Distally Controlled Medical Devices

Abstract

According to some embodiments, the device comprises a tubular member having a longitudinal axis with a proximal end and a distal end, and at least one partial cut located at, along or near the distal end of the tubular member, the distal end of the tubular member configured to at least partially rotate when a force application element is advanced relative to the tubular member to facilitate positioning the distal end at a particular location of an endoluminal network of a target. The device further includes a transition intermediate the at least one partial cut and an uncut portion of the tubular member.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 276,216, filed November 5, 2021, which is incorporated herein by reference in its entirety and made a part of this application. Additionally, the entirety of U.S. Patent Application No. 17 / 370,986, filed July 8, 2021, and published as U.S. Patent Application Publication No. 2021 / 0330310 on October 28, 2021, is also incorporated herein by reference and made a part of this application.

[0002] The disclosure of this application is in the general field of surgical instruments, and in particular, catheters, guidewires, intravascular ultrasound devices, intracardiac echocardiography devices, endoscopes, endoscopic devices, and surgical instruments used in minimally invasive procedures, such as cardiovascular and endoscopic and surgical procedures. In at least some embodiments, such devices facilitate placement of devices within endoluminal structures within the body, such as, but not limited to, blood vessels, the gastrointestinal tract, the respiratory tract, the genitourinary tract, and other body cavities. [Background technology]

[0003] A number of devices, including but not limited to endoscopes, laparoscopes, arthroscopes, intracardiac echocardiography catheters, intravascular ultrasound catheters, and electrophysiology catheters, and related endoscopic instruments, are used to diagnose and treat conditions by accessing luminal structures of the body. The luminal and cavity 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 tracts, the subarachnoid space, and the intracranial ventricular system. Various sensing means include sensing light of various spectrums, including but not limited to, detecting electrical signals such as visible light, infrared, ultraviolet, optical coherence tomography (OCT), ultrasonic / ultrasound, cardiac electrophysiology, etc.

[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 and is highly dependent on the modulus of elasticity of the material employed within the device. A device with a high modulus of elasticity is able to transmit forces efficiently along the length of the device, while a device with a low modulus of elasticity transmits forces less 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 refers to the ability of the device to bend and deflect along its transverse axis. Flexibility is necessary to allow the device to follow the bends and curvatures present in the human vasculature. Flexibility may 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 stiffness moduli, and thus comes at the expense of push and torque capabilities. Additionally, in some circumstances, it may be desirable to have variable stiffness along its length that can help the device navigate along a path. It is desirable for the device to have

[0007] In some configurations, devices such as catheters, guidewires, intravascular ultrasound devices, intracardiac echocardiography (ICE) devices, endoscopes or endoscopic instruments advantageously demonstrate a one-to-one rotation of the distal end relative to the 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 are subordinate to the curvature of the body's luminal structures. The inherent curvature of the body structures (blood vessels, GI tract and GU tract) means that each part of the device is subject to frictional forces as the device moves through the body.

[0008] These frictional forces may impede the transmission of force from the proximal end to the distal end of the device. One area that is particularly problematic 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 the potential energy stored within the device exceeds the frictional forces exerted along the device, a sudden rotation of the device, also known as a "device whip," may occur when the potential energy is released. This may make it difficult to cannulate the desired lumen branch and may cause injury to the patient. For this reason, current devices such as catheters, guidewires, endoscopes, and endoscopic instrument devices strive to balance stiffness and flexibility in various ways.

[0009] Current devices strive to strike a balance between overall cross-sectional profile or size, image quality, the possibility of one or more additional lumens to engage in other operations, diagnostic tests or therapeutic operations, and a reasonable cost of the device to provide value to the healthcare system. There is a need for improved apparatus, systems, devices, and methods for precisely rotating the distal end of a medical device using one or more sensing elements that provide good image quality with the possibility of one or more additional lumens with functional cross-sections at a cost-effective price. Various embodiments of the systems, devices, and methods disclosed herein provide improvements and other advantages over comparable existing technologies. Summary of the Invention

[0010] According to some embodiments, a device comprises an elongate member having a longitudinal axis, a proximal end, and a distal end, the elongate member including at least one section at, along, or near the distal end, the at least one section including at least one aforementioned physical property that differs from a physical property of a section of the elongate member directly adjacent to the at least one section, a displacement element configured to alter a length of the elongate member along at least one portion, at least one sensing element, and a bending assembly configured to cause a distal end of the elongate member to at least partially rotate about the longitudinal axis and bend the distal end of the elongate member relative to the longitudinal axis when the length of the elongate member along the at least one section is altered using the displacement element, wherein advancement of the device through an endoluminal network of a subject is facilitated by a rotational movement produced by operation of the displacement element and a bending movement produced by operation of the bending assembly, and the at least one sensing element is configured to enable the device to be used in conjunction with an advancement system that operates at least in part autonomously.

[0011] According to some embodiments, the at least one sensing unit comprises at least one sensor, at least one section at, along or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and the bending assembly is actuated using an electrical control device. can be.

[0012] According to some embodiments, the at least one sensing unit comprises at least one sensor. In some embodiments, the at least one sensor comprises at least one of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and a marker. In some embodiments, the at least one sensor comprises at least one of a camera, a visualization device, an imaging device, and a light source.

[0013] According to some embodiments, the at least one sensing unit is fixedly secured to or near the distal end of the elongate member. According to some embodiments, the at least one sensing unit is at least partially integrated into or near the distal end of the elongate member. In some embodiments, the at least one sensing unit is removably or releasably secured to or near the distal end of the elongate member.

[0014] According to some embodiments, at least one therapeutic device, element, or component. In some embodiments, the at least one therapeutic device, element, or component is disposed at, along, or near the distal end of the elongate member. In some embodiments, the at least one therapeutic device, element, or component includes an energy delivery element. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In one embodiment, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0015] According to some embodiments, the device further comprises at least one tool or auxiliary device. In some embodiments, the device is configured to receive or otherwise accommodate the at least one tool or auxiliary device. In some embodiments, the at least one tool or auxiliary device is configured to pass through an internal passage or opening of the device. In some embodiments, the at least one tool or auxiliary device comprises a grasper, a tissue penetrating member, a cauterizing device, a tissue removal device, a biopsy device, an energy delivery device, an ablation device, a treatment device, a diagnostic device, or an imaging device.

[0016] According to some embodiments, the device includes at least one internal channel, lumen, or opening through which another component or device can be advanced.

[0017] According to some embodiments, at least one internal channel, lumen, or opening is disposed in the elongate member. In some embodiments, at least one internal channel, lumen, or opening is disposed in the displacement element.

[0018] According to some embodiments, the device further comprises at least one lumen or channel along the longitudinal axis of the at least one sensing element, said lumen or channel having at least one flap, sealing member, cut, or similar feature along the longitudinal axis. In some embodiments, the diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can change in response to the passage or removal of one or more instruments, auxiliary devices, and / or similar features. The flap, sealing member, or similar feature is configured to at least partially block fluid communication between an internal channel, lumen, or opening of the device and an area external to the device.

[0019] According to some embodiments, at least one section at, along, or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. In some embodiments, the at least one partial cut includes a cut having a helical shape. In some embodiments, the at least one partial cut extends through a wall of the elongate member. In one embodiment, the at least one partial cut does not extend through a wall of the elongate member.

[0020] According to some embodiments, the at least one physical property that differs includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition, hi some embodiments, the at least one physical property that differs includes stiffness or toughness that is less in at least one section than in sections of the elongate member immediately adjacent to the at least one section.

[0021] According to some embodiments, the elongated member comprises a tube or tubular member. In some embodiments, the elongated member comprises a single component. In some embodiments, the elongated member comprises at least two components that together form the elongated member.

[0022] According to some embodiments, the displacement element comprises a pusher member or a force applying member.

[0023] According to some embodiments, the displacement element is collinear with the elongate member, hi some embodiments, the displacement element extends from a proximal end of the elongate member to or near at least one section of the elongate member.

[0024] According to some embodiments, the displacement element is disposed at least partially along the interior of the elongate member.

[0025] According to some embodiments, the displacement element is disposed at least partially along the exterior of the elongate member. In some embodiments, the displacement element is controlled by a separate device. In some embodiments, the separate device is disposed outside the subject during use. In one embodiment, the separate device includes a magnetic component. In some embodiments, the separate device comprises a wireless component configured to wirelessly supply energy to or communicate with the displacement element during use.

[0026] According to some embodiments, the flexion assembly is configured to be mechanically actuated. In some embodiments, the flexion assembly includes a pull wire system or component. In some embodiments, the flexion assembly is configured to be non-mechanically actuated. In some embodiments, the flexion assembly is actuated using an electrical control device. In some embodiments, the electrical control device includes at least one solenoid. In one embodiment, the device further comprises a power source configured to be electrically coupled to the electrical control device. In one embodiment, the power source is located in or on the device. In one embodiment, the power source is integrated into the device. In one embodiment, the power source is external to the device or separate from the device.

[0027] According to some embodiments, the device further comprises at least one electrical conductor extending from the proximal end of the elongate member to or near the distal end of the elongate member, the at least one electrical conductor configured to electrically couple to at least one sensing unit or another electrical component disposed along the distal end. In one embodiment, the at least one electrical conductor is included in or integrated within the elongate member. In some embodiments, the at least one electrical conductor is included in or integrated within the displacement member.

[0028] According to some embodiments, the devices include microcatheters, navigation catheters, intracardiac echocardiography catheters, intravascular ultrasound catheters, electrophysiology catheters, catheters, sheaths, guidewires, endoscopes, laparoscopes, arthroscopes, visualization scopes, scopes, robotically controlled intraluminal devices, manually controlled intraluminal devices, both robotically and manually controlled devices, endoscopic instruments or tools, and surgical instruments.

[0029] According to some embodiments, the advancement system comprises at least one robotic component. In some embodiments, the device further comprises at least one robotic component for manipulating at least one of the displacement element and the bending assembly.

[0030] According to some embodiments, the advancement system comprises at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or device.

[0031] According to some embodiments, the distal end of the elongate member is angled relative to the longitudinal axis.

[0032] According to some embodiments, a device is provided that includes an elongate member having a longitudinal axis, a proximal end, and a distal end, where the elongate member includes at least one section at, along, or near the distal end, the at least one section including at least one aforementioned physical characteristic that is different from a physical characteristic of a section of the elongate member immediately adjacent to the at least one section, and where a length of the elongate member along or proximal to the at least one section is configured to be deflected by a displacement element; and at least one sensing or therapeutic element or component.

[0033] wherein when the length of the elongate member along at least one section is altered using the displacement element, the distal end of the elongate member is configured to at least partially rotate about the longitudinal axis and the distal end of the elongate member is configured to be bent relative to the longitudinal axis using the bending assembly, wherein advancement of the device through a target endoluminal network is facilitated by the rotational movement produced by operation of the displacement element and the bending motion produced by operation of the bending assembly, and wherein the at least one sensing element is configured to enable the device to be used in conjunction with an advancement system that operates at least partially autonomously.

[0034] According to some embodiments, at least one detection or treatment element or component is fixedly secured at or near the distal end of the elongate member. In some embodiments, at least one detection or treatment element or component is at least partially integrated at or near the distal end of the elongate member. In one embodiment, at least one detection or treatment element or component is removably or releasably secured at or near the distal end of the elongate member. In some embodiments, the at least one detection or treatment element or component comprises at least one sensor. In one embodiment, the at least one sensor comprises at least one of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and a marker. In one embodiment, the at least one sensor comprises at least one of a camera, a visualization device, an imaging device, and a light source. In one embodiment, the at least one detection or treatment element or component comprises an energy delivery element. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In some embodiments, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0035] According to some embodiments, the device is configured to receive or otherwise accommodate at least one tool or auxiliary device. In some embodiments, the at least one tool or auxiliary device is configured to pass through an internal passage or opening of the device. In some embodiments, the at least one tool or auxiliary device includes a grasper, a tissue penetrating member, a cauterizing device, a tissue removal device, a biopsy device, an energy delivery device, an ablation device, a treatment device, a diagnostic device, or an imaging device.

[0036] According to some embodiments, it includes at least one internal channel, lumen, or opening through which another component or device can be advanced.

[0037] According to some embodiments, at least one section at, along, or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. In some embodiments, the at least one physical property that differs includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition. In some embodiments, the at least one physical property that differs includes stiffness or toughness, which is less in at least one section than in a section of the elongate member immediately adjacent to the at least one section.

[0038] According to some embodiments, the displacement element is collinear with the elongate member. In some embodiments, the displacement element is controlled by a separate device. In some embodiments, the bending assembly is configured to be mechanically actuated.

[0039] According to some embodiments, the flexion assembly includes a pull wire system or component. In some embodiments, the flexion assembly is configured to be non-mechanically actuated. In some embodiments, the flexion assembly is actuated using an electrical control device. In some embodiments, the electrical control device includes at least one solenoid. In some embodiments, the device further comprises a power source configured to be electrically coupled to the electrical control device. In some embodiments, the power source is located in or on the device. In some embodiments, the power source is integrated into the device. In some embodiments, the power source is external to the device or separate from the device.

[0040] According to some embodiments, the device further comprises at least one electrical conductor extending from the proximal end of the elongate member to or near the distal end of the elongate member, the at least one electrical conductor configured to electrically couple to at least one sensing or therapeutic element or component or another electrical component disposed along the distal end. In some embodiments, the at least one electrical conductor is included in or incorporated within the elongate member. In one embodiment, the at least one electrical conductor is included in or incorporated within the displacement member.

[0041] According to some embodiments, the devices include microcatheters, navigation catheters, intracardiac echocardiography catheters, intravascular ultrasound catheters, electrophysiology catheters, catheters, sheaths, guidewires, endoscopes, laparoscopes, arthroscopes, visualization scopes, scopes, robotically controlled intraluminal devices, manually controlled intraluminal devices, both robotically and manually controlled devices, endoscopic instruments or tools, and surgical instruments.

[0042] According to some embodiments, the advancement system moves at least one robotic component In some embodiments, the device further comprises at least one robotic component for manipulating at least one of the displacement element and the bending assembly. In some embodiments, the advancement system comprises at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or the device.

[0043] According to some embodiments, a device configured to bend includes an elongate member (e.g., a tube) having a longitudinal axis, a proximal end, and a distal end, and a bending assembly located at, along, or proximal to the distal end, where the bending assembly is configured to be manipulated using a powered actuation component.

[0044] According to some embodiments, the actuation component includes at least one solenoid. In some embodiments, the flexion assembly is integral with the elongated member. In other configurations, the flexion assembly is not integral with the elongated member. In some configurations, the flexion assembly is configured to be rigidly secured to the elongated member. In some embodiments, the flexion assembly is configured to be removably secured to the elongated member.

[0045] According to some embodiments, the elongated member includes at least one preferred bend portion along which the elongated member is configured to bend when the bending assembly is manipulated. In some embodiments, the at least one preferred bend portion includes at least one partial cut in a wall of the elongated member. In some configurations, the at least one preferred bend portion includes a vertebra-like region or a plurality of rib-like members. According to some embodiments, the at least one preferred bend portion includes at least one of the aforementioned physical properties that differ from a physical property of a portion of the elongated member directly adjacent to the at least one preferred bend portion. In some embodiments, the at least one different physical property includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition. In one embodiment, the at least one different physical property includes stiffness or toughness, which is less in the at least one preferred bend portion than in the directly adjacent portions of the elongated member.

[0046] According to some embodiments, the flexion assembly includes a power source, the power source (eg, a battery, other energy storage component, etc.) configured to provide electrical energy to the actuation components.

[0047] In some embodiments, the actuation components are configured to be controlled using a controller (e.g., a button, a roller wheel, a knob, a switch, a touch screen, or another controller, etc.) In some embodiments, the controller is configured to be operated by a user during a procedure.

[0048] According to some embodiments, the device further comprises at least one detection or treatment element or component. In one embodiment, the at least one detection or treatment element or component comprises at least one sensor (e.g., one or more of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, an optical sensor, a marker, a camera, a visualization device, an imaging device, and a light source, etc.).

[0049] According to some embodiments, at least one sensing or therapeutic element or component comprises an energy delivery element. In some embodiments, the energy delivery element is In some configurations, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasonic, or other forms of energy.

[0050] FIG. 8A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising a tube 21 having at least one or more at least partial helical cuts 22, at least one sensing unit 15 coupled (e.g., fixedly or removably) to or near a distal end 28 of tube 21, a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to or near a distal end 25 of tube 21, a working channel 14, an electromagnetic element 29 disposed within or otherwise disposed at the distal end of the device, at least one auxiliary device 31, and a flap or similar member or mechanism 35. In some configurations, auxiliary device 31 is configured to pass through working channel 14. In some embodiments, flap or similar member or mechanism 35 includes an element 36 configured to interact with electromagnetic element 29. Flap 35 may preferentially include an inflection point 37. In some configurations, the flap 35 is configured to remain or assume an open state when the auxiliary device 31 exits the working channel 14 .

[0051] According to some embodiments, the device comprises a tubular member having a longitudinal axis, the tubular member having a proximal end and a distal end, at least one partial cut located at, along, or proximal to the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, a displacement element disposed collinearly with the tubular member and configured to selectively advance the distal end of the tubular member longitudinally along a region of the at least one partial cut, at least one sensing element configured to assist in advancement of the device within the luminal network of the subject, and a sensing element disposed within the tubular member and configured to be oriented in a direction that is oblique to the longitudinal axis by a user. and at least one bending member configured to enable selective bending of the distal end of the tubular member at an angle, wherein as the displacement element is advanced relative to the tubular member, movement of the displacement element relative to the tubular member converts the longitudinal displacement into a rotational movement, causing the distal end of the tubular member to at least partially rotate along the longitudinal axis, and actuation of the at least one bending member bends the distal end of the tubular member relative to the longitudinal axis, facilitating advancement of the device through the target endoluminal network and positioning the distal end of the device within a specific branch of the target endoluminal network via the rotational movement by manipulating the displacement element and via the bending motion by manipulating the at least one bending member.

[0052] According to some embodiments, the at least one partial cut comprises a cut having a helical shape. In some embodiments, the at least one bending member comprises at least one pull wire. In some embodiments, the at least one sensing unit is fixedly secured at or near a distal end of the tubular member.

[0053] According to some embodiments, at least one sensing unit is removably or releasably secured to or near the distal end of the tubular member. According to some embodiments, the displacement element includes an internal channel or opening through which one or more components or devices can be advanced.

[0054] According to some embodiments, the device further comprises at least one energy delivery element disposed at or along a distal end of the device. In some embodiments, the at least one energy delivery element comprises an element configured to emit radio frequency, other electromagnetic energy, ultrasound, and / or the like. In some configurations, the at least one energy delivery element is configured to selectively heat and / or cool tissue. It has been done.

[0055] According to some embodiments, the at least one sensing unit comprises at least one sensor. In some embodiments, the at least one sensing unit comprises a visualization device or component.

[0056] In any of the embodiments disclosed herein, the at least one sensing unit may include one or more components, devices, elements, members, and / or the like, including, for example, but not limited to, pressure sensors, contact sensors, proximity sensors, position sensors, temperature sensors, contact, tracking sensors, light sensors, visualization sensors, as well as optical sensors, markers, cameras, visualization devices, imaging devices, light sources, and / or the like.

[0057] According to some embodiments, the device further comprises at least one auxiliary device or component. In some embodiments, the device further comprises at least one flap or similar feature.

[0058] According to some embodiments, a system includes a device according to any configuration disclosed herein and one or more robotic components for manipulating at least the displacement element and at least one flexion member.

[0059] According to some embodiments, the robotic component includes at least one motor, at least one actuator, and at least one processor configured to determine and control the movement of the robotic component.

[0060] According to some embodiments, a method of advancing a device through an endoluminal anatomical network of a subject includes steps included in one or more flowcharts or figures provided herein (see, for example, Figures 13 and 14).

[0061] According to some embodiments, the device includes one or more sensing units. The sensing unit(s) are removable and / or otherwise separable from the remainder of the device and can be reused. As described in more detail herein, the sensing unit(s) can be configured to be secured and detached to the remainder of the device using any type of connection or fastening technique, as desired or necessary. In some embodiments, at least a portion of the remainder of the device is configured for single use (i.e., disposable). Thus, at least a portion of the device is configured to be discarded after use. The sensing unit(s) can include a low-profile electrical connector and a tubular member having a longitudinal axis, with a proximal end and a distal end. The at least one partial cut can be located at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. The device can further include a displacement element having a collinear orientation with respect to the tubular member and configured to selectively change a length of a portion of the tubular member by the at least one partial cut. The distal end of the tubular member is configured to at least partially rotate when the displacement element alters the length of the portion of the tubular member having the at least one partial cut, thereby facilitating placement of the distal end at a particular location within the lumen and / or endoluminal network of the subject. The device may further include means for deflecting the tip of the device, including, but not limited to, the pull wire(s) and / or vertebrate tube(s), and a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device. Not limited.

[0062] According to another embodiment, the device comprises one or more sensing units, which are removable or separable from the remainder of the device and can be reused. As described in more detail herein, the sensing units can be configured to be secured and detached to the remainder of the device using any type of connection or fastening technique, as desired or necessary. In some embodiments, on the other hand, the remainder of the device can be single-use and then discarded after use, said sensing unit(s) comprising a low-profile electrical connector, a tubular member having a longitudinal axis, with a proximal end and a distal end, at least one partial cut that can be disposed at, along or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and a displacement element disposed collinearly with the tubular member and configured to selectively change a length of a portion of the tubular member by the at least one partial cut, the displacement element being configured to selectively change a length of the portion of the tubular member by the at least one partial cut, the displacement element being configured to selectively change a length of the portion of the tubular member by the at least one partial cut, the at least one partial cut ... The distal end of the tubular member is configured to at least partially rotate when altering the length of a portion of the tubular member having a partial cut therein, thereby facilitating placement of the distal end at a specific location in the target endoluminal network, said displacement element having one or more lumens, wherein a distal end of said lumen(s) is / are collinear with a longitudinal axis of the tubular member, and means for deflecting the tip of the device, including, but not limited to, pull wire(s) and / or vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0063] According to another embodiment, the device comprises one or more sensing units, said sensing units being detachable from the remainder of the device and reusable, while the remainder of the device can be single-use and then discarded after use, said sensing units having a low-profile electrical connector, a tubular member having a longitudinal axis with a proximal end and a distal end, at least one partial cut that can be disposed at, along or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and a displacement element disposed within the lumen of the tubular member and configured to selectively change a length of a portion of the tubular member by the at least one partial cut, wherein the displacement element is configured to at least partially rotate the distal end of the tubular member when changing the length of the portion of the tubular member having the at least one partial cut, thereby facilitating placement of the distal end at a specific location of the intraluminal network of the subject. In some configurations, the displacement element has one or more lumens. Additionally, the distal end of the lumen can be angled or offset relative to the longitudinal axis of the tubular member. For example, it can include a side hole or opening as opposed to an end hole or opening. The device further includes a means for deflecting the tip of the device, including, but not limited to, a pull wire(s) and / or vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0064] According to other embodiments, the device includes one or more sensing units that may be removable, disassembled, and / or otherwise separable from one or more other parts of the device and can be reused, while the remaining parts of the device can be single-use and then discarded after use. In some embodiments, the sensing units (or The device may include a low-profile electrical connector, a tubular member having a longitudinal axis, with a proximal end and a distal end, and at least one partial cut located at, along, or proximal to the distal end of the tubular member. The at least one partial cut may include an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. The device may further include a displacement element disposed collinearly with the tubular member and configured to selectively change a length of a portion of the tubular member through the at least one partial cut. The distal end of the tubular member may be configured to at least partially rotate as the displacement element changes a length of the portion of the tubular member having the at least one partial cut, thereby facilitating placement of the distal end at a particular location of the endoluminal network of the subject. In some embodiments, the displacement element may include, but is not limited to, one or more low-profile electrical connectors and associated elements of the sensing unit, and / or one or more closed-loop coils, low-profile electrical connectors, and associated elements. The cross-sectional area of ​​at least a portion of the tubular member can be altered (e.g., using an expandable material, a material that can be folded into a low profile shape, etc.). The device further includes a means for deflecting the tip of the device, including, but not limited to, pull wire(s) and / or vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0065] According to another embodiment, a device comprises one or more sensing unit(s), said sensing unit(s) being detachable from the remainder of the device and reusable, while the remainder of the device can be single use and then discarded after use, said sensing unit(s) comprising a low profile electrical connector, a tubular member having a longitudinal axis with a proximal end and a distal end, at least one partial cut that can be disposed at, along or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and a displacement element disposed collinearly with the tubular member and configured to selectively change a length of a portion of the tubular member by the at least one partial cut, wherein the displacement element changes a length of the portion of the tubular member having the at least one partial cut, thereby wherein the distal end of the tubular member is configured to at least partially rotate in facilitating placement of the distal end at a particular location in the target endoluminal network; said displacement element may include a low profile electrical connector and associated elements of one or more sensing units and / or one or more closed loop coils; at least one or more side holes are disposed in the distal portion of the tubular member, said one or more side hole(s) being in communication with the lumen of the tubular member; a force element including, but not limited to, a magnet is embedded in the portion of the tubular member distal to the sensing unit and / or the one or more side holes; and a means for deflecting the tip of the device including, but not limited to, pull wire(s) and / or vertebrate tube(s), and a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0066] According to another embodiment, a device comprises one or more sensing unit(s), said sensing unit(s) being detachable from the remainder of the device and reusable, while the remainder of the device may be single use and then discarded after use, said sensing unit(s) comprising a low profile electrical connector, a tubular member having a longitudinal axis, having a proximal end and a distal end, at least one partial cut that may be disposed at, along or near the distal end of the tubular member, and at least one The distal end of the tubular member is configured to at least partially rotate when the displacement element changes the length of the portion of the tubular member having the at least one partial cut to facilitate placement of the distal end at a particular location of the endoluminal network of the target, the displacement element may include a low-profile electrical connector and associated elements of one or more sensing units, and / or one or more closed-loop coils, and may include at least one or more sensing units. A side hole is disposed in a distal portion of the tubular member, said one or more side hole(s) being in communication with a lumen of the tubular member, a force element including, but not limited to, a magnet, a sensing unit, and / or a flap embedded in a portion of the tubular member distal to the one or more side holes and extending beyond the side hole(s), said flap interacting with the force element such that said flap preferentially remains in a collapsed state, and a means for deflecting the tip of the device, including, but not limited to, a pull wire(s) and / or vertebrate tube(s), and a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0067] According to another embodiment, a device comprises one or more sensing unit(s), said sensing unit(s) being detachable from the remainder of the device and reusable, while the remainder of the device may be single use and then discarded after use, said sensing unit(s) being self-contained, comprising a tubular member having a longitudinal axis, said tubular member having a proximal end and a distal end, at least one partial cut that may be disposed at, along or near the distal end of the tubular member, wherein the at least one partial cut includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and a displacement element (e.g., a pusher, force application member or element, etc.) disposed collinearly with the tubular member and configured to selectively change a length of a portion of the tubular member by the at least one partial cut, wherein the displacement element changes a length of the portion of the tubular member having the at least one partial cut, thereby providing a specific location of the endoluminal network of the target. the distal end of the tubular member is configured to at least partially rotate in facilitating placement of the distal end in the tubular member; said displacement elements can include low profile electrical connectors and associated elements of the one or more sensing units, and / or one or more closed loop coils; the distal end of the tubular member has at least one aperture (side hole) on a contact surface of the tubular member distal to the cut portion of the tubular member but proximal to the portion of the tubular member housing the one or more sensing units; the distal end of the tubular member can be reversibly configured such that the portion of the tubular member including the one or more sensing units is offset such that the one or more sensing units are offset from the longitudinal axis of the inner lumen of the tubular member; and means for deflecting the tip of the device, including, but not limited to, pull wire(s) and / or vertebrate tube(s), and a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0068] According to another embodiment, the device includes one or more sensing units, a tubular member having a longitudinal axis, the tubular member having a proximal end and a distal end, and at least one partial cut that may be disposed at, along, or near the distal end of the tubular member, the at least one partial cut being oriented along the longitudinal axis and transverse to the longitudinal axis. and an axis of sectioning, the axis of sectioning including at least one partial cut ... The aforementioned means for stabilizing may include, but is not limited to, a collinear / concurrent tubular element (herein referred to as a "brake element") that can reversibly engage with the tubular member distal to the at least one partial cut such that when the brake element engages the tubular member distal to the at least one partial cut, the tubular member distal to the at least one partial cut and the aforementioned brake element are not freely rotatable relative to one another; and a means for deflecting the tip of the device, including, but not limited to, pull wire(s) and / or vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0069] According to another embodiment, a device includes one or more sensing unit(s); at least two or more tubular members each having a longitudinal axis having a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; a displacement element disposed collinearly with each of the respective tubular members and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut; and a distal end of each of the tubular members configured to at least partially rotate when the displacement element varies a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a particular location of a subject, said displacement element being configured to at least partially rotate the distal end of each of the tubular members when the displacement element is ... by at least one partial cut, thereby facilitating placement of the distal end at a particular location of a subject, said displacement element being configured to at least partially rotate the distal end of each of the tubular members when the displacement element is configured to at least partially rotate the distal end of each of the tubular members by at least one partial cut, and and / or one or more closed loop coils; means for reversibly fixing the rotational position of each of the tubular members distal to the at least one partial cut, said means for reversibly fixing / stabilizing the rotational position may include, but is not limited to, collinear / concurrent tubular elements (herein referred to as "brake elements") that can be reversibly engaged with the tubular member distal to the at least one partial cut such that when the brake element engages the tubular member distal to the at least one partial cut, the tubular member distal to the at least one partial cut and said brake element are not freely rotatable relative to each other; and means for deflecting the tip of the device, including but not limited to pull wire(s) and / or vertebrate tube(s), and a handle / user interface at the proximal end of the device to allow a user to operate and control the device.

[0070] According to another embodiment, there is provided a device and method for a motion control system having at least three mechanisms to impart linear / longitudinal motion to a device / instrument, at least one mechanism effects rotation, at least one mechanism effects bending / articulation / deflection of a portion of the device, and at least one mechanism effects longitudinal motion of the entire device.

[0071] According to another embodiment, a device includes one or more sensing unit(s); at least two or more tubular members each having a longitudinal axis, having a proximal end and a distal end; and at least one partial cut that may be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, the at least one partial cut being disposed collinearly with each of the respective tubular members, and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut. and a displacement element, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element changes a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a specific location on the subject, the sensing unit(s) are in direct electrical contact with the distal end of the tubular member, and current and / or signals are transmitted between the sensing unit and an external component(s) of the device via one or more conductors passing through the tubular member including at least one partial cut, the conductors including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis.

[0072] According to another embodiment, a device comprises one or more sensing unit(s); at least two or more tubular members each having a longitudinal axis having a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a displacement element disposed collinearly with each of the respective tubular members and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element varies a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a specific location of the subject, wherein the tubular members are electrically insulated from one another, and the distal ends of the two or more tubular members are in electrical communication with the sensing unit(s).

[0073] According to another embodiment, the device includes one or more sensing units, at least two or more tubular members each having a longitudinal axis, having a proximal end and a distal end, and at least one partial cut that may be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, the at least one partial cut being disposed collinearly with each of the respective tubular members, the at least one partial cut being adapted to select a portion of the length of each of the tubular members. and a displacement element configured to selectively change a length of a portion of each of the tubular members having at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element changes a length of a portion of each of the tubular members having at least one partial cut to thereby facilitate placement of the distal end at a specific location of the subject, the sensing unit(s) are in direct electrical contact with the distal end of the tubular member, and current and / or signals are transmitted between the sensing unit(s) and an external component(s) of the device via the longitudinal axis and one or more conductors passing through, along and / or using the displacement element.

[0074] According to another embodiment, a device includes one or more sensing units, at least two or more tubular members each having a longitudinal axis, having a proximal end and a distal end, and at least one partial cut that may be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and a sensing unit disposed in a collinear manner with respect to each of the respective tubular members. and a displacement element configured to selectively change a length of a portion of each of the tubular members by at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element changes the length of the portion of each of the tubular members having at least one partial cut, thereby facilitating placement of the distal end at a specific location on the subject, and the detection unit comprises one or more movable ribs, whereby the rib(s) form a working channel and are capable of expanding or collapsing, thereby changing the cross-sectional area of ​​the working channel.

[0075] According to another embodiment, a device comprises one or more sensing unit(s); at least two or more tubular members each having a longitudinal axis having a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a displacement element disposed collinearly with each of the respective tubular members and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element varies a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a specific location of the subject, and the sensing unit can undergo flexion by one or more solenoid(s).

[0076] According to another embodiment, a device comprises one or more sensing units (which may be multiple); at least two or more tubular members each having a longitudinal axis having a proximal end and a distal end; at least one partial cut that may be disposed at, along, or near the distal end of each tubular member, wherein the at least one partial cut includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a displacement element disposed collinearly with each of the respective tubular members and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element varies a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a specific location of the subject, and the sensing unit may undergo bending by one or more MEMS actuators.

[0077] According to another embodiment, a device comprises one or more sensing units (which may be multiple); at least two or more tubular members each having a longitudinal axis having a proximal end and a distal end; at least one partial cut that may be disposed at, along, or near the distal end of each tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a displacement element disposed collinearly with each of the respective tubular members and configured to selectively vary a length of a portion of each of the tubular members by the at least one partial cut, wherein the distal end of each of the tubular members is configured to at least partially rotate when the displacement element varies a length of a portion of each of the tubular members having the at least one partial cut, thereby facilitating placement of the distal end at a specific location of the subject; and the sensing units have a self-contained power source and may be operated wirelessly via a wireless receiver / transmitter.

[0078] Various embodiments for controlling the distal end of a device disclosed in U.S. Patent Application Publication No. 2021 / 0330310 are incorporated herein and made a part of this application. As noted above, U.S. Patent Application Publication No. 2021 / 0330310 is incorporated in its entirety into this application. It is incorporated into and becomes a part of it.

[0079] The present application relates to medical devices comprising one or more sensing unit(s) that can be fixed (e.g., fixed or otherwise attached, integrated, integrated with, etc.) or removable (e.g., can be split or separated) to one or more remaining portions of the device. In some embodiments, the sensing unit(s) are at least partially housed in and / or on an elongate member (e.g., a tubular member) having a longitudinal axis, with a proximal end and a distal end, and at least one partial or full thickness cut that can be located at, along, or near the distal end of the tubular member includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. The device includes a displacement element or member (e.g., a rotation imparting element or member) that is collinear or substantially collinearly disposed with the tubular member. The device is configured to at least partially rotate (e.g., about a longitudinal axis of the elongate member and device) when the displacement element or member is moved or otherwise manipulated relative to the elongate member (e.g., tubular member). For example, the device is configured to allow at least a length of a portion of the tubular member having at least one partial or full thickness cut to be changed when the displacement element is moved or otherwise manipulated (e.g., relative to the elongate member). In some embodiments, the distal end of the elongate member (e.g., tubular member) is configured to at least partially rotate when the displacement element is manipulated (e.g., moved to change the length of at least a portion of the elongate member by at least one partial or full thickness cut). This can facilitate placement of the distal end of the device at a particular location in the endoluminal network of a subject.In some configurations, the device further includes a means for deflecting the tip of the device, including, but not limited to, a pull wire(s) and / or vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow the user to manipulate and control the device.

[0080] While the medical devices disclosed herein find application in human surgical and diagnostic procedures, the disclosure contemplates devices having applications and uses in human and non-human medical procedures, as well as non-medical applications, such as for industrial and diagnostic procedures, such as testing.

[0081] According to some embodiments, the intraluminal device comprises an elongate (e.g., tubular) member having at least one cut or feature that facilitates translation of linear movement of the displacement element relative to the tubular member into modification of a distal portion of the device. In some embodiments, such at least one cut or feature can be located at, along, or near the distal end of the device. Rotational movement of the instrument device can facilitate movement of the distal end of the device through the vasculature or other intraluminal structure of the subject as desired or required (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in more detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other intraluminal, anatomical location (e.g., through the respiratory tract, digestive system, genitourinary system, other system or structure, etc. of a subject).

[0082] 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., an endoscope, a guidewire, a catheter, a microcatheter, a sheath, a robotic controlled device or system, other intraluminal devices, etc.). In some embodiments, the device can include one or more cuts (e.g., a tube or an outer The tubular member includes a cut (either partial or complete) through the wall of the side member. In some embodiments, the cut or similar feature extends through the entire thickness of the tubular member. However, in other embodiments, the cut extends only partially through the tubular member, as desired or required.

[0083] 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. In other configurations, however, the cuts have two or more orientations (e.g., angles, pitches, phase angles, etc.), opening sizes, spacing, and / or other characteristics relative to the longitudinal axis, as desired or required. For example, in some configurations, the cut(s) have a dual helix or dual helical symmetric helix design. In other embodiments, however, the cuts have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0084] According to some embodiments, the device includes a tubular member having a longitudinal axis, the tubular member having a proximal end and a distal end, at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, a force application element disposed collinearly with the tubular member and configured to selectively advance the distal end of the tubular member in a longitudinal direction, the force application element being configured to at least partially rotate the distal end of the tubular member as the force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular location in the endoluminal network of the target, and a force application element configured to selectively advance the distal end of the tubular member in a longitudinal direction, the force application element being configured to at least partially rotate the distal end of the tubular member when the force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular location in the endoluminal network of the target. and a transition section intermediate one of the partial cuts and an uncut portion, the transition section having at least one partial slot cut to provide a robustness at a distal end of the tubular member that is greater than a robustness of the at least one partial cut located along or near the distal end and less than a robustness of the uncut portion of the tubular member, and at least one tip deflection member to facilitate steering of the device within the target anatomy, wherein displacement of the tip deflection member results in deflection of the distal end of the device, the tip deflection occurring independent of rotation of the device, and the distal end of the tubular member is configured to elongate longitudinally along or proximal to the area of ​​the at least one partial cut.

[0085] According to some embodiments, the device includes a tubular member having a longitudinal axis, the tubular member having a proximal end and a distal end, at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation relative to both the longitudinal axis and an axis transverse to the longitudinal axis, a force application element disposed collinearly with the tubular member and configured to selectively advance the distal end of the tubular member in a longitudinal direction, and a force application element configured to apply force to the tubular member such that the force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular location in the endoluminal network of the target. and a transition section intermediate the at least one partial cut and an uncut portion of the tubular member, the transition section having at least one partial slot cut for providing a robustness at the distal end of the tubular member that is greater than a robustness of the at least one partial cut located along or near the distal end and less than a robustness of the uncut portion of the tubular member, the transition section being configured such that the distal end of the tubular member is elongated longitudinally along or proximal to the area of ​​the at least one partial cut.

[0086] 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.

[0087] In some embodiments, the at least one partial cut comprises a spiral or helical shape, hi some embodiments, the angle of the at least one partial cut relative to the longitudinal axis is between 10 degrees and 80 degrees.

[0088] According to some embodiments, the force application element is secured to the tubular member along a distal end of the tubular member. In some embodiments, the force application element is secured to the tubular member using at least one of an adhesive and a mechanical connection. In some configurations, the force application element is not secured to the tubular member.

[0089] According to some embodiments, the tubular member comprises a lumen through which the force application element is selectively moved. In some configurations, 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 tip deflection member to facilitate steering of the device within the target anatomy, where displacement of the tip deflection member results in deflection of the distal end of the device, and where tip deflection occurs independently of rotation of the device.

[0090] According to 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 force application element, and movement of the first portion relative to the second portion of the handle assembly facilitates movement of the tubular member relative to the force application element.

[0091] According to some embodiments, at least one partial cut has a single helix oriented in a single pitch direction. In some configurations, at least one partial cut includes a dual helix symmetry helix.

[0092] According to some embodiments, the device further comprises at least one pull wire to facilitate steering of the device within the target anatomy, with movement of the pull wire assisting in bending the device and movement of the force application element assisting in rotating the device.

[0093] According to some embodiments, the device comprises a guidewire, hi some embodiments, the device comprises a catheter (e.g., a microcatheter) and / or any other intraluminal device.

[0094] According to some embodiments, a device comprises a tubular member having a longitudinal axis, the tubular member having a proximal end and a distal end; at least one partial cut that can be located at, along or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; a force application element that is collinearly disposed with respect to the tubular member and configured to selectively advance the distal end of the tubular member longitudinally; and a transition section intermediate the at least one partial cut and an uncut portion of the tubular member, the transition section having at least one partial slot cut for providing a robustness greater than a robustness of the at least one partial cut located at, along or near the distal end of the tubular member and less than a robustness of the uncut portion of the tubular member, wherein when the force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular location of the endoluminal network of the target, Movement of the force application element relative to the tubular member is configured to convert the longitudinal displacement into rotational movement such that the distal end of the tubular member is at least partially rotated and the distal end of the tubular member is configured to elongate longitudinally along or proximal to the area of ​​the at least one partial cut.

[0095] According to some embodiments, a method of rotating a distal end of an endoluminal device includes providing an endoluminal device comprising a tubular member and a force application element configured to be selectively moved relative to the tubular member, the tubular member comprising at least one cut along a distal end of the tubular member, wherein movement of the force application element relative to the tubular member such that the force application element distally moves the distal end of the tubular member selectively rotates the distal end of the tubular member; and moving the force application element relative to the tubular member to selectively rotate the distal end of the device.

[0096] According to some embodiments, the at least one cut extends through the entire thickness of the wall of the tubular member. In some configurations, the at least one cut does not extend through the entire thickness of the wall of the tubular member. In some embodiments, the at least one partial cut includes a single helix oriented in a single pitch direction. In some configurations, the at least one partial cut includes a dual helix symmetry helix.

[0097] According to some embodiments, the device comprises a tubular member having a longitudinal axis with a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a force application element disposed collinear with the tubular member and configured to selectively apply a force to the cut portion of the tubular member, said force resulting in a longitudinal displacement of the cut portion of the tubular member to at least partially rotate the distal end of the tubular member, the degree of rotation being relative to the amount of longitudinal displacement, thereby facilitating placement of the distal end at a specific location of the endoluminal network of the target.

[0098] According to some embodiments, the tubular member can have two or more at least partial cuts, where the at least partial cuts have the same helical angle but are out of phase with each other by a predetermined angle (e.g., as in a double helix configuration). For example, in one embodiment having two at least partial cuts, the at least two partial cuts can be 180 degrees out of phase. The presence of two or more at least partial cuts increases the flexibility of the cut portion of the tubular member. Additionally, the presence of two or more at least partial cuts having the same helical angle but out of phase with each other by a predetermined angle leads to less spreading, unwinding, unrolling, etc., compared to a single cut.

[0099] According to some embodiments, the device comprises a tubular member having a longitudinal axis, with a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a force application element disposed within the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, such that as the force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular location of the endoluminal network of the target, movement of the force application element (e.g., a pusher or inner member) relative to the tubular member converts a longitudinal displacement into a rotational movement, such that the distal end of the tubular member is at least partially rotated and the distal end of the tubular member is elongated longitudinally along or proximal to the area of ​​the at least one partial cut. The tubular member has a varying stiffness along its longitudinal axis. The varying stiffness of the tubular member may include: 1) one of the tubular members; or multiple cuts or partial cuts, 2) differences in the elastic modulus of the tubular member or the force application element, 3) differences in the thickness of the tubular member or the force application element. Further, one or more portions of the tubular member proximal to said at least one partial cut have one or more apertures to reduce potential friction between the force application element and the tubular member.

[0100] According to some embodiments, the device comprises a tubular member having a longitudinal axis with a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a force application element (e.g., a pusher member) disposed collinearly with the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, wherein the distal end of the tubular member is configured to at least partially rotate when the force application element (e.g., the pusher member) is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular branch of the target endoluminal network, and wherein the distal end of the tubular member is configured to elongate longitudinally along or proximal to the area of ​​the at least one partial cut.

[0101] According to some embodiments, the device comprises a tubular member having a longitudinal axis with a proximal end and a distal end; at least one partial cut that can be disposed at, along, or near the distal end of the tubular member, the at least one partial cut including an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis; and a force application element or member (e.g., a pusher member) disposed within the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, such that as the force application element or other force application element is advanced relative to the tubular member, thereby facilitating placement of the distal end at a particular branch of the target endoluminal network, movement of the force application element (e.g., the pusher member) relative to the tubular member converts a longitudinal displacement into a rotational movement, such that the distal end of the tubular member is at least partially rotated and the distal end of the tubular member is elongated longitudinally along or proximal to the area of ​​the at least one partial cut.

[0102] According to some embodiments, a method of selectively rotating a distal end of an intraluminal device includes providing an intraluminal device comprising a tubular member and a force application element (e.g., a pusher member) configured to be selectively moved relative to the tubular member, the tubular member comprising at least one cut along a distal end of the tubular member, and wherein movement of the force application element (e.g., the pusher member) relative to the tubular member such that the force application element distally moves the distal end of the tubular member selectively rotates the distal end of the tubular member. The method further includes moving the force application element relative to the tubular member to selectively rotate the distal end of the device.

[0103] 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 degrees and 80 degrees (e.g., 10 degrees to 15 degrees, 15 degrees 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, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device.

[0104] According to some embodiments, the force application element (e.g., a pusher member) is secured to the tubular member along a distal end of the tubular member. In certain configurations, the force application element is secured to the tubular member using at least one of an adhesive and a mechanical connection. In other embodiments, the force application element 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 force application element is moved sufficiently distally, the pusher or other force application element is configured to abut at least one surface along the interior of the tubular member to advance the tubular member distally.

[0105] According to some embodiments, the tubular member comprises a lumen through which a force application element (e.g., a pusher member) is selectively moved. In some embodiments, the pusher member or other force application element includes a lumen.

[0106] 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 patient's anatomy. In one embodiment, the pull member comprises a pull wire. In one embodiment, the pull member comprises a shape memory material.

[0107] According to some embodiments, the force application element (e.g., a pusher member) comprises a coiled member configured to maintain its structural integrity during use. In some embodiments, the device additionally 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 force application element (e.g., the pusher member), such that 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 or other force application element.

[0108] 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 dual helix symmetry helix.

[0109] 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 patient's vasculature or other intraluminal structure as desired or required (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in more detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other intraluminal, anatomical location (e.g., through a patient's airway, digestive system, etc.)).

[0110] 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 throughout 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 required.

[0111] In some embodiments, the distal portion of the tube or outer member may include one or more catheters. In some embodiments, such cuts are helical or spiral in shape. In some embodiments, such helical cuts have a constant or uniform orientation. In other configurations, however, the cuts have two or more orientations (e.g., angle, pitch, etc.), opening sizes, spacing, and / or other characteristics relative to the longitudinal axis, as desired or required. For example, in some configurations, the cut(s) have a dual helix or dual helical symmetric helix design. In other embodiments, however, the cuts have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0112] According to some embodiments, the device comprises a tube or outer member, a force application element (e.g., a pusher, inner member, etc.), and one or more cuts or other features along the distal end of the tube. In some embodiments, linear movement of the force application element 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 of the device and / or manipulation of the device through the patient's vasculature or other intraluminal system. In some embodiments, the tube or other member is secured along one or more locations (e.g., the distal end of the device) to the force application element or member using one or more fastening (e.g., direct or indirect) methods, features, devices, techniques, etc.

[0113] In some embodiments, the cuts made (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 degrees to 80 degrees (e.g., 10 degrees to 15 degrees, 15 degrees 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, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device. In some embodiments, the helical angle is in the range of 15 degrees to 75 degrees.

[0114] 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.).

[0115] According to some embodiments, the inner member, and thus the entire endoluminal device, is cannulated or otherwise comprises 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 comprise one or more outer members, layers, coatings, and / or other members.

[0116] 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, specifically a medical device with a dual helical symmetric helix that converts linear movement into rotational movement at the distal end.

[0117] One embodiment of the present disclosure includes a medical device comprising: a tubular member having a longitudinal axis with a distal end and a proximal end, a distal aspect terminating at a distal end having a distal helix formed by a distal helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at a proximal end having a proximal helix formed by a proximal helical cut terminating distally of the proximal aspect, where the proximal helical cut is one of right-handed or left-handed and the distal helical cut is the other of right-handed or left-handed; a junction where the distal aspect and the proximal aspect are joined; 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, the distal helical cut width may be equal to or different from the proximal helical cut width, and each of the helical cuts may range between about 0.1 micrometers and about 30 millimeters. The helical cuts each have a helical cut angle, which may be the same or different in size 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 tube, or other suitable material as understood by one of ordinary skill in the art. The attachment means may include 1) adhesive, 2) welding, 3) brazing, 4) soldering, 5) mechanical linkage, or other suitable means as understood by one of ordinary skill 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 a distal end of the tubular member to prevent forward movement of the longitudinal displacer. The longitudinal displacer includes a membrane configured to extend upon injection of fluid and longitudinally displace a distal end of the dual helical symmetry 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 magnetic element and the second magnetic element. The distal helix and the proximal helix 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 a current 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 a current and generate a magnetic field.

[0118] Another embodiment of the present disclosure is a medical device comprising a tubular member having a longitudinal axis with a distal end and a proximal end, the distal aspect terminating at a distal end with a helix formed by a helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at a proximal end, and a longitudinal displacer disposed within the tubular member and slidable relative to the tubular member and configured to apply a longitudinal force to the distal helix. 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 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, 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, the tubular member having an inner diameter, such that a portion between a 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. Except for the inner diameter of the tubular member being greater than the outer diameter of the longitudinal member, 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 and preventing 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 helical-cut tube. The distal helix may include at least one of a shape memory alloy and a shape memory polymer, and further comprises 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 a 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 a current through it and generate a magnetic field.

[0119] 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 having a longitudinal axis with a distal end and a proximal end, a distal aspect terminating at a distal end having a distal helix formed by a distal helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at a proximal end having 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; a junction where the distal aspect and the proximal aspect are joined; 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 dual spiral symmetric helix and rotate the distal tip, observing the change in position of the distal tip on the display, and adjusting the longitudinal displacement so as to adjust 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.

[0120] Another embodiment according to the present disclosure is a device including a tube having a distal end and a proximal end, with a dual helical symmetry helix cut into the distal aspect of the tube, a wire, a slidable sleeve located coaxially on the wire, a distal segment coupled to the junction of the two helices of the dual helical symmetry helix, and a handle with controlled linear displacement. By its nature, the connection of the left hand helix and the right hand helix rotates as the ends of the dual helical symmetry 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 is disposed around the circumference of the distal aspect of the tube, where the dual helical symmetry helix is ​​cut. The distal segment is coupled to the helical junction of the dual helical symmetry helix. The tip of the distal segment can have an angled tip, thereby helping to improve guidance of the device. The tube has a shelf that reduces the inner diameter of the lumen distal to the dual helical symmetry 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 leads to linear displacement of the dual helical symmetric helix. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the longitudinal axis of the tube. This is , which then leads to a rotation of the connection point between the left-handed helix and the right-handed helix, and subsequently a rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the dual-helical symmetric helices of the tube.

[0121] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a dual helical symmetry helix cut into the distal aspect of the tube, a wire tapered at the distal end, a distal segment coupled to the junction of the two helices of the dual helical symmetry helix, and a handle with controlled linear displacement. By its nature, the connection of the left hand helix and the right hand helix rotates as the ends of the dual helical symmetry 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 is disposed around the circumference of the distal aspect of the tube, where the dual helical symmetry helix is ​​cut. The distal segment is coupled to the helix junction of the dual helical symmetry helix. The tip of the distal segment can have an angled tip, which helps improve guidance of the device. The tube has a shelf that reduces the inner diameter of the lumen distal to the dual helical symmetry 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 a linear displacement of the dual helical symmetric helix. A handle with controlled linear displacement allows for controlled movement of the wire relative to the long axis of the tube. This then leads to a rotation of the connection point of the left hand helix and the right hand helix and then a rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the dual helical symmetric helix of the tube.

[0122] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, with a dual helical symmetric 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 dual helical symmetric 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 of the left hand helix and the right hand helix rotates as the end of the dual helical symmetric helix is ​​linearly extended or retracted, resulting in translating the linear movement of the connection point of the two helices into a rotational movement. The distal segment is circumferentially located around the distal end of the tube and is coupled to the junction of the left hand helix and the right hand helix of the dual helical symmetric helix. The tip of the distal segment can have an angled tip to better select the 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. Subsequent advancement of the wire thus leads to a linear displacement of the dual helical symmetric helix. A linear displacement controlled handle allows for controlled movement of the wire relative to the long axis of the tube. This then leads to a rotation of the connection point of the left hand helix and the right hand helix, and then a rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the dual helical symmetric helix of the tube.

[0123] Another embodiment according to the present disclosure is a tube having a distal end and a proximal end, with a dual helical symmetric helix cut into the distal aspect of the tube and a cap on the distal end. The device includes a tube, a wire, a distal segment coupled to the junction of the two helices of the dual helical symmetry helix, and a handle by which linear displacement is controlled. By its nature, the connection of the left hand helix and the right hand helix rotates as the ends of the dual helical symmetry 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 is disposed around the circumference of the distal aspect of the tube, in which the dual helical symmetry helix is ​​inscribed. The distal segment is coupled to the junction of the helices of the dual helical symmetry helix. The tip of the distal segment can have an angled tip, thereby helping to improve guidance of the device. 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 results in linear displacement of the dual helical symmetry helix. The linear displacement controlled handle allows for controlled movement of the wire relative to the long axis of the tube, which then leads to rotation of the connection point between the left and right hand helices and subsequently rotation of the distal segment, the angle of rotation being proportional to the linear displacement of the dual helical symmetric helices of the tube.

[0124] Another embodiment of the present disclosure is a device including a tube having a distal end and a proximal end, a dual helical symmetric helix cut into the distal aspect of the tube and capped at the distal end, a liner containing the dual helical symmetric helix, a distal segment coupled to the junction of the two helices of the dual helical symmetric helix, and a handle with controlled linear displacement. By its nature, the connection of the left hand helix and the right hand helix rotates as the end of the dual helical symmetric 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 dual helical symmetric helix is ​​cut. The distal segment is coupled to the junction of the helices of the dual helical symmetric helix. The tip of the distal segment can have an angled tip, thereby helping to improve guidance of the device. Injecting a fluid into the lumen of the tube leads to varying degrees of linear displacement of the dual helical symmetric helix, which in turn leads to rotation of the connection point between the left and right hand helices and subsequently of the distal segment, with the angle of rotation being proportional to the linear displacement of the dual helical symmetric helix of the tube.

[0125] A handle can be applied to the proximal end of the sleeve or wire and to the proximal end of the tube to more precisely move the sleeve or wire relative to the elongated tube. The handle can be composed of two coaxial tubes that can be displaced relative to each other along the tube's longitudinal axis. Means for translation relative to each other 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 each other (a mechanism similar to the linear movement of threading a bolt into a nut). The handle can coaxially receive the inner wire and the elongated tube within the lumen of the gripper device. Fastening mechanisms can be located along each end of the handle to grip the sleeve or wire at one end and the tube at the other end. These fastening mechanisms can be permanently or reversibly fixed in place. These fastening mechanisms may also pivot about the sleeve or wire or elongated tube, thereby preventing the sleeve, wire, or elongated tube from rotationally moving while the coaxial tube or tubes are rotating.

[0126] Another embodiment of the present disclosure is a tube having a distal end and a proximal end, A device comprising: a tube, said elongated tube being made of a material capable of undergoing a shape change in response to changes in the surrounding environment, a dual helical symmetric helix being cut into a distal aspect of the tube; a distal segment connected to the junction of the two helices of the dual helical symmetric helix; a means for inducing a shape change in the tube; and a means for reacting to the shape change in the tube. By its nature, the connection of the left hand helix and the right hand helix rotates as the end of the dual helical symmetric helix is ​​linearly extended or retracted, resulting in translating the linear movement of the connection point of the two helices into a rotational movement. The distal segment is circumferentially located around the distal end of the tube and connected to the junction of the left hand helix and the right hand helix of the dual helical symmetric helix. The tip of the distal segment can have an angled tip to better select the branch lumen. A change in the environment, including but not limited to temperature, electric field, pH, light, and ion concentration, causes a shape change in the tube such that there is a linear displacement of the dual helical symmetry helix. This then leads to a rotation of the connection point between the left hand helix and the right hand helix, and a subsequent rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the dual helical symmetry helix of the tube. Means for reacting to the shape change in the tube include but are not limited to coupling a conduit to the distal end of the tube. A varying amount of tension can be applied to the conduit to react to the linear displacement of the dual helical symmetry helix.

[0127] Another embodiment of the present disclosure is a device comprising a tube having a distal end and a proximal end, with a dual helical symmetry helix cut into the distal aspect of the tube, a distal segment coupled to the junction of the two helices of the dual helical symmetry helix, and means for linear displacement of the tube including the dual helical symmetry cut, including but not limited to electric field repulsion or magnetic field repulsion. By its nature, the connection of the left hand helix and the right hand helix rotates as the end of the dual helical symmetry helix is ​​linearly extended or retracted, resulting in translating the linear movement of the connection point of the two helices into a 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 dual helical symmetry helix. The tip of the distal segment can have an angled tip to better select the branch lumen. Examples of means for applying opposing electric or magnetic fields along or proximal to a region of the dual helical symmetric helix include, but are not limited to, 1) applying a permanent electric or magnetic charge to one end of the dual helical symmetric helix and a variable, inductive electric or magnetic charge to the opposite end of the dual helical symmetric helix; 2) applying an inductive electric or magnetic charge to one end of the dual helical symmetric helix and a variable, inductive electric or magnetic charge to the opposite end of the dual helical symmetric helix; and 3) applying an electric or magnetic charge to one end of a cut in the dual helical symmetric helix and applying an electric or magnetic charge to a portion of the guidewire proximal to the dual helical symmetric helix. The opposing electric or magnetic forces lead to a linear displacement of the dual helical symmetric helix. This then leads to a rotation of the connection point between the left hand helix and the right hand helix and then a rotation of the distal segment. The angle of rotation is proportional to the linear displacement of the dual-helical symmetry helix of the tube.

[0128] 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. A dual helical symmetry helix is ​​cut into the tube immediately adjacent the tube where the inner diameter of the lumen is reduced. By its nature, the connection between the left hand helix and the right hand helix rotates as the ends of the dual helical symmetry 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, may be used to engage the connection point of the left hand helix and the right hand helix. The wire is provided with a tubing having a distal end and a proximal end. The tubing has a distal end and a proximal end. The tubing has a distal end and a proximal end. The tubing has a distal end and a proximal end. The tubing has a distal end and a proximal end. The tubing has a proximal end and a distal ...

[0129] 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) provided in a distal aspect of the tube, and a slidable sleeve located 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 extends or retracts, resulting in a conversion from linear to rotational movement. The distal end of the tube at the helical / spiral cut 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 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 a linear displacement of the cut portion of the tube. Alternatively, the sleeve can be attached to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or mechanical links. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the long axis of the tube. This then results in a 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 located 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 most distal 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, thereby allowing the outer sheath to 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.

[0130] Another embodiment of the present disclosure includes a medical device comprising a tube having a distal end and a proximal end, with one or more helical or spiral cut(s) provided in a distal aspect of the tube, an outer layer around the tube, and a slidable sleeve located 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 extends or retracts, resulting in a conversion from linear to rotational movement. The distal end of the tube at the helical / spiral cut 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 greater than the inner diameter of the tube shelf, but is smaller than the inner diameter of the tube near said shelf. The sleeve slidably abuts and engages the aforementioned shelf of the tube. Advancing the sleeve results in a linear displacement of the cut portion of the tube. Alternatively, the sleeve can be attached to the tube distal to the helical or spiral cut(s) by means including, but not limited to, adhesives, soldering, welding, brazing, and / or mechanical links. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the long axis of the tube. This then results in a 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 attached to the proximal and distal aspects of the tube. The outer layer can be extended as the tube is linearly displaced (extended). The slidable sleeve may be removable 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.

[0131] 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 a distal aspect of the tube; 2) a tubular member disposed coaxially around the helical or spiral cut tube; 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, 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 extends or retracts, 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 rotates. The distal end of the helical or spiral cut tube can have a number of configurations including, but not limited to: 1) an angled tip to aid in improved guidance of the device, 2) a beveled edge to aid in advancing the device through a severe stenosis or occlusion, 3) one or more flutes / grooves to aid in advancing the device through a severe stenosis or occlusion or along a curved path, and 4) one or more radiopaque markers. The handle assembly is comprised of a proximal component and a distal component.

[0132] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, where one or more helical or spiral cut(s) are provided in a distal aspect of the tube; and 2) a tubular member coaxially disposed about the helical or spiral cut tube, where the outer diameter of the helical or spiral cut tube distal to the cut increases to be greater than the inner diameter of the tubular member. (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, 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 nature, the portion of the tube distal to the helical or spiral cut(s) rotates as the helical or spiral cut(s) linearly extends or retracts, resulting in a conversion of linear movement 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 is The catheter may have a number of configurations, including, but not limited to: 1) an angled tip to aid in improved guidance of the device; 2) beveled edges to aid in advancing the device through severe stenosis or occlusion; 3) one or more flutes / grooves to aid in advancing the device through severe stenosis or occlusion or along a curved path; and 4) one or more radiopaque markers.

[0133] Another embodiment of the present disclosure includes a medical device comprising: 1) a tube having a distal end and a proximal end, with one or more helical or spiral cut(s) provided in a 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 about 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. Similarly, 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, and 3) a hypotube. 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 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 a number of configurations including, but not limited to: 1) an angled tip to aid in improved device guidance; 2) a beveled edge to aid in advancing the device through a severe stenosis or occlusion; 3) one or more flutes / grooves to aid in advancing the device through a severe stenosis or occlusion or along a curved path; and 4) one or more radiopaque markers.

[0134] Another embodiment according to 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 a distal aspect of the tube; 2) an expandable layer disposed about the helical or spiral cut tube, the expandable layer having a proximal end and a distal end 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 and handle assembly located within the lumen of the helical or spiral cut tube. The expandable layer may 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. Similarly, 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 mechanical links. The tubular member can be composed of one or more elements including, but not limited to, 1) coiled wire, 2) polymer with or without reinforcement (e.g., braided or coil reinforcement), and 3) 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 extends or retracts, resulting in a conversion from 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, but is not limited to, 1) an angled tip to help improve device guidance and 2) a tubular member that can be used to move the tube past a severe stenosis or occlusion. The catheter may have multiple configurations including: 1) a beveled edge to aid in advancing the device through a narrow opening; 2) one or more flutes / grooves to aid in advancing the device through a tight stenosis or occlusion or along a curved path; and 3) one or more radiopaque markers.

[0135] 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 comprise two coaxial components that can be displaced relative to each other along the longitudinal axis 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 axis 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 fixed in place. These fastening mechanisms may also pivot about the proximal ends of the tubes or wires and the proximal ends of the outer tubular member, thereby preventing the tubes or wires and the outer tubular member from rotationally moving while one or more of the coaxial components are rotating.

[0136] Another embodiment of the present disclosure is a medical device comprising a tubular member having a longitudinal axis with a distal end and a proximal end, the distal aspect terminating at a distal end with a helix formed by a partial thickness helical cut terminating proximally of the distal aspect, and a proximal aspect terminating at a proximal end, and a longitudinal displacer disposed within the tubular member and 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 tube, 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, 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 a distal end of the distal aspect and a connection 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 a 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 a 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 comprises 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 a 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 a current through it and generate a magnetic field.

[0137] 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) provided in a distal aspect 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 extends or retracts, 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 guidance of the device. Means for deflecting the orientation of the distal end of the tube include, but are not limited to, pull wire(s), slotted tube, shape memory alloy, and / or shape memory polymer. The tube is located 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 most distal 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 the deflected distal end of the tube. Advancement of the outer sheath relative to the tube results in a linear displacement (e.g., extension) of the cut portion of the tube. A handle with controlled linear displacement allows for controlled movement of the outer sheath relative to the long axis of the tube. This in turn results in a 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 delivery of diagnostic and / or therapeutic agent(s), including, but not limited to, injection of contrast agent(s), drug(s), stents, and embolic agents.

[0138] Another embodiment according to 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) provided in a distal aspect of the tube, and a slidable sleeve disposed 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 extends or retracts, resulting in a conversion from linear to rotational movement. The tube is located 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 most distal aspect of the cut portion of the tube is less than the overall length of the outer sheath). The tube distal to the helical 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 over 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 fully straight (e.g., the angle of deflection of the tip is approximately 0 degrees relative to the longitudinal axis of the device). This can allow the user to selectively deflect the tip of the device. The tube can have a shelf that reduces the inner diameter of the lumen distal to the helical or helical cut. Sleeve 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. Advancement of 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 mechanical links. A handle with controlled linear displacement allows for controlled movement of the sleeve relative to the long 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 can 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.

[0139] According to some embodiments, a device comprises an elongate member having a longitudinal axis, a proximal end, and a distal end, the elongate member including at least one section at, along, or near the distal end, the at least one section including at least one aforementioned physical property that differs from a physical property of a section of the elongate member directly adjacent to the at least one section, a displacement element configured to alter a length of the elongate member along at least one portion, at least one sensing element, and a bending assembly configured to cause a distal end of the elongate member to at least partially rotate about the longitudinal axis and bend the distal end of the elongate member relative to the longitudinal axis when the length of the elongate member along the at least one section is altered using the displacement element, wherein advancement of the device through an endoluminal network of a subject is facilitated by a rotational movement produced by operation of the displacement element and a bending movement produced by operation of the bending assembly, and the at least one sensing element is configured to enable the device to be used in conjunction with an advancement system that operates at least in part autonomously.

[0140] According to some embodiments, the at least one sensing unit comprises at least one sensor, at least one section at, along or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis, and the bending assembly is actuated using an electrical control device.

[0141] According to some embodiments, the at least one sensing unit comprises at least one sensor. In some embodiments, the at least one sensor comprises at least one of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and a marker. In some embodiments, the at least one sensor comprises at least one of a camera, a visualization device, an imaging device, and a light source.

[0142] According to some embodiments, the at least one sensing unit is fixedly secured to or near the distal end of the elongate member. According to some embodiments, the at least one sensing unit is at least partially integrated into or near the distal end of the elongate member. In some embodiments, the at least one sensing unit is removably or releasably secured to or near the distal end of the elongate member.

[0143] According to some embodiments, at least one therapeutic device, element, or component is disposed at, along, or near the distal end of the elongate member. In some embodiments, at least one therapeutic device, element, or component is disposed at, along, or near the distal end of the elongate member. In some embodiments, at least one therapeutic device, element, or component is disposed at, along, or near the distal end of the elongate member. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In one embodiment, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0144] According to some embodiments, the device further comprises at least one tool or auxiliary device. In some embodiments, the device is configured to receive or otherwise accommodate the at least one tool or auxiliary device. In some embodiments, the at least one tool or auxiliary device is configured to pass through an internal passage or opening of the device. In some embodiments, the at least one tool or auxiliary device comprises a grasper, a tissue penetrating member, a cauterizing device, a tissue removal device, a biopsy device, an energy delivery device, an ablation device, a treatment device, a diagnostic device, or an imaging device.

[0145] According to some embodiments, the device includes at least one internal channel, lumen, or opening through which another component or device can be advanced.

[0146] According to some embodiments, at least one internal channel, lumen, or opening is disposed in the elongate member. In some embodiments, at least one internal channel, lumen, or opening is disposed in the displacement element.

[0147] According to some embodiments, the device further comprises at least one lumen or channel along the longitudinal axis of the at least one sensing element, said lumen or channel having at least one flap, sealing member, cut, or similar feature along the longitudinal axis. In some embodiments, the diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can change in response to the passage or removal of one or more instruments, auxiliary devices, and / or similar features. The flap, sealing member, or similar feature is configured to at least partially block fluid communication between an internal channel, lumen, or opening of the device and an area external to the device.

[0148] According to some embodiments, at least one section at, along, or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. In some embodiments, the at least one partial cut includes a cut having a helical shape. In some embodiments, the at least one partial cut extends through a wall of the elongate member. In one embodiment, the at least one partial cut does not extend through a wall of the elongate member.

[0149] According to some embodiments, the at least one physical property that differs includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition, hi some embodiments, the at least one physical property that differs includes stiffness or toughness that is less in at least one section than in sections of the elongate member immediately adjacent to the at least one section.

[0150] According to some embodiments, the elongated member comprises a tube or tubular member. In some embodiments, the elongated member comprises a single component. In some embodiments, the elongated member comprises at least two components that together form the elongated member.

[0151] According to some embodiments, the displacement element comprises a pusher member or a force applying member.

[0152] According to some embodiments, the displacement element is collinear with the elongate member, hi some embodiments, the displacement element extends from a proximal end of the elongate member to or near at least one section of the elongate member.

[0153] According to some embodiments, the displacement element is disposed at least partially along the interior of the elongate member.

[0154] According to some embodiments, the displacement element is disposed at least partially along the exterior of the elongate member. In some embodiments, the displacement element is controlled by a separate device. In some embodiments, the separate device is disposed outside the subject during use. In one embodiment, the separate device includes a magnetic component. In some embodiments, the separate device comprises a wireless component configured to wirelessly supply energy to or communicate with the displacement element during use.

[0155] According to some embodiments, the flexion assembly is configured to be mechanically actuated. In some embodiments, the flexion assembly includes a pull wire system or component. In some embodiments, the flexion assembly is configured to be non-mechanically actuated. In some embodiments, the flexion assembly is actuated using an electrical control device. In some embodiments, the electrical control device includes at least one solenoid. In one embodiment, the device further comprises a power source configured to be electrically coupled to the electrical control device. In one embodiment, the power source is located in or on the device. In one embodiment, the power source is integrated into the device. In one embodiment, the power source is external to the device or separate from the device.

[0156] According to some embodiments, the device further comprises at least one electrical conductor extending from the proximal end of the elongate member to or near the distal end of the elongate member, the at least one electrical conductor configured to electrically couple to at least one sensing unit or another electrical component disposed along the distal end. In one embodiment, the at least one electrical conductor is included in or integrated within the elongate member. In some embodiments, the at least one electrical conductor is included in or integrated within the displacement member.

[0157] According to some embodiments, the devices include microcatheters, navigation catheters, intracardiac echocardiography catheters, intravascular ultrasound catheters, electrophysiology catheters, catheters, sheaths, guidewires, endoscopes, laparoscopes, arthroscopes, visualization scopes, scopes, robotically controlled intraluminal devices, manually controlled intraluminal devices, both robotically and manually controlled devices, endoscopic instruments or tools, and surgical instruments.

[0158] According to some embodiments, the advancement system comprises at least one robotic component. In some embodiments, the device further comprises at least one robotic component for manipulating at least one of the displacement element and the bending assembly.

[0159] According to some embodiments, the advancement system comprises at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or device.

[0160] According to some embodiments, the distal end of the elongate member is angled relative to the longitudinal axis.

[0161] According to some embodiments, an elongate member having a longitudinal axis, a proximal end, and a distal end. and, wherein the elongate member includes at least one section at, along, or near the distal end, the at least one section including at least one of the aforementioned physical characteristics that is different from a physical characteristic of a section of the elongate member immediately adjacent to the at least one section, and a length of the elongate member along or proximal to the at least one section is configured to be deflected by a displacement element, and at least one sensing or therapeutic element or component;

[0162] wherein when the length of the elongate member along at least one section is altered using the displacement element, the distal end of the elongate member is configured to at least partially rotate about the longitudinal axis and the distal end of the elongate member is configured to be bent relative to the longitudinal axis using the bending assembly, wherein advancement of the device through a target endoluminal network is facilitated by the rotational movement produced by operation of the displacement element and the bending motion produced by operation of the bending assembly, and wherein the at least one sensing element is configured to enable the device to be used in conjunction with an advancement system that operates at least partially autonomously.

[0163] According to some embodiments, at least one detection or treatment element or component is fixedly secured at or near the distal end of the elongate member. In some embodiments, at least one detection or treatment element or component is at least partially integrated at or near the distal end of the elongate member. In one embodiment, at least one detection or treatment element or component is removably or releasably secured at or near the distal end of the elongate member. In some embodiments, the at least one detection or treatment element or component comprises at least one sensor. In one embodiment, the at least one sensor comprises at least one of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and a marker. In one embodiment, the at least one sensor comprises at least one of a camera, a visualization device, an imaging device, and a light source. In one embodiment, the at least one detection or treatment element or component comprises an energy delivery element. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In some embodiments, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0164] According to some embodiments, the device is configured to receive or otherwise accommodate at least one tool or auxiliary device. In some embodiments, the at least one tool or auxiliary device is configured to pass through an internal passage or opening of the device. In some embodiments, the at least one tool or auxiliary device includes a grasper, a tissue penetrating member, a cauterizing device, a tissue removal device, a biopsy device, an energy delivery device, an ablation device, a treatment device, a diagnostic device, or an imaging device.

[0165] According to some embodiments, it includes at least one internal channel, lumen, or opening through which another component or device can be advanced.

[0166] According to some embodiments, at least one section at, along, or near the distal end includes at least one partial cut that includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. In some embodiments, the at least one physical property that differs includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition. In some embodiments, the at least one physical property that differs includes stiffness or toughness, and the stiffness or toughness is directly proportional to the at least one section in the at least one section. Smaller than the section of the adjacent elongated member.

[0167] According to some embodiments, the displacement element is collinear with the elongate member. In some embodiments, the displacement element is controlled by a separate device. In some embodiments, the bending assembly is configured to be mechanically actuated.

[0168] According to some embodiments, the flexion assembly includes a pull wire system or component. In some embodiments, the flexion assembly is configured to be non-mechanically actuated. In some embodiments, the flexion assembly is actuated using an electrical control device. In some embodiments, the electrical control device includes at least one solenoid. In some embodiments, the device further comprises a power source configured to be electrically coupled to the electrical control device. In some embodiments, the power source is located in or on the device. In some embodiments, the power source is integrated into the device. In some embodiments, the power source is external to the device or separate from the device.

[0169] According to some embodiments, the device further comprises at least one electrical conductor extending from the proximal end of the elongate member to or near the distal end of the elongate member, the at least one electrical conductor configured to electrically couple to at least one sensing or therapeutic element or component or another electrical component disposed along the distal end. In some embodiments, the at least one electrical conductor is included in or incorporated within the elongate member. In one embodiment, the at least one electrical conductor is included in or incorporated within the displacement member.

[0170] According to some embodiments, the devices include microcatheters, navigation catheters, intracardiac echocardiography catheters, intravascular ultrasound catheters, electrophysiology catheters, catheters, sheaths, guidewires, endoscopes, laparoscopes, arthroscopes, visualization scopes, scopes, robotically controlled intraluminal devices, manually controlled intraluminal devices, both robotically and manually controlled devices, endoscopic instruments or tools, and surgical instruments.

[0171] According to some embodiments, the advancement system comprises at least one robotic component. In some embodiments, the device further comprises at least one robotic component for manipulating at least one of the displacement element and the bending assembly. In some embodiments, the advancement system comprises at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or device.

[0172] According to some embodiments, a device configured to bend includes an elongate member (e.g., a tube) having a longitudinal axis, a proximal end, and a distal end, and a bending assembly located at, along, or proximal to the distal end, where the bending assembly is configured to be manipulated using a powered actuation component.

[0173] According to some embodiments, the actuation component includes at least one solenoid. In some embodiments, the flexion assembly is integral with the elongated member. In other configurations, the flexion assembly is not integral with the elongated member. In some configurations, the flexion assembly is configured to be rigidly secured to the elongated member. In some embodiments, the flexion assembly is configured to be removably secured to the elongated member.

[0174] According to some embodiments, the elongated member includes at least one preferred bend portion along which the elongated member is configured to bend when the bending assembly is manipulated. In some embodiments, the at least one preferred bend portion includes at least one partial cut in a wall of the elongated member. In some configurations, the at least one preferred bend portion includes a vertebra-like region or a plurality of rib-like members. According to some embodiments, the at least one preferred bend portion includes at least one of the aforementioned physical properties that differ from a physical property of a portion of the elongated member directly adjacent to the at least one preferred bend portion. In some embodiments, the at least one different physical property includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition. In one embodiment, the at least one different physical property includes stiffness or toughness, which is less in the at least one preferred bend portion than in the directly adjacent portions of the elongated member.

[0175] According to some embodiments, the flexion assembly includes a power source, the power source (eg, a battery, other energy storage component, etc.) configured to provide electrical energy to the actuation components.

[0176] In some embodiments, the actuation components are configured to be controlled using a controller (e.g., a button, a roller wheel, a knob, a switch, a touch screen, or another controller, etc.) In some embodiments, the controller is configured to be operated by a user during a procedure.

[0177] According to some embodiments, the device further comprises at least one detection or treatment element or component. In one embodiment, the at least one detection or treatment element or component comprises at least one sensor (e.g., one or more of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, an optical sensor, a marker, a camera, a visualization device, an imaging device, and a light source, etc.).

[0178] According to some embodiments, at least one sensing or therapeutic element or component comprises an energy delivery element. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In some configurations, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0179] The present application relates to medical devices comprising one or more sensing unit(s) that can be fixed (e.g., fixed or otherwise attached, integrated, integrated with, etc.) or removable (e.g., can be split or separated) to one or more remaining portions of the device. In some embodiments, the sensing unit(s) are at least partially housed in and / or on an elongate member (e.g., a tubular member) having a longitudinal axis, with a proximal end and a distal end, and at least one partial or full thickness cut that can be located at, along, or near the distal end of the tubular member includes an oblique orientation with respect to both the longitudinal axis and an axis transverse to the longitudinal axis. The device includes a displacement element or member (e.g., a rotation imparting element or member) that is collinear or substantially collinearly disposed with the tubular member. The device is configured to at least partially rotate (e.g., about a longitudinal axis of the elongated member and the device) when the displacement element or member is moved or otherwise manipulated relative to the elongated member (e.g., tubular member). For example, the device may rotate at least partially when the displacement element is moved or otherwise manipulated (e.g., relative to the elongated member). The device is configured to allow at least a length of a portion of the tubular member having at least one partial or full thickness cut to be altered. In some embodiments, the distal end of the elongate member (e.g., the tubular member) is configured to at least partially rotate when the displacement element is manipulated (e.g., moved to alter the length of at least a portion of the elongate member by at least one partial or full thickness cut). This can facilitate placement of the distal end of the device at a specific location in the endoluminal network of a subject. In some configurations, the device further includes a means for deflecting the tip of the device, including, but not limited to, a pull wire(s) and / or a vertebrate tube(s), as well as a handle / user interface at the proximal end of the device to allow a user to manipulate and control the device.

[0180] While the medical devices disclosed herein find application in human surgical and diagnostic procedures, the disclosure contemplates devices having applications and uses in human and non-human medical procedures, as well as non-medical applications, such as for industrial and diagnostic procedures, such as testing. [Brief description of the drawings]

[0181] 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:

[0182] [Figure 1] 1 shows a diagram of a device according to one embodiment of the present disclosure. [Figure 2A] FIG. 1 shows a longitudinal cross-sectional view of a distal portion of one embodiment of the device. [Figure 2B] 2B shows a transverse cross-sectional view of the device of FIG. 2A taken along the line B-B'. [Figure 2C] FIG. 1 shows a longitudinal cross-sectional view of a distal portion of one embodiment of the device. [Figure 2D]FIG. 2C shows a transverse cross-sectional view of the device of FIG. 2C taken along the line D-D'. [Figure 3A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 3B] 3B shows a transverse cross-sectional view of the device of FIG. 3A taken along center line B-B'. [Figure 4A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 4B] 4B shows a transverse cross-sectional view of the device of FIG. 4A taken along the line B-B'. [Figure 4C] FIG. 4B shows a transverse cross-sectional view of the device of FIG. 4A taken along center line CC'. [Figure 5A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 5B] 5B shows a transverse cross-sectional view of the device of FIG. 5A taken along the line B-B'. [Figure 5C] FIG. 5B shows a transverse cross-sectional view of the device of FIG. 5A taken along center line CC'. [Figure 6A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 6B] 6B shows a transverse cross-sectional view of the device of FIG. 6A taken along the line B-B'. [Figure 6C] 6B shows a transverse cross-sectional view of the device of FIG. 6A taken along center line CC'. [Figure 7A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 7B] 7B shows a transverse cross-sectional view of the device of FIG. 7A taken along the line B-B'. [Figure 7C] 7B shows a transverse cross-sectional view of the device of FIG. 7A taken along center line CC'. [Figure 8A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 8B] 8B shows a transverse cross-sectional view of the device of FIG. 8A taken along the line B-B'. [Figure 8C]8B shows a transverse cross-sectional view of the device of FIG. 8A taken along center line CC'. [Figure 9A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 9B] 9B shows a transverse cross-sectional view of the device of FIG. 9A taken along the line B-B'. [Figure 10A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 10B] 10B shows a transverse cross-sectional view of the device of FIG. 10A taken along the line B-B'. [Figure 11A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 11B] 11B shows a transverse cross-sectional view of the device of FIG. 11A taken along the line B-B'. [Figure 11C] FIG. 11B shows a transverse cross-sectional view of the device of FIG. 11A taken along center line CC'. [Figure 12A] FIG. 13 shows a longitudinal cross-sectional view of the distal part of another embodiment of a device comprising at least two units. [Figure 12B] 12B shows a transverse cross-sectional view of the device of FIG. 12A taken along the line B-B'. [Figure 13] 1 shows a flow chart or diagram relating to one embodiment of a method for controlling movement of a distal end of a device. [Figure 14] 13 shows a flow chart or diagram relating to another embodiment of a method for controlling movement of a distal end of a device. [Figure 15A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 15B] A transverse cross-sectional view of the device of FIG. 15A taken along center line B-B' is shown. [Figure 15C] 15B shows a transverse cross-sectional view of the device of FIG. 15A taken along center line CC'. [Figure 15D] 15B shows a transverse cross-sectional view of the device of FIG. 15A taken along the line D-D'. [Figure 15E]13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 15F] A transverse cross-sectional view of the device of FIG. 15E taken along center line F-F' is shown. [Figure 15G] A transverse cross-section of the device of FIG. 15E taken along center line G-G' is shown. [Figure 15H] A transverse cross-sectional view of the device of FIG. 15E taken along center line H-H' is shown. [Figure 16A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 16B] 16B shows a transverse cross-sectional view of the device of FIG. 16A taken along the line B-B'. [Figure 16C] FIG. 16B shows a transverse cross-sectional view of the device of FIG. 16A taken along center line CC'. [Figure 16D] 16B shows a transverse cross-sectional view of the device of FIG. 16A taken along the line D-D'. [Figure 17A] 13 shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device with a sensing unit. [Figure 17B] 17B shows a transverse cross-sectional view of the device of FIG. 17A taken along the line B-B'. [Figure 17C] 17B shows a transverse cross-sectional view of the device of FIG. 17A taken along center line CC'. [Figure 17D] 17B shows a transverse cross-sectional view of the device of FIG. 17A taken along the line DD'. [Figure 17E] 17B shows a transverse cross-sectional view of the device of FIG. 17A taken along the line EE'. [Figure 18A] 1 shows a longitudinal cross-sectional view of one embodiment of a sensing unit. [Figure 18B] 18B shows a transverse cross-sectional view of the detection unit of FIG. 18A taken along the line B-B'. [Figure 18C] FIG. 18B shows a transverse cross-sectional view of the detection unit of FIG. 18A taken along the line CC'. [Figure 18D] 18B shows a transverse cross-sectional view of the detection unit of FIG. 18A taken along the line D-D'. [Figure 18E]FIG. 18B shows a transverse cross-sectional view of the detection unit of FIG. 18A taken along the line E-E'. [Figure 19A] 1 shows a longitudinal cross-sectional view of one embodiment of a sensing unit. [Figure 19B] 19B shows a transverse cross-sectional view of the detection unit of FIG. 19A taken along the line B-B'. [Figure 19C] FIG. 19B shows a transverse cross-sectional view of the detection unit of FIG. 19A taken along the line CC'. [Figure 19D] 19B shows a transverse cross-sectional view of the detection unit of FIG. 19A taken along the line D-D'. [Figure 19E] 19B shows a transverse cross-sectional view of the detection unit of FIG. 19A taken along the line EE'. [Figure 20] FIG. 1 is a diagram of a medical system including a medical device according to an embodiment of the present disclosure. [Figure 21A] 1 is a view of the distal end of a medical device in its original orientation and positioned within a branch segment of an intraluminal structure within a body prior to selection of a desired intraluminal structure. [Figure 21B] 1 is a view of the distal end of the medical device after selection of a branch within a branched intraluminal structure within a body. [Figure 22A] FIG. 13 is a diagram of 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 22B] FIG. 22B is a cutaway view of the forces in FIG. 22A. [Figure 23A] FIG. 13 is a cross-sectional view along the long axis of a tube with dual helical symmetry helical cuts where the distal end of the tube is not linearly displaced, according to one embodiment of the present disclosure. [Figure 23B] 23B is a cross-sectional view along the long axis of the tube of FIG. 23A, with the distal end of the tube being linearly displaced. FIG. [Figure 23C] 23B is a cross-sectional view along the longitudinal axis of the tube of FIG. 23A, with the distal end of the tube being further linearly displaced. FIG. [Figure 24]13 is a flow chart of a method for imparting rotational movement to a distal end of a device by converting linear displacement into rotational movement via a dual helical symmetry mechanism. [Figure 25A] FIG. 2 is a view of a proximal end of a medical device according to an embodiment of the present disclosure. [Figure 25B] 1 is a view of a distal end of a medical device according to an embodiment of the present disclosure. [Figure 26A] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of a device with an open distal end in its unactuated state according to an embodiment of the present disclosure. [Figure 26B] FIG. 26B is a longitudinal cross-sectional view of a distal embodiment of the open distal end device of FIG. 26A with linear displacement of the dual spiral symmetric helix through a sleeve abutting a shelf. [Figure 27A] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of a device with an open distal end in its unactuated state, with an inner shelf and wires according to an embodiment of the present disclosure. [Figure 27B] FIG. 27B is a longitudinal cross-sectional view of a distal embodiment of the open distal end device of FIG. 27A with linear displacement of the dual spiral symmetric helix through the unreduced diameter of the wire abutting the shelf. [Figure 28A] FIG. 13 is a longitudinal cross-sectional view of a distal embodiment of the device with the open distal end in its unactuated state, in which the wire has an expandable member. [Figure 28B] FIG. 28B is a longitudinal cross-sectional view of a distal embodiment of the open distal end device of FIG. 28A with linear displacement of the dual helical symmetric helices via an expanded member of wire abutting the distal ends of the dual helical symmetric helices. [Figure 29A] FIG. 2 is a longitudinal cross-sectional view of a distal embodiment of a medical device with the capped distal end in its unactivated state. [Figure 29B] 29B is a longitudinal cross-sectional view of a distal embodiment of the open distal end medical device of FIG. 29A with linear displacement of the dual spiral symmetric helix via a wire abutting the capped end. FIG. [Figure 30A]FIG. 13 is a longitudinal cross-sectional view of a distal embodiment of the device with the capped distal end in its unactuated state, configured to receive injection of fluid into the lumen of the tube. [Figure 30B] FIG. 30B is an enlarged longitudinal cross-sectional view of the distal embodiment of the device having an open distal end of FIG. 30A with linear displacement of the dual helical symmetric helix via injection of fluid into the lumen of the tube. [Figure 31A] FIG. 13 is a longitudinal cross-sectional view of a linear displacement controlled handle in an open state. [Figure 31B] FIG. 31B is a transverse cross-sectional view of the linear displacement controlled handle taken along line A-A' of FIG. 31A. [Diagram 32] FIG. 13 is a longitudinal cross-sectional view of a linear displacement controlled handle in a closed state. [Figure 33A] FIG. 13 is a longitudinal cross-sectional view of a linear displacement controlled handle in an open state. [Figure 33B] FIG. 33B is a transverse cross-sectional view of the linear displacement controlled handle taken along line BB' of FIG. 33A. [Figure 33C] FIG. 33B is a transverse cross-sectional view of the linear displacement controlled handle taken along CC' in FIG. 33A. [Figure 34A] FIG. 13 is a longitudinal cross-sectional view of a linear displacement controlled handle in a closed state. [Figure 34B] FIG. 34B is a transverse cross-sectional view of the linear displacement controlled handle taken along line BB' of FIG. 34A. [Figure 34C] FIG. 34B is a transverse cross-sectional view of the linear displacement controlled handle taken along CC' in FIG. 34A. [Diagram 35] FIG. 11 is a diagram of a second embodiment of a medical device in which a dual helical symmetry helix is ​​displaced through a tube that changes shape in response to changes in the surrounding environment. [Figure 36A] FIG. 13 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 36B]FIG. 36B is a longitudinal cross-sectional view of a distal embodiment of the medical device of FIG. 36A with linear displacement of the dual helical symmetry helix secondary to the shape change of the tube. [Figure 37] FIG. 13 is a diagram of another embodiment of a medical device in which a dual helical symmetric helix is ​​displaced via magnetic forces. [Figure 38A] FIG. 13 is a longitudinal cross-sectional view of a distal embodiment of a medical device with the magnetic displacement mechanism in its unactivated state. [Figure 38B] FIG. 38B is a longitudinal cross-sectional view of a distal embodiment of a medical device with a magnetic displacement mechanism of FIG. 38A with linear displacement of a dual helical symmetry helix dependent on magnetic force applied to the tube. [Figure 39A] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of another embodiment of a medical device with a magnetic displacement mechanism in its unactivated state, where one of the magnetic forces is provided via a shaft having a magnetic element. [Figure 39B] FIG. 39B is a longitudinal cross-sectional view of a distal embodiment of a medical device with a magnetic displacement mechanism of FIG. 39A involving linear displacement of a dual spiral symmetric helix in response to a magnetic force applied to a tube via a shaft having a magnetic element. [Figure 40A] FIG. 13 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 dual helical symmetric helix. [Figure 40B] FIG. 40B is a transverse cross-sectional view of the distal embodiment of the medical device of FIG. 40A through B-B' with no force applied to the distal end of the dual helical symmetric helix. [Figure 40C] FIG. 40B is a transverse cross-sectional view of the distal embodiment of the medical device of FIG. 40A through CC' with no force applied to the distal end of the dual helical symmetric helix. [Figure 41A] FIG. 13 is a longitudinal cross-sectional view of a distal embodiment of a guidewire at the level of the tooth-gear interface as the dual helical symmetric helix undergoes longitudinal displacement. [Figure 41B]FIG. 13 is a longitudinal cross-sectional view of a distal embodiment of a guidewire at the level of the tooth-gear interface as the dual helical symmetric helix undergoes longitudinal displacement. [Figure 42A] FIG. 1 illustrates a catheter having a single helix formed from a tube according to an embodiment of the present disclosure. [Figure 42B] FIG. 42B is a cross-sectional view of FIG. 42A. [Figure 42C] FIG. 42B is a transverse cross-sectional view of FIG. 42A taken through line CC'. [Fig.42D] FIG. 42B is a transverse cross-sectional view of FIG. 42A taken through line D-D'. [Figure 42E] FIG. 42B is a transverse cross-sectional view of FIG. 42A taken through line E-E'. [Fig.42F] FIG. 42B is a diagram of a handle connected to the catheter of FIG. 42A. [Figure 43A] FIG. 42B is a diagram of the catheter of FIG. 42A with a distal member, unactuated (no longitudinal force applied). [Figure 43B] FIG. 42B is a diagram of the catheter of FIG. 42A, in which a longitudinal force at the proximal end rotates the distal end by 90 degrees. [Figure 43C] FIG. 42B is a diagram of the catheter of FIG. 42A, in which a longitudinal force at the proximal end rotates the distal end by 180 degrees. [Fig. 43D] FIG. 42B is a diagram of the catheter of FIG. 42A, in which a longitudinal force at the proximal end rotates the distal end by 270 degrees. [Figure 44A] FIG. 42B is a diagram of the catheter of FIG. 42A in an unactuated state (0 degrees rotation). [Figure 44B] FIG. 42B is a diagram of the catheter of FIG. 42A with the sleeve retracted to reverse the rotation of the distal end to −90 degrees. [Figure 45A] 13A-13C are schematic diagrams illustrating an embodiment of a distal segment chronic total occlusion crossing device. [Figure 45B] 13A-13C are schematic diagrams illustrating an embodiment of a distal segment chronic total occlusion crossing device. [Figure 46A] 1 illustrates an embodiment of a distal segment endoscope. [Figure 46B] 1 illustrates an embodiment of a distal segment endoscope. [Figure 47] 13A-13C are diagrams of an embodiment of a grasping tool of the distal segment endoscope. [Figure 48] 13A-13C are diagrams of an embodiment of a distal segment endoscopic ablation tool. [Figure 49A] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of another embodiment of a medical device in which the sleeve and tube have a shelf within its lumen distal to the helical cut. [Figure 49B] 49B 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. 49A. [Figure 49C] FIG. 49B is a longitudinal cross-sectional view of a distal aspect of another embodiment of a medical device in which the sleeve shown in FIG. 49A is replaced with a liner, resulting in an increased diameter lumen of the device. [Figure 50A] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device in its unactuated state, in which the sleeve has an expandable member. [Figure 50B] FIG. 13 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 50C] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device, in which the expandable member of the sleeve is collapsed by a straightening element. [Figure 51A] FIG. 13 is a longitudinal cross-sectional view of the distal aspect of another embodiment of the device in its unactuated state, in which the sleeve is attached to the tube distal to the helical cut. [Figure 51B] FIG. 13 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 51C] FIG. 13 is a longitudinal cross-sectional view of a distal aspect of another embodiment of the device with the coupling removed. [Figure 52A]1 shows 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 said tube. [Figure 52B] FIG. 52B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 52A when in its unactuated state (eg, 0 degrees rotation), according to one embodiment. [Figure 52C] FIG. 52B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 52A, where a longitudinal force at the proximal end rotates the distal end by 180 degrees, according to one embodiment. [Fig. 52D] A transverse cross-section of FIG. 52B is shown through line 33D-33D'. [Figure 52E] A transverse cross-sectional view of FIG. 52B is shown through line 33E-33E'. [Fig. 52F] A transverse cross-sectional view of FIG. 52B is shown through line 33F-33F'. [Figure 53A] FIG. 13 shows a longitudinal cross-sectional view of a medical device for converting 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 said tube, and an outer layer disposed around said tube. [Figure 53B] A transverse cross-sectional view of FIG. 53A is shown through line 34B-34B'. [Figure 54A] 1A and 1B illustrate schematic diagrams of an embodiment of a medical device for translating linear movement into rotational movement along a distal aspect of the device. [Figure 54B] FIG. 54B is a detailed view of a distal embodiment of the device of FIG. 54A. [Fig. 54C] FIG. 54B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 54A, where a longitudinal force at the proximal end causes the distal end to rotate. [Fig. 54D] 54B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 54A when in its unactuated state (eg, 0 degrees rotation). [Figure 54E] A transverse cross-sectional view of FIG. 54D is shown through line 35E-35E'. [Fig. 54F] A transverse cross-sectional view of FIG. 54D is shown through line 35F-35F'. [Figure 54G] A transverse cross-sectional view of FIG. 54D is shown through line 35G-35G'. [Fig. 54H] A transverse cross-sectional view of FIG. 54D is shown through line 35H-35H'. [Figure 55A] 1 illustrates one embodiment of a medical device for translating linear movement into rotational movement along a distal aspect of the device. [Figure 55B] FIG. 55B shows a detailed view of the distal embodiment of the device of FIG. 55A. [Figure 55C] FIG. 55B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 55A, where a longitudinal force at the proximal end rotates the distal end by 180 degrees. [Fig. 55D] FIG. 55B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 55A when in its unactuated state (0 degrees rotation). [Figure 55E] A transverse cross-sectional view of FIG. 55D is shown through line 36E-36E'. [Fig. 55F] A transverse cross-sectional view of FIG. 55D is shown through line 36F-36F'. [Figure 55G] A transverse cross-section of FIG. 55D is shown through line 36G-36G'. [Figure 56A] 1 illustrates one embodiment of a medical device for translating linear movement into rotational movement along a distal aspect of the device. [Figure 56B] FIG. 56B shows a detailed view of the distal embodiment of the device of FIG. 56A. [Figure 56C] FIG. 56B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 56A, where a longitudinal force at the proximal end rotates the distal end by 180 degrees. [Figure 56D] FIG. 56B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 56A when in its unactuated state (0 degrees rotation). [Figure 56E] A transverse cross-sectional view of FIG. 56D is shown through line 37E-37E'. [Fig. 56F] A transverse cross-sectional view of FIG. 56D is shown through line 37F-37F'. [Figure 56G] A transverse cross-sectional view of FIG. 56D is shown through line 37G-37G'. [Figure 57A] 13A shows 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 57B] A transverse cross-sectional view of FIG. 57A is shown through line 38B-38B'. [Figure 57C] 1 shows 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. [Fig. 57D] A transverse cross-sectional view of FIG. 57C is shown through line 38C-38C'. [Figure 58] 13A shows 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 59] 13A shows 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 60A] 13 shows a longitudinal cross-sectional view of another embodiment of a medical device with a single helix. [Figure 60B] 60B shows a transverse cross-sectional view of the device of FIG. 60A taken along line BB'. [Figure 60C] A transverse cross-sectional view of the device of FIG. 60A is shown through line CC'. [Figure 60D] A transverse cross-sectional view of the device of FIG. 60A is shown through line DD'. [Figure 61A] 13A-13C are schematic diagrams illustrating another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 61B] 42B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 42A in a first orientation. [Figure 61C] 61B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 61A in a second orientation. [Figure 61D] A transverse cross-sectional view of the device of FIG. 61B is shown through line DD'. [Figure 61E] A transverse cross-sectional view of the device of FIG. 61B is shown through line E-E'. [Figure 62A] 13A-13C are schematic diagrams illustrating another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 62B] 62B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 62A with the distal end of the tube in a first orientation. [Figure 62C] 62B shows a longitudinal cross-sectional view of the distal end of the device of FIG. 62A with the distal end of the tube in a second orientation. [Fig.62D] A transverse cross-sectional view of the device of FIG. 62B is shown through line DD'. [Figure 62E] A transverse cross-sectional view of the device of FIG. 62B is shown through line E-E'. [Figure 63A] 13A-13C are schematic diagrams illustrating another embodiment of a medical device configured to translate linear movement into rotational movement along a distal aspect of the device. [Figure 63B] FIG. 63B shows a longitudinal cross-section of the distal end of the device of FIG. 63A where the outer sheath does not engage the curved portion of the tube, resulting in a 180 degree curve of the distal aspect of the tube. [Figure 63C] FIG. 63B shows a longitudinal cross-section of the distal end of the device of FIG. 63A, 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. [Fig. 63D] FIG. 63B shows a longitudinal cross-section of the distal end of the device of FIG. 63A, where 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 63E] FIG. 63B shows a longitudinal cross-section of the distal end of the device of FIG. 63A, with the outer sheath fully engaged with the curved portion of the tube, resulting in the distal aspect of the tube being straight (0 degree curve). [Fig.63F]A transverse cross-sectional view of the device of FIG. 63E is shown through line FF'. [Figure 63G] A transverse cross-sectional view of the device of FIG. 63E is shown through line G-G'. [Figure 64] 13A-13C show side views of another embodiment of a medical device configured to selectively rotate along a distal aspect of the device. [Figure 65A] 1A-1C are schematic longitudinal cross-sectional views of a medical device configured for selective rotation along a distal aspect of the device. [Figure 65B] A transverse cross-sectional view of the device of FIG. 65A is shown through line BB'. [Figure 65C] A transverse cross-sectional view of the device of FIG. 65A is shown through line CC'. [Fig. 65D] A transverse cross-sectional view of the device of FIG. 65A is shown through line D-D'. [Figure 66A] 1A-1C are schematic longitudinal cross-sectional views of a medical device configured for selective rotation along a distal aspect of the device. [Figure 66B] A transverse cross-sectional view of the device of FIG. 66A is shown through line BB'. [Figure 66C] A transverse cross-sectional view of the device of FIG. 66A is shown through line CC'. [Figure 66D] A transverse cross-sectional view of the device of FIG. 66A is shown through line D-D'. [Figure 67A] 65 is a graph of stiffness versus length for a device such as the device shown in FIG. 64. [Figure 67B] 65B is a graph of stiffness versus length for a device such as the device shown in FIG. 65A. [Figure 67C] 66B is a graph of stiffness versus length for a device such as that shown in FIG. 66A. [Figure 68] 1 shows a cut portion of a tubular member, where there is a single cut and the cut portion is curved. [Figure 69A] The two cuts show a cut portion of a tubular member such that the two cuts are 180 degrees out of phase with each other. [Figure 69B]69 shows a transverse cross-section of the tubular membrane through B-B' in FIG. 68. [Figure 69C] 1 shows a cut portion of a tubular member where two cuts are present such that the two cuts are 180 degrees out of phase with each other, showing a linear configuration of the cut portions. [Figure 69D] 1 shows a cut portion of a tubular member where two cuts are present such that the two cuts are 180 degrees out of phase with each other, illustrating the curved configuration of the cut portions. [Figure 70A] 13A-13C show side views of another embodiment of a medical device configured to selectively rotate along a distal aspect of the device with a tip deflection mechanism. [Figure 70B] 1A-1C are schematic longitudinal cross-sectional views of a medical device configured to selectively rotate along a distal aspect of the device with a tip deflection mechanism. [Figure 70C] 1A-1C are schematic longitudinal cross-sectional views of a medical device configured to selectively rotate along a distal aspect of the device with an alternative tip deflection mechanism. [Fig. 70D] A transverse cross-sectional view of the device of FIG. 70B is shown through line DD'. [Figure 70E] A transverse cross-sectional view of the device of FIG. 70B is shown through line E-E'. [Fig. 70F] A transverse cross-sectional view of the device of FIG. 70B is shown through line FF'. [Fig. 70G] FIG. 70C illustrates a schematic longitudinal cross-sectional view of a medical device configured to selectively rotate along a distal aspect of the device with an alternative tip deflection mechanism, with the distal tip deflected in one direction. [Fig. 70H] FIG. 70C is a schematic longitudinal cross-sectional view of a medical device configured to selectively rotate along a distal aspect of the device with an alternative tip deflection mechanism, with the distal tip deflected in a semi-axial direction from the direction shown in FIG. 70G. [Figure 71A] 13 shows a side view of another embodiment of an alternative force application mechanism, in which a groove or channel is disposed along the distal end of the force application mechanism. FIG. [Figure 71B]13A-13C are schematic longitudinal cross-sectional views of alternative force application elements in which grooves or channels are disposed along the distal end of the force application mechanism; [Figure 71C] A transverse cross-sectional view of the device of FIG. 71B is shown through line CC'. [Fig. 71D] A transverse cross-sectional view of the device of FIG. 71B is shown through line DD'. [Figure 72A] One embodiment of a medical device is shown herein generally in which relative movement of one member or portion of the device relative to another member or portion can advantageously produce rotation along the distal end of the device. [Fig. 72B] 1 shows a longitudinal cross-sectional view of a distal embodiment of a device configured to selectively rotate along its distal portion. [Fig. 72C] 13 illustrates another embodiment of a device configured to selectively rotate along its distal portion. [Fig. 72D] FIG. 72C shows an axial cross-sectional view of the device of FIG. 72B. [Fig. 72E] FIG. 72C shows an axial cross-sectional view of the device of FIG. 72B. [Fig. 72F] FIG. 72C shows an axial cross-sectional view of the device of FIG. 72B. [Fig. 72G] 13 illustrates another embodiment of a device configured to selectively rotate along its distal portion. [Fig. 72H] FIG. 72H shows an axial cross-sectional view of the device of FIG. 72G. [Fig. 72I] FIG. 72H shows an axial cross-sectional view of the device of FIG. 72G. [Fig. 72J] FIG. 72H shows an axial cross-sectional view of the device of FIG. 72G. [Figure 73A] 1 illustrates one embodiment of a medical device that can be used to treat a chronic total vascular occlusion. [Figure 73B] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Figure 73C] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73D]73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Figure 73E] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73F] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73G] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73H] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73I] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Fig. 73J] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Figure 73K] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Figure 73L] 73B-73C show various embodiments and / or diagrams related to the device of FIG. 73A. [Figure 74] FIG. 1 shows a cross-sectional view through the longitudinal axis of one embodiment of a CTO device that also includes a pull wire. [Fig. 75A] 1 shows a cross-sectional view through the longitudinal axis of another embodiment of an endoluminal device, where the longitudinal axis of the distal tip is angled relative to the longitudinal axis of the device. [Fig. 75B] 75B shows a cross-sectional view along a portion of the device of FIG. 75A. [Figure 76] 13 shows a cross-sectional view through the longitudinal axis of another embodiment of an endoluminal device in which a tube is disposed within the lumen of an outer sheath. [Figure 77] 1 provides a detailed view of a distal aspect or portion of a reentry wire according to one embodiment, the distal tip of the reentry wire being tapered to aid in penetrating the intima of a target organ. [Fig. 78A] 13 illustrates one embodiment of a distal tip engaging with a proximal cap of a CTO. [Fig. 78B]13 shows one embodiment of a distal tip engaged with a microchannel in the proximal cap of a CTO. [Fig. 78C] 1 shows one embodiment of a distal tip within a microchannel within the body of a CTO. [Fig. 78D] 1 illustrates one embodiment of a distal tip just distal to the distal cap of a CTO within a vessel lumen. [Figure 79A] 13 illustrates another embodiment of a method for crossing a CTO, where the distal tip engages the subintimal space at the level of the proximal cap of the CTO. [Figure 79B] 1 shows one embodiment of the distal tip of the subintimal space at the level of the body of the CTO. [Figure 79C] 1 shows one embodiment of the distal tip of the subintimal space just distal to the distal cap of the CTO. [Fig. 79D] Shown is the distal tip oriented toward the vessel lumen and the re-entry wire advancing through the tube lumen, piercing the intima and re-entering the vessel.

[0183] Each figure is depicted solely to facilitate the explanation of the basic teachings of the present disclosure. Expansions to the drawings with respect to the number, location, relationship and dimensions of parts to form a preferred embodiment will be explained or will be readily apparent to those skilled in the art after reading and understanding the following teachings of the present disclosure. Moreover, the precise dimensions and dimensional proportions required to meet particular force, weight, strength, and similar requirements will likewise be within the skill of one in the art upon reading and understanding the following teachings of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0184] According to some embodiments, the intraluminal device comprises an elongate (e.g., tubular) member having at least one cut or feature that facilitates translation of linear movement of the displacement element relative to the tubular member into modification of a distal portion of the device. In some embodiments, such at least one cut or feature can be located at, along, or near the distal end of the device. Rotational movement of the instrument device can facilitate movement of the distal end of the device through the vasculature or other intraluminal structure of the subject as desired or required (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in more detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other intraluminal, anatomical location (e.g., through the respiratory tract, digestive system, genitourinary system, other system or structure, etc. of a subject).

[0185] 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., an endoscope, a guidewire, a catheter, a microcatheter, a sheath, a robotically controlled device or system, other intraluminal devices, etc.). In some embodiments, the device includes a tubular member with one or more cuts (e.g., partial or complete cuts through the wall of a tube or outer member). In some embodiments, the cuts or similar features extend throughout the entire thickness of the tubular member. However, in other embodiments, the cuts extend only partially through the tubular member, as desired or required.

[0186] 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. In other configurations, however, the cuts have two or more orientations (e.g., angles, pitches, phase angles, etc.), opening sizes, spacing, and / or other characteristics relative to the longitudinal axis, as desired or required. For example, in some configurations, the cut(s) have a dual helix or dual helical symmetric helix design. In other embodiments, however, the cuts have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0187] According to some embodiments, the device comprises an elongate (e.g., tubular) member, a displacement element, member, or feature (e.g., a pusher, force application member or element, other rotation-imparting member, feature or element, etc.), and one or more cuts or other features along a distal end of the elongate member (e.g., a tube). In some embodiments, linear movement of the displacement element relative to the tubular member results in rotational movement (e.g., rotation, twist, pivoting, etc.) of a distal portion of the tube. Such movement can aid in movement of the device and / or manipulation of the device through the patient's vasculature or other intraluminal system. In some embodiments, the elongate or tubular member is secured to the displacement element along one or more locations (e.g., the distal end of the device) using one or more securing (e.g., direct or indirect) methods, features, devices, techniques, etc.

[0188] According to some embodiments, the device may include one or more The device comprises a tubular member having cuts or other features. In some embodiments, linear movement of the cut portion of the tubular member results in rotational movement (e.g., rotation, twist, pivoting, etc.) of a distal portion of the tube (e.g., about or around a longitudinal axis of the tubular member). Such movement can aid in moving and / or manipulating the device through a patient's vasculature or other intraluminal system. In some embodiments, the linear movement of the tubular member is imparted by a force from a displacement element (e.g., a pusher, force application member or element, etc.) collinear with the tubular member. In some embodiments, the linear movement of the tubular member is imparted by a force external to the system (e.g., outside the body in the case of medical applications).

[0189] In some embodiments, the cuts made (e.g., partially or completely) through the tubular 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 degrees to 80 degrees (e.g., 10 degrees to 15 degrees, 15 degrees 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, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device. In some embodiments, the helical angle is in the range of 5 degrees to 85 degrees.

[0190] As discussed in further detail herein, the embodiments disclosed herein may 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 endoluminal devices disclosed herein may vary from 1 mm to 100 mm, or from 1 French to 300 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, 23 French, 24 French, 25 French, 26 French, 27 French, 28 French, 29 French, 30 French, 31 French, 32 French, 33 French, 34 French, 35 French, 36 French, 37 French, 38 French, 39 French, 40 French, 41 French, 42 French, 43 French, 44 French, 45 French, 46 French, 47 French, 48 French, 49 French, 50 French, 51 French, 52 French, 53 French, 54 French, 55 French, 56 French, 57 French, 58 French, 59 French, 59 French, 60 French, 61 French, 62 French, 63 French, 64 French, 65 French, 66 French, 67 French, 68 French, 69 French, 69 French, 70 French, 71 French, 72 French, 73 French, 74 French, 75 French, 76 French, 77 French, 78 French, 79 French, 80 French, 81 French, 82 French, 83 French, 84 French, 85 French, 86 French, 87 French, 88 French, 89 French, 90 French, 91 French , 45 French, 46 French, 47 French, 48 French, 49 French, 50 French, 51 French, 52 French, 53 French, 54 French, 55 French, 56 French, 57 French, 58 French, 59 French, 60 French, 61 French, 62 French, 63 French, 64 French, 65 French, 66 French, 67 French, 68 French, 69 French, 70 French, 70 French to 75 French, 75 French to 80 French, 80 French to 85 French, 85 French to 90 French, 90 French to 95 French, 95 French to 100 French, 100 French to 125 French, 125 French to 150 French, 150 French to 175 French, 175 French to 200 French, 200 French to 250 French, 250 French to 300 French, any French value between the aforesaid values, etc. However, in other embodiments, the intraluminal device can include any other diameter or size, such as, for example, but not limited to, custom sizes below, above, or between the values ​​recited above.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). cm, 100cm to 110cm, 110cm to 120cm, 120cm 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.

[0191] According to some embodiments, the intraluminal devices disclosed herein can be used in a variety of applications and procedures. For example, the devices can be used to reach a particular organ or vasculature of a patient (e.g., the heart or cardia, head and neck, liver, kidneys, hepatic vasculature, renal vasculature, extremities, 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 part of a patient's anatomy that is accessible through a tortious vascular or other intraluminal route (e.g., one that requires the intraluminal device to bend or change direction several times). The various devices disclosed herein can be used for a variety of indications and procedures, such as, for example, but not limited to, ablative procedures, stimulation or neuromodulation procedures, extractions, biopsies, aspiration, delivery of drugs, fluids, energy (e.g., radio frequency or RF, ultrasound, cryogenics, etc.), and / or the like.

[0192] In some embodiments, imparting rotation to a distal portion at a distal end (e.g., as opposed to rotating the entire length of the medical device) can help reduce stress on the vasculature, improve precision of rotation 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 efficiency of the procedure, 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 complications associated with the procedure, reduce fatigue of 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.

[0193] 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 a reference to the structures shown in the figures and are utilized only 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.

[0194] 1 shows a diagram of a device 10 according to one embodiment of the present disclosure. The illustrated medical device 10 includes a distal end 12, a proximal end 11, a handle 13, a sensing unit 15, a rotation controller (e.g., a rotation knob) 16, a tip deflection or bending controller (e.g., a knob) 17, a cable 18, and a cable connector 19. In some embodiments, one or more of the components listed above and illustrated in FIG. 1 (and / or other figures of the present application) can be omitted and / or replaced with one or more other components (e.g., a memory, a control unit, a communication device, etc.) as desired or necessary.

[0195] During operation, according to some configurations, the data and / or information acquired and / or provided by the sensing unit 15 may be displayed using a user interface or other output. It may be provided (e.g., displayed, otherwise communicated, etc.) to a user. In some configurations, data detected or acquired by the sensing unit 15 may be processed (e.g., using a processor or control unit of the device 10, a separate device operably coupled to the device, a system or component operably coupled to the device, etc.). Such data may be used to enhance a medical procedure in one or more ways. For example, the data may assist a physician or other practitioner in properly, efficiently, and safely advancing an endoluminal device through the anatomical network (e.g., vascular system, digestive system, etc.) of the subject. In other configurations, data from the sensing unit 15, regardless of whether it is acquired, where and how it is collected, transmitted, processed, etc., may be communicated to a robotic guidance system, device, or component to enable robotic manipulation and placement of the device within the subject. Such a guidance system, device, or component may be provided with or separate from the device.

[0196] In some embodiments, the handle 13 is configured to control at least one aspect of the motion of the distal end 12 of the device. For example, manipulation of the handle can rotate at least a portion of the distal end of the device (e.g., around the longitudinal axis of the device) and / or bend at least a portion of the device (e.g., tilt the distal end relative to the longitudinal axis of the device) as desired or required. 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. Thus, in some embodiments, any of the devices disclosed herein or their equivalents are configured to both rotate and bend (e.g., relative to the longitudinal axis of the device, as described above) to facilitate movement through an anatomical network. In some configurations, at least a portion of the endoluminal device (e.g., the distal end of the device as described above) can be configured to simultaneously rotate and bend relative to the longitudinal axis of the device as required.

[0197] 2A shows a longitudinal cross-sectional view of a distal portion of one embodiment of device 10 including at least one sensing unit 15. Sensing unit 15 can be coupled (e.g., fixedly, removably, detachably, etc.) to an elongated member (e.g., tube or tubular member 21). Elongated member (e.g., tube) 21 can include one or more at least partial cuts 22 (e.g., helical cuts, cuts oriented at an angle relative to the longitudinal axis and / or an axis perpendicular to said longitudinal axis). Device 10 can include a displacement element or member (e.g., a displacement or other rotation-imparting element) (e.g., a pusher, force-applying member or element, etc.) 23 and, in some embodiments, a pull wire 24 (or other bending feature) operably coupled to or proximal to a distal end 25 of elongated member (e.g., tube) 21.

[0198] As described herein, in any of the embodiments disclosed in the present application, the at least one sensing unit may include one or more components, devices, elements, members, and / or the like, including, for example, but not limited to, pressure sensors, contact sensors, proximity sensors, position sensors, temperature sensors, contact, tracking sensors, light sensors, visualization sensors, as well as optical sensors, markers, cameras, visualization devices, imaging devices, light sources, and / or the like.

[0199] In some embodiments, one or more of the embodiments disclosed herein allow the device to be rotated or twisted (e.g., about or around the longitudinal axis of tube 21 and device 10), bent at an angle relative to the longitudinal axis of tube 21 and device 10, or otherwise moved. As described in detail, the rotational and bending motions, along with axial movement (e.g., axial advancement or translation) of the device within the subject, enable a physician or other user to predictably and easily move the device in all three dimensions through the vasculature or other intraluminal system of the subject.

[0200] 2B shows a transverse cross-sectional view of the device of FIG. 2A taken along center line B-B', where a displacement element or displacement elements (e.g., pusher, force application member, or element, etc.) 23 are disposed within the lumen of elongate member (e.g., tube) 21, and cable 18 and pull wire 24 are disposed within the lumen of displacement element 23. In other embodiments, the relationship or orientation of elongate member (e.g., tube) 21 and displacement element 23 can be reversed, such that the tube is disposed within the lumen of displacement element 23.

[0201] 2C shows a longitudinal cross-sectional view of a distal portion of one embodiment of device 10. In some embodiments, the device comprises a sensing unit 15 coupled (e.g., fixedly or removably) to a tube 21 having at least one or more at least partial cuts 22 (e.g., spiral cuts). Device 10 includes a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23 and a pull wire 24, which in some embodiments is coupled to a distal end 25 of tube 21. The device further comprises a working channel 14 exiting through an end hole and a light-emitting element 26, the output of which may include, but is not limited to, light, infrared light, ultrasound, other types of energy (e.g., radio frequency, electromagnetic, etc.), heat or cold (e.g., cryogenic energy), etc.

[0202] In any of the embodiments disclosed herein, the use of light emitting elements 26 can be used to stimulate, denervate, and / or otherwise modulate tissue within an anatomical structure. The ability to predictably manipulate and move a device (e.g., a distal end of the device) through an anatomical network can facilitate targeted delivery of stimulation to a subject, as desired or needed.

[0203] 2D shows a transverse cross-sectional view of the device of FIG. 2C taken along center line D-D', where a displacement or rotation-imparting element (e.g., pusher, force-applying member, or element, etc.) 23 is disposed within the lumen of an elongate member (e.g., tube) 21, and cable 18 and pull wire 24 are disposed within the lumen of the displacement element 23. In some configurations, the space within the lumen of the displacement element 23 forms the working channel 14. As noted with reference to other embodiments herein, and as applies to all embodiments contained herein, the relationship between tube 21 and displacement element 23 can be reversed, such that the tube is disposed within the lumen of the displacement element 23.

[0204] FIG. 3A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10, comprising a sensing unit 15 (e.g., fixedly or removably) coupled to tube 21 with at least one or more at least partial cuts 22 (e.g., spiral cuts), a displacement element 23, a pull wire 24 coupled to a distal end 25 of tube 21, and a working channel 14 exiting through a side hole.

[0205] 3B shows a transverse cross-sectional view of the device of FIG. 3A taken along line B-B', where a displacement element (e.g., pusher, force application member, or element, etc.) 23 is disposed within the lumen of tube 21, and cable 18 and pull wire 24 are disposed within the lumen of displacement element 23. In some embodiments, the space within the lumen of displacement element 23 forms working channel 14. The relationship between tube 21 and displacement element 23 can be reversed, such that the tube is disposed within the lumen of displacement element 23.

[0206] 4A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising a tube 21 having at least one or more at least partial cuts 22 (e.g., spiral cuts), at least one sensing unit 15 coupled (e.g., fixedly or removably) to a distal end 28 of elongate member (e.g., tube) 21, a displacement or rotation-imparting element (e.g., pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to a distal end 25 of tube 21, and a working channel 14 having an at least partially expandable portion 27. In the illustrated configuration, the expandable portion is shown in a folded, retracted, or contracted state.

[0207] 4B shows a transverse cross-sectional view of the device of FIG. 4A through center B-B', where a displacement element or rotation-imparting element (e.g., pusher, force application member, or element, etc.) 23 is disposed within the lumen of tube 21, and cable 18 and pull wire 24 are disposed within the lumen of displacement element 23. In some embodiments, the space within the lumen of displacement element 23 forms at least one working channel 14. In some configurations, the orientation or relationship of tube 21 and displacement element 23 is reversed, as desired or needed, such that the tube is disposed within the lumen of displacement element 23.

[0208] FIG. 4C shows a transverse cross-sectional view of the device of FIG. 4A taken along center line C-C', with the sensing unit 15 coupled (e.g., directly, indirectly, fixedly, detachably, etc.) to the distal end 28 of the tube and the expandable portion 27 in a folded, retracted, or contracted state.

[0209] 5A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising a tube 21 having at least one or more at least partial cuts 22 (e.g., helical cuts), at least one sensing unit 15 coupled (e.g., fixedly or removably) to a distal end 28 of the tube 21, a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire or other bending assembly 24 coupled to a distal end 25 of the tube 21, and a working channel 14 including an at least partially expandable portion 27. In the illustrated configuration, the expandable portion is in an expanded, or uncontracted, or unwithdrawn state.

[0210] 5B shows a transverse cross-sectional view of the device of FIG. 5A taken along center line B-B', where a displacement element or rotation-imparting element (e.g., pusher, force application member, or element, etc.) 23 is disposed or otherwise positioned within the lumen of tube 21, and cable 18 and pull wire 24 are disposed within the lumen of displacement element 23. In some embodiments, the space within the lumen of displacement element 23 forms at least one working channel 14. The relationship between tube 21 and displacement element 23 can be reversed, such that the tube is disposed within the lumen of displacement element 23.

[0211] 5C shows a transverse cross-sectional view of the device of FIG. 5A taken along center line C-C', with sensing unit 15 coupled to the distal end 28 of the tube. In the illustrated configuration, expandable portion 27 is shown in an expanded or uncontracted state or orientation.

[0212] FIG. 6A illustrates a device including a tube 21 having at least one or more at least partial cuts 22 (e.g., helical cuts), at least one sensing unit 15 fixedly or removably coupled to a distal end 28 of the tube 21, a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to or near a distal end 25 of the elongate member (e.g., tube) 21, a working channel 14, and an electromagnetic transducer disposed along or near the distal end of the device. 1 shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising an electromagnetic element or other energy delivery element 29 and one or more auxiliary devices 31. In some embodiments, auxiliary device 31 includes a collar 32 capable of interacting with electromagnetic element 29. Collar 32 can be oriented circumferentially (e.g., at least partially) about a long axis of auxiliary device 31 such that collar 32 can freely translate and rotate about auxiliary device 31. In some embodiments, auxiliary device 31 includes one or more ridges or similar features 33, the outer dimensions of said ridges or other features 33 being larger than the inner diameter of collar 32 so as to prevent or reduce the possibility of distal dislodgement of collar 32.

[0213] 6B shows a transverse cross-sectional view of the device of FIG. 6A along center B-B', where a displacement or rotation-imparting element (e.g., pusher, force-applying member, or element, etc.) 23 is disposed within the lumen of elongate member (e.g., tube) 21, and cable 18 and pull wire (or other bending assembly, such as any of the bending assembly embodiments disclosed herein, see, e.g., FIGS. 18A-19E) 24 are disposed within the lumen of displacement element 23. As shown, one or more auxiliary devices 31 may be disposed within the lumen of working channel 14 or otherwise positioned. The relationship between tube 21 and displacement element 23 may be reversed, such that the tube is disposed within the lumen of displacement element 23.

[0214] 6C shows a transverse cross-sectional view of the device of FIG. 6A centered on C-C', where the sensing unit 15 is coupled at or proximal to the distal end 28 of the tube, and the electromagnetic element 29 interacts with the collar 32. In some configurations, the interaction between the electromagnetic element (and / or other energy element) 29 and the collar includes an attractive force between the elements, and the auxiliary device 31 passes through the collar 32.

[0215] 7A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising a tube 21 having at least one or more at least partial spiral cuts 22, at least one sensing unit 15 coupled (e.g., fixedly or removably) to a distal end 28 of the tube 21, a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to or near a distal end 25 of the tube 21, a working channel 14, an electromagnetic element (and / or other energy element or modality) 29 disposed at least partially at, on, along and / or within the distal end of the device, and a flap 35. In some embodiments, the flap or similar feature 35 includes an element 36 configured to interact with the electromagnetic element 29 such that the flap 35 can assume a closed state or orientation.

[0216] FIG. 7B shows a transverse cross-sectional view of the device of FIG. 7A centered on B-B', in which the displacement element 23 is positioned or disposed at least partially on or within the lumen of the tube 21, and the cable 18 and pull wire 24 are disposed within the lumen of the displacement element 23.

[0217] 7C shows a transverse cross-sectional view of the device of FIG. 7A taken along center line C-C', where sensing unit 15 is coupled at or proximal to distal end 28 of tube, and electromagnetic element 29 interacts with element 36 within flap 35. In some configurations, such interaction includes an attractive force between electromagnetic element 29 and element 36.

[0218] FIG. 8A illustrates a tube 21 having at least one or more at least partial helical cuts 22, at least one sensing unit 15 coupled (e.g., fixedly or removably) to or near a distal end 28 of the tube 21, and a displacement element or FIG. 1 shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 including a rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to or near a distal end 25 of tube 21, a working channel 14, an electromagnetic element 29 disposed within or otherwise disposed at the distal end of the device, at least one auxiliary device 31, and a flap or similar member or mechanism 35. In some configurations, auxiliary device 31 is configured to pass through working channel 14. In some embodiments, flap or similar member or mechanism 35 includes an element 36 configured to interact with electromagnetic element 29. Flap 35 may preferentially include a bend point 37. In some configurations, flap 35 is configured to maintain or assume an open state when auxiliary device 31 exits working channel 14.

[0219] 8B shows a transverse cross-sectional view of the device of FIG. 8A through center B-B', where a displacement element or rotation-imparting element (e.g., pusher, force application member, or element, etc.) 23 is disposed or positioned within the lumen of tube 21, and cable 18 and pull wire 24 are disposed within the lumen of displacement element 23. In some configurations, auxiliary device 31 is disposed or otherwise positioned within the lumen of working channel 14. The relationship between tube 21 and displacement element 23 can be reversed, such that the tube is disposed within the lumen of displacement element 23.

[0220] 8C shows a transverse cross-sectional view of the device of FIG. 8A centered on C-C', with sensing unit 15 coupled at or proximal to the distal end 28 of the tube, and flap 35 displaced from electromagnetic element (and / or other energy element) 29 as auxiliary device 31 exits working channel 14. In some embodiments, the interaction between electromagnetic element 29 and element 36 in flap 35 is attractive, orienting the distal end of auxiliary device 31 parallel to sensing unit 15. However, in other embodiments, a different type of interaction can be used (e.g., a non-attractive interaction).

[0221] FIG. 9A shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 10 comprising a tube 21 having at least one or more at least partial spiral cuts 22 and at least one sensing unit 15 coupled (e.g., fixedly or removably) to a distal end 28 or proximal to the elongate member (e.g., tube) 21. The tube 21 can be configured to articulate along one or more portions or regions, referred to herein as an articulation zone 41. In some configurations, the articulation zone 41 is disposed between the sensing unit 15 and the one or more at least partial spiral cuts 22. The device further comprises a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a pull wire 24 coupled to a deflectable zone 42 of the tube 21, a working channel 14, and a straightening element 43. In some embodiments, the straightening element 43 is configured to pass through the working channel 14 and engage a proximal end of the sensing unit 15 such that the articulation zone 41 is in a straight or linear (or substantially straight or linear) configuration.

[0222] FIG. 9B shows a transverse cross-sectional view of the device of FIG. 9A taken along center line B-B', with the distal end of the straightening element 43 disposed or positioned within at least one groove or feature along the proximal end of the sensing unit 15, thereby maintaining the articular zone 41 in a straight or substantially straight configuration.

[0223] 10A shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 10 comprising a tube 21 having at least one or more at least partial cuts (e.g., spiral cuts) 22 and at least one sensing unit 15 coupled (e.g., fixedly or removably) to or proximal to a distal end 28 of the tube 21. In embodiments, at least a portion of the tube 21 is configured to articulate along one or more articulation zones 41, which may be disposed between the sensing unit 15 and one or more at least partial spiral cuts 22. The device further comprises a displacement or rotation-imparting element (e.g., a pusher, force-applying member or element, etc.) 23, a working channel 14, and a pull wire 24 coupled to a deflectable zone 42 of the tube 21. The articulation zones may be in a bent state or orientation that allows an auxiliary device 31 to pass through the working channel 14. In some embodiments, the pull wire or other bend assembly 24 passes through and is disposed within the working channel 14.

[0224] 10B shows a transverse cross-section of the device of FIG. 10A through center line B-B', having articulation zone 41 in a bent configuration, allowing sensing unit 15 to move away from the longitudinal axis of working channel 14. This, in turn, can facilitate the utilization of a larger auxiliary device 31 or multiple auxiliary devices, as desired or required.

[0225] FIG. 11A shows a longitudinal cross-sectional view of a distal portion of another embodiment of device 10 comprising a longitudinal member (e.g., tube) 21 having at least one or more at least partial cuts (e.g., spiral cuts) 22, at least one sensing unit 15 coupled (e.g., fixedly or removably) to a distal end 28 or proximal to the tube 21, a displacement element 23, a pull wire (or other bending assembly) 24, and a working channel 14. In some configurations, at least a portion of the tube 21 is configured to articulate along one or more zones or regions (e.g., referred to herein as articulation zones 41). In some embodiments, the articulation zones 41 are positioned or disposed between the sensing unit 15 and the one or more at least partial spiral cuts 22 of the tube. The pull wire or other bending assembly 24 can be coupled to a deflectable zone 42 of the tube 21.

[0226] With further attention to the device 10 of FIG. 11A, in some embodiments, the articular zone is in a bent state after removal of the straightening element 43, which allows one or more auxiliary devices to pass through the working channel 14. In some embodiments, when the rotational stabilizer 51 engages the fastener 53, the torsional stiffness of the distal end of the device 10 is increased, thereby reducing (e.g., reducing, minimizing, etc.) undesirable and / or undesirable rotational movement. However, in some configurations, when the rotational stabilizer 51 is not engaged with the fastener 53, the torsional stiffness of the distal end of the device 10 is decreased (e.g., a minimum level, a low level, a reduced level, etc.), and the distal end of the device 10 can rotate when the displacement element 23 causes a change in length of one or more at least partial spiral cuts 22. Once a desired angular position of the distal end of the device 10 is achieved, this angular position can be maintained by engaging the rotational stabilizer 51 with the fastener 53.

[0227] FIG. 11B shows a transverse cross-sectional view of the device of FIG. 11A centered on B-B', where tube 21 is disposed within the lumen of rotational stabilizer 51 and displacement element 23 is disposed within the lumen of tube 21.

[0228] FIG. 11C shows a transverse cross-sectional view of the device of FIG. 11A centered on CC', in which the tube 21 is disposed within the lumen of the rotational stabilizer 51 and the displacement element 23 is disposed within the lumen of the tube 21.

[0229] FIG. 12A shows a distal portion of another embodiment of the device 10 with at least two units. 1 shows a longitudinal cross-section of each unit, with each unit including at least one tubular member 21 having at least one partial spiral cut 22, at least one displacement or rotation imparting element (e.g., a pusher, force applying member or element, etc.) 23, and at least one rotational stabilization element 51. In some embodiments, each unit is configured to translate and rotate independently of the other unit(s). This allows the device 10 to have multiple articulated sections, increasing the degrees of freedom of the device. Additionally, this allows the device 10 to have multiple separated actuators in a low profile and cost-effective manner.

[0230] FIG. 12B shows a transverse cross-sectional view of the device of FIG. 12A about B-B', with three units (e.g., for reference and illustrative purposes, units A, B, and C) disposed or otherwise positioned within the lumen of each successively larger unit. For example, in some embodiments, unit A includes an elongated member (e.g., tube) 21A having one or more at least partial spiral cuts 22A disposed or otherwise positioned within the lumen of a rotational stabilizer 51A, and a displacement element 23A positioned within the lumen of the tube 21A. Unit A can be disposed within the lumen of unit B. Unit B can comprise an elongated member (e.g., tube) 21B having one or more at least partial spiral cuts 22B, and can be disposed within the lumen of the rotational stabilizer 51B, and a displacement element 23B positioned within the lumen of the tube 21B. Additionally, unit B can be disposed within the lumen of unit C. In some embodiments, unit C comprises an elongate member (e.g., tube) 21C having one or more at least partial cuts (e.g., spiral cuts) 22C. The tube can be disposed or otherwise positioned within the lumen of rotational stabilizer 51C and displacement element 23C, which is disposed within the lumen of tube 21C.

[0231] FIG. 13 shows a flow chart or diagram relating to one embodiment of a method for controlling movement of a distal end of a device 10 (e.g., any device disclosed herein or equivalent). As shown, first, the position of the tip or distal end of the device can be sensed (e.g., with a sensing unit, alone or in combination with separate techniques). The position of the device can be displayed or otherwise provided to a physician or other practitioner or user. For example, the position can be provided to a visual output device (e.g., a monitor or other display).

[0232] With continued reference to the flow diagram of FIG. 13, a user can provide one or more inputs (e.g., via a touch screen, personal computer, keyboard, other smart device, and / or any other user input device). The device or system can process the data and other information acquired and / or provided to it (e.g., sensory data, user input, imaging data, etc.) to determine a desired or required movement, which may include tip rotation, tip deflection, and / or longitudinal movement. Such movement information and instructions can be provided to one or more movement devices (e.g., motors, linear or other actuators, etc.) configured to selectively move the device.

[0233] 14 shows a flow chart or diagram relating to another embodiment of a method for controlling movement of the distal end of device 10. As shown, the method may include one or more additional and / or fewer steps or processes. For example, relative to the embodiment of FIG. 13, the embodiment of FIG. 14 also includes steps for determining a desired or required anatomical destination or location for the tip of the device, calculating and determining one or more possible paths to such target location, determining whether the calculated paths are acceptable, and determining whether the calculated paths are acceptable. The method may also be configured to include one or more of: verifying the presence or absence of a target anatomical location (e.g., in response to any internal criteria, in response to a user, etc.), determining alternative routes for reaching the target anatomical location, and providing one or more additional or alternative efficacy and / or safety measures and / or the like.

[0234] Various embodiments disclosed herein can be designed, adapted, and / or otherwise configured to operate with another type of robotically guided advancement system or similar systems that operate at least partially autonomously. Thus, in some embodiments, the device includes one or more sensing units (e.g., sensors) to enable accurate positioning and proper and safe advancement of the device through the target anatomy (e.g., anatomical network). Data and other information obtained at least in part using the device's sensing unit(s) can be communicated to a processor (e.g., internal or external to an endoluminal device, a robotic system or other advancement system, etc.) to aid in advancement of the device through the target anatomy, regardless of whether such advancement is fully autonomous or automated (e.g., using a robotic system) or whether the advancement is a hybrid of autonomous / automated and manual (e.g., with input and manipulation from a physician or other practitioner).

[0235] FIG. 15A shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 1510 comprising a tube 1521 having at least two or more cuts (e.g., helical cuts) 1543 and 1544 and connected to at least two conductors 1541 and 1542 (e.g., 1543 connected to 1541 and 1544 connected to 1542), at least one sensing unit 1515 coupled (e.g., fixedly or removably) to or near the distal end of the tube 1521, a displacement element 1523, and a working channel 1514. In some configurations, the at least two or more cuts and their corresponding conductors 1541 and 1543 and 1542 and 1544, respectively, are electrically isolated from each other. This allows current to flow from the handle to the sensing unit 1515. Additionally, electrical signals can be transmitted to and from the handle to the sensing unit 1515. The sensing unit 1515 is comprised of at least one or more sensors 1550 , a housing 1552 , one or more movable ribs 1551 , and a coupling 1553 along the proximal end of the sensing unit 1515 .

[0236] 15B shows a transverse cross-section of the device of FIG. 15A along center line B-B', with the ribs 1551 of the housing 1552 in a folded state, thereby reducing the overall profile of the sensing unit 1515. This lower profile can be advantageous when navigating to a desired location.

[0237] 15C shows a transverse cross-section of the device of FIG. 15A taken along line C-C', illustrating at least two cuts 1543 and 1544. For purposes of this illustration, the at least two cuts 1543 and 1544 are disposed within the lumen of the displacement element 1523. Note that in other embodiments, the at least two cuts 1543 and 1544 can be disposed circumferentially around the displacement element 1523. In some embodiments, as shown in this configuration, the at least two cuts 1543 and 1544 form a working channel 1514.

[0238] 15D shows a transverse cross-sectional view of the device of FIG. 15A taken along line D-D' and showing at least two electrical conductors 1541 and 1542. For purposes of this illustration, the at least two electrical conductors 1541 and 1542 are disposed within a lumen of the displacement element 1523. In other embodiments, the at least two electrical conductors 1541 and 1542 can be disposed circumferentially around the displacement element 1523.

[0239] In any of the embodiments disclosed herein, a section of an elongate member or tube configured to undergo a change in length for the purpose of generating a rotation about the longitudinal axis of the device can include physical properties that are different from the corresponding physical properties of the section of the elongate member immediately adjacent to the section. By way of example, in some embodiments, as described herein in multiple arrangements, a section can include one or more partial cuts and / or other features along the elongate member, while the adjacent portion of the elongate member to the section does not have such cuts or features. According to some embodiments, the at least one physical property that differs includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition, and / or the like. In some embodiments, the at least one physical property that differs includes stiffness or toughness, where the stiffness or toughness is less in at least one section than in the section of the elongate member immediately adjacent to the at least one section.

[0240] FIG. 15E shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 1510 comprising an elongate member or tube 1521 having at least two or more cuts (e.g., helical cuts) 1543 and 1544 and connected to at least two conductors 1541 and 1542 (e.g., 1543 connected to 1541 and 1544 connected to 1542) coupled via an insulator 1524 (e.g., plastic or polymeric material, another composition, etc.), at least one sensing unit 1515 coupled (e.g., fixedly or removably) to or near the distal end of the tube 1521, a displacement element 1523, and a working channel 1514. In some configurations, the at least two or more cuts and their corresponding conductors 1541 and 1543 and 1542 and 1544, respectively, are electrically insulated from each other. This allows current to flow from the handle to the sensing unit 1515. Additionally, electrical signals can be transmitted to and from the handle to the sensing unit 1515. The sensing unit 1515 comprises at least one or more sensors 1550, a housing 1552, one or more movable ribs or similar features 1551, a preferential deflection section 1555, and a coupling 1553 along a proximal end of the sensing unit 1515, the preferential deflection section enabling the longitudinal axis of the one or more sensors 1550 to remain aligned with the longitudinal axis of the elongated member 1521 when the one or more sensors 1550 are deflected toward or away from the longitudinal axis of the elongated element.

[0241] 15F shows a transverse cross-section of the device of FIG. 15E through center F-F', with the ribs or similar features 1551 of the housing 1552 in a folded state, thereby reducing the overall profile of the sensing unit 1515. This lower profile can be advantageous, for example, when navigating to a desired location.

[0242] 15G shows a transverse cross-section of the device of FIG. 15E taken along center G-G' and illustrating at least two cuts 1543 and 1544. For purposes of this illustration, the at least two cuts 1543 and 1544 are disposed within the lumen of the displacement element 1523. In other embodiments, the at least two cuts 1543 and 1544 can be disposed circumferentially around the displacement element 1523. In the illustrated embodiment, the at least two cuts 1543 and 1544 form the working channel 1514.

[0243] Figure 15H shows a transverse cross-sectional view of the device of Figure 15E taken along center line H-H', illustrating at least two electrical conductors 1541 and 1542. In the configuration shown, the at least two electrical conductors 1541 and 1542 are disposed within the lumen of the displacement element 1523. However, in other embodiments, the at least two electrical conductors 1541 and 1542 can be disposed circumferentially around the displacement element 1523 as desired or required.

[0244] 16A shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 1510 comprising an elongate member (e.g., tube) 1521 having at least two or more cuts (e.g., spiral cuts) 1543 and 1544 and connected to at least two electrical conductors 1541 and 1542. For example, but not by way of limitation, in the illustrated embodiment, 1543 is connected to electrical conductor 1541 and 1544 is connected to electrical conductor 1542. Additionally, in some embodiments, as shown, the device further includes at least one sensing unit 1515 coupled (e.g., fixedly or removably) to or near the distal end of the tube 1521, with a displacement element 1523 and / or an auxiliary device 1531 (such as an instrument) disposed in the working channel 1514.

[0245] In some configurations, at least two or more cuts and their corresponding conductors 1541 and 1543 and 1542 and 1544, respectively, are electrically isolated from one another. This allows current to flow from the handle to the sensing unit 1515. Additionally, electrical signals can be transmitted to and from the handle to the sensing unit 1515. In some embodiments, the sensing unit 1515 includes at least one or more sensors 1550, a housing 1552, one or more movable ribs 1551, a coupling 1553 along a proximal end of the sensing unit 1515, and / or any other components or features as desired or required. The auxiliary device 1531 can be configured to expand or otherwise move one or more ribs or similar features 1551 outward, thus increasing the cross-sectional area of ​​the working channel 1514 in the sensing unit 1515. Such configurations can be incorporated into any of the embodiments disclosed herein.

[0246] 16B shows a transverse cross-sectional view of the device of FIG. 16A through center B-B', with the ribs 1551 and / or similar features of the housing 1552 in an expanded state and subordinate to the presence of the auxiliary device 1531. This larger cross-sectional area may be advantageous or otherwise beneficial as it allows for larger or multiple instruments to be used (e.g., as compared to embodiments that are not expandable or otherwise configured to expand).

[0247] Figure 16C shows a transverse cross-sectional view of the device of Figure 16A about C-C' showing auxiliary device 1531 within working channel 1514, which in the illustrated embodiment includes at least two cuts (e.g., at least partial cuts) 1543 and 1544. Additional cuts and / or other features along this portion can be used as desired or needed.

[0248] Figure 16D shows a transverse cross-sectional view of the device of Figure 16A along center line D-D', illustrating auxiliary device 1531 positioned within working channel 1514, formed by (and / or comprising) at least two electrical conductors 1541 and 1542. In the configuration shown, at least two electrical conductors 1541 and 1542 are disposed within the lumen of displacement element 1523. However, in other embodiments, the position, orientation and / or other characteristics of the conductors may vary as desired or needed.

[0249] 17A shows a longitudinal cross-sectional view of a distal portion of another embodiment of a device 1710 comprising an elongate member (e.g., tube) 1721 having at least one or more at least partial cuts (e.g., spiral cuts) 1722, at least one sensing unit 1715 coupled (e.g., fixedly or removably) to or near the distal end of the tube 1721, a displacement element 1723, and / or any other components, elements, and / or features. In some configurations, at least one or more conductive The bodies 1725, 1726, 1727, 1727, 1728, and 1729 are disposed or extend at least partially within the displacement element 1723. The conductors 1725, 1726, 1727, 1727, 1728, and 1729 can be electrically insulated from one another by an insulator 1724 (e.g., a coating or covering, a material disposed along the outside of the conductors, etc.). The conductors 1725, 1726, 1727, 1727, 1728, and 1729 can allow electrical current to be transmitted from the handle to the sensing unit 1715 and / or to another device, component, or member that needs to be electrically coupled to another device or component (e.g., a power source, a sensor, a processor, etc.).

[0250] Additionally, in some configurations, electrical signals can be transmitted to and from the handle to the sensing unit 1715. In the illustrated embodiment, the electrical conductors 1725, 1726, 1727, 1727, 1728, and 1729 are arranged, positioned, or extend along the displacement element 1723 in a helical or some other non-linear manner. However, in other embodiments, the electrical conductors 1725, 1726, 1727, 1727, 1728, and 1729 can be arranged along the displacement element 1723 in a different orientation, such as, for example, a linear orientation along the longitudinal axis of the device 1710. The sensing unit 1715 can include at least one or more sensors 1750, a housing 1752, one or more movable ribs or similar members 1751, a coupling 1753, one or more electrical connectors 1754 along a proximal end of the sensing unit 1715, etc., as desired or required.

[0251] 17B shows a transverse cross-section of the device of FIG. 17A along center line B-B', with ribs 1751 of housing 1752 in a folded state, thereby reducing the overall profile of sensing unit 1715. This lower profile can be advantageous when navigating to a desired location.

[0252] 17C shows a transverse cross-sectional view of the device of FIG. 17A taken along line C-C' and shows one or more electrical connectors 1754 in electrical communication with conductors 1725, 1726, 1727, 1728, and 1729. The one or more electrical connectors 1754 are electrically insulated from one another by insulator 1724. The insulator abuts the distal end of tube 1738.

[0253] 17D shows a transverse cross-sectional view of the device of FIG. 17A centered on D-D′, illustrating a portion of the tube 1721 including at least one or more at least partial cuts 1722 and / or similar features. In the illustrated configuration, the elongated member (e.g., tube) 1721 is at least partially (e.g., partially, completely, etc.) disposed within the lumen of the displacement element 1723. However, in other embodiments, the elongated member (e.g., tube) 1721 is disposed circumferentially around the displacement element 1723 and / or along any other portion of the device. In some embodiments, one or more electrical conductors 1725, 1726, 1727, 1727, 1728, and 1729 are at least partially disposed within the displacement element 1723. The one or more electrical connectors 1725, 1726, 1727, 1727, 1728, and 1729 can be electrically insulated from one another by an insulator 1724.

[0254] 17E shows a transverse cross-section of the device of FIG. 17A taken along centerline E-E', illustrating elongate member (e.g., tube) 1721 proximal to one or more at least partial cuts 1722. In some embodiments, one or more electrical conductors 1725, 1726, 1727, 1728, and 1729 are at least partially disposed within displacement element 1723. Such electrical conductors may be inserted into one or more insulators 172. 4, which allows them to be electrically insulated from each other.

[0255] FIG. 18A shows a longitudinal cross-sectional view of a sensing unit 1815 comprising a cylindrical housing 1830, at least one sensing element 1832, a solenoid 1842, a magnetic element 1841 located (e.g., at least partially) within the solenoid 1842, a solenoid controller unit 1843, at least one lighting element 1834, a working channel 1814, a non-conductive housing 1850, one or more movable ribs or similar members or features 1851, at least one coupler 1853, one or more electrical connectors 1854 along a proximal end of the sensing unit 1815, one or more electrical conductors (e.g., wires) 1855 and 1856 in electrical continuity with the solenoid 1842, a solenoid controller unit 1843, the sensing unit or element 1832, the lighting element 1834, and / or the like. As shown, the tubular housing 1830 can include a vertebral (e.g., sectioned, ribbed, etc.) region or other preferential bending region 1831. The bending region or portion 1831 can include one or more at least partial cuts 1833 to help create a preferential bending in the vertebral region 1831 when a solenoid or similar device, component, or feature 1842 is actuated or otherwise moved or manipulated. In the illustrated embodiment, the solenoid controller is located within the sensing unit 1815. However, in alternative embodiments, the solenoid controller unit can be located external to the patient, such as in a handle, an external box, incorporated into a separate device, etc., as desired or required. A coupler 1853 and one or more electrical connectors 1854 can allow the sensing unit 1815 to be reversibly or irreversibly connected to one or more other portions of the device. Current may be sent or otherwise communicated from the handle or external controller(s) to the solenoid 1842, solenoid controller unit 1843, sensing element 1832, and / or lighting element 1834 via one or more conductors (e.g., wires, insulated leads, etc.) 1855 and 1856.Electrical signals may be sent or otherwise communicated to and / or from the handle or external controller(s) via one or more electrical conductors (e.g., wires, insulated leads, etc.) 1855 and 1856 to and / or from the solenoid 1842, solenoid controller unit 1843, sensing element 1832, and / or lighting element 1834.

[0256] 18B illustrates a transverse cross-sectional view of the sensing unit 1815 of FIG. 18A along center B-B', with the ribs or similar features 1851 of the non-conductive housing 1850 in a folded state, thereby reducing the overall profile of the sensing unit 1815. This lower profile can be advantageous when navigating to a desired location. The tubular housing 1830 can include one or more sensing elements 1832, lighting elements 1834, etc. In some embodiments, the one or more ribs 1851 can include and / or help form the working channel 1814.

[0257] FIG. 18C shows a transverse cross-sectional view of sensing unit 1815 of FIG. 18A taken along center line CC′, showing magnetic element 1841 within solenoid 1842.

[0258] FIG. 18D shows a transverse cross-sectional view of the sensing unit 1815 of FIG. 18A taken along centerline D-D′, illustrating a magnetic element 1841 within a solenoid 1842 in one or more at least partial cuts 1833 in the vertebral portion of the tubular housing 1830.

[0259] FIG. 18E shows a transverse cross-sectional view of sensing unit 1815 of FIG. 18A along center line E-E′, illustrating coupler 1853 and one or more electrical conductors (eg, wires) 1855 and 1856.

[0260] FIG. 19A shows a longitudinal cross-sectional view of a sensing unit 1815 including a cylindrical housing 1830, at least one sensing element 1832, a solenoid 1842, a magnetic element 1841 located within the solenoid 1842, a wireless receiver / transmitter unit 1847, at least one lighting element 1834, a working channel 1814, a non-conductive housing 1850, one or more movable ribs or similar features 1851, at least one coupler 1853, one or more power sources 1844 in electrical continuity with the solenoid 1842, the receiver / transmitter unit 1847, the sensing element 1832, and / or the lighting element 1834. The cylindrical housing 1830 may include a vertebral or segmented region 1831 that includes one or more at least partial cuts 1833 and / or other features (as described herein) to create preferential bending in the vertebral region 1831 when a solenoid or similar electrically powered device, component, or feature 1842 is actuated or otherwise manipulated (e.g., manually by a physician or other user, by a robotic system, etc.).

[0261] 19A , in some embodiments, the sensing unit 1815 operates in a wireless manner via an enclosed power supply 1844 and a wireless receiver / transmitter unit 1847. However, in alternative embodiments, the power supply 1844 can be located external to the patient, such as in a handle or an external box that can be supplied by embedded wiring as described above, as desired or necessary. In some embodiments, a coupler 1853 allows the sensing unit(s) 1815 to be reversibly or irreversibly connected to one or more other components or portions of the device. For example, current can be sent from the power supply 1844 via one or more conductors (e.g., wires) 1845 and 1846 to the solenoid 1842, the wireless receiver / transmitter unit 1847, the sensing element 1832, and / or the lighting element 1834. Additionally, data can be sent between the sensing element 1832, the solenoid 1842, and / or the lighting element 1834 via the wireless receiver / transmitter unit 1847 to one or more external controller(s).

[0262] 19B illustrates a transverse cross-sectional view of the sensing unit 1815 of FIG. 19A centered on B-B', with the ribs or similar features 1851 of the non-conductive housing 1850 in a folded state (e.g., partially or fully folded state), thereby reducing the overall profile of the sensing unit 1815. This lower profile can be advantageous when navigating to a desired location. The tubular housing 1830 can include one or more sensing elements 1832, lighting elements 1834, etc. According to some embodiments, the one or more ribs or similar features 1851 can help form the working channel 1814.

[0263] FIG. 19C shows a transverse cross-sectional view of sensing unit 1815 of FIG. 19A taken along line CC′, showing magnetic element 1841 within solenoid 1842 and electrical conductor 1846.

[0264] FIG. 19D shows a transverse cross-sectional view of the sensing unit 1815 of FIG. 19A taken along centerline D-D′, illustrating one embodiment of a magnetic element 1841 within a solenoid 1842 and conductor 1846 in one or more at least partial cuts 1833 in the vertebral portion of the cylindrical housing 1830.

[0265] FIG. 19E shows a transverse cross-sectional view of sensing unit 1815 of FIG. 19A taken along line EE′, showing coupler 1853.

[0266] Any of the embodiments disclosed herein may include bent arms similar to those shown in Figures 18A-19A-19E and / or as otherwise described in the specification of this application. The assembly may be incorporated into any arrangement disclosed herein or its equivalent. Thus, in some embodiments, the bending assembly, either incorporated within or provided with the endoluminal device, or a separate assembly adapted for use with the endoluminal device, may include a solenoid and / or another electrically powered or electrically actuated device to help achieve the desired bending of the distal portion or aspect of the device. In some embodiments, such a solenoid or other device may provide one or more advantages or benefits over existing technology (e.g., pull wire systems). For example, a solenoid need not have a mechanical connection that extends from the distal end (e.g., at or near the bending portion of the elongated member) to or near the proximal end of the elongated member (e.g., tube). Such a configuration may simplify the overall design of the endoluminal device, increase the available cross-sectional area of ​​other features / components (e.g., more or larger lumens or other working openings for passing tools and / or other devices), reduce costs, improve manufacturing and / or the like.

[0267] Embodiments of the solenoid and / or similar bending assemblies can be incorporated into any of the configurations of the endoluminal devices disclosed herein. In some configurations, the bending assembly can be provided as a separate item that is incorporated into the endoluminal device (e.g., either at the time of manufacture or as an add-on or aftermarket item) as desired or needed.

[0268] According to some embodiments, a device configured to bend includes an elongate member (e.g., a tube) having a longitudinal axis, a proximal end, and a distal end, and a bending assembly located at, along, or proximal to the distal end, where the bending assembly is configured to be manipulated using a powered actuation component.

[0269] According to some embodiments, the actuation component includes at least one solenoid. In some embodiments, the flexion assembly is integral with the elongated member. In other configurations, the flexion assembly is not integral with the elongated member. In some configurations, the flexion assembly is configured to be rigidly secured to the elongated member. In some embodiments, the flexion assembly is configured to be removably secured to the elongated member.

[0270] According to some embodiments, the elongated member includes at least one preferred bend portion along which the elongated member is configured to bend when the bending assembly is manipulated. In some embodiments, the at least one preferred bend portion includes at least one partial cut in a wall of the elongated member. In some configurations, the at least one preferred bend portion includes a vertebra-like region or a plurality of rib-like members. According to some embodiments, the at least one preferred bend portion includes at least one of the aforementioned physical properties that differ from a physical property of a portion of the elongated member directly adjacent to the at least one preferred bend portion. In some embodiments, the at least one different physical property includes tensile strength, compressive strength, stiffness, toughness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material or material composition. In one embodiment, the at least one different physical property includes stiffness or toughness, which is less in the at least one preferred bend portion than in the directly adjacent portions of the elongated member.

[0271] According to some embodiments, the flexion assembly includes a power source, the power source (eg, a battery, other energy storage component, etc.) configured to provide electrical energy to the actuation components.

[0272] In some embodiments, the actuation components are configured to be controlled using a controller (e.g., a button, a roller wheel, a knob, a switch, a touch screen, or another controller, etc.) In some embodiments, the controller is configured to be operated by a user during a procedure.

[0273] According to some embodiments, the device further comprises at least one detection or treatment element or component. In one embodiment, the at least one detection or treatment element or component comprises at least one sensor (e.g., one or more of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, an optical sensor, a marker, a camera, a visualization device, an imaging device, and a light source, etc.).

[0274] According to some embodiments, at least one sensing or therapeutic element or component comprises an energy delivery element. In some embodiments, the energy delivery element is configured to selectively heat and / or cool tissue. In some configurations, the energy delivery element includes an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other forms of energy.

[0275] The present application is directed to a medical device with 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 form) a rotational movement at the distal end of the 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 dual helical symmetry helix. In some embodiments, as discussed in more detail herein, the dual helical symmetry 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 cross each other. According to some embodiments, a displacement (e.g., linear displacement or other displacement) of the dual helical symmetry helix along its long axis will rotate 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 surgical uses and applications, as well as industrial and diagnostic applications such as testing.

[0276] 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 patient's vasculature or other intraluminal structure as desired or required (e.g., to reach or approach a desired anatomical location). In some embodiments, as discussed in more detail herein, the intraluminal device is configured to be directed to an intraluminal location (e.g., within a blood vessel, other intraluminal, anatomical location (e.g., through a patient's airway, digestive system, etc.)).

[0277] 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 may extend only partially through the tube or outer member, as desired or required.

[0278] 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. In other configurations, however, the cuts have two or more orientations (e.g., angle, pitch, etc.), opening sizes, spacing, and / or other characteristics relative to the longitudinal axis, as desired or required. For example, in some configurations, the cut(s) have a dual helix or dual helical symmetric helix design. In other embodiments, however, the cuts have a single helix design (e.g., cuts having the same pitch, general direction of orientation, other characteristics, and / or the like).

[0279] According to some embodiments, the device comprises a tube or outer member, a pusher member or other force application element, and one or more cuts or other features along the distal end of the tube. In some embodiments, linear movement of the force application element 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 of the device and / or manipulation of the device through the patient's vasculature or other intraluminal system. In some embodiments, the tube or other member is secured to the pusher member or other force application element along one or more locations (e.g., the distal end of the device) using one or more fastening (e.g., direct or indirect) methods, features, devices, techniques, etc.

[0280] In some embodiments, the cuts made (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 degrees to 80 degrees (e.g., 10 degrees to 15 degrees, 15 degrees 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, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device. In some embodiments, the helical angle is in the range of 15 degrees to 75 degrees.

[0281] 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.).

[0282] According to some embodiments, the inner member, and thus the entire endoluminal device, is cannulated or otherwise comprises 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 comprise one or more outer members, layers, coatings, and / or other members.

[0283] While some configurations disclosed herein have dual helix or dual helical symmetric helix designs, linear to rotational translation can also be achieved; Also, certain embodiments may be preferred and / or may otherwise exhibit certain advantages over a dual helix configuration. Thus, any embodiment disclosed herein may be configured and / or otherwise adapted to include a single or multiple (e.g., dual helix symmetry) helix design. Additionally, the medical devices disclosed herein may be adapted to perform linear to rotational transformations using designs that do not include a helix, as discussed in more detail herein and shown in the accompanying drawings.

[0284] As discussed in further detail herein, the embodiments disclosed herein may 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 endoluminal devices disclosed herein may vary from 1 mm to 25 mm (e.g., 1 mm to 25 mm, 1 mm to 5 mm, 5 mm to 10 mm, 1 mm to 10 mm, 10 mm to 15 mm, 15 mm to 20 mm, 20 mm to 25 mm, 10 mm to 20 mm, 15 mm to 25 mm, 10 mm to 25 mm, values ​​between the aforementioned ranges, etc.) or from 1 French to 75 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, 23 French, 24 French, 25 French, 26 French, 27 French, 28 French, 29 French, 30 French, 31 French, 32 French, 33 French, 34 French, 35 French, 36 French, 37 French, 38 French, 39 French, 40 French, 41 French, 42 French, 43 French, 44 French, 45 French, 46 French, 47 French, 48 French, 49 French, 50 French, 51 French, 52 French, 53 French, 54 French, 55 French, 56 French, 57 French, 58 French, 59 French, 60 French, 61 French, 62 French, 63 French, 64 French, 65 French, 66 French, 67 French, 68 French, 69 French, 70 French, 71 French, , 25 French, 26 French, 27 French, 28 French, 29 French, 30 French, 31 French, 32 French, 33 French, 34 French, 35 French, 36 French, 37 French, 38 French, 39 French, 40 French, 41 French, 42 French, 43 French, 44 French, 45 French, 46 French, 47 French, 48 French, 49 French, 50 French, 51 French, 52 French, 53 French, 54 French, 55 French, 56 French, 57 French, 58 French, 59 French, 60 French, 61 French, 62 French, 63 French, 64 French, 65 French, 66 French, 67 French, 68 French, 69 French, 70 French, 71 French, 72 French, 73 French, 74 French, 75 French, and any value in between the foregoing. However, in other embodiments, the intraluminal device may include any other diameter or size, such as, for example, but not limited to, custom sizes below, above, or between the values ​​recited above. Additionally, the length of the device may 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 130 cm, 140 cm to 150 cm, 150 cm to 160 cm, 160 cm to 170 cm, 170 cm to 180 cm, 180 cm to 200 cm, 200 cm to 220 cm, 220 cm to 240 cm, 240 cm to 280 cm, 260 cm to 280 cm, 280 cm to 290 cm, 290 cm to 300 cm, 30 cm to 320 cm, 320 cm to 360 cm, 34 cm to 380 cm, 360 cm to 390 cm, 380 cm to 400 cm, 380 cm to 400 cm, 380 cm to 400 cm, 380 cm to 500 cm, 380 cm to 500 cm, 380 cm to 500 cm, 380 cm to 500 cm, 380 cm to 600 cm, 380 cm to 700 cm, 380 cm to 800 cm, 380 cm to 90 cm, 380 cm to 100 cm, 380 cm to 110 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.

[0285] 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 patient (e.g., the heart or cardia, head and neck, liver, kidneys, hepatic vasculature, renal vasculature, extremities, etc.). Any other part of the anatomy can also be reached and targeted using the device. Various embodiments disclosed herein can be used to reach parts of a patient's anatomy that are accessible through tortious vascular or other endoluminal routes (e.g., the endoluminal device). This can be particularly advantageous when a professional is attempting to reach and treat a variety of conditions (such as those that require bending or changing direction of the chair 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.

[0286] In some embodiments, imparting rotation to a distal portion at a distal end (e.g., as opposed to rotating the entire length of the medical device) can help reduce stress on the vasculature, improve precision of rotation 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 efficiency of the procedure, 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 complications associated with the procedure, reduce fatigue of 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.

[0287] 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 a reference to the structures shown in the figures and are utilized only 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.

[0288] 20 illustrates a system for imaging a medical device 10 within a 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.) can be incorporated and synchronized with any embodiment disclosed herein, regardless of whether they are included in the device.

[0289] 21A and 21B show the distal end 12 of the device 10 within an intraluminal structure 20 according to one embodiment. Intraluminal structures include, but are not limited to, blood vessels, heart, gastrointestinal (GI) tract, genitourinary (GU) tract, peritoneal cavity, thoracic cavity, diaphragm, bronchial tract, subarachnoid space, and intracranial ventricular system. In FIG. 21A, a guidewire 14 is shown within the device 10 with the device's distal end 12 facing away from a desired intraluminal branch 21. In FIG. 21B, the distal end 12 and guidewire 14 within the intraluminal structure 20 of FIG. 21A have been rotated to face the desired intraluminal branch 21.

[0290] FIG. 22A shows a schematic of a tube 30 having a dual helical symmetry helix 37 formed by a proximal helical cut 31 and a distal helical cut 32 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 range from 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 0.8 millimeters, 0.7 millimeters to 0.9 millimeters, 0.8 millimeters to 0.9 millimeters, 0.9 millimeters to 0.9 millimeters, 0.9 millimeters to 0.8 millimeters, 0.9 millimeters to 0.9 ... mm, 0.5 mm to 0.6 mm, 0.6 mm to 0.7 mm, 0.7 mm to 0.8 mm, 0.8 mm to 0.9 mm, 0.9 mm to 1 mm, 1 mm to 2 mm, 2 mm to 3 mm, 3 mm to 4 mm, 4 mm to 5 mm, 5 mm to 6 mm, 6 mm to 7 mm, 7 mm to 8 mm, 8 mm to 9 mm, 9 mm to 10 mm, values ​​between the aforementioned values, etc. In some embodiments, the cut width is in the range of 10 microns to 1000 microns. The helical angles 39a, 39b can be in the range of 10 degrees to 80 degrees (e.g., 10 degrees to 15 degrees, 15 degrees 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, angles between the aforementioned ranges, etc.) relative to the longitudinal axis of the device. In some embodiments, the helical angles are in the range of 15 degrees to 75 degrees. The cut widths 38a, 38b can be equal or different, and the helical angles 39a, 39b can have the same or different magnitudes. In some embodiments, when a force 34 is applied along the longitudinal axis 40 of the tube 30, the force is translated into a force along the distal helix 35, which is applied at the connection point 33, and a force along the proximal helix 36. The cut widths 38a, 38b and helical angles 39a, 39b change as the dual helical symmetric helix 37 is lengthened or shortened to produce a rotational movement.

[0291] 22B shows a cutaway balance 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.

[0292] 23A-C illustrate the rotation of connection point 54 between proximal helical cut 53 and distal helical cut 52 when a distal portion of tube 51 is extended, according to one embodiment. FIG. 23A illustrates the distal portion of tube 51 that is not extended, while FIG. 23B illustrates 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. 23A). FIG. 23C illustrates the distal portion of tube 51 that has been extended, whereby connection point 54 and distal segment 55 are rotated 180 degrees relative to their respective positions in FIG. 23A.

[0293] FIG. 24 shows a flow chart of an embodiment of a method 500 for controlling the distal end 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 dual spiral symmetric helix 37 to rotate the distal end 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 application of energy to one or more actuators coupled to the medical device, such as the magnetic elements 117, 118 (FIG. 38A). In step 350, the change in position of the distal tip 12 is observed on the display. In step 360, the amount of longitudinal displacement changes the amount of longitudinal force applied to the dual helical symmetric helix 37 via the sleeve 57 / guidewire 62 or through the application of energy to one or more actuators 117, 118. 4. The distal end 12 is adjusted to rotate by a desired angle.

[0294] FIG. 25A is a diagram of a medical device 50 according to one embodiment of the present disclosure. As shown, the device 50 includes a tube 51, a distal segment 55 coupled to a distal end of the tube 51, and a sleeve 58. The sleeve 58 is disposed within the lumen of the tube 51. The sleeve 58 can be advanced or retracted within the tube 51 to longitudinally displace the helices 52, 53. The device 50 also includes a handle 70, comprised of a proximal component 71 and a distal component 72, attached to the proximal end of the tube 51. Each of the proximal component 71 and the distal component 72 has a cylindrical body such that the proximal component 71 can be inserted within the distal component 72 and the sleeve 58 can be inserted within the proximal component 71. The proximal component 71 is reversibly coupled to the sleeve 58 and the distal component 72 is reversibly coupled to the 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.

[0295] 25B focuses on the distal segment and distal end 51. As shown, a dual helical symmetric 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 about the distal end of tube 51 and is joined 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, one or more of 1) adhesive (such as cyanoacrylate), 2) welding, 3) brazing, 4) soldering, and 5) mechanical linkage, with further suitable means known to those skilled in the art. As shown, the wire 62 may be disposed within the lumen of the tube 51 and may be advanced into or withdrawn from the tube 51 slidably along the longitudinal axis of the tube 51. As the wire 62 is advanced, it may abut the capped end 61 of the tube 51. Further advancement of the wire 62 after it abuts the capped end 61 may result in a linear displacement of the dual helical symmetry helix 67. The force associated with the linear displacement of the dual helical symmetry helix 67 generates a rotational force at the connection 54 that rotates the distal segment 55. As is well known to those skilled in the art, a thin coil wire 64 may be wrapped around the proximal end of the distal segment 55 and coupled to the tube 51 to smoothly displace between the distal segment 55 and the tube 51. Advantageously, the linear movement is limited to the distal portion of the tube 51, particularly the dual helical symmetry helix 67 and distal to the dual helical symmetry helix 67. For this reason, it is not necessary to linearly displace the entire tube 51 .

[0296] 26A is a longitudinal cross-sectional view of device 50 with open distal end 65 in distal segment 55 in its unactuated state (i.e., dual helical symmetry helix 67 is not linearly displaced). The distal aspect of device 50 is shown with tube 51, and dual helical symmetry 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 all the way through the wall of the tube. Proximal helix 53 and distal helix 52 are formed such that they are in opposite orientations. For example, proximal helix 53 may be in a left-handed orientation. In some cases, the distal helix 52 may be right handed or vice versa. The connection points 54 of the left and right hand helices rotate as the dual helical symmetry helix 67 is linearly extended or compressed, resulting in translating the linear movement of the connection points 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 dual helical symmetry helix 67 is cut. The distal segment 55 is coupled to the helix connection points 54 of the dual helical symmetry helix 67 via coupling means 56. The distal segment 55 has an angled tip, which helps improve guidance of the device 50. The tube 51 has a reduced inner diameter of the lumen distal to the dual helical symmetry helix 67, forming a shelf 57. The outer diameter of the sleeve 58 is greater than the inner diameter of the shelf 57 of the tube 51 and less than the inner diameter of the tube 51 near the shelf 57. The sleeve 58 is in slidable contact with the shelf 57 of the tube 51 .

[0297] 26B shows the position of the distal end 65 after the sleeve 58 has been advanced, causing a linear displacement of the dual helical symmetry helix 67. This in turn results in a rotation of the connection point 54 of the proximal and distal helices 53 and 52, which in turn rotates the distal segment 55. The angle of rotation of the connection point 54 is proportional to the linear displacement of the dual helical symmetry helix 67 of the tube 51. For purposes of illustration, a 180 degree rotation is shown in FIG. 26B, however, different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the sleeve 58.

[0298] 27A shows a cross-sectional view of another embodiment of a distal segment 55 of device 50 in its unactuated state. The distal aspect of device 50 is shown with a tube 51 having a distal end and a proximal end, and a dual helical symmetric helix 67 is cut into the distal aspect of tube 51, thereby forming a proximal helix 53 and a distal helix 52. Distal segment 55 is joined to a connection point 54 of the two helices of dual helical symmetric helix 67. Proximal helix 53 and distal helix 52 are formed such that the proximal helix 53 and distal helix 52 are in opposite orientations. For example, if proximal helix 53 is in a left-handed orientation, distal helix 52 can be in a right-handed orientation, or vice versa. By its very nature, the connection point 54 of the left hand helix and the right hand helix rotates as the end of the dual helical symmetry helix 67 is linearly extended or retracted, resulting in translating the linear movement of the connection point 54 of the two helices into a rotational movement. A distal segment 55 is disposed around the circumference of the distal aspect of the tube 51, where the dual helical symmetry helix 67 is cut. The distal segment 55 is coupled to the helix connection point 54 of the dual helical symmetry helix 67 via coupling means 56. The distal segment 55 has an angled tip, which helps to improve guidance of the device 50. The tube 51 includes a shelf 57 where the inner diameter of the lumen distal to the dual helical symmetry helix 67 is reduced. The outer diameter of a sleeve 58 is greater than the inner diameter of the shelf 57 of the tube 51 and less than the inner diameter of the tube 51 near said shelf 57. The device 50 also includes a 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 is sized to pass through the reduced distal diameter of shelf 57. The remainder of wire 59, or at least the portion adjacent the distal portion, has a diameter that is greater 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.

[0299] In Fig. 27B, wire 59 is shown advanced into tube 51, linearly displacing dual spiral symmetric helix 67 as shown in Fig. 27B. The linear displacement rotates connection point 54 of proximal helix 53 and distal helix 52. 27B. The distal segment 55 is then rotated. The angle of rotation of the distal segment 55 is proportional to the linear displacement of the dual helical symmetry helix 67 of the tube 51. For purposes of illustration, a 180 degree rotation is shown in FIG. 27B, however, different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the wire 59.

[0300] 28A shows a cross-sectional view of another embodiment of a distal segment 55 of device 50 in its unactuated state with an open distal end 65. The distal aspect of device 50 is shown with a tube 51 having its distal end and its proximal end, and a dual helical symmetric helix 67 is cut into the distal aspect of tube 51, thereby forming a proximal helix 53 and a distal helix 52. Distal segment 55 is joined to a connection point 54 of the two helices of dual helical symmetric helix 67. Proximal helix 53 and distal helix 52 are formed such that the proximal helix 53 and distal helix 52 are in opposite orientations. For example, if proximal helix 53 is in a left-handed orientation, distal helix 52 can be in a right-handed orientation, or vice versa. By its very nature, the connection point 54 of the left hand helix and the right hand helix rotates as the end of the dual helical symmetry helix 67 is linearly extended or retracted, resulting in translating the 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 dual helical symmetry helix 67 is cut. The distal segment 55 is coupled to the helix connection point 54 of the dual helical symmetry helix 67 via coupling means 56. The distal segment 55 has an angled tip, which helps to improve guidance of the device 50. A wire 60 is coaxially disposed within the lumen of the tube 51, the wire 60 being reversibly expandable.

[0301] FIG. 28B shows the device 50 of FIG. 28A with the wire 60 expanded such that the expandable member 66 is expanded to or larger than the diameter of the tube 51. When the reversibly expandable member 66 is expanded, it engages the distal end of the tube 51. When the wire 60 is advanced while the reversibly expanded member 66 is in its expanded state, the wire 60 linearly displaces the dual helical symmetric helix 67. This in turn results in rotating the connection point 54 of 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 dual helical symmetric helix 67 of the tube 51. For purposes of illustration, a 180 degree rotation is shown in FIG. 28B, however, 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. 28A.

[0302] 29A 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 dual helical symmetric helix 67 is 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 dual helical symmetric helix 67. Proximal helix 53 and distal helix 52 are formed such that they are in opposite orientations. For example, if proximal helix 53 is in a left-handed orientation, distal helix 52 can be in a right-handed orientation, or vice versa. By its very nature, the connection point 54 between the left hand helix and the right hand helix rotates as the end of the dual helical symmetry helix 67 is linearly extended or retracted, resulting in translating the linear movement of the connection point 54 of the two helices into rotational movement. 29B. A distal segment 55 is disposed around the circumference of the distal aspect of tube 51, where a dual helical symmetric helix 67 is cut. Distal segment 55 is attached to a helix connection point 54 of dual helical symmetric helix 67 via a connecting means 56. Distal segment 55 has an angled tip, which helps improve guidance of device 50. Wire 62 is disposed coaxially within the lumen of tube 51. Wire 62 contacts capped end 61, and advancing wire 62 applies a force against capped end 61, linearly displacing dual helical symmetric helix 67, as shown in FIG. 29B. This in turn rotates connection point 54 of 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 dual helical symmetric helix 67 of tube 51. For purposes of illustration, a 180 degree rotation is shown in FIG. 29B, however, different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of wire 62.

[0303] 30A 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 dual helical symmetric helix 67 is 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 dual helical symmetric helix 67. Proximal helix 53 and distal helix 52 are formed such that they are in opposite orientations. For example, if proximal helix 53 is in a left-handed orientation, distal helix 52 can be in a right-handed orientation, or vice versa. By its nature, the connection point 54 of the left hand helix and the right hand helix rotates as the end of the dual helical symmetry helix 67 is linearly extended or retracted, resulting in translating the linear movement of the connection point 54 of the two helices into a rotational movement. A distal segment 55 is disposed around the circumference of the distal aspect of the tube 51, where the dual helical symmetry helix 67 is cut. The distal segment 55 is coupled to the helix connection point 54 of the dual helical symmetry helix 67 via a coupling means 56. The tip of the distal segment 55 can have an angled tip, thereby helping to improve guidance of the device 50. A membrane or liner 63 is disposed within the lumen of the tube 51. Injecting a fluid into the lumen of the tube 51 expands the membrane 63, causing a linear displacement of the dual helical symmetry helix 67, as shown in FIG. 30B. This in turn results in a rotation of the connection point 54 of 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 dual helical symmetry helix 67 of the tube 51. The injection of fluid into or extraction of fluid from the interior of the membrane 63 can be precisely controlled, allowing the rotation of the distal segment 55 to be finely tuned.Fine adjustment allows the medical device 100 to be used in vasculature with small vessels and allows selection of a particular 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 precise placement of auxiliary equipment, such as lamps for illumination inside the body. Here, individual and / or fine adjustment of the rotation angle is advantageous or necessary. Note that fine adjustment also reduces the accumulation of potential energy in the distal segment 55, which may result in whip if released too suddenly. For illustrative purposes, a 180 degree rotation is shown in FIG. 30B, but different degrees of rotation may be achieved by increasing or decreasing the degree of linear displacement of the dual helical symmetry helix 67 by expanding / contracting the membrane 63. In some embodiments, a single helix 203 may replace the dual helical symmetry helix 67. See, for example, FIGS. 23-25.

[0304] FIG. 31A shows a cross-sectional view of a handle 70 suitable as an embodiment of the handle 13 shown in FIG. 20 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 of 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.

[0305] A distal fitting 76 is located at the distal end of the distal component 72. The distal fitting 76 flares out from the lumen 73. A proximal fitting 74 is located at the distal end of the proximal end of the proximal component 71 and also flares out from the cylinder 73. A distal compression nut 77 fits around the outer diameter of the distal component 72. The distal fitting 76 is threaded so that its threads mate with the distal compression nut 77. A proximal compression nut 75 fits around the outer diameter of the proximal component 71. The proximal fitting 74 is threaded so that its threads mate with the proximal compression nut 75. FIG. 31B shows a short axis cross section through line A-A'. The proximal and distal components 71 and 72 are coaxial with each other and with the wire 78.

[0306] FIG. 32 shows a cross-sectional view through the longitudinal axis of handle 70 with proximal and distal compression nuts 75, 77 engaging the threaded portions of proximal and distal fittings 74, 76, respectively, such that distal and proximal fittings 76, 74 are compressed toward cylinder 73, rather than flaring out as in FIG. 31A.

[0307] 14A-14C and 15A-15C show a handle 80 suitable as another embodiment of the handle 13 shown in FIG. 20 for gripping the proximal end 11 of the device 10. FIG. 33A shows 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 each other. The proximal component 81 and the distal component 82 may be formed of 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 each other along the long 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.

[0308] 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 proximal fitting 84 flares out from lumen 83. Distal compression nut 87 fits around the outer diameter of distal component 82. Distal fitting 86 is threaded such 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 such that its threads mate with proximal compression nut 85.

[0309] FIG 33B shows a short axis cross section through line B-B' of FIG 33A passing through the distal fitting 86. A longitudinal displacer such as a sleeve or wire 92 is shown coaxial with the tube 91, both of which are coaxial with the distal fitting 86. Similarly, FIG 33C shows a short axis cross section through line C-C' of FIG 33A passing through the proximal fitting 84, where the proximal fitting 84 overlaps the distal fitting 86. The sleeve or wire 92 is shown coaxial with the tube 91, as well as the proximal fitting 84 and the distal fitting 86.

[0310] FIG. 34A shows a cross-section through the longitudinal axis of the handle 80 with the proximal and distal compression nuts 85, 87 engaging the threaded portions of the proximal and distal fittings 84, 86, respectively, such that the distal and proximal fittings 86, 84 are compressed toward the lumen 83. FIG. 34B shows a short axis cross-section through line B-B' of FIG. 34A through the distal fitting 86. A sleeve or wire 92 is shown coaxial with the tube 91, both of which are coaxial with the distal fitting 86. Similarly, FIG. 34C shows a short axis cross-section through line C-C' of FIG. 34A through the proximal fitting 84, where the proximal fitting 84 overlaps the distal fitting 86. A sleeve or wire 92 is shown coaxial with the tube 91 and with the proximal and distal fittings 84 and 86 .

[0311] FIG. 35 is a diagram of another embodiment of an apparatus including a medical device 100 in which a dual helical symmetry helix 1709 (see FIG. 36A) is cut into a distal aspect of a tube 101. The tube 101 includes a material including, but not limited to, nickel titanium (nitinol). The material is selected to undergo a shape change in response to a change in the local environment such that an extension of the dual helical symmetry helix 1709 occurs. A conduit 108 is disposed within the tube 101. The conduit 108 may be connected to a source 109 for an agent for changing the local environment disposed within the tube 101. Exemplary agents for changing the local environment may include, but are not limited to, one or more of a battery, a radio frequency generator, a microwave generator, a heating source for Joule heating or magnetic field change, a light source, and a source of chemicals of releasable ions. In one embodiment, the dual helical symmetry helix 1709 may extend linearly when the temperature is increased. This extension may occur over a temperature range of 40 degrees Celsius to 90 degrees Celsius. In some embodiments, the temperature range for extension may be between 40 degrees Celsius and 60 degrees Celsius. Distal segment 105 is coupled to a distal aspect of tube 101.

[0312] 36A shows a longitudinal cross-sectional view of a distal aspect of one embodiment of a medical device 100 in its unactuated state, where there is no linear displacement ...

Claims

1. A device, an elongate member having a longitudinal axis, a proximal end, and a distal end; the elongate member includes at least one section at, along, or near the distal end, the at least one section including at least one physical characteristic that is different from a physical characteristic of a section of the elongate member immediately adjacent to the at least one section; a displacement element configured to change the length of the elongate member along the at least one portion; at least one sensing element; when the length of the elongate member along the at least one section is changed using the displacement element, the distal end of the elongate member at least partially rotates about the longitudinal axis; a bending assembly configured to bend the distal end of the elongate member relative to the longitudinal axis; advancement of the device through a target endoluminal network is facilitated by a rotational movement produced by operation of the displacement element and a bending movement produced by operation of the bending assembly; A device, wherein the at least one sensing element is configured to enable the device to be used with an advancement system that operates at least partially autonomously.

2. the at least one sensing unit comprises at least one sensor; the at least one section of, along, or near the distal end includes at least one partial cut that includes an oblique orientation relative to both the longitudinal axis and an axis transverse to the longitudinal axis; The device of claim 1 , wherein the flexion assembly is actuated using an electrical control device.

3. The device of claim 1 , wherein the at least one sensing unit comprises at least one sensor.

4. The at least one sensor may be a pressure sensor, a contact sensor, a proximity sensor, a position sensor, The device of claim 3 , comprising at least one of a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and marker.

5. The device of claim 3 , wherein the at least one sensor comprises at least one of a camera, a visualization device, an imaging device, and a light source.

6. The device of claim 1 , wherein the at least one sensing unit is fixedly secured to or near the distal end of the elongate member.

7. The device of claim 6 , wherein the at least one sensing unit is at least partially integrated at or near the distal end of the elongate member.

8. The device of claim 1 , wherein the at least one sensing unit is removably or releasably secured to or near the distal end of the elongate member.

9. The device of claim 1 further comprising at least one therapeutic device, element, or component.

10. The device of claim 9 , wherein the at least one therapeutic device, element, or component is disposed at, along, or near the distal end of the elongate member.

11. The device of claim 9 , wherein the at least one treatment device, element, or component includes an energy delivery element.

12. The device of claim 11 , wherein the energy delivery element is configured to selectively heat and / or cool tissue.

13. The device of claim 11 , wherein the energy delivery element comprises an element configured to emit radio frequency, electromagnetic energy, ultrasound, or other form of energy.

14. The device of claim 1 , wherein the device is configured to receive or otherwise accommodate at least one tool or auxiliary device.

15. The device of claim 14 , wherein the at least one tool or auxiliary device is configured to pass through an internal passage or opening of the device.

16. 15. The device of claim 14, wherein the at least one tool or auxiliary device comprises a grasper, a tissue-piercing member, a cauterizing device, a tissue-removing device, a biopsy device, an energy delivery device, an ablation device, a therapeutic device, a diagnostic device, or an imaging device.

17. The device of claim 1 , wherein the device includes at least one internal channel, lumen, or opening through which another component or device can be advanced.

18. The device of claim 1 , wherein the at least one internal channel, lumen, or opening is disposed within the elongate member.

19. The device of claim 1 , wherein the at least one internal channel, lumen, or opening is disposed within the displacement element.

20. 10. The device of claim 1, further comprising at least one lumen or channel along the longitudinal axis of the at least one sensing element, the lumen or channel having at least one cut or similar feature along the longitudinal axis.

21. 21. The device of claim 20, wherein a diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can change in response to the passage or removal of one or more instruments, auxiliary devices, and / or similar features.

22. 10. The device of claim 1, wherein the at least one section of, along, or near the distal end includes at least one partial cut that includes an oblique orientation relative to both the longitudinal axis and an axis transverse to the longitudinal axis.

23. 23. The device of claim 22, wherein the at least one partial cut comprises a cut having a spiral shape.

24. 23. The device of claim 22, wherein the at least one partial cut extends through a wall of the elongate member.

25. 23. The device of claim 22, wherein the at least one partial cut does not extend entirely through a wall of the elongate member.

26. 10. The device of claim 1, wherein the at least one physical property that differs comprises tensile strength, compressive strength, toughness, stiffness, elasticity, thickness, radial thickness uniformity, axial thickness uniformity, material, or material composition.

27. 10. The device of claim 1, wherein the at least one physical property that differs comprises stiffness or rigidity, the stiffness or rigidity being less in the at least one section than in the section of the elongate member immediately adjacent to the at least one section.

28. The device of claim 1 , wherein the displacement element comprises a pusher member or a force applying member.

29. The device of claim 1 , wherein the displacement element is collinear with the elongate member.

30. 30. The device of claim 29, wherein the displacement element extends from the proximal end of the elongate member to or near the at least one section of the elongate member.

31. The device of claim 1 , wherein the displacement elements are controlled by separate devices.

32. 32. The device of claim 31 , wherein the separate device is positioned outside the subject during use.

33. 32. The device of claim 31, wherein the separate device includes a magnetic component.

34. 32. The device of claim 31 , wherein the separate device comprises a wireless component configured to wirelessly supply energy to or communicate with the displacement element during use.

35. The device of claim 1 , wherein the flexion assembly is configured to be mechanically actuated.

36. The device of claim 1 , wherein the flexion assembly includes a pull wire system or component.

37. The device of claim 1 , wherein the flexion assembly is configured to be non-mechanically actuated.

38. The device of claim 1 , wherein the flexion assembly is actuated using an electrical control device.

39. 39. The device of claim 38, wherein the electrical control device includes at least one solenoid.

40. 10. The device of claim 1, further comprising at least one electrical conductor extending from the proximal end of the elongate member to or near the distal end of the elongate member, the at least one electrical conductor configured to electrically couple to the at least one sensing unit or another electrical component disposed along the distal end.

41. 41. The device of claim 40, wherein the at least one electrical conductor is included in or integrated within the elongate member.

42. 41. The device of claim 40, wherein the at least one electrical conductor is included in or integrated within the displacement member.

43. 10. The device of claim 1, wherein the device comprises a microcatheter, a navigation catheter, an intracardiac echocardiography catheter, an intravascular ultrasound catheter, an electrophysiology catheter, a catheter, a sheath, a guidewire, an endoscope, a laparoscope, an arthroscope, a visualization scope, a scope, a robotically controlled intraluminal device, a manually controlled intraluminal device, a device that is both robotically and manually controlled, an endoscopic instrument or tool, and a surgical instrument.

44. The system of claim 1 , wherein the advancement system comprises at least one robotic component.

45. 45. The system of claim 44, further comprising the at least one robotic component for manipulating at least one of the displacement element and the bending assembly.

46. The system of claim 1 , wherein the advancement system comprises at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or the device.

47. The system of claim 1 , wherein the distal end of the elongate member is angled relative to the longitudinal axis.

48. A device, an elongate member having a longitudinal axis, a proximal end, and a distal end; The elongate member includes at least one section at, along, or near the distal end, the at least one section having physical characteristics that differ slightly from those of a section of the elongate member immediately adjacent to the at least one section. at least one of said physical characteristics; a length of the elongate member along or near the at least one section is configured to be changed by a displacement element; at least one detection or treatment element or component; when the length of the elongate member along the at least one section is changed using the displacement element, the distal end of the elongate member at least partially rotates about the longitudinal axis; a distal end of the elongate member configured to be bent relative to the longitudinal axis using a bending assembly; advancement of the device through a target endoluminal network is facilitated by a rotational movement generated by operation of the displacement element and a bending movement generated by operation of the bending assembly; A device, wherein the at least one sensing element is configured to enable the device to be used with an advancement system that operates at least partially autonomously.

49. 49. The device of claim 48, wherein the at least one sensing or therapeutic element or component is fixedly secured to or near the distal end of the elongate member.

50. 49. The device of claim 48, wherein the at least one sensing or therapeutic element or component is removably or releasably secured to or near the distal end of the elongate member.

51. 49. The device of claim 48, wherein the at least one detection or treatment element or component comprises at least one sensor.

52. 52. The device of claim 51, wherein the at least one sensor comprises at least one of a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor, and an optical sensor and marker.

53. 52. The device of claim 51, wherein the at least one sensor includes at least one of a camera, a visualization device, an imaging device, and a light source.

54. 49. The device of claim 48, wherein the at least one detection or treatment element or component includes an energy delivery element.

55. 49. The system of claim 48, wherein the advancement system comprises at least one robotic component.

56. 56. The system of claim 55, further comprising the at least one robotic component for manipulating at least one of the displacement element and the bending assembly.

57. 49. The system of claim 48, wherein the advancement system includes at least one of a motor, an actuator, and a processor configured to determine and control the operation of the advancement system or the device.

58. 1. A device configured to bend, comprising: an elongate member having a longitudinal axis, a proximal end, and a distal end; a bending assembly disposed at, along, or near the distal end, the bending assembly configured to be manipulated using an actuation component that is powered.

59. 59. The device of claim 58, wherein the actuating component includes at least one solenoid.

60. 59. The device of claim 58, wherein the bending assembly is integral with the elongate member.

61. 60. The device of claim 58, wherein the bending assembly is not integral with the elongate member.

62. 59. The device of claim 58, wherein the bending assembly is configured to be rigidly secured to the elongate member.

63. 60. The device of claim 58, wherein the flexion assembly is configured to be removably secured to the elongate member.

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