitating placement of the distal end within a particular branch of a network within the subject's lumen, and wherein the distal end of the tubular member is configured to extend longitudinally along or near the area of ​​the at least one partial cut.

[0011] According to some embodiments, a method for selectively rotating a distal end of an endoluminal device includes providing an endoluminal device comprising a tubular member and a pusher member configured for selective movement relative to the tubular member, the tubular member comprising at least one cut along a distal end of the tubular member, such that movement of the pusher member relative to the tubular member causes the pusher member to distally move the distal end of the tubular member and selectively rotate the distal end of the tubular member. The method includes moving the pusher member relative to the tubular member to selectively rotate the distal end of the device. The method further includes selectively rotating the distal end.

[0012] According to some embodiments, the at least one partial cut extends through the entire thickness of the wall of the tubular member. In some embodiments, the at least one partial cut does not extend through the entire thickness of the wall of the tubular member. In some embodiments, the at least one partial cut has a spiral or helical shape. In some embodiments, the angle of the at least one partial cut relative to the longitudinal axis is between 10 and 80 degrees relative to the longitudinal axis of the device (e.g., 10 to 15 degrees, 15 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, angles between the aforementioned ranges, etc.).

[0013] According to some embodiments, the pusher member is secured to the tubular member along the distal end of the tubular member. In certain configurations, the pusher member is secured to the tubular member using at least one of an adhesive and a mechanical connection. In other embodiments, the pusher member is not secured to the tubular member (e.g., configured to move freely relative to and disengage from the tubular member). In one embodiment, when the pusher member is moved sufficiently distally, the pusher member is configured to abut at least one surface along the interior of the tubular member to advance the tubular member distally.

[0014] According to some embodiments, the tubular member comprises a lumen through which the pusher member selectively moves. In some embodiments, the pusher member comprises a lumen.

[0015] According to some embodiments, the device further comprises at least one outer member or coating disposed along the exterior of the tubular member. In some embodiments, the device further comprises at least one pull member to facilitate steering the device within the subject's anatomy. In one embodiment, the pull member comprises a pull wire. In one embodiment, the pull member comprises a shape memory material.

[0016] According to some embodiments, the pusher member comprises a coiled member configured to maintain its structural integrity during use. In some embodiments, the device further includes a handle assembly, a first portion of the handle assembly secured to the tubular member and a second portion of the handle assembly secured to the pusher member, wherein movement of the first portion relative to the second portion of the handle assembly facilitates movement of the tubular member relative to the pusher member.

[0017] According to some embodiments, at least one partial cut has a single helix oriented in a single pitch direction, while in other embodiments, at least one partial cut includes a double chiral helix.

[0018] According to some embodiments, the intraluminal device comprises an outer member having at least one cut or feature that facilitates translation of linear movement of the inner member relative to the outer member into rotation of a distal portion of the device. Such rotational movement can facilitate movement of the distal end of the device through the vasculature or other intraluminal structure of a subject as desired or needed (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in further detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other lumen, anatomical location (e.g., through the respiratory tract, digestive system, etc. of a subject), etc.).

[0019] As discussed in more detail herein, various embodiments disclosed herein are suitable for use in medical devices. Advantageous devices, systems, and / or methods can be provided for manipulating the distal end of a device (e.g., a catheter, microcatheter, sheath, other intraluminal device, etc.). In some embodiments, the device includes a tube or outer member with one or more cuts (e.g., partial or complete cuts through the wall of the tube or outer member). In some embodiments, the cuts or similar features extend through the entire thickness of the tube or outer member. However, in other embodiments, the cuts extend only partially through the tube or outer member, as desired or needed.

[0020] In some embodiments, the distal portion of the tube or outer member includes one or more cuts or other features. In some embodiments, such cuts are helical or spiral in shape. In some embodiments, such helical cuts have a constant or uniform orientation. However, in other configurations, the cuts have two or more orientations (e.g., angle, pitch, etc.) relative to the longitudinal axis, opening sizes, spacing, and / or other characteristics, as desired or required. For example, in some configurations, the cut(s) have a dual helix or double chiral helix design. However, in other embodiments, the cut(s) have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0021] According to some embodiments, the device includes a tube or outer member, a pusher or inner member, and one or more cuts or other features along the distal end of the tube. In some embodiments, linear movement of the pusher member relative to the tube or outer member results in rotational movement (e.g., rotation, twist, pivoting, etc.) of the distal portion of the tube. Such movement can aid in movement and / or manipulation of the device through the subject's vasculature or other intraluminal system. In some embodiments, the tube or other member is secured to the pusher or inner member along one or more locations (e.g., at the distal end of the device) using one or more securement (e.g., direct or indirect) methods, features, devices, techniques, etc.

[0022] In some embodiments, the cuts (e.g., partially or completely) through the tube or outer member have a helical or spiral shape. For example, in some embodiments, the cuts are angled relative to the longitudinal axis of the device (or an axis perpendicular to the longitudinal axis). For example, the helical angle can be in the range of 10 to 80 degrees relative to the longitudinal axis of the device (e.g., 10 to 15 degrees, 15 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, angles between the aforementioned ranges, etc.). In some embodiments, the helical angle is in the range of 15 to 75 degrees.

[0023] In some embodiments, the cuts are only along or proximal to the distal end of the tube or distal member, for example, the cut(s) are located along the distal 0 to 20 percent (e.g., 0% to 1%, 1% to 2%, 2% to 3%, 3% to 4%, 4% to 5%, 5% to 6%, 6% to 7%, 7% to 8%, 8% to 9%, 9% to 10%, 10% to 15%, 15% to 20% of the tube and / or device, percentages between the aforementioned ranges and values, etc.).

[0024] According to some embodiments, the inner member, and thus the entire endoluminal device, is cannulated or otherwise provided with a lumen. In some embodiments, such a device allows for the insertion of one or more other devices, instruments, and In some embodiments, the devices disclosed herein include one or more outer members, layers, coatings, and / or other members.

[0025] The present disclosure is directed to methods and apparatus involving rotation of the distal end of a medical device, such as a catheter, guidewire, chronic total occlusion crossing device, endoscope or endoscopic instrument, particularly a medical device with a double chiral helix that converts linear movement to rotational movement at the distal end.

[0026] One embodiment of the present disclosure includes a medical device comprising: a tubular member with a longitudinal axis having a distal end and a proximal end, a distal aspect terminating at the distal end with a distal helix formed by a distal helical cut terminating proximally of the distal aspect, a proximal aspect terminating at the proximal end with a proximal helix formed by a proximal helical cut terminating distally of the proximal aspect, the proximal helical cut being one of right-handed or left-handed and the distal helical cut being the other of right-handed or left-handed, and a junction connecting the distal aspect and the proximal aspect; a longitudinal displacer disposed within the tubular member and slidable relative to the tubular member; and a distal segment disposed around a portion of the tubular member and coupled to the tubular member at the junction. The distal helical cut has a distal helical cut width, and the proximal helical cut has a proximal helical cut width, which may be equal to or different from the proximal helical cut width, and each of the helical cuts may range from about 0.1 micrometers to about 30 millimeters. The helical cuts may each have a helical cut angle, which may be the same or different, and may range from about 10 degrees to about 80 degrees. The tubular member may be formed of one or more of polyimide, polyurethane, polyester block amide, nylon, nickel titanium, stainless steel braid, and hollow helical stranded tubing, or other suitable materials understood by those skilled in the art. The attachment means may include 1) adhesive, 2) welding, 3) brazing, 4) soldering, 5) mechanical linkage, or other suitable means understood by those skilled in the art. The longitudinal displacer may include a longitudinal member having an outer diameter. The tubular member has an inner diameter such that the inner diameter of the tubular member is greater than the outer diameter of the longitudinal member except between the distal end of the distal aspect and the connection portion where the inner diameter of the tubular member is reduced to less than the outer diameter of the longitudinal member, such that longitudinal movement of the longitudinal member toward the distal end of the tubular member imparts a longitudinal force to the distal aspect.The medical device may include a cap disposed at the distal end of the tubular member to prevent forward movement of the longitudinal displacer. The longitudinal displacer includes a membrane configured to extend upon fluid injection and longitudinally displace the distal end of the double-handed helix. The medical device may include a first magnetic element disposed at a distal aspect of the tubular member, a second magnetic element disposed at a proximal aspect of the tubular member, and a power source configured to energize at least one of the first and second magnetic elements. The distal and proximal helices are comprised of at least one of a shape memory alloy and a shape memory polymer. The first magnetic element may be one of a magnet, an electret, a wire, and a coil configured to pass an electric current therethrough and generate a magnetic field, and the second magnetic element may be one of a magnet, a ferromagnetic material, an electret, a wire, and a coil configured to pass an electric current therethrough and generate a magnetic field.

[0027] Another embodiment of the present disclosure includes a tubular member with a longitudinal axis having a distal end and a proximal end, the tubular member including a distal aspect terminating at the distal end with a helix formed by a helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at the proximal end; and a catheter disposed within the tubular member and slidable relative to the tubular member and configured to apply a longitudinal force to the distal helix. a longitudinal displacer; and a distal cut width may be in the range of about 0.1 micrometers to about 30 millimeters, and the angle of the distal helical cut may be between about 10 degrees and about 80 degrees. The tubular member may be formed of one or more of polyimide, polyurethane, polyester block amide, nylon, nickel titanium, stainless steel braid, and hollow helical stranded tubing, and the attachment means includes at least one of 1) adhesive, 2) welding, 3) brazing, 4) soldering, and 5) mechanical link. The longitudinal displacer may include a longitudinal member having an outer diameter, and the tubular member having an inner diameter such that the inner diameter of the tubular member is greater than the outer diameter of the longitudinal member, except between the distal end of the distal aspect and the connection portion where the inner diameter of the tubular member is reduced to less than the outer diameter of the longitudinal member, such that longitudinal movement of the longitudinal member toward the distal end of the tubular member imparts a longitudinal force to the distal aspect. The medical device may also include a cap disposed on the distal end of the tubular member that prevents forward movement of the longitudinal displacer. The longitudinal displacer may include a membrane configured to expand upon fluid injection and longitudinally displace the distal end of the helical-cut tube. The distal helix may include at least one of a shape memory alloy and a shape memory polymer, and further includes a first magnetic element disposed on one of the distal and proximal aspects of the tubular member, a second magnetic element disposed on the other of the distal and proximal aspects of the tubular member, and a power source configured to energize at least one of the first and second magnetic elements, wherein the first magnetic element is one of a magnet, an electret, a wire, and a coil configured to pass an electric current through it and generate a magnetic field, and the second magnetic element is one of a magnet, a ferromagnetic material, an electret, a wire, and a coil configured to pass an electric current through it and generate a magnetic field.

[0028] Another embodiment of the present disclosure is a method for controlling a distal end of a medical device, the medical device comprising: a tubular member with a longitudinal axis having a distal end and a proximal end, a distal aspect terminating at the distal end with a distal helix formed by a distal helical cut terminating proximally of the distal aspect, a proximal aspect terminating at the proximal end with a proximal helix formed by a proximal helical cut terminating distally of the proximal aspect, the proximal helical cut being one of right-handed or left-handed and the distal helical cut being the other of right-handed or left-handed, and a junction connecting the distal aspect and the proximal aspect; a longitudinal displacer disposed within the tubular member and slidable relative to the tubular member; and a distal segment disposed around a portion of the tubular member and coupled to the tubular member at the junction. The method includes inserting a medical device into an intraluminal structure of the body, displaying an image of the medical device within the body, selecting a region of interest within the image, applying a longitudinal force to displace the double antipodal helix and rotate the distal tip, observing the change in position of the distal tip on the display, and adjusting the longitudinal displacement to rotate the distal tip a desired angle of rotation. The display can be in the form of any imaging technology of a subject within the human body, including, but not limited to, x-ray fluoroscopy, ultrasound imaging, computed tomography (CAT) imaging, magnetic resonance imaging (MRI), and / or endoscopic imaging.

[0029] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a double helix cut into the distal aspect of the tube, a wire, a slidable sleeve positioned coaxially on the wire, a distal segment coupled to the junction of the two helices of the double helix, and a handle for controlling linear displacement. By its nature, the connection between the left-hand helix and the right-hand helix rotates as the ends of the double helix are linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment The sleeve is disposed around the circumference of the distal aspect of the tube, where a double-handed helix is ​​inscribed. The distal segment joins the helical junction of the double-handed helix. The distal segment can have an angled tip, which helps improve device guidance. The tube has a shelf that reduces the inner diameter of the lumen distal to the double-handed helix. The outer diameter of the sleeve is larger than the inner diameter of the tube shelf but smaller than the inner diameter of the tube near said shelf. The sleeve slidably abuts and engages said shelf of the tube. Advancing the sleeve results in linear displacement of the double-handed helix. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the longitudinal axis of the tube. This then results in rotation of the connection point between the left-hand helix and the right-hand helix, and subsequently rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the double-handed helix of the tube.

[0030] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a double helix cut into the distal aspect of the tube; a wire tapered at the distal end; a distal segment connected to the junction of the two helices of the double helix; and a handle with controlled linear displacement. By its nature, the connection between the left-hand helix and the right-hand helix rotates as the end of the double helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment is disposed around the circumference of the distal aspect of the tube, where the double helix is ​​cut. The distal segment is connected to the junction of the helices of the double helix. The tip of the distal segment can have an angled tip, thereby helping to improve device guidance. The tube has a shelf that reduces the inner diameter of the lumen distal to the double helix. The diameter of the tapered portion of the wire is less than the inner diameter of the shelf. The outer diameter of the non-tapered portion of the wire is greater than the inner diameter of the tube shelf but less than the inner diameter of the tube near said shelf. The non-tapered portion of the wire abuts and engages said shelf of the tube. Advancing the wire leads to linear displacement of the double-handed helix. A handle with controlled linear displacement allows for controlled movement of the wire relative to the longitudinal axis of the tube. This then leads to rotation of the connection point between the left-hand helix and the right-hand helix, and subsequently rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the double-handed helix of the tube.

[0031] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a double anti-chiral helix cut into the distal aspect of the tube; a wire having a reversibly expandable member; a distal segment coupled to the junction of the two helices of the double anti-chiral helix; and a handle with controlled linear displacement. The wire slidably engages the lumen of the tube. The reversibly expandable member is located along the distal aspect of the wire. By its nature, the connection between the left-hand helix and the right-hand helix rotates as the end of the double anti-chiral helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment is circumferentially located around the distal end of the tube and coupled to the junction of the left-hand helix and the right-hand helix of the double anti-chiral helix. The tip of the distal segment can have an angled tip to better select a branch lumen. When the expandable member is collapsed, the outer diameter of the wire is less than the inner diameter of the hypotube, allowing the wire to move freely within the lumen of the tube. However, the outer diameter of the expandable member in its expanded state is greater than the inner diameter of the tube. When the reversibly expandable member is expanded, it engages the distal end of the tube. Therefore, subsequent advancement of the wire expands the linearity of the double chiral helix. The linear displacement of the handle allows for controlled movement of the wire relative to the longitudinal axis of the tube. This then leads to rotation of the connection point between the left-hand helix and the right-hand helix, and subsequently rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the double-handed helix of the tube.

[0032] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a double helix cut into the distal aspect of the tube and a capped distal end, a wire, a distal segment connected to the junction of the two helices of the double helix, and a handle for controlling linear displacement. By its nature, the connection between the left-hand helix and the right-hand helix rotates as the end of the double helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment is disposed around the circumference of the distal aspect of the tube, in which the double helix is ​​cut. The distal segment is connected to the junction of the helices of the double helix. The tip of the distal segment can have an angled tip, thereby helping to improve device guidance. The outer diameter of the wire is less than the inner diameter of the tube. The distal end of the wire abuts and engages the capped distal end of the tube. Advancing the wire leads to a linear displacement of the double-handed helix. A handle with controlled linear displacement allows for controlled movement of the wire relative to the longitudinal axis of the tube. This then leads to a rotation of the connection point between the left-hand and right-hand helices, and subsequently a rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the double-handed helix of the tube.

[0033] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a double helix cut into the distal aspect of the tube and a capped distal end; a liner containing the double helix; a distal segment connected to the junction of the two helices of the double helix; and a handle through which linear displacement is controlled. By its nature, the connection between the left-hand helix and the right-hand helix rotates as the end of the double helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment is disposed around the circumference of the distal aspect of the tube, in which the double helix is ​​cut. The distal segment is connected to the junction of the helices of the double helix. The tip of the distal segment can have an angled tip, thereby helping to improve device guidance. Injecting fluid into the lumen of the tube results in varying the degree of linear displacement of the double helix. This then leads to a rotation of the connection point between the left-handed and right-handed helices and a subsequent rotation of the distal segment, the angle of rotation being proportional to the linear displacement of the two chiral helices of the tube.

[0034] Handles can be applied to the proximal end of the sleeve or wire and the proximal end of the tubing to more precisely move the sleeve or wire relative to the elongated tube. The handles can be comprised of two coaxial tubes that can be displaced relative to one another along the tube's longitudinal axis. Means for translation relative to one another include, but are not limited to, 1) manual displacement of the two coaxial tubes along the tube's longitudinal axis and 2) threaded portions of each tube that are coaxially receivable such that rotation of the tubes along the threaded portions results in linear displacement of the tubes relative to one another (a mechanism similar to the linear movement of threading a bolt into a nut). The handles can coaxially receive the inner wire and elongated tube within the lumen of the gripper device. Fastening mechanisms can be located along each end of the handles to grip the sleeve or wire at one end and the tubing at the other end. These fastening mechanisms can be permanently or reversibly fixed. These fastening mechanisms can also pivot around the sleeve or wire or elongate tube, thereby preventing the sleeve, wire, or elongate tube from rotationally moving while the coaxial tube or tubes are rotating.

[0035] Another embodiment of the present disclosure is a device including: a tube having a distal end and a proximal end, wherein a double anti-chiral helix is ​​cut into the distal aspect of the tube, said elongated tube being made of a material capable of undergoing a shape change in response to changes in its surrounding environment; a distal segment connected to the junction of the two helices of the double anti-chiral helix; means for causing a shape change in the tube; and means for reacting to the shape change in the tube. By its nature, the connection between the left-handed helix and the right-handed helix rotates when the end of the double anti-chiral helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. The distal segment is circumferentially positioned around the distal end of the tube and connected to the junction of the left-handed helix and the right-handed helix of the double anti-chiral helix. The tip of the distal segment can have an angled tip to better select a branch lumen. Changes in the environment, including but not limited to temperature, electric field, pH, light, and ion concentration, cause the shape of the tube to change such that there is a linear displacement of the double-handed helix. This then leads to a rotation of the connection point between the left-handed and right-handed helices, and a subsequent rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the double-handed helix of the tube. Means for counteracting the shape change of the tube include, but are not limited to, attaching a conduit to the distal end of the tube. Varying amounts of tension can be applied to the conduit to counteract the linear displacement of the double-handed helix.

[0036] Another embodiment of the present disclosure is a device comprising: a tube having a distal end and a proximal end, wherein a double helix is ​​cut into the distal aspect of the tube; a distal segment coupled to the junction of the two helices of the double helix; and means for linear displacement of the tube comprising the dual helical symmetry cut, including, but not limited to, electric field repulsion or magnetic field repulsion. By its nature, the junction of the left-handed and right-handed helices rotates as the end of the double helix is ​​linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. A distal segment is circumferentially positioned around the distal end of the tube and coupled to the junction of the left-handed and right-handed helices of the double helix. The tip of the distal segment can have an angled tip to better select a branch lumen. Examples of means for applying opposing electric or magnetic fields along or proximal to the region of the double helix include, but are not limited to, 1) applying a permanent electric or magnetic charge to one end of the double helix and a variable, inductive electric or magnetic charge to the opposite end of the double helix; 2) applying an inductive electric or magnetic charge to one end of the double helix and a variable, inductive electric or magnetic charge to the opposite end of the double helix; and 3) applying an electric or magnetic charge to one end of the cut of the double helix and a charge or magnetic charge to a portion of the guidewire proximal to the double helix. The opposing electric or magnetic forces lead to a linear displacement of the double helix, which in turn leads to a rotation of the connection point between the left-handed and right-handed helices and a subsequent rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the two chiral helices of the tube.

[0037] Another embodiment according to the present disclosure is a device including a tube having a distal end and a proximal end, a wire having two or more outer diameters, and a means for advancing the wire. The left-handed helix is ​​cut into the tube immediately adjacent to the tube where the inner diameter of the lumen is reduced. By its nature, the connection between the left-handed helix and the right-handed helix rotates as the ends of the double-handed helix are linearly extended or retracted, resulting in translating linear movement of the connection point of the two helices into rotational movement. Means for engaging the wire, including, but not limited to, teeth, are present at the connection point between the left-handed helix and the right-handed helix. One or more grooves are located along the longitudinal axis of the wire along the tapered portion of the wire, the grooves extending slightly proximal to the diameter displacement of the wire. The teeth slidably engage the one or more grooves along the distal aspect of the inner wire. The diameter of the distal aspect of the wire is less than the proximal diameter. The inner diameter of the lumen at the distal end of the tube is greater than the diameter of the distal aspect of the wire but less than the diameter of the proximal aspect of the wire. Advancement of the wire into the tube leads to a linear displacement of the double-handed helix, which in turn leads to a rotation of the connection point between the left-handed and right-handed helices and a subsequent rotation of the distal aspect of the wire, with the angle of rotation being proportional to the linear displacement of the double-handed helix of the tube.

[0038] Another embodiment of the present disclosure includes a medical device comprising an outer sheath, a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in a distal aspect of the tube, and a slidable sleeve positioned within the lumen of the tube. Due to its nature, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in a conversion from linear to rotational movement. The distal end of the helical / spiral cut tube can have an angled tip, thereby helping to improve device guidance. The tube can have a shelf that reduces the inner diameter of the lumen distal to the helical or spiral cut. The outer diameter of the sleeve is larger than the inner diameter of the tube shelf but smaller than the inner diameter of the tube near the shelf. The sleeve slidably abuts and engages the shelf of the tube. Advancing the sleeve results in linear displacement of the cut portion of the tube. Alternatively, the sleeve can be coupled to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the longitudinal axis of the tube. This, in turn, results in rotation of the distal end of the tube. The angle of rotation is proportional to the linear displacement of the helical or spiral cut portion of the tube. The tube is positioned within the lumen of the outer sheath such that the helical or spiral cut portion of the tube is disposed within the lumen of the outer sheath, while the distal end of the tube can extend beyond the outer sheath (e.g., the overall length of the tube is greater than the overall length of the outer sheath, while the length from the proximal end of the tube to the distal-most aspect of the cut portion of the tube is less than the overall length of the outer sheath).The tube and slidable sleeve may be removed from the outer sheath, which may then serve as a conduit for the delivery of diagnostic and / or therapeutic agent(s), including, but not limited to, injection of contrast agent(s), drug(s), stents, and embolic agents.

[0039] Another embodiment of the present disclosure includes a medical device comprising a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) provided on a distal aspect of the tube, an outer layer around the tube, and a slidable sleeve positioned within the lumen of the tube, such that the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in a conversion from linear to rotational movement. The distal end can have an angled tip, thereby helping to improve guidance of the device. The tube can have a shelf that reduces the inner diameter of the lumen distal to the helical or spiral cut. The outer diameter of the sleeve is larger than the inner diameter of the tube shelf but smaller than the inner diameter of the tube near said shelf. The sleeve slidably abuts and engages said shelf of the tube. Advancing the sleeve results in linear displacement of the cut portion of the tube. Alternatively, the sleeve can be coupled to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the longitudinal axis of the tube. This, in turn, results in rotation of the distal end of the tube. The angle of rotation is proportional to the linear displacement of the helical or spiral cut portion of the tube. Around the outside of the tube is an outer layer bonded to the proximal and distal aspects of the tube. The outer layer may be elongated when the tube is linearly displaced (elongated). A slidable sleeve may be removed from the tube and may serve as a conduit for delivery of diagnostic and / or therapeutic agent(s), including, but not limited to, injection of contrast agent(s), drug(s), stents, and embolic agents.

[0040] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in a distal aspect of the tube; 2) a tubular member coaxially disposed around the helical or spiral cut(s); and 3) a handle assembly. The distal end of the tubular member can be coupled to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. The tubular member can be comprised of one or more elements including, but not limited to, 1) a coiled wire, 2) a polymer, or 3) a hypotube. Due to its properties, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in conversion of linear to rotational movement. The distal aspect of the tubular member can withstand torsional strain as the distal end of the helical or spiral cut tube is rotated. The distal end of the helical or spiral cut tube can have multiple configurations including, but not limited to: 1) an angled tip to aid in improved device guidance; 2) beveled edges to aid in advancing the device through significant stenoses or occlusions; 3) one or more helical grooves / grooves to aid in advancing the device through significant stenoses or occlusions or along tortuous paths; and 4) one or more radiopaque markers. The handle assembly is comprised of a proximal component and a distal component.

[0041] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) provided in the distal aspect of the tube; and 2) a tubular member coaxially disposed around the helical or spiral cut tube, the outer diameter of the helical or spiral cut tube increasing such that it is greater than the inner diameter of the tubular member distal to the cut. (Note that the outer diameter of the helical or spiral cut tube from the proximal end to the helical or spiral cut is less than the inner diameter of the helical or spiral cut tube.) The tubular member can be comprised of one or more elements, including, but not limited to, 1) a coiled wire, 2) a polymer, or 3) a hypotube. Advancement of the tubular member relative to the helical or spiral cut tube results in an extension of the helical or spiral cut. Due to its properties, the helical or spiral cut(s) can be extended. The portion of the tube more distal to the helical or spiral cut (or cuts) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in a conversion from linear to rotational movement. The distal end of the tubular member and the distal end of the tube can rotate relative to one another. The distal end of the helical or spiral cut tube can have several configurations, including, but not limited to: 1) an angled tip to aid in improved device guidance; 2) beveled edges to aid in advancing the device through significant stenoses or occlusions; 3) one or more spiral grooves / grooves to aid in advancing the device through significant stenoses or occlusions or along tortuous paths; and 4) one or more radiopaque markers.

[0042] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in the distal aspect of the tube; 2) a wire coupled to the proximal end of the helical or spiral cut tube; and 3) a tubular member coaxially disposed around the helical or spiral cut tube. The distal end of the wire can be coupled to the proximal end of the helical or spiral cut tube by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. Again, the distal end of the tubular member can be coupled to the helical or spiral cut tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. The tubular member can be comprised of one or more elements, including, but not limited to, 1) a coiled wire, 2) a polymer, or 3) a hypotube. Due to its properties, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in the conversion of linear to rotational movement. The distal aspect of the tubular member can withstand torsional strain as the distal end of the helical or spiral cut tube rotates. The distal end of the helical or spiral cut tube can have several configurations, including, but not limited to: 1) an angled tip to aid in improved device guidance; 2) beveled edges to aid in advancing the device through significant stenoses or occlusions; 3) one or more helical grooves / grooves to aid in advancing the device through significant stenoses or occlusions or along tortuous paths; and 4) one or more radiopaque markers.

[0043] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in a distal aspect of the tube; 2) an expandable layer positioned around the circumference of the helical or spiral cut tube, the expandable layer having its proximal and distal ends bonded to the helical or spiral cut tube just proximal and just distal to the helical or spiral cut(s); and 3) a tubular member positioned within the lumen of the helical or spiral cut tube and the handle assembly. The expandable layer can be bonded to the helical or spiral cut tube by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. Again, the distal end of the tubular member can be bonded to the helical or spiral cut tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. The tubular member may be comprised of one or more elements, including, but not limited to, 1) coiled wire, 2) polymer with or without reinforcement (e.g., braided or coiled reinforcement), and 3) hypotube, the properties of which allow the portion of the tube distal to the helical or spiral cut(s) to rotate and move linearly as the helical or spiral cut(s) linearly extend or retract. This results in a translation from rotational to axial movement. The distal aspect of the tubular member can withstand torsional strain as the distal end of the helical or spiral cut tube rotates. The distal end of the helical or spiral cut tube can have multiple configurations including, but not limited to: 1) an angled tip to aid in improved device guidance; 2) beveled edges to aid in advancing the device through significant stenoses or occlusions; 3) one or more helical grooves / grooves to aid in advancing the device through significant stenoses or occlusions or along tortuous paths; and 4) one or more radiopaque markers.

[0044] A handle assembly can be applied to the proximal end of the tube or wire and the proximal end of the outer tubular member to more precisely move the tube or wire relative to the outer tubular member. The handle can include two coaxial components that can be displaced relative to each other along the longitudinal axes of the components. Means for translation relative to each other include, but are not limited to, 1) manual displacement of the two coaxial tubes along the longitudinal axes of the tubes and 2) threaded portions of each tube that are coaxially receivable such that rotation of the tubes along the threaded portions results in linear displacement of the tubes relative to each other (a mechanism similar to the linear movement of threading a bolt into a nut). The handle assembly can coaxially receive the proximal end of the tube or wire and the outer tubular member. Fastening mechanisms can be located along both the proximal and distal handle components to grip the proximal end of the tube or wire and the proximal end of the outer tubular member. These fastening mechanisms can be permanently or reversibly locked in place. These fastening mechanisms may also pivot about the proximal ends of the tube or wire and the proximal ends of the outer tubular member, thereby preventing rotational movement of the tube or wire and the outer tubular member while one or more of the coaxial components are rotating.

[0045] Another embodiment of the present disclosure is a medical device including a tubular member with a longitudinal axis having a distal end and a proximal end, the tubular member including a distal aspect terminating at the distal end with a helix formed by a partial thickness helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at the proximal end; and a longitudinal displacer disposed within the tubular member, slidable relative to the tubular member, and configured to apply a longitudinal force to the distal helix. The partial thickness cut is elastic and can be extended. The width of the distal cut can be in the range of about 0.1 micrometers to about 30 millimeters, and the angle of the distal helical cut can be between about 10 degrees and about 80 degrees. The tubular member may be formed of one or more of polyimide, polyurethane, polyester block amide, nylon, nickel titanium, stainless steel braid, and hollow helical stranded tubing, and the attachment means may include at least one of 1) adhesive, 2) welding, 3) brazing, 4) soldering, and 5) mechanical link. The longitudinal displacer may include a longitudinal member having an outer diameter, the tubular member having an inner diameter such that the inner diameter of the tubular member is greater than the outer diameter of the longitudinal member, except between the distal end of the distal aspect and a connection portion where the inner diameter of the tubular member is reduced below the outer diameter of the longitudinal member, such that longitudinal movement of the longitudinal member toward the distal end of the tubular member imparts a longitudinal force to the distal aspect. The medical device may also include a cap disposed at the distal end of the tubular member to prevent forward movement of the longitudinal displacer. The longitudinal displacer may include a membrane configured to extend upon injection of fluid and longitudinally displace the distal end of the helically cut tube. The distal helix may include at least one of a shape memory alloy and a shape memory polymer, a first magnetic element disposed on one of the distal and proximal aspects of the tubular member, a second magnetic element disposed on the other of the distal and proximal aspects of the tubular member, and a power source configured to energize at least one of the first and second magnetic elements, wherein the first magnetic element is configured to pass a current and generate a magnetic field. , and a power source, the second magnetic element being one of a magnet, an electret, a wire, and a coil, configured to pass a current through the second magnetic element and generate a magnetic field, the power source being one of a magnet, a ferromagnetic material, an electret, a wire, and a coil.

[0046] Another embodiment of the present disclosure includes a medical device comprising an outer sheath and a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in a distal aspect of the tube. Due to this characteristic, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in a conversion from linear to rotational movement. The distal end of the helical / spiral cut tube can have a deflected distal end, thereby helping to improve device guidance. Means for deflecting the distal end of the tube include, but are not limited to, pull wire(s), slotted tubing, shape memory alloys, and / or shape memory polymers. The tube is positioned within the lumen of the outer sheath such that the helical or spiral cut portion of the tube is disposed within the lumen of the outer sheath while the distal end of the tube can extend beyond the outer sheath (e.g., the overall length of the tube is greater than the overall length of the outer sheath while the length from the proximal end of the tube to the distal-most aspect of the cut portion of the tube is less than the overall length of the outer sheath). When the distal end of the tube is deflected, the distal end of the outer sheath slidably abuts and engages with the deflected distal end of the tube. Advancing the outer sheath relative to the tube results in linear displacement (e.g., extension) of the cut portion of the tube. A handle that controls the linear displacement allows for controlled movement of the outer sheath relative to the longitudinal axis of the tube. This, in turn, results in rotation of the distal end of the tube. The angle of rotation is proportional to the linear displacement of the helical or spiral cut portion of the tube. When the tube is not deflected (e.g., the distal end of the tube is straight), the tube can be removed from the outer sheath, which may then serve as a conduit for the delivery of diagnostic and / or therapeutic agent(s), including, but not limited to, injection of contrast agent(s), drug(s), stents, and embolic agents.

[0047] Another embodiment of the present disclosure includes a medical device comprising an outer sheath, a tube having a distal end and a proximal end, the tube having one or more helical or spiral cut(s) in a distal aspect of the tube, and a slidable sleeve positioned within the lumen of the tube. Due to its nature, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extend or retract, resulting in a conversion from linear to rotational movement. The tube is positioned within the lumen of the outer sheath such that the helical or spiral cut portion of the tube is disposed within the lumen of the outer sheath, while the distal end of the tube can extend beyond the outer sheath (e.g., the overall length of the tube is greater than the overall length of the outer sheath, while the length from the proximal end of the tube to the distal-most aspect of the cut portion of the tube is less than the overall length of the outer sheath). The tube distal to the helically cut portion of the tube can have a curved portion, which helps improve guidance of the device, where said curved portion has a lower modulus of stiffness (e.g., is more flexible) than the modulus of elasticity of the distal aspect of the outer sheath. When the outer sheath is advanced distally past the curved portion of the tube or when the curved portion of the tube is retracted into the outer sheath, the curved portion of the tube straightens. The degree to which the curved portion of the tube is straightened is related to the amount of the curved portion of the tube disposed within the lumen of the outer sheath. When the curved portion of the tube is fully disposed within the lumen of the outer sheath, the curved portion of the tube is completely straight (e.g., the angle of deflection of the tip is less than the longitudinal axis of the device). The sleeve may have a reduced inner diameter of the lumen distal to the helical or spiral cut. The outer diameter of the sleeve is greater than the inner diameter of the tube shelf but less than the inner diameter of the tube near said shelf. The sleeve slidably abuts and engages said shelf of the tube. Advancing the sleeve results in linear displacement of the cut portion of the tube. Alternatively, the sleeve may be coupled to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or a mechanical link. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the longitudinal axis of the tube. This, in turn, results in rotation of the distal end of the tube. The angle of rotation is proportional to the linear displacement of the helical or spiral cut portion of the tube. The tube and slidable sleeve may be removable from the tube and may serve as a conduit for the delivery of diagnostic and / or therapeutic agent(s), including, but not limited to, the injection of contrast agent(s), drug(s), stents, and embolic agents. [Brief explanation of the drawings]

[0048] 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 are given like reference numerals, and in which:

[0049] [Figure 1] FIG. 1 is a diagram of a medical system including a medical device according to one embodiment of the present disclosure. [Figure 2A] FIG. 2A is a view of the distal end of the medical device in its original orientation and positioned within a branch segment of an intraluminal structure within the body, prior to selection of the desired intraluminal structure. [Figure 2B]FIG. 2B is a view of the distal end of the medical device after branch selection within an intra-branch lumen structure within the body. [Figure 3A] FIG. 3A illustrates a dual helix symmetric helical cut into a tube, with force vectors showing rotational forces while the distal end of the tube is linearly displaced, according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a free body diagram of the forces of FIG. 3A. [Figure 4A] FIG. 4A is a cross-sectional view along the long axis of a tube with a dual helix symmetric helical cut where the distal end of the tube is not linearly displaced, according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is a cross-sectional view along the longitudinal axis of the tube of FIG. 4A, with the distal end of the tube being linearly displaced. [Figure 4C] FIG. 4C is a cross-sectional view along the longitudinal axis of the tube of FIG. 4A, with the distal end of the tube being further linearly displaced. [Figure 5] FIG. 5 is a flow chart of a method for imparting rotational movement to the distal end of the device by converting linear displacement into rotational movement via a dual helical symmetry mechanism. [Figure 6A] FIG. 6A is a view of the proximal end of a medical device according to one embodiment of the present disclosure. [Figure 6B] FIG. 6B is a view of the distal end of a medical device according to one embodiment of the present disclosure. [Figure 7A] FIG. 7A is a longitudinal cross-sectional view of a distal embodiment of a device with the open distal end in its unactuated state according to one embodiment of the present disclosure. [Figure 7B] FIG. 7B is a longitudinal cross-sectional view of a distal embodiment of the device having the open distal end of FIG. 7A with linear displacement of the double chiral helix through a sleeve abutting a shelf. [Figure 8A] FIG. 8A is a longitudinal cross-sectional view of a distal embodiment of a device with an open distal end in its unactuated state, having an inner shelf and wire, according to one embodiment of the present disclosure. [Figure 8B]Figure 8B is a longitudinal cross-sectional view of a distal embodiment of the device having the open distal end of Figure 8A with linear displacement of the double chiral helix through the unreduced diameter of the wire abutting the shelf. [Figure 9A] FIG. 9A is a longitudinal cross-sectional view of a distal embodiment of the device with the open distal end in its unactuated state, with the wire bearing the expandable member. [Figure 9B] Figure 9B is a longitudinal cross-sectional view of a distal embodiment of the device having the open distal end of Figure 9A with linear displacement of the double chiral helix via an expanded member of wire abutting the distal end of the double chiral helix. [Figure 10A] FIG. 10A is a longitudinal cross-sectional view of a distal embodiment of a medical device with the capped distal end in its unactuated state. [Figure 10B] FIG. 10B is a longitudinal cross-sectional view of a distal embodiment of a medical device having the capped distal end of FIG. 10A with linear displacement of the double chiral helix via a wire abutting the capped end. [Figure 11A] FIG. 11A is a longitudinal cross-sectional view of a distal embodiment of the device in its unactuated state with the capped distal end configured to receive infusion fluid into the lumen of the tube. [Figure 11B] Figure 11B is an enlarged longitudinal cross-sectional view of a distal embodiment of the device having the capped distal end of Figure 11A, with linear displacement of the double chiral helix via injection of fluid into the lumen of the tube. [Figure 12A] FIG. 12A is a longitudinal cross-sectional view of the handle in an open position with controlled linear displacement. [Figure 12B] FIG. 12B is a transverse cross-sectional view of the handle with controlled linear displacement taken through A-A' of FIG. 12A. [Figure 13] FIG. 13 is a longitudinal cross-sectional view of the handle in a closed position with controlled linear displacement. [Figure 14A]FIG. 14A is a longitudinal cross-sectional view of the handle in an open position with controlled linear displacement. [Figure 14B] FIG. 14B is a transverse cross-sectional view of the handle with controlled linear displacement taken through BB' of FIG. 14A. [Figure 14C] FIG. 14C is a transverse cross-sectional view of the handle with controlled linear displacement taken through CC' of FIG. 14A. [Figure 15A] FIG. 15A is a longitudinal cross-sectional view of a linear displacement controlled handle in a closed position. [Figure 15B] FIG. 15B is a transverse cross-sectional view of the handle with controlled linear displacement taken through BB' of FIG. 15A. [Figure 15C] FIG. 15C is a transverse cross-sectional view of the handle with controlled linear displacement taken through CC' of FIG. 15A. [Figure 16] FIG. 16 is a diagram of a second embodiment of a medical device in which a double chiral helix is ​​displaced through a tube that changes shape in response to changes in the surrounding environment. [Figure 17A] FIG. 17A is a longitudinal cross-sectional view of a distal aspect of a device in its unactuated state according to another embodiment of the present disclosure. [Figure 17B] FIG. 17B is a longitudinal cross-sectional view of the distal embodiment of the medical device of FIG. 17A with linear displacement of the double chiral helix secondary to the shape change of the tube. [Figure 18] FIG. 18 is a diagram of another embodiment of a medical device in which the double chiral helix is ​​displaced via magnetic forces. [Figure 19A] FIG. 19A is a longitudinal cross-sectional view of a distal embodiment of a medical device with the magnetic displacement mechanism in its unactuated state. [Figure 19B] 19B is a longitudinal cross-sectional view of a distal embodiment of a medical device with a magnetic displacement mechanism of FIG. 19A, with linear displacement of the double chiral helix dependent on the magnetic force applied to the tube. [Figure 20A]FIG. 20A is a longitudinal cross-sectional view of the distal aspect of another embodiment of a medical device with the magnetic displacement mechanism in its unactivated state, one of the magnetic forces being provided via a shaft having a magnetic element. [Figure 20B] Figure 20B is a longitudinal cross-sectional view of a distal embodiment of a medical device with a magnetic displacement mechanism of Figure 20A, with linear displacement of the double chiral helix in response to magnetic force applied to the tube via a shaft having a magnetic element. [Figure 21A] FIG. 21A is a longitudinal cross-sectional view of a distal embodiment of a medical device having a tooth-gear interface between a guidewire and a tube with no force applied to the distal end of the double chiral helix. [Figure 21B] FIG. 21B is a transverse cross-sectional view of the distal embodiment of the medical device through B-B' of FIG. 21A with no force applied to the distal end of the double chiral helix. [Figure 21C] FIG. 21C is a transverse cross-sectional view of the distal embodiment of the medical device through CC' of FIG. 21A with no force applied to the distal end of the double chiral helix. [Figure 22A] FIG. 22A is a longitudinal cross-sectional view of a distal embodiment of a guidewire at the level of the tooth-gear interface when the double chiral helix is ​​longitudinally displaced. [Figure 22B] FIG. 22B is a longitudinal cross-sectional view of the distal embodiment of the guidewire at the level of the tooth-gear interface when the double chiral helix is ​​longitudinally displaced. [Figure 23A] FIG. 23A is an illustration of a catheter having a single helix formed from a tube according to one embodiment of the present disclosure. [Figure 23B] FIG. 23B is a cross-sectional view of FIG. 23A. [Figure 23C] FIG. 23C is a transverse cross-sectional view of FIG. 23A taken through line CC'. [Figure 23D] FIG. 23D is a transverse cross-section of FIG. 23A taken through line DD'. [Figure 23E]FIG. 23E is a transverse cross-section of FIG. 23A taken through line EE'. [Figure 23F] FIG. 23F is a diagram of a handle connected to the catheter of FIG. 23A. [Figure 24A] FIG. 24A is a view of the catheter of FIG. 23A with the distal member unactuated (no longitudinal force applied). [Figure 24B] FIG. 24B is a diagram of the catheter of FIG. 23A in which a longitudinal force at the proximal end rotates the distal end by 90 degrees. [Figure 24C] FIG. 24C is a diagram of the catheter of FIG. 23A in which a longitudinal force at the proximal end rotates the distal end by 180 degrees. [Figure 24D] FIG. 24D is a diagram of the catheter of FIG. 23A in which a longitudinal force at the proximal end rotates the distal end by 270 degrees. [Figure 25A] FIG. 25A is a diagram of the catheter of FIG. 23A in an unactuated state (0 degrees rotation). [Figure 25B] FIG. 25B is a view of the catheter of FIG. 23A with the sleeve retracted to reverse the rotation of the distal end to −90 degrees. [Figure 26A] FIG. 26A is a schematic diagram illustrating an embodiment of a distal segment chronic total occlusion crossing device. [Figure 26B] FIG. 26B is a schematic diagram illustrating an embodiment of a distal segment chronic total occlusion crossing device. [Figure 27A] FIG. 27A illustrates an embodiment of a distal segment endoscope. [Figure 27B] FIG. 27B illustrates an embodiment of a distal segment endoscope. [Figure 28] FIG. 28 illustrates an embodiment of a grasping tool for a distal segment endoscope. [Figure 29] FIG. 29 illustrates an embodiment of a distal segment endoscope cauterization tool. [Figure 30a]FIG. 30a is a longitudinal cross-sectional view of the distal aspect of another embodiment of a medical device in which the sleeve and tube have a shelf within their lumen distal to the helical cut. [Figure 30b] FIG. 30b is a longitudinal cross-sectional view of a distal aspect of another embodiment of a medical device in which the sleeve displaces the shelf, resulting in a 180 degree rotation relative to FIG. 30a. [Figure 30c] FIG. 30c is a longitudinal cross-sectional view of the distal aspect of another embodiment of a medical device in which the sleeve shown in FIG. 30a is replaced with a liner, resulting in an increased diameter lumen of the device. [Figure 31a] FIG. 31a is a longitudinal cross-sectional view of the distal aspect of another embodiment of the device in its unactuated state, in which the sleeve has an expandable member. [Figure 31b] FIG. 31b is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device, in which the distal end of the tube has been longitudinally displaced by advancement of the sleeve. [Figure 31c] FIG. 31c is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device in which the expandable member of the sleeve has been collapsed by a straightening element. [Figure 32a] FIG. 32a is a longitudinal cross-sectional view of the distal aspect of another embodiment of the device in its unactuated state, with the sleeve attached to the tube distal to the helical cut. [Figure 32b] FIG. 32b is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device, in which the distal end of the tube has been longitudinally displaced by advancement of the sleeve. [Figure 32c] FIG. 32c is a longitudinal cross-sectional view of the distal aspect of another embodiment of the device with the coupling removed. [Figure 33A]FIG. 33A is a diagram of a medical device for converting linear movement into rotational movement along a distal aspect of the device, according to one embodiment of the present disclosure, the device comprising an outer sheath, a tube having one or more helical or spiral cuts, and a slidable sleeve disposed within the lumen of the tube. [Figure 33B] FIG. 33B is a longitudinal cross-sectional view of the distal end of the device of FIG. 33A in its unactuated state (eg, 0 degrees rotation), according to one embodiment. [Figure 33C] FIG. 33C is a longitudinal cross-sectional view of the distal end of the device of FIG. 33A, where a longitudinal force at the proximal end rotates the distal end by 180 degrees, according to one embodiment. [Figure 33D] FIG. 33D is a transverse cross-section of FIG. 33B taken through line 33D-33D'. [Figure 33E] FIG. 33E is a transverse cross-section of FIG. 33B taken through line 33E-33E'. [Figure 33F] FIG. 33F is a transverse cross-section of FIG. 33B taken through line 33F-33F'. [Figure 34A] FIG. 34A is a longitudinal cross-sectional view of a medical device for translating linear movement into rotational movement along a distal aspect of the device, according to another embodiment of the present disclosure, comprising a tube having one or more helical or spiral cuts, a slidable sleeve disposed within the lumen of the tube, and an outer layer disposed around the tube. [Figure 34B] FIG. 34B is a transverse cross-sectional view of FIG. 34A taken through line 34B-34B'. [Figure 35A] FIG. 35A is a schematic illustration of one embodiment of a medical device for translating linear movement into rotational movement along the distal aspect of the device. [Figure 35B] FIG. 35B is a detailed view of the distal embodiment of the device of FIG. 35A. [Figure 35C] FIG. 35C is a longitudinal cross-sectional view of the distal end of the device of FIG. 35A, in which a longitudinal force at the proximal end causes the distal end to rotate. [Figure 35D] FIG. 35D is a longitudinal cross-sectional view of the distal end of the device of FIG. 35A when in its unactuated state (eg, 0 degrees rotation). [Figure 35E] FIG. 35E is a transverse cross-section of FIG. 35D taken through line 35E-35E'. [Figure 35F] FIG. 35F is a transverse cross-section of FIG. 35D taken through line 35F-35F'. [Figure 35G] FIG. 35G is a transverse cross-section of FIG. 35D taken through line 35G-35G'. [Figure 35H] FIG. 35H is a transverse cross-section of FIG. 35D taken through line 35H-35H'. [Figure 36A] FIG. 36A is an illustration of one embodiment of a medical device for converting linear movement into rotational movement along the distal aspect of the device. [Figure 36B] FIG. 36B is a detailed view of the distal embodiment of the device of FIG. 36A. [Figure 36C] FIG. 36C is a longitudinal cross-sectional view of the distal end of the device of FIG. 36A, where a longitudinal force at the proximal end causes the distal end to rotate by 180 degrees. [Figure 36D] FIG. 36D is a longitudinal cross-sectional view of the distal end of the device of FIG. 36A in its unactuated state (0 degrees rotation). [Figure 36E] FIG. 36E is a transverse cross-section of FIG. 36D taken through line 36E-36E'. [Figure 36F] FIG. 36F is a transverse cross-sectional view of FIG. 36D taken through line 36F-36F'. [Figure 36G] FIG. 36G is a transverse cross-section of FIG. 36D taken through line 36G-36G'. [Figure 37A] FIG. 37A is an illustration of one embodiment of a medical device for converting linear movement into rotational movement along the distal aspect of the device. [Figure 37B] FIG. 37B is a detailed view of the distal embodiment of the device of FIG. 37A. [Figure 37C]FIG. 37C is a longitudinal cross-sectional view of the distal end of the device of FIG. 37A, where a longitudinal force at the proximal end causes the distal end to rotate by 180 degrees. [Figure 37D] FIG. 37D is a longitudinal cross-sectional view of the distal end of the device of FIG. 37A in its unactuated state (0 degrees rotation). [Figure 37E] FIG. 37E is a transverse cross-section of FIG. 37D taken through line 37E-37E'. [Figure 37F] FIG. 37F is a transverse cross-section of FIG. 37D taken through line 37F-37F'. [Figure 37G] FIG. 37G is a transverse cross-section of FIG. 37D taken through line 37G-37G'. [Figure 38A] FIG. 38A is a longitudinal cross-sectional view of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 38B] FIG. 38B is a transverse cross-sectional view of FIG. 38A taken through line 38B-38B'. [Figure 38C] FIG. 38C is a longitudinal cross-sectional view of one embodiment of a medical device for translating linear movement into rotational movement along a distal aspect of the device. [Figure 38D] FIG. 38D is a transverse cross-sectional view of FIG. 38C taken through line 38C-38C'. [Figure 39] FIG. 39 is a longitudinal cross-sectional view of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 40] FIG. 40 is a longitudinal cross-sectional view of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 41A] FIG. 41A is a longitudinal cross-sectional view of another embodiment of a medical device with a single helix. [Figure 41B] FIG. 41B is a transverse cross-sectional view of the device of FIG. 41A taken along line BB'. [Figure 41C]FIG. 41C is a transverse cross-sectional view of the device of FIG. 41A taken through line CC'. [Figure 41D] FIG. 41D is a transverse cross-sectional view of the device of FIG. 41A taken through line DD'. [Figure 42A] FIG. 42A is a schematic illustration of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 42B] FIG. 42B is a longitudinal cross-sectional view of the distal end of the device of FIG. 42A in a first orientation. [Figure 42C] FIG. 42C is a longitudinal cross-sectional view of the distal end of the device of FIG. 42A in a second orientation. [Figure 42D] FIG. 42D is a transverse cross-sectional view of the device of FIG. 42B through line DD'. [Figure 42E] FIG. 42E is a transverse cross-sectional view of the device of FIG. 42B taken through line EE'. [Figure 43A] FIG. 43A is a schematic illustration of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 43B] FIG. 43B is a longitudinal cross-sectional view of the distal end of the device of FIG. 43A with the distal end of the tube in a first orientation. [Figure 43C] FIG. 43C is a longitudinal cross-sectional view of the distal end of the device of FIG. 43A with the distal end of the tube in a second orientation. [Figure 43D] FIG. 43D is a transverse cross-sectional view of the device of FIG. 43B through line DD'. [Figure 43E] FIG. 43E is a transverse cross-sectional view of the device of FIG. 43B through line EE'. [Figure 44A] FIG. 44A is a schematic illustration of another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 44B]FIG. 44B is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A in which the outer sheath does not engage the curved portion of the tube, resulting in a 180 degree curve in the distal aspect of the tube. [Figure 44C] FIG. 44C is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A, in which the outer sheath partially engages the curved portion of the tube, resulting in a 90 degree bend in the distal aspect of the tube. [Figure 44D] FIG. 44D is a longitudinal cross-sectional view of the distal end of the device of FIG. 3A, in which the outer sheath further engages the curved portion of the tube, resulting in a 45 degree curve in the distal aspect of the tube. [Figure 44E] FIG. 44E is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A, showing the outer sheath fully engaged with the curved portion of the tube, resulting in a straight distal aspect of the tube (0 degree curve). [Figure 44F] FIG. 44F is a transverse cross-sectional view of the device of FIG. 44E taken through line FF'. [Figure 44G] FIG. 44G is a transverse cross-sectional view of the device of FIG. 44E taken through line GG'.

[0050] Each figure is depicted solely to facilitate the explanation of the basic teachings of the present disclosure. Expansions to the drawings regarding the number, location, relationship, and dimensions of parts to form preferred embodiments will be explained or will be within the skill of the art after reading and understanding the following teachings of the present disclosure. Furthermore, specific dimensions and dimensional proportions that meet specific force, weight, strength, and similar requirements will likewise be within the skill of the art after reading and understanding the following teachings of the present disclosure. It is within the technology. DETAILED DESCRIPTION OF THE INVENTION

[0051] The present application is directed to medical devices having a distal portion, a proximal portion, and a helical structure incorporated into the distal end of the device to convert linear movement into (or otherwise create) rotational movement at the distal end of a device such as a catheter (e.g., a catheter, microcatheter, sheath, other intraluminal device, etc.). The helical structure may be a single helix or a double chiral helix. In some embodiments, as discussed in more detail herein, the double chiral helix comprises a helix (e.g., having a first rotation, such as a clockwise rotation) and a helix (e.g., having a second rotation opposite to the first rotation, such as a counterclockwise rotation). In some embodiments, the two helices intersect with one another. According to some embodiments, displacement (e.g., linear or other) of the double chiral helix along its longitudinal axis results in a rotation of the junction of the two helices. While medical devices have applications in human surgery and diagnostics, the present disclosure contemplates devices having non-medical applications for human and non-human medical surgery uses and applications, as well as industrial and diagnostic applications such as testing.

[0052] According to some embodiments, the intraluminal device comprises an outer member having at least one cut or feature that facilitates translation of linear movement of the inner member relative to the outer member into rotation of a distal portion of the device. Such rotational movement can facilitate movement of the distal end of the device through the vasculature or other intraluminal structure of a subject as desired or needed (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in further detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other lumen, anatomical location (e.g., through the respiratory tract, digestive system, etc. of a subject), etc.).

[0053] As discussed in further detail herein, various embodiments disclosed herein can provide advantageous devices, systems, and / or methods for manipulating the distal end of a medical device (e.g., a catheter, microcatheter, sheath, other intraluminal device, etc.). In some embodiments, the device includes a tube or outer member with one or more cuts (e.g., partial or complete cuts through the wall of the tube or outer member). In some embodiments, the cuts or similar features extend through the entire thickness of the tube or outer member. However, in other embodiments, the cuts extend only partially through the tube or outer member, as desired or needed.

[0054] In some embodiments, the distal portion of the tube or outer member includes one or more cuts or other features. In some embodiments, such cuts are helical or spiral in shape. In some embodiments, such helical cuts have a constant or uniform orientation. However, in other configurations, the cuts have two or more orientations (e.g., angle, pitch, etc.) relative to the longitudinal axis, opening sizes, spacing, and / or other characteristics, as desired or required. For example, in some configurations, the cut(s) have a dual helix or double chiral helix design. However, in other embodiments, the cut(s) have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0055] According to some embodiments, the device comprises a tube or outer member, a pusher or inner member, and one or more cuts or other features along the distal end of the tube. In some embodiments, linear movement of the pusher member relative to the tube or outer member results in rotational movement (e.g., rotation, twist, pivoting, etc.) of the distal portion of the tube. Such movement can aid in movement and / or manipulation of the device through the subject's vasculature or other intraluminal system. In some embodiments, the tube or other member is secured to the pusher or inner member along one or more locations (e.g., at the distal end of the device) using one or more securement (e.g., direct or indirect) methods, features, devices, techniques, etc.

[0056] In some embodiments, the cuts (e.g., partially or completely) through the tube or outer member have a helical or spiral shape. For example, in some embodiments, the cuts are angled relative to the longitudinal axis of the device (or an axis perpendicular to the longitudinal axis). For example, the helical angle can be in the range of 10 to 80 degrees relative to the longitudinal axis of the device (e.g., 10 to 15 degrees, 15 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, angles between the aforementioned ranges, etc.). In some embodiments, the helical angle is in the range of 15 to 75 degrees.

[0057] In some embodiments, the cuts are only along or proximal to the distal end of the tube or distal member, for example, the cut(s) are located along the distal 0 to 20 percent (e.g., 0% to 1%, 1% to 2%, 2% to 3%, 3% to 4%, 4% to 5%, 5% to 6%, 6% to 7%, 7% to 8%, 8% to 9%, 9% to 10%, 10% to 15%, 15% to 20% of the tube and / or device, percentages between the aforementioned ranges and values, etc.).

[0058] According to some embodiments, the inner member, and thus the entire endoluminal device, is cannulated or otherwise includes a lumen. In some embodiments, such a device may allow for the passage of one or more other devices, instruments, and / or other members therethrough, as desired or required. In some embodiments, the devices disclosed herein include one or more outer members, layers, coatings, and / or other members.

[0059] While some configurations disclosed herein have dual helix or double chiral helix designs, conversion from linear to rotational movement can also be achieved and may be preferred in certain embodiments and / or may otherwise exhibit certain advantages over dual helix configurations. Thus, any embodiment disclosed herein may be configured and / or otherwise adapted to include single or multiple (e.g., dual helix symmetry) helix designs. Furthermore, the medical devices disclosed herein may be adapted to perform linear to rotational conversion using designs that do not include helices, as discussed in more detail herein and shown in the accompanying drawings.

[0060] As discussed in more detail herein, the embodiments disclosed herein can take the form of any one of a variety of intraluminal devices, such as, for example, catheters, microcatheters, sheaths, other intraluminal devices, and / or the like. In some embodiments, the diameter (e.g., outer diameter) of any of the intraluminal devices disclosed herein varies from 1 mm to 11.333 mm, or from 1 French to 34 French (e.g., 1 French, 2 French, 3 French, 4 French, 5 French, 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 15 French, 16 French, 17 French, 18 French, 19 French, 20 French, 21 French, 22 French), as desired or needed. , 23 French, 24 French, 25 French, 26 French, 27 French, 28 French, 29 French, 30 French, 31 French, 32 French, 33 French, 34 French, French values ​​between the aforementioned values, etc. However, in other embodiments, the endoluminal device can include any other diameter or size, such as, for example, but not limited to, custom sizes below, above, or between the aforementioned values. Additionally, the length of the device can vary depending on the application or use. In some embodiments, the length of the device is between 10 cm and 500 cm (e.g., 50 cm to 100 cm, 100 cm to 300 cm, 10 cm to 20 cm, 20 cm to 30 cm, 30 cm to 40 cm, 40 cm to 50 cm, 50 cm to 60 cm, 60 cm to 70 cm, 70 cm to 80 cm, 80 cm to 90 cm, 90 cm to 100 cm, 100 cm to 110 cm, 110 cm to 120 cm, 120 cm to 140 cm, 140 cm to 150 cm, 150 cm to 200 cm, 150 cm to 250 cm, 160 cm to 260 cm, 160 cm to 270 cm, 170 cm to 280 cm, 170 cm to 290 cm, 180 cm to 300 cm, 180 cm to 310 cm, 180 cm to 320 cm, 180 cm to 330 cm, 180 cm to 340 cm, 180 cm to 350 cm, 180 cm to 360 cm, 180 cm to 370 cm, 180 cm to 380 cm, 180 cm to 390 cm, cm to 130cm, 130cm to 140cm, 140cm to 150cm, 150cm to 160cm, 160cm to 170cm, 170cm to 180cm, 180cm to 190cm, 190cm to 200cm, 200cm to 250cm, 250cm to 300cm, 300cm to 350cm, 350cm to 400cm, 400cm to 450cm, 450cm to 500cm, lengths in between the aforementioned values, etc.

[0061] According to some embodiments, the endoluminal devices disclosed herein can be used in a variety of applications and procedures. For example, the devices can be used to reach specific organs or vasculature of a subject (e.g., the heart or cardia, head and neck, liver, kidneys, hepatic vasculature, renal vasculature, limbs, etc.). Any other part of the anatomy can also be reached and targeted using the devices. The various embodiments disclosed herein can be particularly advantageous when a professional is attempting to reach and treat a portion of a subject's anatomy that is accessible through a tortious vascular or other endoluminal route (e.g., one that requires the endoluminal device to bend or change direction several times). The various devices disclosed herein can be used in connection with a variety of indications and procedures, such as, but not limited to, ablative procedures, stimulation or neuromodulation procedures, extractions, biopsies, aspiration, delivery of drugs, fluids, energy (e.g., RF, ultrasound, cryogenics, etc.), and / or the like.

[0062] In some embodiments, imparting rotation to a distal portion at the distal end (e.g., as opposed to rotating the entire length of the medical device) can help reduce stress on the vasculature, improve rotational precision of the medical device, reduce the risk of uncontrolled release of potential energy from the medical device, and / or provide one or more additional advantages or benefits. These qualities can improve surgical efficiency, reduce the overall time the patient is in the operating room, reduce the time the patient needs to be exposed to anesthesia, reduce the risk of surgical morbidity, reduce fatigue for surgical staff during the medical procedure, reduce the time the patient is exposed to radiation (e.g., if a radiation source is required during the procedure), etc.

[0063] Terms such as "top," "bottom," "first," "second," "upper," "lower," "height," "width," "length," "end," "side," "horizontal," "vertical," and similar terms are used herein. It is understood that these terms have only reference to the structures shown in the figures and are utilized solely to facilitate the description of the embodiments of the present disclosure. Features described in some embodiments may be used in other embodiments disclosed herein, as will be understood by those skilled in the art.

[0064] FIG. 1 shows a system for imaging a medical device 10 within a human body 1, according to one embodiment. The depicted medical device includes a distal end 12 configured for use within the body 1, a proximal end 11 for use outside the body 1, and a handle 13. In operation, the device 10 can be monitored with an imaging device 3. The imaging device 3 may project an image 5 of the medical device onto a monitor 4. The handle 13 may be configured to control the operation of the distal end 12. The use of imaging (e.g., imaging device, monitor, etc.), whether or not included in the device, can be incorporated and synchronized with any of the embodiments disclosed herein.

[0065] 2A and 2B show the distal end 12 of device 10 within an intraluminal structure 20, according to one embodiment. Intraluminal structures include, but are not limited to, blood vessels, the heart, the gastrointestinal (GI) tract, the genitourinary (GU) tract, the peritoneal cavity, the thoracic cavity, the diaphragm, the bronchial tract, the subarachnoid space, and the intracranial ventricular system. In FIG. 2A, a guidewire 14 is shown within device 10 with the device's distal end 12 pointing away from a desired intraluminal branch 21. In FIG. 2B, the distal end 12 and guidewire 14 within the intraluminal structure 20 of FIG. 2A have been rotated to point toward the desired intraluminal branch 21.

[0066] 3A shows a tube 30 having a double chiral helix 37 formed by a proximal helical cut 31 and a distal helical cut 32, the cuts 31 and 32 being proximal and distal to a connection point 33. In the illustrated embodiment, the distal cut 32 includes a cut width 38a and a helical angle 39a. Similarly, the proximal cut 31 has a cut width 38b and a helical angle 39b. The cut widths 38a, 38b can be in the range of 0.1 micrometers to 10 millimeters (e.g., 0.1 millimeters to 0.2 millimeters, 0.2 millimeters to 0.3 millimeters, 0.3 millimeters to 0.4 millimeters, 0.4 millimeters to 0.5 millimeters, 0.5 millimeters to 0.6 millimeters, 0.6 millimeters to 0.7 millimeters, 0.7 millimeters to 0.8 millimeters, 0.8 millimeters to 0.9 millimeters, 0.9 millimeters to 1 millimeter, 1 millimeter to 2 millimeters, 2 millimeters to 3 millimeters, 3 millimeters to 4 millimeters, 4 millimeters to 5 millimeters, 5 millimeters to 6 millimeters, 6 millimeters to 7 millimeters, 7 millimeters to 8 millimeters, 8 millimeters to 9 millimeters, 9 millimeters to 10 millimeters, values ​​between the aforementioned values, etc.). In some embodiments, the cut width is in the range of 10 microns to 1000 microns. Helical angles 39a, 39b can range from 10 to 80 degrees (e.g., 10 to 15 degrees, 15 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device. In some embodiments, the helical angle ranges from 15 to 75 degrees. Cut widths 38a, 38b can be equal or different, and helical angles 39a, 39b can have the same or different magnitudes.In some embodiments, when force 34 is applied along the longitudinal axis 40 of tube 30, the force is translated into a force along distal helix 35 and a force along proximal helix 36 applied at connection point 33. Cut widths 38a, 38b and helical angles 39a, 39b change as double chiral helix 37 is lengthened or shortened, resulting in rotational movement.

[0067] 3B shows a free body diagram of the forces along distal helix 35 and proximal helix 36, separated into forces along the axis of the tube and forces tangential to tube 30. This diagram illustrates how, in one embodiment, the forces tangential to tube 30 are applied, exerting a torque on connection point 33.

[0068] 4A-4C illustrate the rotation of connection point 54 between proximal helical cut 53 and distal helical cut 52 when the distal portion of tube 51 is extended, according to one embodiment. While FIG. 4A shows the distal portion of tube 51 in an unextended position, FIG. 4B shows the distal portion of tube 51 in an extended orientation (e.g., whereby connection point 54 and distal segment 55 are rotated 90 degrees relative to their respective positions in FIG. 4A). FIG. 4C shows the distal portion of tube 51 extended, whereby connection point 54 and distal segment 55 are rotated 180 degrees relative to their respective positions in FIG. 4A.

[0069] FIG. 5 shows a flowchart of one embodiment of a method 500 for controlling the distal tip 12 of the device 10. In step 510, the device 10 is inserted into the intraluminal structure 20 of the body 1. In step 520, an image of the device 10 within the body 1 is displayed. The display can be in the form of any imaging technology of an object within the human body, including, but not limited to, x-ray fluoroscopy, ultrasound imaging, computed tomography (CAT) imaging, magnetic resonance imaging (MRI), and / or endoscopic imaging. In step 530, a region of interest is selected within the image. In step 540, a longitudinal force and displacement is applied to the double handed helix 37, rotating the distal tip 12. The longitudinal force may be applied by manipulation of the sleeve 57 or the wire 62. In some embodiments, the longitudinal force may be applied through the application of energy to one or more actuators coupled to the medical device, such as magnetic elements 117, 118 ( FIG. 19A ). In step 350, the change in position of distal tip 12 is observed on the display. In step 360, the amount of longitudinal displacement is adjusted to rotate distal tip 12 the desired angle of rotation by varying the amount of longitudinal force applied to double-handed helix 37 via sleeve 57 / guidewire 62 or through the application of energy to one or more actuators 117, 118.

[0070] FIG. 6A is a diagram of a medical device 50 according to one embodiment of the present disclosure. As shown, device 50 includes a tube 51, a distal segment 55 coupled to the distal end of tube 51, and a sleeve 58. Sleeve 58 is disposed within the lumen of tube 51. Sleeve 58 can be advanced or retracted within tube 51 to longitudinally displace helices 52, 53. Device 50 also includes a handle 70 comprised of a proximal component 71 and a distal component 72 and attached to the proximal end of tube 51. Each of proximal component 71 and distal component 72 has a cylindrical body such that proximal component 71 can be inserted into distal component 72 and sleeve 58 can be inserted into proximal component 71. Proximal component 71 is reversibly coupled to sleeve 58, and distal component 72 is reversibly coupled to tube 51. Each of the tube 51, distal segment 55, and sleeve 58 may be formed from one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel braid, and hollow helical stranded tubing. Additionally, the distal segment 55 may have, but is not limited to, straight, angled, and reverse curved shapes.

[0071] 6B focuses on the distal segment and distal end 51. As shown, a double chiral helix 67 is formed by distal helix 52 and proximal helix 53 joined at connection point 54. Distal helix 52 and proximal helix 53 are formed from tube 51 by helical cuts, with proximal helix 53 and distal helix 52 meeting at connection point 54. Distal segment 55 is disposed around the distal end of tube 51 and is coupled to connection point 54 via coupling means 56. Suitable coupling means between distal segment 55 and connection point 54 include, but are not limited to: 1) a coupling means; Attachment techniques include one or more of: 1) adhesive (e.g., cyanoacrylate), 2) welding, 3) brazing, 4) soldering, and 5) mechanical linkage; further suitable means will be known to those skilled in the art. As shown, wire 62 can be disposed within the lumen of tube 51 and can be slidably advanced into or withdrawn from tube 51 along the longitudinal axis of tube 51. As wire 62 is advanced, it can abut capped end 61 of tube 51. Further advancement of wire 62 after abutting capped end 61 can result in linear displacement of double helix 67. The force associated with the linear displacement of double helix 67 generates a rotational force at connection 54 that rotates distal segment 55. As is well known to those skilled in the art, thin coiled wire 64 can be wrapped around the proximal end of distal segment 55 and coupled to tube 51 to allow smooth transition between distal segment 55 and tube 51. Advantageously, linear movement is limited to the distal portion of tube 51, particularly double chiral helix 67 and distal to double chiral helix 67. Thus, linear displacement of the entire tube 51 is not required.

[0072] FIG. 7A is a longitudinal cross-sectional view of device 50 with open distal end 65 in distal segment 55 in its unactuated state (i.e., double-handed helix 67 is not linearly displaced). The distal aspect of device 50 is shown with tube 51, and double-handed helix 67 cut into the distal aspect of tube 51, thereby forming proximal helix 53 and distal helix 52. The cut section of tube 51 may be cut entirely through the wall of the tube. Proximal helix 53 and distal helix 52 are formed such that they are oppositely oriented. For example, if proximal helix 53 is left-handed, distal helix 52 may be right-handed, or vice versa. Connection point 54 of the left-handed and right-handed helices rotates as double-handed helix 67 is linearly extended or compressed, resulting in translating linear movement of connection point 54 of the two helices into rotational movement. Distal segment 55 is disposed around the circumference of the distal aspect of tube 51, where double-handed helix 67 is cut. Distal segment 55 is attached to helix connection point 54 of double-handed helix 67 via attachment means 56. Distal segment 55 has an angled tip, which helps improve guidance of device 50. Tube 51 has a reduced inner diameter in the lumen distal to double-handed helix 67, forming shelf 57. The outer diameter of sleeve 58 is larger than the inner diameter of shelf 57 of tube 51 and smaller than the inner diameter of tube 51 near shelf 57. Sleeve 58 is in slidable contact with shelf 57 of tube 51.

[0073] FIG. 7B shows the position of distal end 65 after sleeve 58 has been advanced. The advancement of sleeve 58 linearly displaces double-handed helix 67. This, in turn, rotates connection point 54 between proximal helix 53 and distal helix 52, which in turn rotates distal segment 55. The angle of rotation of connection point 54 is proportional to the linear displacement of double-handed helix 67 of tube 51. For illustrative purposes, a 180-degree rotation is shown in FIG. 7B, but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of sleeve 58.

[0074] 8A shows a cross-sectional view of another embodiment of distal segment 55 of device 50 in its unactuated state. The distal aspect of device 50 is shown with tube 51 having a distal end and a proximal end, and a double chiral helix 67 cut into the distal aspect of tube 51, thereby forming proximal helix 53 and distal helix 52. Distal segment 55 is joined at connection point 54 of the two helices of double chiral helix 67. Proximal helix 53 and distal helix 52 are connected by these proximal helices. The proximal helix 53 and the distal helix 52 are formed so that their orientations are opposite. For example, if the proximal helix 53 is left-handed, the distal helix 52 can be right-handed, or vice versa. By its nature, the connection point 54 between the left-handed and right-handed helices rotates as the end of the double-handed helix 67 is linearly extended or retracted, resulting in translating linear movement of the connection point 54 of the two helices into rotational movement. A distal segment 55 is disposed around the circumference of the distal aspect of the tube 51, where the double-handed helix 67 is truncated. The distal segment 55 is connected to the helix connection point 54 of the double-handed helix 67 via a connecting means 56. The distal segment 55 has an angled tip, which helps improve guidance of the device 50. The tube 51 includes a shelf 57, which reduces the inner diameter of the lumen distal to the double-handed helix 67. The outer diameter of sleeve 58 is larger than the inner diameter of shelf 57 of tube 51 and smaller than the inner diameter of tube 51 near said shelf 57. Device 50 also includes wire 59. Wire 59 is disposed within the lumen of tube 51, with a distal portion of wire 59 having a reduced diameter such that the distal portion of wire 59 passes through the reduced distal diameter of shelf 57. The remainder of wire 59, or at least the portion adjacent to the distal portion, has a diameter larger than the inner diameter of shelf 57. Thus, wire 59 with its reduced distal diameter slidably abuts and engages said shelf 57 of tube 51.

[0075] In FIG. 8B, wire 59 is shown advanced within tube 51, linearly displacing double-handed helix 67 as shown in FIG. 8B. The linear displacement rotates connection point 54 between proximal helix 53 and distal helix 52, which in turn rotates distal segment 55. The angle of rotation of distal segment 55 is proportional to the linear displacement of double-handed helix 67 of tube 51. For illustrative purposes, a 180-degree rotation is shown in FIG. 8B, but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of wire 59.

[0076] 9A shows a cross-sectional view of another embodiment of distal segment 55 of device 50 in its unactuated state, with open distal end 65. The distal aspect of device 50 is shown with tube 51 having its distal end and its proximal end, and a double-handed helix 67 cut into the distal aspect of tube 51, thereby forming proximal helix 53 and distal helix 52. Distal segment 55 is joined to connection point 54 of the two helices of double-handed helix 67. Proximal helix 53 and distal helix 52 are shaped such that they are oppositely oriented. For example, if proximal helix 53 is left-handed, distal helix 52 can be right-handed, or vice versa. By its very nature, the connection point 54 between the left-hand and right-hand helices rotates as the end of the double-handed helix 67 is linearly extended or retracted, resulting in translating linear movement of the connection point 54 of the two helices into rotational movement. A distal segment 55 is disposed around the circumference of the distal aspect of the tube 51, where the double-handed helix 67 is truncated. The distal segment 55 is attached to the helix connection point 54 of the double-handed helix 67 via a coupling means 56. The distal segment 55 has an angled tip, which helps improve guidance of the device 50. A wire 60 is coaxially disposed within the lumen of the tube 51, and the wire 60 is reversibly expandable.

[0077] 9B shows the device 50 of FIG. 9A with the wire 60 expanded so that the expandable member 66 is expanded to the diameter of the tube 51 or is larger than the diameter of the tube 51. When the reversibly expandable member 66 is expanded, the member 66 extends beyond the diameter of the tube 51. 9B , the reversibly expandable member 66 is in its expanded state, the wire 60 linearly displaces the double-handed helix 67. This, in turn, rotates the connection point 54 between the proximal and distal helices 53 and 52, which in turn rotates the distal segment 55. The angle of rotation is proportional to the linear displacement of the double-handed helix 67 of the tube 51. For illustrative purposes, a 180-degree rotation is shown in FIG. 9B , but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the sleeve 58. When the reversibly expandable member 66 is collapsed, the outer diameter of the wire 60 is less than the inner diameter of the lumen of the tube 51, allowing the wire to move freely within the lumen of the tube 51, as shown in FIG. 9A .

[0078] 10A shows a cross-sectional view of another embodiment of the distal aspect of device 50 in its unactuated state, including tube 51 with capped end 61. The distal aspect of device 50 is shown with tube 51 having a distal end and a proximal end, and a double-handed helix 67 cut into the distal aspect of tube 51, thereby forming proximal helix 53 and distal helix 52. Distal segment 55 connects to connection point 54 of the two helices of double-handed helix 67. Proximal helix 53 and distal helix 52 are shaped such that they are oppositely oriented. For example, if proximal helix 53 is left-handed, distal helix 52 can be right-handed, or vice versa. By its very nature, the connection point 54 between the left- and right-handed helices rotates as the end of the double-handed helix 67 is linearly extended or retracted, resulting in translating linear movement of the connection point 54 of the two helices into rotational movement. A distal segment 55 is disposed around the circumference of the distal aspect of the tube 51, where the double-handed helix 67 is cut. The distal segment 55 is attached to the helix connection point 54 of the double-handed helix 67 via a coupling means 56. The distal segment 55 has an angled tip, which helps improve guidance of the device 50. A wire 62 is coaxially disposed within the lumen of the tube 51. The wire 62 contacts the capped end 61, and advancing the wire 62 applies a force against the capped end 61, linearly displacing the double-handed helix 67, as shown in FIG. 10B. This, in turn, results in a rotation of the connection point 54 between the proximal helix 53 and the distal helix 52, which in turn rotates the distal segment 55. The angle of rotation is proportional to the linear displacement of the double-handed helix 67 of the tube 51. For purposes of illustration, a 180 degree rotation is shown in FIG. 10B, but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the wire 62.

[0079] 11A shows a cross-sectional view of another embodiment of the distal aspect of device 50 in its unactuated state, with capped end 61 of tube 51. The distal aspect of device 50 is shown with tube 51 having a distal end and a proximal end, and a double chiral helix 67 cut into the distal aspect of tube 51, thereby forming proximal helix 53 and distal helix 52. Distal segment 55 connects to connection point 54 of the two helices of double chiral helix 67. Proximal helix 53 and distal helix 52 are shaped such that they are oppositely oriented. For example, if proximal helix 53 is left-handed, distal helix 52 can be right-handed, or vice versa. By its very nature, the connection point 54 between the left-handed helix and the right-handed helix rotates as the end of the double-handed helix 67 is linearly extended or retracted, resulting in translating linear movement of the connection point 54 of the two helices into rotational movement. Distal segment 55 is disposed around the circumference of the distal aspect of tube 51, where double-handed helix 67 11B ). Distal segment 55 is connected to helix connection point 54 of double-handed helix 67 via connection means 56. The tip of distal segment 55 can have an angled tip, which helps improve guidance of device 50. A membrane or liner 63 is disposed within the lumen of tube 51. Injecting fluid into the lumen of tube 51 expands membrane 63, linearly displacing double-handed helix 67, as shown in FIG. 11B . This, in turn, rotates connection point 54 between proximal helix 53 and distal helix 52, which in turn rotates distal segment 55. The angle of rotation is proportional to the linear displacement of double-handed helix 67 of tube 51. Injection of fluid into or extraction of fluid from the interior of membrane 63 can be precisely controlled, allowing for fine-tuning of the rotation of distal segment 55. Fine adjustment allows the medical device 100 to be used in vasculature with small vessels and allows for the selection of a specific branch with little risk of impacting the vessel wall due to whip or passage of the selected branch during rotation of the distal segment 55. Furthermore, fine adjustment allows for precise placement of auxiliary equipment, such as lamps for interior body illumination. Here, individual and / or subtle adjustment of the rotation angle is advantageous or necessary. Note that fine adjustment also reduces potential energy buildup in the distal segment 55, which can result in whip if released too suddenly. For illustrative purposes, a 180-degree rotation is shown in FIG. 11B , but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the double-handed helix 67 due to expansion / contraction of the membrane 63. In some embodiments, a single helix 203 may replace the double-handed helix 67. See, for example, FIGS. 23-25 ​​.

[0080] FIG. 12A shows a cross-sectional view of a handle 70 suitable as an embodiment of the handle 13 shown in FIG. 1 for gripping the proximal end 11 of the device 10. The handle 70 may include a proximal component 71 and a distal component 72, which are coaxial with one another. The proximal component 71 and the distal component 72 may be formed from one or more of a variety of materials, including, but not limited to, one or more of polycarbonate and metal. The distal component 72 has a cylinder 73 configured to slidably receive the proximal aspect of the tube 51 and the sleeve 58 or wire 78. The proximal component 71 and the distal component 72 are configured to move relative to one another along the longitudinal axis of the handle 70.

[0081] A distal fitting 76 is located at the distal end of distal component 72. This distal fitting 76 flares out from lumen 73. A proximal fitting 74 is located distal to the proximal end of proximal component 71 and also flares out from cylinder 73. A distal compression nut 77 fits around the outer diameter of distal component 72. Distal fitting 76 is threaded to mate with the distal compression nut 77. A proximal compression nut 75 fits around the outer diameter of proximal component 71. Proximal fitting 74 is threaded to mate with the proximal compression nut 75. FIG. 12B shows a minor axis cross section through line A-A'. Proximal component 71 and distal component 72 are coaxial with each other and with wire 78.

[0082] FIG. 13 shows a cross-sectional view through the longitudinal axis of handle 70 with proximal and distal compression nuts 75, 77 engaging the threads of proximal and distal fittings 74, 76, respectively, so that distal and proximal fittings 76, 74 are compressed toward cylinder 73 rather than flaring out as in FIG. 12A.

[0083] 14A-14C and 15A-15C illustrate a handle 80 suitable as an alternative embodiment of the handle 13 shown in FIG. 1 for grasping the proximal end 11 of the device 10. FIG. 14A illustrates the handle 80 including a proximal component 81 and a distal component 82, where the proximal component 81 and the distal component 82 are coaxial with one another. The proximal component 81 and the distal component 82 may be formed from one or more of a variety of materials, including, but not limited to, one or more of polycarbonate and metal. The distal aspect of the proximal component 81 has a threaded portion referred to herein as a proximal component screw 88, and the proximal portion of the distal component 82 has a threaded portion referred to herein as a distal component screw 89. The proximal component 81 and the distal component 82 are displaceable relative to one another along the longitudinal axis of the handle 80 via rotation of the proximal component 81 relative to the distal component 82. The swivel 90 is disposed within the proximal component 81 such that the proximal fitting 84 and the proximal component 81 can rotate relative to one another. The handle 80 has a lumen 83 that is dimensioned to receive the proximal aspect of the tube 91 and a sleeve or wire 92 that is coaxially disposed within the tube 91 for at least a portion of its length.

[0084] Distal fitting 86 is located at the distal end of distal component 82. The distal end of distal fitting 86 flares out from lumen 83. Proximal fitting 84 is located at the proximal end of proximal component 81. The proximal end of the proximal fitting flares out from lumen 83. Distal compression nut 87 fits around the outer diameter of distal component 82. Distal fitting 86 is threaded so that its threads mate with distal compression nut 87. Proximal compression nut 85 fits around the outer diameter of proximal component 81. Proximal fitting 84 is threaded so that its threads mate with proximal compression nut 85.

[0085] FIG. 14B shows a short-axis cross section through line B-B' of FIG. 14A passing through distal fitting 86. A longitudinal displacer, such as sleeve or wire 92, is shown coaxial with tube 91, and both sleeve or wire 92 and tube 91 are coaxial with distal fitting 86. Similarly, FIG. 14C shows a short-axis cross section through line C-C' of FIG. 14A passing through proximal fitting 84. Here, proximal fitting 84 overlaps distal fitting 86. Sleeve or wire 92 is shown coaxial with tube 91, as well as proximal fitting 84 and distal fitting 86.

[0086] FIG. 15A shows a cross-section through the longitudinal axis of handle 80, with proximal and distal compression nuts 85 and 87 engaging the threads of proximal and distal fittings 84 and 86, respectively, thereby compressing the distal and proximal fittings 86 and 84 toward lumen 83. FIG. 15B shows a minor axis cross-section through line B-B' of FIG. 15A through distal fitting 86. Sleeve or wire 92 is shown coaxial with tube 91, and both sleeve or wire 92 and tube 91 are coaxial with distal fitting 86. Similarly, FIG. 15C shows a minor axis cross-section through line C-C' of FIG. 15A through proximal fitting 84, where proximal fitting 84 overlaps distal fitting 86. A sleeve or wire 92 is shown coaxial with the tube 91 and the proximal and distal fittings 84 and 86 .

[0087] 16 illustrates another embodiment of an apparatus including a medical device 100. In this embodiment, a double chiral helix 1709 (see FIG. 17A) is cut into the distal aspect of a tube 101. The tube 101 comprises a material including, but not limited to, nickel titanium (nitinol), which is selected to undergo a shape change in response to a change in the local environment, such that an extension of the double chiral helix 1709 occurs. Conduit 108 is disposed within tube 101. Conduit 108 may be connected to source 109, disposed within tube 101, of an agent for altering the local environment. Exemplary agents for altering the local environment may include, but are not limited to, one or more of a battery, a radio frequency generator, a microwave generator, a heat source for Joule heating or magnetic field alteration, a light source, and a chemical source of releasable ions. In one embodiment, double chiral helix 1709 may linearly elongate upon increasing temperature. This elongation may occur over a temperature range of 40 degrees Celsius to 90 degrees Celsius. In some embodiments, the temperature range for elongation may be between 40 degrees Celsius and 60 degrees Celsius. Distal segment 105 is coupled to a distal aspect of tube 101.

[0088] 17A shows a longitudinal cross-sectional view of the distal aspect of one embodiment of medical device 100 in its unactuated state, with no linear displacement of double-handed helix 1709. The distal aspect of medical device 100 is shown with tube 101 having distal and proximal ends, and double-handed helix 1709 cut into the distal aspect of tube 101, thereby forming proximal helix 103 and distal helix 102. Conduit 108 is coaxially positioned within the lumen of tube 101, with distal segment 105 connecting to connection point 104 of the two helices 102, 103 of double-handed helix 1709. Proximal helix 103 and distal helix 102 are formed such that the proximal helix 103 and distal helix 102 are oppositely oriented. For example, if proximal helix 103 is left-handed, distal helix 102 may be right-handed, or vice versa.

[0089] By its very nature, the connection point 104 between the left-hand and right-hand helices rotates as the end of the double-handed helix 1709 is linearly extended or retracted, resulting in translating linear movement of the connection point 104 of the two helices 102, 103 into rotational movement. A distal segment 105 is disposed around the circumference of the distal aspect of the tube 101, where the double-handed helix 1709 is cut. The distal segment 105 is coupled to the connection point 104 of the helices 102, 103 of the double-handed helix 1709 via coupling means 106. Coupling means 106 include, but are not limited to, one or more of: 1) adhesive (such as cyanoacrylate), 2) welding, 3) brazing, 4) soldering, and 5) mechanical linkage. The distal segment 105 has an angled tip, which helps improve guidance of the medical device 100. Some embodiments may include optional means for counteracting the shape change of tube 101, including, but not limited to, coupling conduit 108 to the distal end of tube 101. In one embodiment, tube 101 has a distal diameter that is slightly larger than the remainder of tube 101, and thin wire 1081 runs within tube 101 adjacent to said conduit 108, such as in the annular space between tube 101 and conduit 108. When tension is applied to conduit 108 with thin wire 1081 in place, the tension in thin wire 1081 counteracts the linear displacement of double-handed helix 1709.

[0090] 17B shows a longitudinal cross-sectional view of the distal aspect of the embodiment of FIG. 17A when a change in local environment 107 is imposed on the environment around double-chiral helix 1709 locally proximal to double-chiral helix 1709. An exemplary change in local environment may be a local change in temperature, which may cause a portion of medical device 100 to change shape due to thermal expansion or contraction. The change in local environment may include one or more of a change in temperature, pH, magnetic field strength, ion concentration, and light. The change in local environment 107 may result in a shape change of proximal helix 103 and distal helix 102 and may result in a linear displacement of double-chiral helix 1709. The change in local environment 107 may result in a shape change of proximal helix 103 and distal helix 102 and may result in a linear displacement of double-chiral helix 1709. The connection point 104 with the distal segment 102 rotates, which in turn rotates the distal segment 105. The angle of rotation of the distal segment 105 is proportional to the linear displacement of the double chiral helix 1709 of the tube 101. For purposes of illustration, a 180 degree rotation is shown. In some embodiments, the distal helix 102 and the proximal helix 103 may be comprised of a shape memory alloy (such as, but not limited to, Nitinol) or a shape memory polymer (such as, but not limited to, a block copolymer of polyethylene terephthalate (PET) and polyethylene oxide (PEO)).

[0091] In some embodiments, a thin wire 1081 may be used to constrain longitudinal movement of connection point 104. Thus, by releasing tension on wire 1081, a user may allow connection point 104 to extend longitudinally in a controlled manner.

[0092] FIG. 18 illustrates another embodiment of an apparatus including a medical device 120. In this embodiment, a double chiral helix 1937 (see FIG. 19A) is cut into the distal aspect of the tube 121, providing another means for linear tube displacement, including a dual helical symmetry helical cut. The tube 212 can be formed from one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel braid, coiled wire, and hollow, helical, stranded tube. The proximal end of the medical device 120 is connected to a power source 129, such as a battery, and energy can be transmitted along the device via a conductive element, such as a thin wire. A distal segment 125 is coupled to the distal aspect of the tube 121. The linear displacement means includes, but is not limited to, the repulsion or attraction of an electric or magnetic field between an element capable of emitting a permanent or inductive magnetic field at or coupled to the distal end of double handed helix 1937 and an element capable of emitting a permanent or inductive magnetic field proximal to, but not in direct contact with, the distal end of double handed helix 1937. Examples of these elements include, but are not limited to, rare earth magnets, coiled wires capable of passing electric current, electrets, and flat plate capacitors. Examples of methods for applying opposing electric or magnetic fields along or proximal to the region of the double chiral helix 1937 include, but are not limited to, 1) applying a permanent electric or magnetic charge to one end of the double chiral helix 1937 and applying a variable, inductive electric or magnetic charge to the opposite end of the double chiral helix 1937; 2) applying an inductive electric or magnetic charge to one end of the double chiral helix 1937 and applying a variable, inductive electric or magnetic charge to the opposite end of the double chiral helix 1937; and 3) applying an electric or magnetic charge to one end of the double chiral helix 1937 and applying an electric or magnetic charge to a portion of the guidewire 119 proximal to the double chiral helix 1937.

[0093] 19A shows a longitudinal cross-sectional view of a distal embodiment of a medical device 110 suitable for use as an alternative to the distal embodiment of the medical device 120 of FIG. 18 , with the device in an unactivated state. The distal embodiment of the medical device 110 is shown with a tube 111 having a distal end and a proximal end, and a double chiral helix 1937 cut into the distal embodiment of the tube 111 to form a proximal helix 113 and a distal helix 112, a distal magnetic element 117, a proximal magnetic element 118, and a distal segment 115 connected to a connection point 114 between the two helices 112, 113 of the double chiral helix 1937. Each of the magnetic elements 117, 118 may be biocompatible. Exemplary magnetic elements 117, 118 may include rare earth magnets and coil electromagnets. The type of electromagnets used for magnetic elements 117 and 118 may be the same or different. Magnetic elements 117, 118 are arranged such that the attractive / repulsive forces between magnetic elements 117 and 118 form a double chiral helix when energized. The magnetic force of magnetic elements 117, 118 is selected to be sufficient to overcome the spring force of double-handed helix 1937. Magnetic elements 117, 118 can be connected to tube 111 near either end of double-handed helix 1937 such that the magnetic force between magnetic elements 117, 118, when energized, longitudinally extends or shortens double-handed helix 1937 (attractive or repulsive magnetic force), depending on the configuration of magnetic elements 117, 118. In this manner, energizing one or both of magnetic elements 117, 118 extends or shortens double-handed helix 1937, thereby applying a rotational force to distal segment 115 without rotating guidewire 119. Exemplary magnetic elements 117, 118 can include permanent magnets (such as rare earth magnets) and electromagnets. In some embodiments, one of magnetic elements 117, 118 can be a ferromagnetic material that responds to magnetic fields but is not itself magnetic. Proximal helix 113 and distal helix 112 are formed such that the proximal and distal helices 113 and 112 are oppositely oriented. For example, if proximal helix 113 is left-handed, distal helix 112 can be right-handed, or vice versa. By its nature, connection point 114 between the left-handed and right-handed helices rotates as the end of double-handed helix 1937 is linearly extended or retracted, resulting in translating linear movement of connection point 114 of the two helices into rotational movement. Distal segment 115 is disposed around the circumference of the distal aspect of tube 111, where double-handed helix 1937 is truncated. Distal segment 115 is coupled to connection point 114 of helices 112, 113 of double-handed helix 1937 via coupling means 116. The attachment means 116 may include one or more of: 1) adhesives (such as cyanoacrylate), 2) welding, 3) brazing, 4) soldering, and 5) mechanical linkages. The distal segment 115 has an angled tip to help improve guidance of the medical device 110.

[0094] 19B is a longitudinal cross-sectional view of the distal embodiment of medical device 110 from FIG. 19A when the magnetic field of at least one of distal magnetic element 117 and proximal magnetic element 118 is changed. This magnetic field change causes a linear displacement of double-handed helix 1937. This in turn rotates connection point 114 of proximal helix 113 and distal helix 112, which in turn rotates distal segment 115. The angle of rotation is proportional to the linear displacement of double-handed helix 1937 of tube 111. For purposes of illustration, a 180-degree rotation is shown.

[0095] In some embodiments, a single helix 203 (see, e.g., FIGS. 23-25) can be used as a substitute for the double chiral helix 1937 of medical device 110, such that magnetic elements 117, 118 can be disposed on or within tube 111 contacting both sides of single helix 203 to effect lengthening or shortening of single helix 203 in order to rotationally translate distal segment 115 and / or the distal end of tube 111. Similarly, this rotational translation can be imparted to the distal end of tube 201 of FIGS. 25A and 25B when magnetic elements 117, 118 are disposed within device 200 in positions substantially the same or identical to those in FIGS. 19A and 19B.

[0096] 20A is a longitudinal cross-sectional view of a distal aspect of an embodiment of medical device 120, with medical device 120 in its unactuated state. The distal aspect of medical device 120 is shown with tube 121 having a distal end and a proximal end (a double chiral helix 2037 has been cut into the distal aspect of tube 121 to form proximal helix 123 and distal helix 122), tube magnetic element 127, guidewire magnetic element 128, and distal segment 125 coupled to connection point 124 of two helices 122, 123 of double chiral helix 2037. Proximal helix 123 and distal helix 122 are connected to each other by a magnetic element 127, a magnetic element 128, and a magnetic element 128. Helix 122 is formed such that the helices 122 and 123 are oppositely oriented. For example, if proximal helix 123 is left-handed, distal helix 122 can be right-handed, or vice versa. By its nature, connection point 124 between the left-handed and right-handed helices rotates as the ends of double-handed helix 2037 are linearly extended or retracted, resulting in translating linear movement of connection point 124 of the two helices into rotational movement. Distal segment 125 is disposed around the circumference of the distal aspect of tube 121, where double-handed helix 2037 is truncated. Distal segment 125 is coupled to connection point 124 of helices 122, 123 of double-handed helix 2037 via coupling means 126. Distal segment 125 may have an angled tip, thereby helping to improve guidance of medical device 120. The magnetic elements 127, 128 may include one or more of permanent magnets and electromagnets. In some embodiments, one or both of the magnetic elements 127, 128 may be rare earth magnets. The magnetic element 127 of the tube may include the same or a different magnetic element as the magnetic element 128 of the guidewire. The magnetic elements 127, 128 may be configured to exert an attractive or repulsive force between each other to linearly displace the double-handed helix 2037.

[0097] 20B illustrates that a linear displacement of the double-handed helix 2037 occurs when 1) a change in the magnetic field of the tube magnetic element 127 or the guidewire magnetic element 128 occurs, or 2) a change in the distance between the tube magnetic element 127 and the guidewire magnetic element 128 occurs. The linear displacement rotates the connection point 124 of the proximal helix 123 and the distal helix 122, which in turn rotates the distal segment 125. The angle of rotation is proportional to the linear displacement of the double-handed helix 2037 of the tube 121. For purposes of illustration, a 180-degree rotation is shown.

[0098] 21A is a longitudinal cross-sectional view of the distal aspect of another embodiment of the device in its unactuated state. The distal aspect of the device is shown with a tube 130 having a distal end and a proximal end, and a double chiral helix 138 cut into the distal aspect of the tube 130 to form a proximal helix 132 and a distal helix 131, as well as a guidewire 137 located within the lumen of the tube 130. The tube 130 can be formed from one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel braid, coiled wire, and hollow, helical, stranded tube. The proximal and distal helices 132, 131 are formed so that the proximal and distal helices 132, 131 are oppositely oriented. For example, if proximal helix 132 is left-handed, distal helix 131 can be right-handed, or vice versa. By its nature, connection point 133 between left-handed helix 131 and right-handed helix 132 rotates as the end of double-handed helix 138 is linearly extended or retracted, resulting in translating linear movement of connection point 133 of the two helices into rotational movement. Tube 130 has a reduced inner diameter 136 along its distal aspect. The distal aspect of guidewire 137 is reduced in diameter. The inner diameter of the distal end of tube 130 is larger than the diameter of the distal aspect of guidewire 137, but smaller than the unreduced diameter of guidewire 137. Guidewire 137 may include one or more grooves 135 located along the longitudinal axis of guidewire 137. Engagement means 134 for engaging guidewire 137, such as teeth 134, are disposed between guidewire 137 and tube 130 at connection point 133 of double antipodal helix 138. Teeth 134 slidably engage one or more of grooves 135 along the distal aspect of guidewire 137. FIG. 21B shows a minor axis cross section through line B-B' of FIG. 21A, passing through the tube at connection point 133.A tooth 134 is shown protruding from the tube 130 at the connection point 133 and mating with one of the grooves 135 in the guidewire 137. FIG. 21C shows the tube. 21A shows a short-axis cross section through line C-C' in FIG. 21A, passing through proximal helix 132 of tube 130. Advancement of guidewire 137 into tube 130 leads to linear displacement of double-handed helix 138. This in turn rotates connection point 133 and teeth 134, which in turn rotates the distal aspect of guidewire 137, as shown in FIGS. 22A and 22B.

[0099] Figure 22A shows a longitudinal cross section through line A-A' of Figure 21B when double-handed helix 138 is displaced. Figure 22B shows a longitudinal cross section through line B-B' of Figure 21B when double-handed helix 138 is displaced. The angle of rotation is proportional to the displacement of double-handed helix 138 of tube 130.

[0100] FIG. 23a illustrates a medical device 200 according to another embodiment of the present application. As shown, device 200 can include a tube 201, a longitudinal displacer, such as a sleeve 202, and a handle 270 attached to the proximal end of tube 201. In some embodiments, a helical or spiral cut 203 is present in the distal aspect of tube 201, and helical or spiral cut 203 has a cut width 208 and a helical angle 209. The end of tube 201 distal to helical cut 203 can include a curvature to aid in guiding medical device 200 through the vasculature. Cut width 208 can range from 0.1 micrometers to 30 millimeters. In some embodiments, cut width can range from about 0.1 millimeters to about 10 millimeters. The helical angle can range from 10 degrees to 80 degrees relative to the longitudinal axis of tube 201. In some embodiments, the helical angle ranges from 15 degrees to 75 degrees. Sleeve 202 is disposed within the lumen of tube 201. Tube 201 may have a reduced inner diameter at its distal end to form a shelf 204 that prevents forward movement of sleeve 202. In some embodiments, sleeve 202 may abut shelf 204 to transfer longitudinal force from sleeve 202 to tube 201. In some embodiments, sleeve 202 may be coupled to tube 201 at a point distal to helical or spiral cut 203, such as shelf 204, and may be advanced or retracted within tube 201, where advancement or retraction of sleeve 202 results in advancement or retraction of tube 201 distal to helical or spiral cut 203. In some embodiments, the coupling means may be reversible, such as a solder connection that can be melted by application of electrical current or heat to release sleeve 202 from tube 201. Means for joining sleeve 202 and tube 201 include, but are not limited to, one or more of: 1) friction fit, 2) adhesive (such as cyanoacrylate), 3) welding, 4) brazing, 5) soldering, and 6) mechanical linkage.As shown in FIG. 23f, device 200 also includes a handle 270 comprised of a proximal component 271 and a distal component 272 and attached to the proximal end of tube 201. Proximal component 271 and distal component 272 each have a cylindrical body such that proximal component 271 can be inserted into distal component 272 and sleeve 202 can be inserted into proximal component 271. Proximal component 271 is reversibly coupled to sleeve 202, and distal component 272 is reversibly coupled to tube 201. Each of tube 201 and sleeve 202 can be formed from one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nitinol, stainless steel braid, coiled wire, and hollow helical stranded tube. The lumen of tube 201 and the outer surface of sleeve 202 preferentially have a low coefficient of friction, including PTFE or a hydrophilic coating. Additionally, the distal aspect of tube 201 may have, but is not limited to, a straight, angled, and reverse curved shape. Figure 23c is an axial cross-sectional view through line C-C' of Figure 23a. Figure 23d is an axial cross-sectional view of Figure 23. Figure 23b is an axial cross-section through line DD' in Figure 23a. Figure 23e is an axial cross-section through line EE' in Figure 23a.

[0101] Figure 24a shows device 200 in its unactuated state (not longitudinally displaced) at the distal end of tube 201. Figure 24b shows device 200 after advancement of sleeve 202 has caused a longitudinal displacement of the distal end of tube 201, resulting in the distal end of tube 201 rotating 90 degrees relative to the position of the distal end of tube 201 in Figure 24A. Figure 24c shows device 200 after advancement of sleeve 202 has caused a further longitudinal displacement of the distal end of tube 201, resulting in the distal end of tube 201 rotating 180 degrees relative to the position of the distal end of tube 201 in Figure 24A. Figure 24d shows device 200 such that advancement of sleeve 202 results in further longitudinal displacement of the distal end of tube 201, thereby rotating the distal end of tube 201 270 degrees relative to the distal position of tube 201 in Figure 24A.

[0102] Figure 25a shows device 200 in its unactuated state (no longitudinal displacement) at the distal end of tube 201. Figure 25b shows device 200 with retraction of sleeve 202 resulting in a longitudinal displacement of the distal end of tube 201, which has resulted in the distal end of tube 201 being rotated -90 degrees.

[0103] Figure 26A is a longitudinal cross-sectional view of a chronic total occlusion crossing device embodiment 170 of distal segment 171, here distal segment 171 and lumen 173. In one embodiment, distal segment 171 has a chamfered tip 172. Figure 26B is a short axis view through line B-B' of Figure 26A.

[0104] Figure 27A is a longitudinal cross-sectional view of a distal segment endoscope embodiment 180, with a camera 181 and light source 182 located at the distal end. There is a conduit 184 for the camera (fiber optic or wire) to transmit information to the proximal end of the device, and a conduit for a light source 185 (fiber optic or wire) to transmit energy (such as light or electrical current) to light source 182. Additionally, this embodiment 180 can have a working channel for the passage of instruments or for the delivery or aspiration of fluids. Figure 27B is a short-axis view through line B-B' of Figure 27A.

[0105] FIG. 28 is a longitudinal cross-sectional view of an embodiment 190 of an endoscopic instrument, showing a hollow portion 191, a solid portion 192, and a grasper 196.

[0106] FIG. 29 is a longitudinal cross-sectional view of an embodiment 190 of an endoscopic instrument, showing a hollow portion 191, a solid portion 192, and a cautery element 197.

[0107] FIG. 30a shows a longitudinal cross-section of the distal end of device 3000, with device 3000 in its unactuated state (not longitudinally displaced). Device 3000 includes a tube 3001 and a longitudinal displacer, such as sleeve 3002. A helical or spiral cut 3003 is present on the distal aspect of tube 3001. Sleeve 3002 is disposed within the lumen of tube 3001. Sleeve 3002 is coupled to tube 3001 distal to helical or spiral cut 3003, such that sleeve 3002 can be advanced or retracted within tube 3001. Here, advancement or retraction of sleeve 3002 results in advancement or retraction of tube 3001 distal to helical or spiral cut 3003. The aforementioned Advancement or retraction of the sleeve 3002 rotates the tube 3001 distal to the helical or spiral cut 3003, where the amount of rotation is proportional to the amount of advancement or retraction of the tube 3001. Means for coupling the sleeve 3002 and the tube 3001 include, but are not limited to, one or more of: 1) a friction fit; 2) an adhesive (such as cyanoacrylate); 3) welding; 4) brazing; 5) soldering; 6) a mechanical link; and 7) a direct link via a member capable of undergoing electrolysis, such as that taught by Guglielmi in U.S. Pat. No. 5,122,136 (incorporated herein by reference in its entirety), or other suitable means as would be understood by one of ordinary skill in the art. Additionally, the tube 3001 may have a reduced inner diameter of the lumen distal to the helical or spiral cut 3003, forming a shelf 3007. The outer diameter of sleeve 3002 is larger than the inner diameter of shelf 3007 of tube 3001, and the outer diameter of sleeve 3002 is smaller than the inner diameter of tube 3001 near shelf 3007. Sleeve 3002 slidably contacts shelf 3007 of tube 3001. FIG. 30b shows device 3000 after advancement of sleeve 3002 has caused the distal end of tube 3001 to be longitudinally displaced, thereby causing the distal end of tube 3001 to rotate 180 degrees relative to the position of the distal end of tube 3001 in FIG. 30a. While a 180-degree rotation is shown, this angle is for illustrative purposes only, as the amount of rotation can be adjusted to be less than or greater than 180 degrees by adjusting the linear displacement. FIG. 30c shows device 3000. In this illustration, sleeve 3002 has been removed and liner 3009 has been coaxially inserted within tubing 3001. The ability to remove and / or replace sleeve 3002 allows a user to modify device properties such as pushability, trackability, or to increase the lumen diameter. For example, replacing sleeve 3002 (e.g., a coiled wire) with a thin-walled liner 3009 (e.g., a thin-walled polyimide tubing) creates a larger lumen diameter through which a therapeutic agent such as an embolic material (e.g., coils, particles, liquid embolic material) can be delivered.Alternatively, if improved pushability or trackability is desired, a coiled wire or braided tube can be employed. As shown in Figures 30a and 30b, sleeve 3002 is constructed of coiled wire such that the distal aspect of the coiled wire has a reduced outer diameter that is less than the inner diameter of shelf 3007. This provides a tapered or smooth transition between guidewire 3010 and the distal tip of tube 3001. The outer diameter of sleeve 3002 proximal to shelf 3007 is greater than the inner diameter of shelf 3007.

[0108] FIG. 31a shows a longitudinal cross-section of the distal end of device 3100, with device 3100 in its unactuated state (not longitudinally displaced). Device 3100 includes a tube 3101 and a longitudinal displacer, such as sleeve 3102. A helical or spiral cut 3103 is present on the distal aspect of tube 3101. Sleeve 3102 is disposed within the lumen of tube 3101. Guidewire 3104 is disposed within the lumen of sleeve 3102. Sleeve 3102 has a radially expanded portion 3110 such that radially expanded portion 3110 abuts tube 3101 distal to helical or spiral cut 3103. Radially expanded portion 3110 can be constructed of a Marcot-type tube or braided material or other suitable readily expandable material, as will be understood by those skilled in the art. The sleeve 3102 can be advanced or retracted within the tube 3101, where advancement or retraction of the sleeve 3102 results in advancement or retraction of the tube 3101 distal to the helical or spiral cut 3103. Said advancement or retraction of the tube 3101 causes rotation of the tube 3101 distal to the helical or spiral cut 3103, where the amount of rotation is proportional to the amount of advancement or retraction of the tube 3101. FIG. 31b shows how advancement of the sleeve 3102 longitudinally displaces the distal end of the tube 3101, thereby moving the distal end of the tube 3101 in a direction substantially parallel to the direction of the tube 3101 in FIG. 31a. 31c shows the device 3100 in a collapsed state, resulting in a 180 degree rotation relative to the position of the distal end of the sleeve 3102. However, it is anticipated that the device 3100 can be used to adjust the amount of rotation to be greater or less than 180 degrees by adjusting the longitudinal displacement. FIG. 31c shows the radially expanded portion 3110 in a collapsed state, with the straightening element 3111 advanced within the lumen of the sleeve 3102, creating tension in the radially expanded portion 3110 and thus collapsing the radially expanded portion 3110.

[0109] FIG. 32a shows a longitudinal cross-section of the distal end of device 3200, with device 3200 in its unactuated state (not longitudinally displaced). Device 3200 includes a tube 3201 and a longitudinal displacer, such as sleeve 3202. A helical or spiral cut 3203 is present on the distal aspect of tube 3201. Sleeve 3202 is disposed within the lumen of tube 3201. A guidewire 3210 is disposed within the lumen of sleeve 3202. Sleeve 3202 is coupled to tube 3201 distal to helical or spiral cut 3203 and can be advanced or retracted within tube 3201. Here, advancement or retraction of sleeve 3202 results in advancement or retraction of tube 3201 distal to helical or spiral cut 3203. Said advancement or retraction of the tube 3201 rotates the tube 3201 distal to the helical or spiral cut 3203, where the amount of rotation is proportional to the amount of advancement or retraction of the tube 3201. The means 3209 for coupling the sleeve 3202 and the tube 3201 include, but are not limited to, one or more of: 1) a friction fit; 2) an adhesive (such as cyanoacrylate); 3) welding; 4) brazing; 5) soldering; 6) a mechanical link; and 7) a direct link via a member capable of undergoing electrolysis, or other suitable means as would be understood by one of ordinary skill in the art. Figure 32b illustrates the device 3200 in which advancement of the sleeve 3202 longitudinally displaces the distal end of the tube 3201, thereby resulting in a 180 degree rotation of the distal end of the tube 3201 relative to the position of the distal end of the tube 3201 in Figure 32a. However, this angle of rotation may be adjusted to be greater or less than 180 degrees by adjusting the linear displacement. Figure 32c shows device 3200 where bond 3209 has been removed, thereby allowing for removal of sleeve 3202. The ability to remove and / or replace sleeve 3202 allows the user to change device properties such as pushability, trackability, or to increase lumen diameter.

[0110] FIG. 33A schematically illustrates a medical device 4010 according to another embodiment of the present disclosure. As illustrated, the device 4010 includes a tube 4011, an outer sheath 4015, a sleeve 4012, and a handle assembly 4020. In the illustrated configuration, the sleeve 4012 is disposed within the lumen of the tube 4011. In the illustrated embodiment, the tube 4011 is disposed within the lumen of the outer sheath 4015. The tube 4011, outer sheath 4015, and sleeve 4012 can each comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, and hollow helical braided tubing. Additionally, the distal end of the tube 4011 can have, but is not limited to, a straight, angled, or reverse-curved shape. In some embodiments, the tube 4011 is located within the lumen of the outer sheath 4015, such that one or more helical or spiral cut(s) 4013 in the distal aspect of the tube 4011 are disposed within the lumen of the outer sheath 4015, while the distal end of the tube 4011 extends beyond the outer sheath 4015 (e.g., the overall length of the tube is greater than the overall length of the outer sheath, while the length from the proximal end of the tube to the most distal aspect of the cut portion of the tube is less than the overall length of the outer sheath).

[0111] FIG. 33B is a longitudinal cross-sectional view focusing on the distal aspect of device 4010. In the configuration shown, one or more helical or spiral cut(s) 4013 are present in the distal aspect of tube 4011, with the one or more helical or spiral cut(s) 4013 having a cut width and a helical angle. The end of tube 4011 distal to the one or more helical or spiral cut(s) 4013 may include a curvature to aid in guiding device 4010 through the vasculature. However, in other embodiments, the end of tube 4011 (for both the configurations shown in FIGS. 33A and 33B , as well as any other configurations or variations thereof disclosed herein) may be straight (not curved) and / or include some other feature or characteristic (e.g., tapered, flared, etc.) as desired or needed. In some embodiments, the helical or spiral cut extends through the entire wall thickness or depth of the tube 4011. However, in alternative embodiments, the cut extends only partially through the wall, as desired or necessary. Thus, the cut can be a recessed or engraved portion of the tube, with a certain amount (e.g., but less than all, e.g., 5% to 10%, 10% to 25%, 25% to 50%, 50% to 75%, 75 to 99% of the material removed or absent) removed from the adjacent portion of the wall at the first location. These characteristics or properties of the cut can be applied to any embodiment disclosed herein. Furthermore, in some embodiments, as used herein, the helical or spiral cut is configured to include an oblique orientation relative to both the longitudinal axis of the tube and a radial or lateral angle of the tube (e.g., oblique relative to an axis perpendicular to the longitudinal axis).

[0112] In some configurations, the cut width can range from 0.1 micrometers to 30 millimeters, depending on the size of the device, the material used, the desired level and rotation response, and / or one or more other factors or considerations. In some embodiments, the cut width can be in the range of about 0.1 millimeters to about 10 millimeters (e.g., 0.1 millimeters to 0.2 millimeters, 0.2 millimeters to 0.5 millimeters, 0.5 millimeters to 1 millimeter, 1 millimeter to 2 millimeters, 2 millimeters to 3 millimeters, 3 millimeters to 4 millimeters, 4 millimeters to 5 millimeters, 5 millimeters to 6 millimeters, 6 millimeters to 7 millimeters, 7 millimeters to 8 millimeters, 8 millimeters to 9 millimeters, 9 millimeters to 10 millimeters, values ​​between the aforementioned ranges, etc.), as desired or needed. The helical angle can be in the range of 10 to 80 degrees (e.g., 10 to 15 degrees, 15 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the tube 4011. In some embodiments, the helical angle can be in the range of 15 to 75 degrees. The sleeve 4012 is disposed within the lumen of the tube 4011. The tube 4011 may have a reduced inner diameter at its distal end to form a shelf 4014 that prevents or at least partially limits forward movement of the sleeve 4012. In some embodiments, the sleeve 4012 may abut against the shelf 4014 to transfer longitudinal forces from the sleeve 4012 to the tube 4011. In some embodiments, the sleeve 4012 may be coupled to the tube 4011 at a point distal to one or more helical or spiral cut(s) 4013, such as the shelf 4014, and may be advanced or retracted within the tube 4011.Here, advancement or retraction of sleeve 4012 results in advancement or retraction of tube 4011 distal to one or more helical or spiral cut(s) 4013 . In some embodiments, the coupling means may be reversible, such as a solder connection that can be melted by applying an electric current or heat to release the sleeve 4012 from the tube 4011. Means for coupling the sleeve 4012 and the tube 4011 include, but are not limited to, one or more of: 1) a friction fit, 2) an adhesive (such as cyanoacrylate), 3) welding, 4) brazing, 5) soldering, and 6) a mechanical link.

[0113] With further attention to the embodiment of FIGS. 33A and 33B , each of the tube 4011 and sleeve 4012 can be formed from one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nitinol, stainless steel, stainless steel braid, coiled wire, hollow helical stranded tubing, or any other suitable material, as desired or required. The lumen of the tube 4011 and the outer surface of the sleeve 4012 preferentially have a low coefficient of friction, including, but not limited to, PTFE or a hydrophilic coating. Furthermore, the distal aspect of the tube 4011 may have, but is not limited to, a straight, angled, and reverse-curved shape. FIG. 33C is a longitudinal cross-sectional view of the distal end of the device of FIG. 33A , in which a longitudinal force at the proximal end has rotated the distal end (e.g., by 180 degrees). Figure 33D is an axial cross-sectional view taken through line 33D-33D' in Figure 33A. Figure 33E is an axial cross-sectional view taken through line 33E-33E' in Figure 33A. Figure 33F is an axial cross-sectional view taken through line 33F-33F' in Figure 33A.

[0114] FIG. 34A shows a longitudinal cross-sectional view of a medical device 5010 according to another embodiment of the present disclosure. As shown, the device 5010 can include a tube 5011, an outer layer 5030, a sleeve 5012, and a handle assembly 5020. The handle assembly 5020 is comprised of a proximal component or portion 5021 and a distal component or portion 5022. The distal component or portion 5022 is coupled to the proximal end of the tube 5011. In the illustrated embodiment, the proximal component 5021 is coupled to the proximal end of the sleeve 5012. The proximal component 5021 and the distal component 5022 can each have a cylindrical body, allowing the proximal component 5021 to be inserted within the distal component 5022. However, in any other embodiment disclosed herein, these components can have any other cross-sectional shape (e.g., rectangular, oval, irregular, other non-circular, etc.) as desired or needed. Each of the tube 5011 and sleeve 5012 may comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, and hollow helical stranded tubing. One or more helical or spiral cut(s) 5013 are present on the distal aspect of the tube 5011. The cut width may range from 0.1 micrometers to 30 millimeters. In some embodiments, the cut width may range from about 0.1 millimeters to about 10 millimeters. The helical angle of the cut(s) 5013 may range from 10 degrees to 80 degrees relative to the longitudinal axis of the tube 5011. In some embodiments, the helical angle may range from 15 degrees to 75 degrees. Additionally, the distal end of the tube 5011 may have, but is not limited to, a straight shape, an angled shape, and a reverse curved shape.

[0115] In some embodiments, sleeve 5012 is disposed within the lumen of tube 5011. Tube 5011 may have a reduced inner diameter at its distal end to form a shelf 5014 that prevents forward movement of sleeve 5012. In some embodiments, sleeve 5012 abuts shelf 5014, applying a longitudinal force to sleeve 5012. 2 to the tube 5011. In some embodiments, the sleeve 5012 may be coupled to the tube 5011 at a point distal to one or more helical or spiral cut(s) 5013, such as at a shelf 5014, and may be advanced or retracted within the tube 5011, where advancement or retraction of the sleeve 5012 results in advancement or retraction of the tube 5011 distal to the helical or spiral cut(s) 5013. In some embodiments, the coupling means may be reversible, such as a solder connection that can be melted by application of electrical current or heat to release the sleeve 5012 from the tube 5011. Means for coupling the sleeve 5012 and tube 5011 include, but are not limited to, one or more of: 1) a friction fit, 2) an adhesive (such as cyanoacrylate), 3) welding, 4) brazing, 5) soldering, and 6) a mechanical link. Each of the tube 5011 and sleeve 5012 may comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nitinol, stainless steel, stainless steel braid, coiled wire, and hollow helical stranded tubing. The lumen of the tube 5011 and the outer surface of the sleeve 5012 preferentially have a low coefficient of friction, including a PTFE or hydrophilic coating. An outer layer 5030 is disposed around the outer surface of the tube 5011. A distal end of the outer layer 5030 is bonded to the tube 5011 distal to the one or more helical or spiral cut(s) 5013. A proximal end of the outer layer 5030 is bonded to the tube 5011 proximal to the one or more helical or spiral cut(s) 5013. The portion of the tube 5011 containing one or more helical or spiral cut(s) 5013 can move along the longitudinal axis relative to the outer layer 5030 .

[0116] In some embodiments, the outer layer 5030, or at least a portion of the outer layer, can be elongated when the portion of the tube 5011 containing one or more helical or spiral cut(s) 5013 is elongated. The outer layer 5030 can comprise one or more of a variety of materials, including, but not limited to, thin-walled PET tubing, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nitinol, stainless steel, stainless steel braid, coiled wire, and hollow helical stranded tubing. Figure 34B is an axial cross-sectional view through line 34B-34B' of Figure 34A.

[0117] 35A is a diagram of a medical device 6010 according to one embodiment of the present disclosure. The device includes a tube 6011, an outer tubular member 6020, and a handle assembly 6025. In the illustrated embodiment, the handle assembly 6025 comprises a proximal handle component 6026 and a distal handle component 6027. The proximal handle component 6026 and the distal handle component 6027 can be coaxial with one another and can slidably engage one another. As shown, the proximal handle component 6026 can be coupled to a proximal end of the tube 6012, and the distal handle component 6027 is coupled to a proximal end of the outer tubular member 6022.

[0118] FIG. 35B provides a detailed view of the distal aspect of the device 6010 of FIG. 35A. One or more helical or spiral cuts 6014 can be disposed along the distal aspect of the tube 6011, as shown in FIG. 35B. In some embodiments, the tube 6011 is disposed within the lumen 6023 of the outer tubular member. In some embodiments, the tube 6011 and the outer tubular member 6020 are each made of one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, coiled wire, and hollow helical stranded tubes. In some embodiments, the lumen 6023 of the outer tubular member and the outer surface of the tube 6011 advantageously have a low coefficient of friction, including, but not limited to, via PTFE, a hydrophilic coating, other relatively low-friction coatings or materials, and / or the like. The distal end 6013 of the tube may have, but is not limited to, a straight, angled, and reverse-curved shape to aid in guiding the device 6010 through the human body. Additionally, the distal end 6013 of the tube may have one or more malleable elements so that the distal end 6013 of the tube can be manually shaped by an operator during use.

[0119] According to some embodiments, one or more helical or spiral cut(s) 6014 are present on a distal aspect of the tube 6011. In some configurations, the one or more helical or spiral cut(s) 6014 have a cut width 6015 and a helical angle 6016. In some embodiments, the cut width 6015 can range from 0.1 micrometer degrees to 30 millimeters. In some embodiments, the cut width 6015 can range from about 0.1 millimeters to about 10 millimeters. In some configurations, the helical angle 6016 can range from 10 degrees to 80 degrees relative to the longitudinal axis of the tube 6011. In some embodiments, the helical angle 6016 can range from 15 degrees to 75 degrees. In some embodiments, the distal end of the outer tubular member 6021 is coupled to the tube 6011 distal to the one or more helical or spiral cut(s) 6014. Means for joining the distal end of the outer tubular member 6021 and the tube 6011 include, but are not limited to, one or more of: 1) friction fit, 2) adhesive (such as cyanoacrylate), 3) welding, 4) brazing, 5) soldering, and 6) mechanical linkage.

[0120] FIG. 35C focuses on a longitudinal cross-section of the distal end of the device of FIG. 35A. As discussed herein, in some embodiments, advancement of the outer tubular member 6020 relative to the tube 6011 causes displacement of the helical or spiral cut(s) and rotates the distal end (e.g., 180 degrees or some other desired angle). FIG. 35D focuses on a longitudinal cross-section of the distal end of the device of FIG. 35A when in its unactuated state (e.g., 0 degrees rotation). Additionally, FIG. 35E shows an axial cross-section through line 35E-35E' of FIG. 35D, FIG. 1F shows an axial cross-section through line 35F-35F' of FIG. 35D, and FIG. 35H shows an axial cross-section through line 35H-35H' of FIG. 35D.

[0121] FIG. 36A schematically illustrates another embodiment of a medical device 7010 configured to facilitate rotation of a distal end or portion. As shown, the device can include a tube 7011, an outer tubular member 7020, and a handle assembly 7025. FIG. 36B is a detailed view of a distal portion or aspect of the device 7010. Like other embodiments disclosed herein, the illustrated device can include one or more helical or spiral cuts 7014 disposed along the distal aspect of the tube 7011. In some embodiments, the tube 7011 is disposed within a lumen 7023 of the outer tubular member. The illustrated tube 7011 includes two or more outer diameters, such that the outer diameter at the distal end 7013 of the tube is larger than the lumen 7023 of the outer tubular member, while the outer diameter from the proximal end of the tube up to or including the helical or spiral cut 7014 is smaller than the lumen 7023 of the outer tubular member.

[0122] With continued attention to FIG. 36A , the handle assembly 7025 of the device 7010 includes a proximal handle component 7026 and a distal handle component 7027. In some embodiments, the proximal handle component 7026 and the distal handle component 7027 7011 and 7020 are coaxial with each other and slidably engage with each other. A proximal handle component 7026 can be coupled to the proximal end of the tube 7012, and a distal handle component 7027 can be coupled to the proximal end of the outer tubular member 7022. The tube 7011 and the outer tubular member 7020 can each comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, coiled wire, and hollow helical stranded tubing. In some embodiments, the lumen 7023 of the outer tubular member and the outer surface of the tube 7011 advantageously have a low coefficient of friction (e.g., through the use of PTFE, one or more hydrophilic coatings, and / or the like).

[0123] According to some configurations, the distal end of tube 7013 may have, but is not limited to (and / or need not have), a straight, angled, or reverse-curved shape to aid in guiding device 7010 through the human body. Additionally, the distal end of tube 7013 may have one or more malleable elements such that the distal end of tube 7013 can be manually shaped by an operator during use. Such shaping features may be incorporated into any of the embodiments disclosed herein. In some embodiments, one or more helical or spiral cut(s) 7014 are present in the distal aspect of tube 7011. By way of example, and not limitation, one or more helical or spiral cut(s) 7014 can have a cut width 7015 and a helical angle 7016. The cut width 7015 may range from 0.1 micrometers to 30 millimeters. In some embodiments, the cut width 7015 may range from about 0.1 millimeters to about 10 millimeters. The helical angle 7016 can range from 10 degrees to 80 degrees relative to the longitudinal axis of the tube 7011. In some embodiments, the helical angle 7016 can range from 15 degrees to 75 degrees.

[0124] In some configurations, the distal end of the tube 7013 is displaced to a larger outer diameter distal to the helical or spiral cut(s) 7014. The distal end of the outer tubular member 7021 may abut the distal end of the tube 7013 at the location of the larger diameter displacement. In some configurations, relative advancement of the outer tubular member 7020 results in the helical or spiral cut(s) 7014 extending, thus rotating the distal end of the tube 7013. In some embodiments, the distal end of the tube 7013 can rotate freely or substantially freely relative to the distal end of the outer tubular member 7021.

[0125] Figure 36C is a longitudinal cross-sectional view of the distal end of the device of Figure 36A. As discussed herein, in some embodiments, advancement of the outer tubular member 7020 relative to the tube 7011 causes displacement of the helical or spiral cut(s), thereby rotating the distal end (e.g., by 180 degrees or some other desired angle). Such rotation of the devices shown in Figures 36A-36F and / or any other device disclosed herein can facilitate advancement of an intraluminal device (e.g., a guidewire, microcatheter, catheter, sheath, endoscope, etc.) within the anatomy of the subject being treated. Additionally, Figure 36D is a longitudinal cross-sectional view focusing on the distal aspect of device 7010 while device 7010 is in an unactuated state (0 degree rotation), Figure 36E shows an axial cross-sectional view through line 36E-36E' of Figure 36D, Figure 36F shows an axial cross-sectional view through line 36F-36F' of Figure 2D, and Figure 2G shows an axial cross-sectional view through line 36G-36G' of Figure 36D.

[0126] Figure 37A illustrates an intraluminal device 8010 according to another embodiment of the present disclosure. As shown, device 8010 comprises tube 8011, core wire 8030, outer tubular member 8020, and handle assembly 8025. FIG. 37B is a detailed view of a distal aspect or portion of device 8010 of FIG. 37A. As with other embodiments disclosed herein, one or more helical or spiral cuts 8014 can be disposed along tube 8011. The proximal end of tube 8012 can be coupled to the distal end of core wire 8032. Means of coupling include, but are not limited to, one or more of: 1) friction fit; 2) adhesive (such as cyanoacrylate); 3) welding; 4) brazing; 5) soldering; and 6) mechanical linking. Core wire 30, the proximal end of tube 8012, and the portion of tube 8011 including helical or spiral cut(s) 14 can be disposed within the lumen of outer tubular member 8023. In some embodiments, the tube 8011 includes two or more outer diameters, such that the outer diameter at the distal end 13 of the tube is larger than the lumen 8023 of the outer tubular member, while the outer diameter from the proximal end of the tube 8011 up to or including the helical or spiral cut 8014 is smaller than the lumen 8023 of the outer tubular member. In some configurations, the outer diameter of the core wire 8030 is smaller than the lumen 8023 of the outer tubular member (e.g., thereby allowing the outer tubular member 8020 to slide coaxially along the core wire 8030).

[0127] 37A , the handle assembly 25 can include a proximal handle component 8026 and a distal handle component 8027. In some embodiments, the proximal handle component 8026 and the distal handle component 8027 are coaxial with and slidably engage one another. The proximal handle component 8026 can be coupled to the proximal end of the core wire 31, and the distal handle component 8027 can be coupled to the proximal end of the outer tubular member 8022. The tube 8011 and the outer tubular member 8020 can each comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, coiled wire, hollow helical stranded tube, and / or the like.

[0128] In some embodiments, the lumen 8023 of the outer tubular member and the outer surface of the tube 8011 advantageously have a low coefficient of friction (e.g., through the use of PTFE, a hydrophilic coating, and / or other materials or features with a relatively low coefficient of friction). The distal end of the tube 8013 may have, without limitation, straight, angled, and reverse-curved shapes to aid in guiding the device 8010 through the human body. Additionally, the distal end of the tube 8013 may have one or more malleable elements such that the distal end of the tube 8013 can be manually shaped by an operator during use. In some embodiments, one or more helical or spiral cut(s) 8014 are present in the distal aspect of the tube 8011. The one or more helical or spiral cut(s) 8014 can have a cut width 8015 and a helical angle 8016. The cut width 8015 can range from 0.1 micrometers to 30 millimeters. In some embodiments, the cut width 8015 can range from about 0.1 millimeters to about 10 millimeters. The helical angle 8016 can range from 10 degrees to 80 degrees relative to the longitudinal axis of the tube 8011. In some embodiments, the helical angle 8016 can range from 15 degrees to 75 degrees. In some configurations, the distal end of the tube 8013 is displaced to a larger outer diameter distal to the helical or spiral cut(s) 8014. The distal end of the outer tubular member 8021 can abut the distal end of the tube 8013 displaced to a larger diameter, where relative advancement of the outer tubular member 8020 displaces the helical or spiral cut(s). This results in extension of the outer tubular member 8021 (or multiple members) 8014, which in turn rotates the distal end of the tube 8013. In some embodiments, the distal end of the tube 8013 is configured to freely or substantially freely rotate relative to the distal end of the outer tubular member 8021.

[0129] Figure 37C is a longitudinal cross-sectional view of the distal end of the device of Figure 37A. As discussed herein, in some embodiments, advancement of the outer tubular member 8020 relative to the tube 8011 causes displacement of the helical or spiral cut(s) and rotates the distal end (e.g., 180 degrees or other desired angle). Figure 37D shows a detailed longitudinal cross-sectional view of a distal aspect of the device 8010, Figure 37E shows an axial cross-sectional view through line 37E-37E' of Figure 37D, Figure 37F shows an axial cross-sectional view through line 37F-37F' of Figure 37D, and Figure 37G shows an axial cross-sectional view through line 37G-37G' of Figure 37D.

[0130] 38A is a longitudinal cross-sectional view of another embodiment of a medical device 9040 within a lumen. As shown, the device includes a tube 9041, an inner tubular member 9047, an inflatable layer or member (e.g., a balloon, other expandable member, etc.) 50 along the outer surface of the cut portion of the tube 9041, and a handle assembly 9025. In some embodiments, the handle assembly 9025 comprises a proximal handle component 9026 and a distal handle component 9027. In some embodiments, the proximal handle component 9026 and the distal handle component 9027 are coaxial with one another and can engage with one another via multiple means, such as, but not limited to, corresponding threaded components. In some embodiments, the proximal handle component 9026 can be coupled to the proximal end of the inner tubular member 9049 via a swivel or other movable portion 9029, and the distal handle component 9027 is coupled to the proximal end of the tube 9042.

[0131] Continuing with reference to FIG. 38A , the proximal handle component 9026 includes an inflation port 9028 for injecting fluid to inflate the inflatable or expandable member 9050 (e.g., a balloon). In some embodiments, as shown, one or more helical or spiral cuts 9044 are disposed along the distal aspect of the tube 9041. An inner tubular member 9047 can be disposed within the lumen of the tube 9041. The tube 9041 and inner tubular member 9047 can comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, nickel titanium (nitinol), stainless steel, stainless steel braid, coiled wire, and hollow helical stranded tubing. In some embodiments, the lumen of the tube 9041 and the outer surface of the inner tubular member 9047 advantageously have a low coefficient of friction, for example, through the use of materials such as PTFE, hydrophilic coatings, and / or the like. In some embodiments, the distal end of the tube 9043 has, but is not limited to, a straight, angled, or reverse curved shape to aid in guiding the device 9040 through the human body. Additionally, the distal end of the tube 9043 can have one or more malleable elements so that the distal end of the tube 9043 can be manually shaped by an operator during use. In some embodiments, helical or spiral cut(s) 9044 are present in the distal aspect of the tube 9041, and the one or more helical or spiral cut(s) 9044 have a cut width and a helical angle as described. The cut width can range from 0.1 micrometers to 30 millimeters. In some embodiments, the cut width can range from about 0.1 millimeters to about 10 millimeters. The helical angle can range from 10 degrees to 80 degrees relative to the longitudinal axis of the tube 9041. In some embodiments, the helical angle can range from 15 to 75 degrees. The distal end of the inner tubular member 9048 is coupled to the tube 9041 distal to the one or more helical or spiral cut(s) 9044. Means for coupling the distal end of the inner tubular member 9048 to the tube 9041 include, but are not limited to, one or more of: 1) friction fit, 2) adhesive (such as cyanoacrylate), 3) welding, 4) brazing, 5) soldering, and 6) mechanical linkage. As shown, an expandable layer 9050 can be located along the outer surface of the cut portion of the tube 9041.

[0132] FIG. 38B is a transverse cross-sectional view of FIG. 38A taken through line 38B-38B'. The expandable layer 9050 can be inflated (e.g., by injecting fluid through inflation port 29), as shown in FIG. 38C. The injected fluid (e.g., water, saline, other liquid, gas, etc.) can travel within the space between the tube 9041 and the inner tubular member 9047. The fluid then travels through one or more helical or spiral cut(s) 9044 into the space between the cut portion of the tube 9041 and the expandable member 9050. FIG. 38D is a transverse cross-sectional view of FIG. 38C taken through line 38C-38C'. These configurations can be useful in preventing backflow and non-target embolization during delivery of embolic materials, including, but not limited to, radioembolic particles (e.g., Y-90).

[0133] FIG. 39 illustrates another embodiment of an intraluminal device 960. As with other embodiments disclosed herein, the device 960 is configured to advantageously use longitudinal movement of one member or component (e.g., relative to another member or component) to create predictable, reliable, and responsive rotation of the distal portion of the device. For example, in the illustrated configuration, the inner member or pusher 962 is sized, shaped, or otherwise configured to slidably move within the lumen of a tube or outer member 961 disposed along the outside of the pusher or inner member 962. In the illustrated configuration, the pusher or inner member 962 is configured to abut a flange or shoulder formed along the interior of the tube 961 along the distal portion of the device. As discussed herein with reference to other embodiments, advancing the pusher or inner member 962 after the distal end of the pusher contacts the shoulder on the interior of the tube rotates the distal portion of the tube or outer member 961. In some embodiments, this results from the presence, configuration, and other details of cut(s) 963 (e.g., helical or spiral cuts) located along the distal end of the tube. In the embodiment of FIG. 39 , the pusher 962 is not attached to the tube 961. As such, the pusher or inner member 962 may be partially or completely removable from the tube (and, in turn, from the remainder of the device). As shown, the device may include one or more outer layers, coatings, portions, components, and / or the like 966 along the exterior of the tube 961. Such layers or portions 966 may be secured to the tube 961 and / or other portions of the device 960 (e.g., using adhesive, a friction-fit connection, etc.).

[0134] FIG. 40 illustrates an embodiment of an intraluminal device 970 similar to the embodiment illustrated in FIG. 39 . However, in the device 970 of FIG. 40 , a pusher or inner member 972 is attached or otherwise coupled (e.g., directly or indirectly) to a tube 971 (and one or more other layers or portions of the device, e.g., an outer layer located along the outside of the device). As illustrated in FIG. 40 , in some embodiments, the pusher or inner member 972 is secured to the tube 971 along a distal end 974 of the device 970. In some embodiments, the distal end 974 of the device 970 may include a tapered tip (or other portion of reduced diameter or other cross-sectional size). This facilitates positioning the distal end 974 of the device at a desired portion of the subject's anatomy. This can aid in the implementation of various features, and such features may be incorporated into any embodiment disclosed herein even if not specifically discussed or illustrated in connection with such embodiment.

[0135] 40 , an outer layer, coating, or other exterior portion 976 can also be secured to, otherwise coupled to, or disposed on the tube 971 at one or more attachment locations. In some embodiments, such attachment location or locations 979 are located at or proximal to the distal end 974 of the device. However, the outer layer 976 and tube 971 can be secured to the device at one or more locations, continuously or intermittently (e.g., directly or indirectly (e.g., using one or more intermediate members or features)), instead of, or in addition to, the distal end 974 of the device 970, as desired or needed. As mentioned above, such outer members, coatings, or other members 976 can be incorporated into any of the embodiments disclosed herein.

[0136] In any embodiment disclosed herein, including the devices shown in FIGS. 39 and 40 , one or more components of the device can include a wire (e.g., a thin coil wire) that is wound (e.g., around a base member, around itself, etc.). For example, the pusher or inner member 962, 972 of FIG. 39 or 40 can include such a wound member, as can any other embodiment disclosed herein or its equivalent. For any embodiment disclosed herein, the pusher or inner member can be sized to provide a desired amount of clearance between the outer diameter or other cross-sectional dimension of the pusher and the inner diameter or other dimension of the tube (e.g., to allow the pusher to freely slidably move relative to the tube without binding, sticking, or other problems). Such a wound member can provide a desired amount of stiffness to the pusher and / or other components or portions of the device without buckling or encountering other problems.

[0137] Similarly, the outer or exterior layer of the device (e.g., outer layer or coating 976 of the embodiment shown in FIG. 40) can include one or more layers of wound wire, coils, or other members, alone or in combination with another coating or member (e.g., a layer of thermoplastic, a metal member, etc.). Such outer members can shield and protect the tube (e.g., a cut section of the tube), provide a smoother outer surface of the device, and / or provide additional benefits or advantages.

[0138] FIG. 41A illustrates a medical device 10000 according to another embodiment of the present application. As illustrated, the device 10000 can include a tube 10001, a longitudinal displacer, a pusher or other inner member 10002, and a handle (not shown) attached to the proximal end of the tube 10001. In the illustrated embodiment, a partial thickness helical or spiral cut 10003 is included at or along a distal portion of the tube 10001. In some embodiments, the partial thickness helical or spiral cut 10003 includes a cut width 10008 and a helical angle 10009. The cut width 10008 and / or helical angle 10009 can be the same as or similar to any embodiment disclosed herein, including, for example, but not limited to, the embodiment described and disclosed with reference to FIG. 3A.

[0139] In some embodiments, the partial thickness cut 10003 extends only partially through the wall of the tube 10001. Such partial thickness cuts 10003 may be incorporated into any of the embodiments disclosed herein. For example, In any configuration of the disclosure, without being limited to the device shown in FIG. 41A , the cut 10003 extends 10 to 90% (e.g., 10% to 15%, 15% to 20%, 20% to 25%, 25% to 30%, 30% to 35%, 35% to 40%, 40% to 45%, 45% to 50%, 50% to 55%, 55% to 60%, 60% to 65%, 65% to 70%, 70% to 75%, 75% to 80%, 80% to 85%, 85 to 90%, percentages between the aforementioned ranges, etc.) of the overall thickness of the wall of the tube 10001, as desired or required.

[0140] With continued reference to FIG. 41A , the end of the tube 10001 distal to the partial thickness helical cut 10003 can include a curvature to aid in guiding the medical device 10000 through the vasculature. For example, such a configuration can assist a user in maneuvering the device 10000 through various curves or bends to access a desired portion or location of a subject's anatomy. In some embodiments, the cut width 10008 is between 0.1 micrometers and 30 millimeters (e.g., 0.1 micrometers to 0.2 micrometers, 0.2 micrometers to 0.3 micrometers, 0.3 micrometers to 0.4 micrometers, 0.4 micrometers to 0.5 micrometers, 0.5 micrometers to 0.6 micrometers, 0.6 micrometers to 0.7 micrometers, 0.7 micrometers to 0.8 micrometers, 0.8 micrometers to 0.9 micrometers, 0.9 micrometers to 10.1 micrometers).9 micrometers to 1 micrometer, 1 micrometer to 2 micrometers, 2 micrometers to 3 micrometers, 3 micrometers to 4 micrometers, 4 micrometers to 5 micrometers, 5 micrometers to 6 micrometers, 6 micrometers to 7 micrometers, 7 micrometers to 8 micrometers, 8 micrometers to 9 micrometers, 9 micrometers to 10 micrometers, 10 micrometers to 15 micrometers, 15 micrometers to 20 micrometers, 20 micrometers to 30 micrometers, 30 micrometers to 40 micrometers, 40 micrometers to 50 micrometers, 50 micrometers to 60 micrometers, 60 micrometers to 70 micrometers, 70 micrometers to 80 micrometers, 80 micrometers to 90 micrometers, 90 micrometers to 100 micrometers, 100 micrometers to 150 micrometers, 150 micrometers In some embodiments, the cut width is 0.01 to 200 micrometers, 200 micrometers to 250 micrometers, 250 micrometers to 300 micrometers, 300 micrometers to 400 micrometers, 400 micrometers to 500 micrometers, 500 micrometers to 600 micrometers, 600 micrometers to 700 micrometers, 700 micrometers to 800 micrometers, 800 micrometers to 900 micrometers, 900 micrometers to 1 millimeter, 1 millimeter to 2 millimeters, 2 millimeters to 3 millimeters, 3 millimeters to 4 millimeters, 4 millimeters to 5 millimeters, 5 millimeters to 6 millimeters, 6 millimeters to 7 millimeters, 7 millimeters to 8 millimeters, 8 millimeters to 9 millimeters, 9 millimeters to 10 millimeters, 10 millimeters to 15 millimeters, 15 millimeters to 20 millimeters, 20 millimeters to 25 millimeters, 25 millimeters to 30 millimeters, widths between the aforementioned values, etc. In some embodiments, the cut width is 0.01 to 200 micrometers, ...In other configurations, the cut width is less than 0.1 micrometers or greater than 30 millimeters (e.g., 30 to 40 millimeters, 40 to 50 millimeters, 50 to 100 millimeters, values ​​between the aforementioned values, or greater than 100 millimeters), as desired or required for a particular application or use.

[0141] In some embodiments, including the configuration shown in FIG. 41A and any other configurations disclosed herein or their equivalents, the helical angle 10009 of the cut can be in the range of 10 degrees to 80 degrees (e.g., 10 degrees to 15 degrees, 1 degree to 20 degrees, 20 degrees to 25 degrees, 25 degrees to 30 degrees, 30 degrees to 35 degrees, 35 degrees to 40 degrees, 40 degrees to 45 degrees, 45 degrees to 50 degrees, 50 degrees to 55 degrees, 55 degrees to 60 degrees, 60 degrees to 65 degrees, 65 degrees to 70 degrees, 70 degrees to 75 degrees, 75 degrees to 80 degrees, between angles in the aforementioned ranges, etc.) relative to the longitudinal axis of the tube 10001. In some embodiments, the helical angle 10009 is in the range of 15 degrees to 75 degrees (e.g., 20 degrees to 70 degrees, 30 degrees to 60 degrees, 15 degrees to 30 degrees, 25 degrees to 40 degrees, 40 degrees to 60 degrees, 60 degrees to 75 degrees, etc.).

[0142] According to some embodiments, as with other configurations disclosed herein, the sleeve 10002 is disposed within the lumen of the tube 10001. In some configurations, the tube 10001 has a smaller diameter (e.g., inner diameter) at or along the distal end to form a shelf 10004 that prevents the sleeve 10002 from moving forward relative to the tube 10001. However, any other configuration that prevents forward movement of the sleeve relative to the tube can be used. For example, the sleeve and tube can be joined (e.g., directly or indirectly via one or more attachment methods or devices) along the distal end using, for example, but not limited to, adhesives, welding or other welding procedures, brazing, soldering, other heat-based methods or techniques, mechanical links, and / or the like. Alternatively, the sleeve 10002 and the tube 10001 can have one or more elements that interact with an electromagnetic field, which can be one of a magnet, a ferromagnetic material, an electret, a material capable of holding an electric charge, a wire, and a coil configured to pass an electric current and generate a magnetic field. In some embodiments, the sleeve 10002 abuts the shelf 10004 to transfer a longitudinal force from the sleeve 10002 to the tube 10001. In some embodiments, the sleeve 10002 can be coupled to the tube 10001 at a point distal to the helical or spiral cut 10003 (e.g., a partial thickness cut), such as the shelf 10004, and can be selectively advanced and / or retracted within the tube 10001. As described herein, in some embodiments, such advancement and retraction of the sleeve 10002 advances or retracts the tube 10001 relative to the sleeve distal to the partial thickness helical or spiral cut 10003.

[0143] In some embodiments, the coupling means or mechanism between the sleeve 10002 and the tube 10001 is reversible. For example, a solder connection can be melted or severed by applying an electric current or heat to release the sleeve 10002 from the tube 10001. Means for coupling the sleeve 10002 and the tube 10001 include, but are not limited to, one or more of a friction fit, an adhesive (e.g., an acrylic-based adhesive (e.g., cyanoacrylate), epoxy, silicone, thermoset, polyurethane, other suitable adhesives, etc.), welding, brazing, soldering, a mechanical link or coupling, and / or the like.

[0144] According to some configurations, the tube, 10001 and / or sleeve 10002 may comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, other polymers, nitinol, stainless steel braid, coiled wire, hollow helical stranded tubing, other metals and / or alloys, and / or any other natural or synthetic material, as desired or required.

[0145] In some embodiments, the partial thickness cut 10003 is elastic and can be extended. and / or shortened. In some configurations, the partial thickness cut 10003 is preferentially extended in light of its relatively reduced thickness compared to the remainder of the tube 10001. The lumen of the tube 10001 and the outer surface of the sleeve 10002 preferentially have a low coefficient of friction. For example, in some embodiments, surfaces and / or components that contact each other may include a relatively low-friction material, coating, layer, etc., such as, for example, PTFE, hydrophilic materials, other polymeric materials, etc. Additionally, the distal aspect of the tube 10001 may have, without limitation, a straight shape, an angled shape, and a reverse curved shape.

[0146] FIG. 42A schematically illustrates a medical device 14010 according to another embodiment of the present application. In some embodiments, as illustrated, the device 14010 includes a tube 14011, an outer sheath 14015, and a handle assembly 14020. As shown in FIG. 42A, the handle assembly 14020 can include a proximal component or portion 14021 and a distal component or portion 14022. In some embodiments, the distal component or portion 14022 is coupled to the proximal end of the tube 14011, and the proximal component or portion 14021 is coupled to the proximal end of the tube 14011. The distal component 14022 can be coupled to the proximal end of the outer sheath 14015.

[0147] 42A , the proximal component or portion 14021 and the distal component or portion 14022 each have a cylindrical body, thereby allowing the proximal component or portion 14021 to be otherwise inserted (e.g., slidably) into or relative to the distal component or portion 14022. To this end, the cross-sectional shapes of the components 14021, 14022 may be circular or rounded. However, in other embodiments, the proximal and distal components may include any other cross-sectional shapes as desired or needed (e.g., square or rectangular, other polygonal, oval, irregular, etc.). Regardless of their distinct shapes, sizes, and other characteristics, the proximal component or portion 14021 and the distal component or portion 14022 may be slidable or otherwise movable relative to one another.

[0148] In the illustrated embodiment, the tube 14011 is disposed within the lumen of the outer sheath 14015. The tube 14011 and the outer sheath 14015 can each comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, other polymers, nickel titanium (nitinol), stainless steel, stainless steel braid, hollow helical braided tubing, other metals or alloys, other synthetic or natural materials, and / or the like, as desired or required. The tube 14011 can be disposed within the lumen of the outer sheath 14015 such that one or more helical or spiral cut(s) 14013 of a distal aspect or portion of the tube 14011 are disposed within the lumen of the outer sheath 14015, while the distal end of the tube 14011 extends beyond (e.g., distally beyond) the outer sheath 14015. Thus, in some embodiments, the overall length of the tube 14011 is greater than the overall length of the outer sheath 14015, while the length from the proximal end of the tube to the most distal aspect of the cut portion of the tube is less than the overall length of the outer sheath.

[0149] Additionally, in any of the embodiments disclosed herein, the pull wire 14016 can be coupled or otherwise secured to the tube 14011, for example, as shown in FIGS. 42B-42E. In the illustrated configuration, the pull wire 14016 is coupled distally to one or more helical or spiral cut(s) 14013. However, in other embodiments, the pull wire can be coupled to any other portion of the tube 14011 and / or or any other position. In still other embodiments, any other feature or method can be used to assist in folding or other manipulation of the device. For example, the use of shape memory materials, e.g., as discussed herein with reference to Figures 43A-43E, can be used, and / or any other method, device, feature, and / or technique can be used, as desired or needed.

[0150] FIG. 42B is a longitudinal cross-sectional view of the distal end of the device 14010 of FIG. 42A. In the configuration shown, no tension is applied to the distal end of the tube 14011 via the pull wire 14016, causing the distal aspect of the tube 14011 to be in a straight position (e.g., 0 degrees tip deflection relative to the longitudinal axis of the device). As shown and described herein in other embodiments, the tube 14011 includes one or more cuts 14013 (e.g., helical or spiral cuts) in or along the distal aspect or portion of the tube. In some configurations, the helical or spiral cut(s) 14013 have a cut width and a helical angle. Thus, the end of the tube 14011 distal to the one or more helical or spiral cuts 14013 may include a curvature to aid in guiding the device 14010 through the vasculature. For example, such a configuration can assist a user in maneuvering the device 14010 through various curves or bends to access a desired portion or location of a subject's anatomy.

[0151] In some embodiments, the cut width is between 0.1 micrometers and 30 millimeters (e.g., 0.1 micrometers to 0.2 micrometers, 0.2 micrometers to 0.3 micrometers, 0.3 micrometers to 0.4 micrometers, 0.4 micrometers to 0.5 micrometers, 0.5 micrometers to 0.6 micrometers, 0.6 micrometers to 0.7 micrometers, 0.7 micrometers to 0.8 micrometers, 0.8 micrometers to 0.9 micrometers, 0.9 micrometers to 1 micrometer, 1 micrometer to 2 micrometers, 2 micrometers to 3 micrometers, 3 micrometers to 4 micrometers, 4 micrometers to 5 micrometers, 5 micrometers to 6 micrometers, 6 micrometers to 7 micrometers, 7 micrometers to 8 micrometers, 8 micrometers to 9 micrometers, 9 micrometers to 10 micrometers, 10 micrometers to 15 micrometers, 15 micrometers to 20 micrometers, 20 micrometers to 30 micrometers, 30 micrometers to 40 micrometers, 40 micrometers to 50 micrometers, 50 micrometers to 60 micrometers, 60 micrometers to 70 micrometers, 70 micrometers to 80 micrometers, 80 micrometers to 90 micrometers, 90 micrometers to 100 micrometers, 100 micrometers or et 150 micrometers, 150 micrometers to 200 micrometers, 200 micrometers to 250 micrometers, 250 micrometers to 300 micrometers, 300 micrometers to 400 micrometers, 400 micrometers to 500 micrometers, 500 micrometers to 600 micrometers, 600 micrometers to 700 micrometers, 700 micrometers to 800 micrometers, 800 micrometers to 900 micrometers, 900 micrometers to 1 millimeter, 1 millimeter to 2 millimeters, 2 millimeters to 3 millimeters, 3 millimeters to 4 millimeters, 4 millimeters to 5 millimeters, 5 millimeters to 6 millimeters, 6 millimeters to 7 millimeters, 7 millimeters to 8 millimeters, 8 millimeters to 9 millimeters, 9 millimeters to 10 millimeters, 10 millimeters to 15 millimeters, 15 millimeters to 20 millimeters, 20. In some embodiments, the cut width ranges from 0.1 micrometers to 25 millimeters, 25 millimeters to 30 millimeters, widths between the aforementioned values, etc. In some embodiments, the cut width ranges from 0.1 millimeters to 10 millimeters (e.g., 0.5-5 millimeters). In other configurations, the cut width is less than 0.1 micrometers or greater than 30 millimeters (e.g., 30 millimeters to 40 millimeters, 40 millimeters to 50 millimeters, 50 millimeters to 100 millimeters, values ​​between the aforementioned values, values ​​greater than 100 millimeters), as desired or required for a particular application or use.

[0152] 42A-42E , as well as any other configurations disclosed herein or their equivalents, the helical angle of the cut can be in the range of 10 to 80 degrees (e.g., 10 to 15 degrees, 1 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, between angles in the aforementioned ranges, etc.) relative to the longitudinal axis of the tube 14011. In some embodiments, the helical angle is in the range of 15 to 75 degrees (e.g., 20 to 70 degrees, 30 to 60 degrees, etc.).

[0153] 42A-42E , the surfaces adjacent to or in contact with the lumen or opening of the outer sheath 14015 and tube 14011 have a low coefficient of friction. For example, these components can include contacting surfaces of a relatively low-friction material or coating such as, but not limited to, PTFE, a hydrophilic coating or material (e.g., from companies such as, but not limited to, BioCoat, DSM Medical, Surmodics, AST Products, Hydromer, Surface Solutions Labs, Harland Medical, Bayer Material Science, Medi-Solve, AdvanSource Biomaterials (e.g., HYDAK®, Comfortcoat™, LubriLast®, Aquacoat, Lubricient®, Baymedix CL, Hydromer), and / or the like.

[0154] FIG. 42C is a longitudinal cross-sectional view of the distal end of the device of FIG. 42A. In the orientation shown, tension is applied to the pull wire 14016, causing a distal aspect or portion of the tube 14011 to be deflected by 90 degrees, or approximately 90 degrees, relative to the longitudinal axis of the tube 14011. In some embodiments, the distal end of the tube 14011 may be deflected at an angle between, but not limited to, 0 degrees and 270 degrees (e.g., 0 degrees to 30 degrees, 0 degrees to 45 degrees, 0 degrees to 60 degrees, 0 degrees to 90 degrees, 0 degrees to 120 degrees, 0 degrees to 150 degrees, 0 degrees to 180 degrees, 0 degrees to 210 degrees, 0 degrees to 240 degrees, 0 degrees to 270 degrees, 15 degrees to 30 degrees, 15 degrees to 45 degrees, 15 degrees to 50 ... degrees to 60 degrees, 15 degrees to 90 degrees, 15 degrees to 120 degrees, 15 degrees to 150 degrees, 15 degrees to 180 degrees, 15 degrees to 210 degrees, 15 degrees to 240 degrees, 15 degrees to 270 degrees, 30 degrees to 45 degrees, 30 degrees to 60 degrees, 30 degrees to 90 degrees, 30 degrees to 120 degrees, 30 degrees to 150 degrees, 30 degrees to 180 degrees, 30 degrees to 210 degrees, 30 degrees to 240 degrees, 30 degrees to 270 degrees, 45 to 60 degrees, 45 to 90 degrees, 45 to 120 degrees, 45 to 150 degrees, 45 to 180 degrees, 45 to 210 degrees, 45 to 240 degrees, 45 to 270 degrees, 60 to 90 degrees, 60 to 120 degrees, 60 to 150 degrees, 60 to 180 degrees, 60 to 210 degrees, 60 to 240 degrees, 60 to 270 degrees, 75 to 90 degrees, 75 The deflection can be at any of a variety of angles relative to the longitudinal axis of the tube 14011, including 90 to 120 degrees, 75 to 150 degrees, 75 to 180 degrees, 75 to 210 degrees, 75 to 240 degrees, 75 to 270 degrees, 90 to 120 degrees, 90 to 150 degrees, 90 to 180 degrees, 90 to 210 degrees, 90 to 240 degrees, and 90 to 270 degrees). FIG. 42D is a transverse cross-section of FIG. 42B taken through line D-D'. 42B is a cross-sectional view, while FIG. 42F is a transverse cross-sectional view of FIG. 42B taken through line EE'.

[0155] 43A schematically illustrates a medical device 14110 according to another embodiment of the present application. Like other configurations disclosed herein, the illustrated device 14110 includes a tube 14111, an outer sheath 14115, and a handle assembly 14120. The handle assembly 14120 can include a proximal component or portion 14121 and a distal component or portion 14122. The distal component 14122 can be coupled to the proximal end of the tube 14111. The proximal component 14121 can be coupled or otherwise secured to the proximal end of the tube 14111. In some embodiments, the distal component 14122 is coupled or otherwise secured to the proximal end of the outer sheath 14115.

[0156] 43A , the proximal component or portion 14121 and the distal component or portion 14122 each have a cylindrical body, thereby allowing the proximal component or portion 14121 to be otherwise inserted (e.g., slidably) into or relative to the distal component or portion 14122. To this end, the cross-sectional shapes of the components 14121, 14122 may be circular or rounded. However, in other embodiments, the proximal and distal components may include any other cross-sectional shape as desired or needed (e.g., square or rectangular, other polygonal, oval, irregular, etc.). Regardless of their distinct shapes, sizes, and other characteristics, the proximal component or portion 14121 and the distal component or portion 14122 may be slidable or otherwise movable relative to one another.

[0157] The tube 14111 and outer sheath 14115 may comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, other polymers, nickel titanium (nitinol), stainless steel, stainless steel braid, hollow helical stranded tubing, other metals or alloys, and / or any other material, as desired or required.

[0158] In some embodiments, the tube 14111 is located within the lumen of the outer sheath 14115, such that one or more cuts 4113 (e.g., helical or spiral cuts) in a distal aspect of the tube 14111 are disposed or otherwise located within the lumen of the outer sheath 14115, while the distal end of the tube 14111 extends beyond the outer sheath 14115. Thus, in some configurations, the overall length of the tube 14111 is greater than the overall length of the outer sheath 14115, while the length from the proximal end of the tube to the distal-most aspect of the cut portion of the tube is less than the overall length of the outer sheath.

[0159] Additionally, according to some configurations, the shape memory element 14116 may be coupled or otherwise secured to the tube 14111 distal to one or more cuts 14113 (e.g., helical or spiral cuts). The shape memory element 14116 may comprise one or more shape memory alloys and / or other materials or configurations, such as, but not limited to, nitinol, other shape memory polymers, etc. In one embodiment, the shape memory element 14116 may undergo a phase / shape change via Joule heating, and the shape memory element 14116 is coupled to two or more wires 14117 and 14119. In such a configuration, one wire 14117 may be coupled to a proximal end of the shape memory element 14116, and a second wire 14119 is coupled to an electrically conductive band 14118. In some embodiments, the electrically conductive band 14118 is coupled or otherwise secured (e.g., directly or indirectly) to a distal end of the shape memory element 14116. The electrically conductive band 14118 may be made of, for example, but not limited to, platinum, gold, palladium, or stainless steel. The electrically conductive band 14118 may include one or more materials such as stainless steel and / or any other metal and / or alloy, hi some embodiments, the electrically conductive band 14118 may advantageously act as a radiopaque marker during use of the device within the anatomy.

[0160] 43B is a longitudinal cross-sectional view of the distal end of the device 14110 of FIG. 43A when a shape memory element 14116 has been applied to the distal end of the tube 14111, thereby causing the distal aspect of the tube 14111 to be in a straight position (e.g., 0 degrees tip deflection relative to the longitudinal axis of the device). In the configuration shown, one or more helical or spiral cut(s) 14113 are present in the distal aspect or portion of the tube 14111. As discussed with reference to other embodiments herein, the cuts 14113 include a cut width and a helical angle.

[0161] In some embodiments, the cut width is between 0.1 micrometers and 30 millimeters (e.g., 0.1 micrometers to 0.2 micrometers, 0.2 micrometers to 0.3 micrometers, 0.3 micrometers to 0.4 micrometers, 0.4 micrometers to 0.5 micrometers, 0.5 micrometers to 0.6 micrometers, 0.6 micrometers to 0.7 micrometers, 0.7 micrometers to 0.8 micrometers, 0.8 micrometers to 0.9 micrometers, 0.9 micrometers to 1 micrometer, 1 micrometer to 2 micrometers, 2 micrometers to 3 micrometers, 3 micrometers to 4 micrometers, 4 micrometers to 5 micrometers, 5 micrometers to 6 micrometers, 6 micrometers to 7 micrometers, 7 micrometers to 8 micrometers, 8 micrometers to 9 micrometers, 9 micrometers to 10 micrometers, 10 micrometers to 15 micrometers, 15 micrometers to 20 micrometers, 20 micrometers to 30 micrometers, 30 micrometers to 40 micrometers, 40 micrometers to 50 micrometers, 50 micrometers to 60 micrometers, 60 micrometers to 70 micrometers, 70 micrometers to 80 micrometers, 80 micrometers to 90 micrometers, 90 micrometers to 100 micrometers, 100 micrometers to 150 micrometers, 150 micrometers In some embodiments, the cut width is 0.01 to 200 micrometers, 200 micrometers to 250 micrometers, 250 micrometers to 300 micrometers, 300 micrometers to 400 micrometers, 400 micrometers to 500 micrometers, 500 micrometers to 600 micrometers, 600 micrometers to 700 micrometers, 700 micrometers to 800 micrometers, 800 micrometers to 900 micrometers, 900 micrometers to 1 millimeter, 1 millimeter to 2 millimeters, 2 millimeters to 3 millimeters, 3 millimeters to 4 millimeters, 4 millimeters to 5 millimeters, 5 millimeters to 6 millimeters, 6 millimeters to 7 millimeters, 7 millimeters to 8 millimeters, 8 millimeters to 9 millimeters, 9 millimeters to 10 millimeters, 10 millimeters to 15 millimeters, 15 millimeters to 20 millimeters, 20 millimeters to 25 millimeters, 25 millimeters to 30 millimeters, widths between the aforementioned values, etc. In some embodiments, the cut width is 0.01 to 200 micrometers, ...In other configurations, the cut width is less than 0.1 micrometers or greater than 30 millimeters (e.g., 30 to 40 millimeters, 40 to 50 millimeters, 50 to 100 millimeters, values ​​between the aforementioned values, or greater than 100 millimeters), as desired or required for a particular application or use.

[0162] 43A and any other configurations disclosed herein or their equivalents, the helical angle of the cut can be in the range of 10 to 80 degrees (e.g., 10 to 15 degrees, 1 to 20 degrees, 20 to 25 degrees, 25 to 30 degrees, 30 to 35 degrees, 35 to 40 degrees, 40 to 45 degrees, 45 to 50 degrees, 50 to 55 degrees, 55 to 60 degrees, 60 to 65 degrees, 65 to 70 degrees, 70 to 75 degrees, 75 to 80 degrees, between angles in the aforementioned ranges, etc.) relative to the longitudinal axis of the tube 14111. In some embodiments, the helical angle is in the range of 15 to 75 degrees (e.g., 20 to 70 degrees, 30 to 60 degrees, etc.).

[0163] In some embodiments, the adjacent contact surfaces of the outer sheath 14115 and the lumen of the tube 14111 can advantageously have a low coefficient of friction, including but not limited to, having a material or coating with a relatively low coefficient of friction, such as, for example, but not limited to, PTFE, a hydrophilic coating or material (e.g., from companies such as, but not limited to, BioCoat, DSM Medical, Surmodics, AST Products, Hydromer, Surface Solutions Labs, Harland Medical, Bayer Material Science, Medi-Solve, AdvanSource Biomaterials (e.g., HYDAK®, Comfortcoat™, LubriLast®, Aquacoat, Lubricient®, Baymedix CL, Hydromer)) and / or the like. FIG. 43C is a longitudinal cross-sectional view of the distal end of the device of FIG. 43A. In the orientation shown, an electric current has been applied to shape memory element 14116 via wires 14117 and 14119, causing a distal aspect or portion of tube 14111 to deflect 90 degrees (e.g., or approximately 90 degrees) relative to the longitudinal axis of tube 14111. Figure 43D is a transverse cross-sectional view of the device of Figure 43B through line D-D', while Figure 43E is a transverse cross-sectional view of the device through line E-E'.In some embodiments, the distal end of the tube 14111 may be angled, for example, but not limited to, at an angle between 0 degrees and 270 degrees (e.g., 0 degrees to 30 degrees, 0 degrees to 45 degrees, 0 degrees to 60 degrees, 0 degrees to 90 degrees, 0 degrees to 120 degrees, 0 degrees to 150 degrees, 0 degrees to 180 degrees, 0 degrees to 210 degrees, 0 degrees to 240 degrees, 0 degrees to 270 degrees, 15 degrees to 30 degrees, 15 degrees to 45 degrees, etc.). , 15 degrees to 60 degrees, 15 degrees to 90 degrees, 15 degrees to 120 degrees, 15 degrees to 150 degrees, 150 degrees to 180 degrees, 15 degrees to 210 degrees, 15 degrees to 240 degrees, 15 degrees to 270 degrees, 30 degrees to 45 degrees, 30 degrees to 60 degrees, 30 degrees to 90 degrees, 30 degrees to 120 degrees, 30 degrees to 150 degrees, 30 degrees to 180 degrees, 30 degrees to 210 degrees, 30 degrees to 240 degrees, 30 degrees to 270 degrees, 45 degrees to 60 degrees, 45 degrees to 90 degrees, 45 degrees to 120 degrees, 45 degrees to 150 degrees, 45 degrees to 180 degrees, 45 degrees to 210 degrees, 45 degrees to 240 degrees, 45 degrees to 270 degrees, 60 degrees to 90 degrees, 60 degrees to 120 degrees, 60 degrees to 150 degrees, 60 degrees to 180 degrees, 60 degrees to 210 degrees, 60 degrees to 240 degrees, 60 degrees to 270 degrees, 75 degrees to 90 degrees, 7 The deflection may be at any of a variety of angles relative to the longitudinal axis of the tube 14111, including 5 degrees to 120 degrees, 75 degrees to 150 degrees, 75 degrees to 180 degrees, 75 degrees to 210 degrees, 75 degrees to 240 degrees, 75 degrees to 270 degrees, 90 degrees to 120 degrees, 90 degrees to 150 degrees, 90 degrees to 180 degrees, 90 degrees to 210 degrees, 90 degrees to 240 degrees, and 90 degrees to 270 degrees).

[0164] 44A shows a schematic diagram of a medical device 14210 according to another embodiment of the present application. As shown and discussed herein with reference to other embodiments, the device 14210 includes a tube 14211, an outer sheath 14215, a sleeve 14212, and a handle assembly 14220. The handle assembly 14220 can include a proximal component or portion 14221 and a distal component or portion 14222. The distal component 14222 can be coupled to a proximal end of the tube 14211. The proximal component 14221 can be coupled to a proximal end of the sleeve 14212.

[0165] 44A , the proximal component 14221 can include a swivel member or portion 14229 that extends around the circumference of the proximal end of the sleeve 14212. In such embodiments, the proximal component 14221 can rotate independently of the sleeve 14212. In some configurations, the proximal component 14221 and the distal component 14222 each have a cylindrical body such that the proximal component 14221 can be inserted within the distal component 14222. The tube 14211 can be disposed or otherwise located within a lumen of the outer sheath 14215. The tube 14211, sleeve 14212, outer sheath 14215, and / or any other portions or components of the device can comprise one or more of a variety of materials, including, but not limited to, polyimide, polyurethane, polyester block amide (such as Pebax®), nylon, other polymers, nickel titanium (nitinol), stainless steel, stainless steel braid, hollow helical stranded tubing, other metals or alloys, and / or any other material.

[0166] In some embodiments, the distal end of the tube 14211 can include, without limitation, one or more angled or reverse curved shapes. In the illustrated configuration, the tube 14211 is located within the lumen of the outer sheath 14215, such that one or more helical or spiral cut(s) 14213 (and / or any other cuts or features) of the distal aspect of the tube 14211 are disposed within the lumen of the outer sheath 14215. The distal end of the tube 14211 can extend beyond the outer sheath 14215. Thus, in some embodiments, the overall length of the tube is greater than the overall length of the outer sheath, while the length from the proximal end of the tube to the distal-most aspect of the cut portion of the tube is less than the overall length of the outer sheath.

[0167] In some embodiments, the sleeve 14212 is disposed within the lumen of the tube 14211. The tube 14211 can have a reduced inner diameter at its distal end to form a shelf 14214 that prevents or otherwise limits forward movement of the sleeve 14212. In some embodiments, the sleeve 14212 abuts the shelf 14214 to transfer longitudinal forces from the sleeve 14212 to the tube 14211. In some embodiments, the sleeve 14212 is coupled to or otherwise secured to the tube 14211 at a point distal to one or more helical or spiral cut(s) 14213, such as the shelf 14214, and can be advanced or retracted within the tube 14211. In some configurations, advancement or retraction of the sleeve 14212 results in advancement or retraction of the tube 14211 distal to the one or more cuts 14213. In some embodiments, the coupling means may be reversible, such as a solder connection that can be melted by applying an electric current or heat to release the sleeve 14212 from the tube 14211. Means for coupling the sleeve 14212 and the tube 14211 include, but are not limited to, one or more of a friction fit, a press fit, an adhesive (e.g., an acrylic-based adhesive (e.g., cyanoacrylate), an epoxy, a silicone, a thermoset, a polyurethane, and / or the like), a welding, a brazing, a soldering, a mechanical link, and / or any other coupling method, device, and / or technique, as desired or required.

[0168] According to some embodiments, the lumen of the tube 14211 and the outer surface of the sleeve 14212 preferentially have a low coefficient of friction. For example, the adjacent contact surfaces of the tube 14211 and the sleeve 14212 may be coated with a coating of various materials, such as, but not limited to, BioCoat, DSM Medical, Surmodics, AST Products, Hydromer, Surface Solutions Labs, Harland Medical, etc. The materials may include PTFE, hydrophilic materials / coatings (e.g., HYDAK®, Comfortcoat™, LubriLast® Aquacoat, Lubricient® Baymedix CL, Hydromer), and / or the like, from companies such as Cal, Bayer Material Science, Medi-Solve, and AdvanSource Biomaterials.

[0169] FIG. 44B is a longitudinal cross-sectional view of the device of FIG. 44A. In the orientation shown, the outer sheath is not engaged with the curved portion of the tube, causing the distal aspect or portion of the tube to curve 180 degrees (e.g., or about 180 degrees) relative to the longitudinal axis. FIG. 44C is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A. In the orientation shown, the outer sheath is partially engaged with the curved portion of the tube, causing the distal aspect of the tube to curve 90 degrees (e.g., about 90 degrees) relative to the longitudinal axis of the device. FIG. 44D is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A. In the orientation shown, the outer sheath is further engaged with the curved portion of the tube, causing the distal aspect of the tube to curve 45 degrees (e.g., about 45 degrees) relative to the longitudinal axis. Additionally, FIG. 44E is a longitudinal cross-sectional view of the distal end of the device of FIG. 44A. In the orientation shown, the outer sheath is fully engaged with the curved portion of the tube, and the distal aspect of the tube is straight (0 degree curvature relative to the longitudinal axis). FIG. 44F is a transverse cross-section of FIG. 44E taken through line F-F', while FIG. 44G is a transverse cross-section of FIG. 44E taken through line G-G'. In some embodiments, the curvature of the distal end of the tube 14211 can be at an angle between 10 and 270 degrees (e.g., 60 to 180 degrees, 90 to 145 degrees, 10 to 45 degrees, 30 to 90 degrees, 30 to 60 degrees, 45 to 90 degrees, 90 to 100 degrees, 100 to 110 degrees, 110 to 120 degrees, 120 to 130 degrees, 130 to 140 degrees, 140 to 150 degrees, The angle can be various angles relative to the longitudinal axis of the tube 14211, including 150 degrees to 160 degrees, 160 degrees to 170 degrees, 170 degrees to 180 degrees, 180 degrees to 190 degrees, 190 degrees to 200 degrees, 200 degrees to 210 degrees, 210 degrees to 220 degrees, 220 degrees to 230 degrees, 230 degrees to 240 degrees, 240 degrees to 250 degrees, 250 degrees to 260 degrees, 260 degrees to 270 degrees, ranges between the aforementioned values, etc.

[0170] It will now be apparent to those skilled in the art that methods and apparatus for improving rotation of the distal aspect of a device have been described herein. While the invention herein has been described in terms of several embodiments, it will be apparent that other adaptations and variations can be adopted without departing from the spirit and scope of the present invention. The terms and expressions employed herein are used as terms of description and not of limitation. As such, no exclusion of equivalents is intended. But to the contrary, the intent is to cover any and all equivalents that may be employed without departing from the spirit and scope of the invention.

[0171] While the present disclosure has been described with reference to particular embodiments, it will be understood that various modifications may be made and equivalents may be substituted for the elements of the present disclosure without departing from the scope of the present disclosure. In addition, many modifications may be recognized to adapt a particular instrument, situation, or material to the teachings of the present disclosure without departing from the essential scope of the present disclosure. Therefore, it is not intended that the present disclosure be limited to the particular embodiment disclosed as the best mode contemplated for carrying out the disclosure, but that the present disclosure will include all embodiments falling within the scope of the appended claims.

[0172] While several embodiments and examples are disclosed herein, the application extends beyond the expressly disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as variations and equivalents thereof. It is also contemplated that various combinations or subcombinations may be made and still fall within the scope of the present invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another to form varying modes of the disclosed invention. Accordingly, it is intended that the scope of the invention disclosed herein not be limited by the particular disclosed embodiments described above, but rather should be determined solely by a fair reading of the appended claims.

[0173] While the embodiments disclosed herein are susceptible to various modifications and alternative forms, specific examples herein are shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to the particular forms or methods disclosed; on the contrary, the present invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any methods disclosed herein need not be performed in the order described. The methods disclosed herein include specific operations performed by a professional. However, these disclosed methods may also include explicit or implicit instruction of these operations by any third party. For example, actions such as "advance a catheter or microcatheter" or "advance a portion of a device (e.g., linearly) relative to another portion of the device and rotate the distal end of the device" include "commanding the catheter to advance" or "commanding the portion of the device to advance," respectively. The scope disclosed herein also encompasses any and all overlaps, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like includes the stated number. Numbers preceded by terms such as "about" or "approximately" include the stated number. For example, "about 10 mm" includes "10 mm." Terms or phrases preceded by terms such as "substantially" include the stated term or phrase. For example, "substantially parallel" includes "parallel."

Claims

1. A first member having a longitudinal axis and a distal end and a proximal end; a region of the first member comprising at least one partial cut or similar feature located at, along, or near the distal end of the first member, the at least one partial cut or similar feature including an orientation that is oblique with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; a second member disposed relative to the first member and configured to move longitudinally relative to the first member to apply a longitudinal force to the region of the first member comprising the at least one partial cut or similar feature of the first member, wherein the distal end of the first member is configured to at least partially rotate as the second member is advanced along the longitudinal axis relative to the first member, thereby facilitating placement of the distal end within a particular anatomical location of a subject; Equipped with a change in length of the region of the first member comprising the at least one partial cut or similar feature of the first member upon application of a longitudinal force by the second member; The device wherein the second member is coupled to the first member or configured to abut the first member without being fixed to the first member at the region of the first member comprising the at least one partial cut or similar feature.

2. The device described in claim 1, wherein at least one of the first member and the second member has a lumen.

3. The device described in claim 1, wherein the at least one partial cut or similar feature has a helical or helical angle of 10 degrees to 80 degrees relative to the longitudinal axis.

4. The device described in claim 1, wherein the region of the first member having the at least one partial cut or similar feature is located along the distal 0 to 20 percent of the first member.

5. The device described in claim 1, wherein at least one of the first member and the second member has a cylindrical shape.

6. The device described in claim 1, wherein the first member is configured to slideably move within the lumen of the second member.

7. The device described in claim 1, wherein the second member is configured to slideably move within the lumen of the first member.

8. The device described in claim 1, wherein the second member is not fixed to the first member.

9. The device described in claim 8, wherein the second member that is not fixed to the first member is at least partially removable from the first member.

10. The device described in claim 1, wherein the second member is coupled to the first member at or near the distal end of the first member, further enabling relative movement between the second member and the first member along the region of the first member having the at least one partial cut or similar feature.

11. The device described in claim 1, wherein the device further comprises at least one outer coating or layer.

12. The device described in claim 1, wherein at least one of the first member and the second member includes a coil-like structure.

13. The device described in claim 1, wherein at least a portion of the distal end of the first member is configured to bend at an angle relative to the longitudinal axis.

14. The device described in claim 1, wherein the first member comprises a shape memory material.

15. The device of claim 1, wherein the first member comprises at least one of nickel titanium (nitinol), other metals or alloys, and polymers.

16. A device described in any one of claims 1 to 15, wherein the device is provided with a guide wire.

17. A device described in any one of claims 1 to 15, wherein the device comprises a microcatheter or a catheter.

18. A device described in any one of claims 1 to 15, wherein the device comprises an endoscopic device or other intraluminal device.

Images