Shapeable re-entry devices and associated systems and methods

Methods for treating a patient using intravascular devices, systems, and methods are disclosed herein. One aspect of the present technology is directed to an intravascular device having an elongated member coupled to and extending between a handle and an angled distal portion. The distal portion is moveable between a first configuration having a first shape configured for intravascular delivery and a second configuration having a second shape, different than the first shape, that is configured for intravascular delivery.

TECHNICAL FIELD

The present technology relates generally to systems, methods, and devices for accessing and/or treating vascular abnormalities and/or complications. In particular, several embodiments are directed to intravascular devices having shapeable distal portions for addressing occlusions within a body vessel, including those related to peripheral vascular disease states, cardiovascular diseases, cerebrovascular diseases, and others.

BACKGROUND

Chronic total occlusions (“CTO”) are vascular lesions characterized by heavy atherosclerotic plaque within the blood vessel, resulting in complete (or nearly complete) obstruction of blood flow across the lesion. Such occlusions can occur anywhere in a patient's vascular system. Since most lesions form gradually over a long period of time, the ischemic tissue downstream of the lesion has time to form collateral circulation. For example, in the case of coronary arteries, collateral vessels can form from the proximal artery and connect into the distal artery (“ipsilateral collaterals”), or collateral vessels can form from the other major arterial branches and connect into the distal artery (“contralateral collaterals”). When the lesion finally becomes a total occlusion, the collateral circulation is typically sufficient to keep the distal tissue alive, though ischemic. Accordingly, it is desirable to reestablish blood flow through or around the blockage in blood vessels by crossing the CTO and advancing therapeutic devices, such as a balloon angioplasty catheter, to dilate and treat the CTO. Likewise, in some cases it may be necessary to cross a CTO to gain access to a location along the vasculature distal to the CTO.

CTOs are more difficult to cross than partially occluded lesions because, rather than navigate a pre-existing lumen, a guidewire must either penetrate the lesion or, when penetrating the occlusion is impractically difficult and/or complicated, go around the lesion via a sub-intimal layer of a vessel wall.FIGS. 1A-1F, for example, are schematic cross-sectional side views of a conventional device used to treat such a CTO. Referring first toFIG. 1A, a guidewire12and/or a catheter10is forced into a sub-intimal layer SL adjacent to an occlusion O. Once the guidewire12and/or catheter10traverse the occlusion O, the device(s) will require re-entry into a true lumen TL of the vessel V. For example, to re-enter the true lumen TL, many current techniques employ advancing the guidewire12such that it bends and/or loops back onto itself at its distal end16as the guidewire12is advanced distally through the sub-intimal layer SL. As best seen inFIGS. 1B and 1C, for example, such techniques can create a “sub-intimal tunnel” As best seen inFIGS. 1D-1F, once a looped end14of the guidewire12is distal to a distal end of the CTO, the guidewire12can be forced to re-enter the true lumen TL, thereby creating a large hole H and/or flap in the vessel wall V. Forcing re-entry utilizing a looped guidewire, however, may cause complications for the patient, such as unnecessarily extending the sub-intimal tunnel, perforation of the vessel V, and/or undesirable dissection of the vessel V that requires additional treatment.

Other current methods of re-entering the true lumen TL during treatment involve utilizing one of the currently available re-entry devices. Such re-entry devices, however, typically have larger diameters than the original tools utilized in the procedure. In many procedures, for example, the catheter in use is removed and the introducer sheath is replaced with a larger sheath (e.g., 7-8 Fr sheath). Such a transition, however, can cause significant disruptions to the procedure and dramatically increase procedure time and x-ray exposure for the patient.

DETAILED DESCRIPTION

The present technology relates generally to systems, methods, and devices for crossing and treating CTOs. Specific details of several embodiments of the present technology are described herein with reference toFIGS. 2-17B. Although many of the embodiments are described below with respect to devices and methods for crossing and/or treating CTOs, any vascular occlusion in addition to those described herein may be crossed and/or treated within the scope of the present technology (e.g., full occlusions, partial occlusions, occlusions resulting from a thrombus, occlusions resulting from an embolism, occlusions resulting from atherosclerosis, etc.). Additionally, other embodiments of the present technology can have different configurations, components, or procedures than those described herein. For example, other embodiments can include additional elements and features beyond those described herein, or other embodiments may not include several of the elements and features shown and described herein.

For ease of reference, throughout this disclosure identical reference numbers are used to identify similar or analogous components or features, but the use of the same reference number does not imply that the parts should be construed to be identical. Indeed, in many examples described herein, the identically-numbered parts are distinct in structure and/or function.

Generally, unless the context indicates otherwise, the terms “distal” and “proximal” within this disclosure reference a position relative to an operator or an operator's control device. For example, “proximal” can refer to a position closer to an operator or an operator's control device, and “distal” can refer to a position that is more distant from an operator or an operator's control device.

FIG. 2Ais a side perspective view of an intravascular device300in a low-profile or generally straight configuration in accordance with an embodiment of the present technology. The intravascular device300can include proximal portion306having a handle310, as well as a distal portion302and an elongated shaft304extending between the handle310and the distal portion302. The handle310can be configured to be positioned at a location external to a patient, and the elongated shaft304can be configured to locate the distal portion302intravascularly at or near a complete or partial occlusion within a blood vessel of the patient. The intravascular device300can have a lumen326(FIG. 5) extending proximally from an opening330at a distal end of the device300to an outlet331at the handle310of the device300.

FIG. 2Bis a side view of the intravascular device300with the distal portion302in an angled or treatment configuration (labeled inFIG. 2Bas302′). In some embodiments, the distal portion302may be “cold-worked” during manufacturing into a permanent, angled shape. In other embodiments, the distal portion302of the intravascular device300inFIG. 2Amay be composed of a malleable or shapeable material so that a clinician can manually transform the generally straight distal portion302into an angled distal portion302′. For example, the intravascular device300can come as part of a kit that includes one or more shaping mandrels (see, for example, the mandrel370shown inFIG. 7C). The mandrels can come in a variety of configurations (e.g., different diameters, shapes, angles, etc.) to address different needs presented by the particular patient's vasculature. The clinician can place the mandrel at least partially within or over the distal portion302and bend or manipulate the distal portion302into the angle or shape of the mandrel. In some embodiments, the clinician can manually bend the distal portion302to a desired angle based on specific requirements presented by a particular procedure (e.g., crossing, steering, targeting for a particular area within the vasculature, etc.). For example, the clinician can manipulate the distal portion302without a mandrel, or in some embodiments, the mandrel can be flexible such that the mandrel bends with the distal portion302and primarily functions to keep the internal diameter of the distal portion302from collapsing or kinking during the shaping process.

Often times, the clinician may find it beneficial and/or necessary to utilize multiple shapes and/or angles during a procedure. As such, the distal portion302of the present technology is configured to be repeatedly angled, shaped, and/or manipulated during a procedure. For example, a clinician may initially utilize a first angle (for example, a 45° angle) or shape but realize, after inserting the device300, that a greater angle (e.g., 70°, 60°, 50°, etc.), lesser angle (e.g., 30°, 20°, 15°, 10°, etc.), or different shape may be needed to navigate the vasculature and/or re-enter the true lumen. The clinician can remove the device300from the patient and bend, angle, shape, and/or otherwise manipulate the device to a second angle or shape that is different from the first angle or shape. The clinician can then re-insert the device300with the second angle or shape. The clinician can remove and re-shape or manipulate the distal portion302as many times as desired during a single procedure (e.g., 2 times, 3 times, 4 times, etc.). In some embodiments, the distal portion302can be bent at multiple portions along its longitudinal axis.

Although the shape of the distal portion302can be affected by the clinician and/or mandrel, once a desired shape is set the distal portion302has sufficient rigidity to retain its desired shape when subjected to tortuous anatomy or when a guidewire and/or interventional device is placed therethrough. The shapeable distal portion302can be made from shape memory plastic, Nitinol, stainless steel, titanium, tungsten, tantalum, Elgiloy, and other suitable materials. In some embodiments, the shapeable distal portion can be between about 0.25 inches to about 1.50 inches in length along its longitudinal axis. In some embodiments, the shapeable distal portion can be a different color than the remainder of the elongated shaft for identification purposes. In other embodiments, however, the shapeable distal portion may have a different arrangement and/or include different features.

FIG. 5is an enlarged cross-sectional view of a portion of the elongated shaft304proximal to the distal portion302.FIGS. 7A and 7Bshow an enlarged side view and a partial cross-sectional side view, respectively, of the intravascular device ofFIG. 2B. Referring toFIGS. 5, 7A and 7Btogether, the elongated shaft304may include one or more layers configured to rotate along a central axis independently of one another. For example, the elongated shaft304can include an outer sheath324and a tubular rotating member322within the outer sheath324. As shown inFIG. 7B, a proximal section of the outer sheath324can be fixed to a first control knob342(e.g., at a first portion343), and a proximal section of the rotating member322can be fixed to a second control knob362(e.g., at a second portion363). Accordingly, rotational motion applied to the first knob342(e.g., by a clinician) causes rotation of the outer sheath324, and rotation of the second knob362causes rotation of the rotating member322. In some embodiments, a proximal region360of the outer sheath324is reinforced to provide strain relief to the outer sheath324and/or the rotating member322during rotation. The outer sheath324may be made of a flexible polymer (e.g., polyurethane, polyether block amide copolymer sold under the trademark PEBAX, etc.) or any suitable material, and may have an outer diameter of about 1.9 Fr to about 5 Fr. In other embodiments, however, the outer sheath324may have a different arrangement and/or include different features. The intravascular catheter can accommodate a range of guidewire sizes (e.g., 0.010 inches, 0.014 inches, 0.018 inches, 0.035 inches and 0.038 inches).

The rotating member322can be made of metal, plastic, and/or any suitable material with sufficient rigidity to adequately transfer rotational forces and/or provide accurate responsiveness at its distal end when actuated by a clinician located at a proximal portion306of the device300. The rotating member322can be a solid, slotted, coiled, and/or braided tube (e.g., a braid-reinforced polyimide), and in some embodiments the rotating member322can have any suitable shape and/or configuration. In some embodiments, the intravascular device300may include a lubricious coating between the rotating member322and the outer sheath324to allow for friction free or relatively low friction manipulation of the rotating member322within the sheath324in various anatomical tortuosity. Without being bound by theory, it is believed that such layering renders the tortuosity impact on torsional response insignificant relative to torque transmission.

The inner lumen326of the rotating member322can be coated with a lubricous coating320(e.g., polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), hydrophilic, etc.) applied directly to the inner walls of the rotating member322. The inner lumen326extends distally from an opening331at the handle310to an opening330at a distal portion302. The inner lining320allows for fluid, guidewires, and/or other intravascular devices (collectively referred to herein as “interventional devices D”) to be slidably positioned within the lumen326of the rotating member322. For example, the handle310can include an opening331for insertion of an interventional device such as the crossing device disclosed in International Patent Application No. PCT/US2010/047170, filed Aug. 30, 2010, entitled “SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS,” which is incorporated herein by reference in its entirety. In some embodiments, however, the handle310may have a different arrangement and/or include different features.

FIG. 3is a side view of the distal portion302of the intravascular device300ofFIG. 2Bwithout an interventional device D placed therethrough, andFIG. 4is a side view of the distal portion302including an interventional device D. Referring toFIGS. 3 and 4together, the distal portion302can be a generally hollow tube having an attachment region316carried by, fixed to, and/or contiguous with a distal region305of the elongated shaft304. The distal portion302can also include an angled region318extending distally at an angle α0from the attachment region316and terminating at an atraumatic distal tip334.

In some embodiments, the attachment region316of the distal portion302is attached to the rotating member322such that rotation of the rotating member322causes rotation of the distal portion302. For example, as shown inFIG. 6A, the distal portion302can be defined by an angled tube308, and at least a portion of the attachment region316of the angled tube can be placed over at least a portion of a distal region of the rotating member322. The overlapping portions can then be joined together (e.g., via adhesive, crimping, soldering, etc.). The outer sheath324may be advanced over the rotating member322until a distal end of the outer sheath324comes in contact with a proximal end of the angled tube308. Accordingly, the transition between the outer sheath324and the distal portion320may be seamless allowing for a low profile and maximum crossing ability.

In embodiments where the distal portion is not shapeable by the clinician, the distal portion302can be made from stainless steel, Nitinol, Elgiloy, other metals and/or similarly stiff materials that allow the distal portion302to retain its bent and/or angled shape while passing through the tortuous vasculature and/or when an interventional device (such as the interventional device D) is slidably positioned through the lumen326at or distal to a bend350in the distal portion302. Many current devices have distal portions that are heat-treated to have an angled configuration. Such heat-treated devices, however, do not retain their shapes once an interventional device D is passed therethrough and/or the device is subject to a tortuous anatomy. In contrast with such current devices, the non-shapeable distal portion302of the present technology is not heat-treated, and rather comprises a hollow, stiff tube308that is “cold-worked” into a permanent, angled shape that is unaffected by anatomical tortuosity and/or placement of an interventional device D therethrough.

Regardless of whether the distal portion is shapeable or non-shapeable, the angle α0remains the same even when an interventional device D is advanced through the lumen326of the distal portion302and extends through the opening330at the distal tip334. Accordingly, the angled distal portion302allows for the predictable angulation of a separate intravascular device and/or guidewire, regardless of the shape of the separate intravascular device or the guidewire. Likewise, it is important to note that the angled distal portion302is not subject to any control wires and/or actuation device that can be manipulated at a proximal portion306of the device300to cause deflection at the distal portion302. In some embodiments, all or a portion of the distal portion302may be coated with or comprised at least in part of radiopaque material to aid in positioning the device.

Even with the angled distal portion302, the overall profile of the intravascular device300remains no greater than 7 Fr. In some embodiments, the overall profile of the intravascular device remains no great than 5 Fr. The angle α0of the distal portion302can vary (e.g., between about 1 to about 90 degrees). In some embodiments, for example, the angle α0is between about 10 and about 40 degrees. In other embodiments, the angle α0is between about 25 degrees and about 35 degrees (e.g., about 25 degrees, about 30 degrees, about 35 degrees, etc.). In some embodiments, the distal portion302may be configured to have any suitable angle and/or length relative to the length of the intravascular device300.

The distal tip334can be atraumatic and have a generally tapered shape. In some embodiments, the distal tip334can also be configured to engage another element of the intravascular device300. For example, the opening330at the distal end of the distal tip334can define a passageway for receiving a guidewire (not shown) for delivery of the treatment device using over-the-wire (“OTW”) or rapid exchange (“RX”) techniques. In other embodiments, however, the distal tip334may have a different arrangement and/or include different features. The distal tip334may also be radiopaque to aid positioning of the device.

FIG. 8Ais a side view of an intravascular device800in a low-profile or generally straight configuration configured in accordance with an embodiment of the present technology. The intravascular device800can include a handle or luer810at a proximal portion306, a distal portion802, and an elongated shaft804extending between the luer810and the distal portion802. The luer810can be configured to be positioned at a location external to a patient, and the elongated shaft804can be configured to locate the distal portion802intravascularly at or near a complete or partial occlusion within a blood vessel of the patient. The intravascular device800can have a lumen826extending from an opening330at a distal end of the device300to an outlet331at the handle310of the device300.

FIG. 8Bis a side view of the intravascular device800with the distal portion802in an angled or treatment configuration802′. In some embodiments, the distal portion802is “cold-worked” during manufacturing into a permanent, angled shape. In other embodiments, the distal portion802of the intravascular device800inFIG. 8Acan be made of a malleable or shapeable material so that a clinician can manually transform the generally straight distal portion802into an angled distal portion802′. For example, the intravascular device800can come as part of a kit that includes a shaping mandrel370(seeFIG. 7C). The clinician may place the mandrel370at least partially within or over the distal portion802to keep the internal diameter of the distal portion802from collapsing or kinking while it is manually bent to the desired shape. In some embodiments, the clinician may manually bend the distal portion802to a desired angle based on specific requirements presented by a particular procedure (e.g., crossing, steering, targeting for a particular area within the vasculature, etc.). Although the shape of the distal portion802can be manipulated by the clinician, once a desired shape is set the distal portion802′ has sufficient rigidity to retain its desired shape when subjected to tortuous anatomy or with a guidewire and/or interventional device placed therethrough. The shapeable distal portion802can be made from shape member plastic, Nitinol, stainless steel, titanium, tungsten, Elgiloy, and others. The shapeable distal portion can be between about 0.25 inches to about 0.30 inches in length along its longitudinal axis.

FIG. 9shows an enlarged cross-sectional view of the intravascular device ofFIG. 8B. The elongated shaft804can include an outer layer824and a braid-reinforced polyimide layer822within the outer layer824. During manufacturing, a polymer (e.g., polyether block amide copolymer sold under the trademark PEBAX) may be melted over the braid822to form the outer layer824. In some embodiments, a proximal region860of the outer layer824can be reinforced by additional material (e.g., additional polyether block amide copolymer sold under the trademark PEBAX is melted onto the braid) to provide strain relief to the outer layer824when rotated. Rotational motion applied to the luer810(e.g., by a clinician) causes rotation of the outer layer824along the entire longitudinal axis of the elongated shaft804. The outer sheath may be made of a flexible polymer (e.g., polyether block amide copolymer sold under the trademark PEBAX). The inner walls826of the braid may also include a lubricous coating820as described above.

The braided layer822may extend partially or completely along the longitudinal axis of the distal portion. The braided layer822is expected to provide a high burst strength (e.g., greater than or equal to 2000 psi) and additional kink resistance.

FIG. 10is a perspective view of a distal portion of an intravascular device1200having a bracing member1250configured in accordance with another embodiment of the present technology. In the illustrated embodiment, the bracing member1250can have a generally “humpback shape” configured to allow for additional deflection from the vessel wall. The bracing member1250can be made from metal and/or plastic materials. The bracing member1250can be delivered in a low-profile or delivery configuration, then expand upon proximal retraction of an outer sheath1300(seeFIG. 11) to add additional support or stability to the distal portion1202of the intravascular device1200. In some embodiments, the bracing member1250could automatically and/or manually extend and/or retract from a layer and/or lumen of the elongated shaft1204(e.g., the outer sheath1224) to add stability. In some embodiments, the sheath1300can be partially retracted to selectively control the angle of the distal portion1202between about 0 and about 90 degrees.

FIG. 12illustrates an intravascular device1400configured in accordance with another embodiment of the present technology. As shown inFIG. 12, the intravascular device1400may have one or more inflatable or expandable rings1402configured to position and support a distal portion1404of the device1400within the vessel. For example, once the distal portion1404is positioned at a target site, the rings1402can be expanded to force at least a portion of the distal portion1404away from an adjacent occlusion or vessel wall. In embodiments where the intravascular device includes a shapeable distal portion, expansion of the rings1402helps guide deflection of the distal portion. In embodiments where the intravascular device1400includes a pre-shaped distal portion, however, expansion of the rings1402does not generally affect angulation of the distal portion. Rather, in such embodiments, the rings1402may reinforce the pre-formed angle of the device1400and also stabilize the device with respect to the surrounding anatomy. In some embodiments, the rings1402can be independently expanded or deployed to provide additional directionality and/or stability to the device1400.

FIG. 13is a side view of another embodiment of an intravascular device1500having a one-sided expandable member1502. Once expanded, the expandable member1502provides additional angulation to the distal portion1504and support to the device1500. For example, in some embodiments, the expandable member1502aids in deflection of the distal portion1504off of the vessel wall and/or in redirecting the device1500.

FIG. 14shows yet another embodiment of an intravascular device1600having a combination of expandable members1602(e.g., balloons, inflatable rings, etc.) and a brace1604. Such a combination is expected to provide both directionality and stability to the distal portion1606. The expandable members1602may be inflated or expanded independent from deployment of the brace1604. In some embodiments, an expandable member1602may be inflated or deflated, thereby allowing the pre-formed wire1604to bend and provide an additional angle to the device1600. In some embodiments, the rings1602and/or pre-formed wire1604can also be sheathed for delivery through the vasculature until the distal portion of the device is positioned at a desired location inside the vessel, as discussed above with reference toFIGS. 12 and 13.

II. Selected Delivery Systems and Methods

The ability to percutaneously access the remote vasculature is well-known and described in the patent and medical literature. Once percutaneous access is achieved (for example, through the femoral or iliac veins), the interventional tools and supporting catheter(s) may be advanced to the target vessel or CTO and positioned at or proximate to the CTO in a variety of manners, as described herein.

FIGS. 17A-17Gillustrate one example for using an intravascular device300and/or one or more interventional devices to cross and/or treat a CTO. Referring first toFIG. 17A, a guidewire800may be advanced along the vasculature until the guidewire800is precluded from further distal movement by a proximal region of the CTO and inadvertently or purposely enters the sub-intimal layer SL (FIG. 17B). At this point, as best seen inFIG. 17C, the distal portion302of the device300can be advanced distally over the guidewire800and into the sub-intimal layer SL. As shown in the top view ofFIG. 17D, once in the sub-intimal layer, the angled distal portion302can be advanced distally through the sub-intimal layer SL until the distal portion302of the device300is positioned at or distal to a distal end of the CTO. While the angled distal portion302is moved through the sub-intimal space, the angled region318is generally perpendicular to a true lumen TL of the vessel V. The distal portion302can be advanced through the sub-intimal layer SL using known imaging systems and techniques such as fluoroscopy, x-ray, MRI, ultrasound or others. Radiopaque material can be incorporated into the guidewire800, distal portion302, and/or along any portion of the intravascular device300to provide additional visibility under imaging guidance. Such marker materials can be made from tungsten, tantalum, platinum, palladium, gold, iridium, or other suitable materials.

Once the distal portion302reaches the distal end of the CTO, the clinician can actuate the knob362(FIGS. 2A-2B and 7A-7B) or rotate the handle (FIGS. 8A and 8B) to rotate the distal portion302(via the rotating member322) so that the angled region318is directed towards the true lumen TL of the vessel V, as shown in the top and side views ofFIGS. 17E-17F, respectively.

As shown inFIGS. 16A and 16BandFIGS. 17A and 17B, in particular embodiments, the intravascular device may include a marking352on the luer or handle that aligns with the bend350such that a clinician can identify (from an extracorporeal location) the direction of the angle α0and/or projection of the angled region318. For example, the knob362may have a marking352at a circumferential position corresponding with the bend350.

A piercing element (not shown) can be advanced through the distal portion302to penetrate the sub-intimal lining and facilitate re-entry into the true lumen TL. As discussed above, a guidewire800and/or an interventional device ID can be advanced through the opening330and into the true lumen TL of the vessel V in a direction and/or angle dictated by the angle α0of the distal portion302(as best seen inFIG. 15G).

In some embodiments the intravascular device300can include one or more distal markers that could be utilized by the various imaging techniques described above. For example, in some embodiments, the distal portion302could have markings (e.g., holes, grooves, radiopaque markings, etc.) along its length so that when an interventional device reaches the distal portion302, corresponding markings on the interventional device will align and confirm that the guidewire and/or interventional device have reached the distal portion302of the device300. Additionally, such distal markings could be utilized when the device is used as a diagnostic catheter or angiographic catheter. Saline or dye could be flushed through the device and out the distal portion through the various holes.

It should be noted that the intravascular device described herein is not limited to a re-entry device. For example, various embodiments of the present technology could also be used when trying to reach areas of the vasculature with tortuosity and/or to provide steering while traversing such anatomy. Because the angled shape of the distal portion stays true and does not lose its configuration, multiple wires and other devices could be fed through the elongated shaft from an opening331at the proximal portion306and selectively positioned without the concern of having to compensate for any changes to the pre-set dimensions prior to entering the anatomy. In some embodiments, for example, the system may be used to reach a complex location having multiple bends, twists, and anatomical variability.

The following examples are illustrative of several embodiments of the present technology:

a handle at a proximal portion;

an elongated member coupled to and extending between the handle and an angled distal portion, wherein the elongated member includes—an outer sheath; anda hollow rotational member with the sheath, wherein the rotational member is coupled to the angled distal portion, and wherein rotation of the rotational member directly causes rotation of the angled distal portion; and

wherein the angled distal portion—defines a lumen therethrough,has a first section and a second section that extends distally at an angle from the first section, andthe angle between the first section and the second section remains the same when an interventional device is at least partially within the lumen of the distal portion and spans at least a portion of the first section and at least a portion of the second section.

a handle at a proximal portion;

an elongated member coupled to and extending between the handle and a distal portion, wherein the elongated member includes—an outer sheath; anda hollow rotational member with the sheath, wherein the rotational member is coupled to the distal portion, and wherein rotation of the rotational member directly causes rotation of the distal portion; and

wherein, in response to a force applied by a clinician while the distal portion is located external to the patient, the distal portion is moveable between:a first configuration that is configured to be intravascularly delivered; anda second configuration that is configured to be intravascularly delivered, and wherein the second configuration is different from the first configuration.

3. The device of example 1 wherein the angle between the first section and the second section remains the same when a guidewire is at least partially within the lumen of the distal portion.

4. The device of any of examples 1-3 wherein the distal portion is not heat set.

5. The device of any of example 1 wherein the angle is about 30 degrees.

6. The device of any of examples 1-5 wherein the distal portion further comprises an atraumatic distal tip.

7. The device of any of examples 1-6 wherein—

the rotational member has a distal end and a proximal end;

the distal end of the rotational shaft is coupled to the distal portion; and

the proximal end of the rotational shaft is coupled to a knob located at the handle.

8. The device of any of examples 1-7 wherein at least a portion of the distal portion is radiopaque.

9. The device of any one of examples 2, 4 and 6-8 wherein—

the first configuration makes a first angle with respect to the longitudinal axis of the elongated member; and

the second configuration makes a second angle with respect to the longitudinal axis of the elongated member, wherein the second angle is different than the first angle.

10. The device of any one of examples 2, 4 and 6-8 wherein—the first configuration is a rounded configuration having a first diameter; and the second configuration is a rounded configuration having a second diameter that is different than the first diameter.

11. The device of any one of examples 2, 4 and 6-8 wherein—

the first configuration is a rounded configuration;

the second configuration is a bent configuration.

12. The device of any one of examples 2, 4 and 6-11 wherein the distal portion is further moveable to a third configuration that is different than at least one of the first configuration and the second configuration.

13. The device of any one of examples 2, 4 and 6-11 wherein—

the distal portion is further moveable to a third configuration that is different than the first configuration and the second configuration, and

when in the third configuration, the distal portion is configured to be intravascularly delivered.

14. A method of using a treatment device having a distal portion, the method comprising:

intravascularly delivering a distal portion in a first configuration;

removing the distal portion in the first configuration to an extracorporeal location;

reconfiguring the distal portion into a second configuration that is different than the first configuration; and

intravascularly delivering the distal portion in a second configuration.

15. The method of example 14 wherein the first configuration is a rounded configuration having a first diameter and the second configuration is a rounded configuration having a second diameter that is different than the first diameter.

16. The method of example 14 wherein the first configuration makes a first angle with respect to the longitudinal axis of the treatment device and the second configuration makes a second angle with respect to the longitudinal axis of the treatment device, wherein the second angle is different than the first angle.

17. The method of example 14 wherein reconfiguring the distal portion includes bending the distal portion.

18. The method of any one of examples 14-17 wherein intravascularly delivering the device includes delivering the distal portion to an intravascular location proximate to a chronic total occlusion.

19. The method of any one of examples 14-18, further comprising:

removing the distal portion in the second configuration to an extracorporeal location; reconfiguring the distal portion into a third configuration that is different than at least one of the first configuration and the second configuration; and intravascularly delivering the distal portion in a third configuration.