Segmental Vascular Ablation

Abstract

The present disclosure includes a sheath having a controller, an open proximal sheath end coupled to the controller, an open distal sheath end configured for insertion into a patient's vasculature, and a working lumen extending through the sheath. The system may include a wire extending from the controller through the working lumen, the wire having a distal wire end configured to mechanically treat a vessel wall of a treatment segment, the length of the distal wire end defining a length of the treatment segment. The working lumen may slidably receive the wire and allow passage of a fluid therethrough around the wire to chemically treat the treatment segment. When the system receives a first input, the distal wire end may mechanically treat the vessel wall. When the system receives a second input and / or a third input, the system may deliver a fluid.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) The entire contents of U.S. Provisional Patent Application No. 63 / 396,176, filed August 8, 2022, entitled "VASCULAR ABLATION," are incorporated herein by reference.

[0002] The entire contents of U.S. Provisional Patent Application No. 63 / 396,586, entitled "VASCULAR ABLATION," filed August 9, 2022, are incorporated herein by reference.

[0003] The entire contents of U.S. Provisional Patent Application No. 63 / 476,156, filed February 19, 2022, entitled "CATHETER WIRE CONTROLLER," are incorporated herein by reference.

[0004] The present disclosure relates to systems and methods for the treatment of varicose veins. [Background technology]

[0005] Mechanochemical ablation (MOCA) is a medical procedure used to treat varicose veins, which are dilated and twisted veins that typically occur in the legs. This minimally invasive procedure aims to close the affected veins using mechanical and / or chemical ablation techniques.

[0006] During the procedure, a special catheter is inserted into the varicose vein through a small incision. The catheter has a rotating tip that mechanically agitates (or abrades, or ablates) the lining of the vein, causing endothelial damage. Simultaneously, a drug, such as a sclerosing agent, is delivered through the catheter, acting as a chemical solution to irritate and close the vein. This combination of mechanical agitation (or abrasion, or ablation) and chemical stimulation induces closure of the varicose vein, causing it to shrink and eventually be absorbed by the body.

[0007] Mechanochemical ablation is considered a safe and effective alternative to traditional surgical procedures for varicose veins, such as phlebotomy or ligation, and currently available endovascular alternatives, such as radiofrequency ablation, laser ablation, and adhesive closure. It is typically performed as an outpatient procedure, and patients are often able to resume normal activities immediately after the procedure. Summary of the Invention

[0008] The present disclosure includes an ablation system (see, e.g., ablation system 10 shown in FIG. 1 ) that includes a controller (see, e.g., controller 20 shown in FIG. 1 ). In some examples, the system includes a sheath (see, e.g., sheath 40 as shown in FIG. 2 ) that includes an open proximal sheath end, an open distal sheath end, and a working lumen extending from the open proximal sheath end to the open distal sheath end. According to some examples, the open proximal sheath end is coupled to the controller, the open distal sheath end is configured for insertion into a patient's vasculature, and the open distal sheath end is located opposite the open proximal sheath end.

[0009] The ablation system may include a wire (see, e.g., wire 30 as shown in FIG. 2) extending from the controller through an open proximal sheath end, through a working lumen, and to an open distal sheath end. In some examples, the wire has a proximal wire end (see, e.g., proximal wire end 1202 as shown in FIG. 12) and a distal wire end (see, e.g., distal wire end 1204 as shown in FIG. 12) opposite the proximal wire end, the distal wire end configured to mechanically treat the vessel wall in a treatment segment (see, e.g., treatment segment 55 as shown in FIG. 2), whereby the length of the distal wire end defines the length of the treatment segment.

[0010] According to some examples, the working lumen is configured to slidably receive the wire and allow passage of fluid therethrough around the wire to chemically treat the treatment segment. When the system receives a first input, the distal wire end may mechanically treat the vessel wall. In some examples, when the system receives a second input, the system delivers fluid into the treatment segment. According to some examples, when the system receives a third input, the system delivers fluid into a subsequent treatment segment.

[0011] The present disclosure also includes methods that include inserting a catheter (see, e.g., catheter 15 shown in FIG. 1 ) into a patient's vasculature. In some examples, the method includes moving the catheter to a first treatment segment (see, e.g., treatment segment 55 as shown in FIG. 2 ). According to some examples, the method includes actuating a motor (see, e.g., motor 610 as shown in FIG. 6A ) and rotating at least a portion of the catheter in response to actuating the motor.

[0012] The method may include abrading the first treatment segment over a predetermined amount of time in response to rotating at least a portion of the catheter. In some examples, the method includes moving the catheter to a second treatment segment. According to some examples, the method includes abrading the second treatment segment over a predetermined amount of time in response to rotating at least a portion of the catheter.

[0013] These and other features and advantages of the present invention will become apparent from the following more detailed description of preferred embodiments of the invention, the accompanying drawings, and the claims. [Brief explanation of the drawings]

[0014] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention, in which like characters indicate corresponding features consistently throughout like embodiments.

[0015] [Figure 1] A schematic diagram of the ablation system is shown as it might appear inside a patient. [Figure 2] 1 shows a side view of an exemplary wire within a blood vessel. [Figure 3] 1 illustrates a cross-sectional view of an exemplary blood vessel. [Figure 4A] 1 illustrates a side view of an ablation system, according to some embodiments. [Figure 4B] 1 illustrates a side view of an ablation system, according to some embodiments. [Figure 5A] FIG. 1 illustrates a perspective view of an exemplary controller. [Figure 5B] 5B illustrates a side view of the controller of FIG. 5A, according to some examples. [Figure 5C] 5B illustrates a top view of the example controller of FIG. 5A. [Figure 6A] 1 shows a schematic side view of an exemplary ablation system. [Figure 6B] FIG. 6B shows a schematic side view of the ablation system of FIG. 6A with exposed wires. [Figure 7] 10 illustrates a projection view of another example controller, according to some examples. [Figure 8] 10 illustrates a projection view of another example controller, according to some examples. [Figure 9A] 10 illustrates a projection view of another example controller, according to some examples. [Figure 9B] 9B illustrates a side view of the controller of FIG. 9A, according to some examples. [Figure 9C] 9B illustrates a top view of the controller of FIG. 9A without a syringe, according to some examples. [Figure 10] 10A-10C illustrate top views of a controller within a sterilization pack, according to some examples. [Figure 11] 1 illustrates a controller including additional features, according to some examples. [Figure 12A] 1 illustrates a side view of an exemplary wire. [Figure 12B] 1 illustrates a side view of an exemplary wire. [Figure 12C] 1 illustrates a side view of an exemplary wire. [Figure 13A] 1 shows an exemplary cross-sectional view of a wire. [Figure 13B] 1 shows an exemplary cross-sectional view of a wire. [Figure 13C] 1 shows an exemplary cross-sectional view of a wire. [Figure 14] 1 illustrates a side view of an exemplary off-axis wire. [Figure 15] 1 illustrates a side view of a wire of varying thickness, according to some examples. [Figure 16] 1 illustrates a side view of an exemplary wire having an angle profile. [Figure 17] 1 illustrates a side view of a wire including a stranded cable structure, according to some examples. [Figure 18] 1 shows a perspective view and inset of an exemplary wire including a helical hollow strand structure. [Figure 19] 1 shows a perspective view of an exemplary wire including a spring-like structure. [Figure 20] 1 illustrates a side view of a wire including a cage-like structure, according to some examples. [Figure 21] 10A-10C illustrate side views of additional wires terminating off-axis, according to some examples. [Figure 22A] 1 shows various examples of wires that include non-uniform amplitude profiles. [Figure 22B] 1 shows various examples of wires that include non-uniform amplitude profiles. [Figure 22C] 1 shows various examples of wires that include non-uniform amplitude profiles. [Figure 23A] 1 illustrates an exemplary wire having a sinusoidal profile. [Figure 23B] 23B illustrates a front view of the wire of FIG. 23A, according to some examples. [Figure 24A] 1 illustrates an exemplary wire including a spring-like profile. [Figure 24B] 24B illustrates a front view of the wire of FIG. 24A, according to some examples. [Figure 25A] 1 illustrates an exemplary wire that includes a profile that extends in a third dimension. [Figure 25B] 25B illustrates a front view of the wire of FIG. 25A, according to some examples. [Figure 26A] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26B] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26C] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26D] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26E] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26F] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26G] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 26H] 10A-10C illustrate side views of exemplary proximal features for a wire and / or sheath. [Figure 27A] 10A-10C illustrate side views of exemplary distal features for wires. [Figure 27B] 10A-10C illustrate side views of exemplary distal features for wires. [Figure 27C] 10A-10C illustrate side views of exemplary distal features for wires. [Figure 27D] 10A-10C illustrate side views of exemplary distal features for wires. [Figure 27E] 10A-10C illustrate side views of exemplary distal features for wires. [Figure 28A] 1 shows various examples of wires that include various features at their distal-most tips. [Figure 28B] 1 shows various examples of wires that include various features at their distal-most tips. [Figure 28C] 1 shows various examples of wires that include various features at their distal-most tips. [Figure 29A] 1 shows a side view of an exemplary wire having additional features at the distal wire end. [Figure 29B] 1 shows a side view of an exemplary wire having additional features at the distal wire end. [Figure 29C] 1 shows a side view of an exemplary wire having additional features at the distal wire end. [Figure 30A] 10 shows a side view of an exemplary wire with additional geometric shapes around the wire. [Figure 30B] 10 shows a side view of an exemplary wire with additional geometric shapes around the wire. [Figure 30C] 10 shows a side view of an exemplary wire with additional geometric shapes around the wire. [Figure 30D] 10 shows a side view of an exemplary wire with additional geometric shapes around the wire. [Figure 31] 1 shows an exemplary luer hub. [Figure 32] 1 illustrates a sheath including various features and wires, according to some embodiments. [Figure 33] FIG. 1 illustrates an exemplary block diagram for powering a motor through a limit switch. [Figure 34] 1 shows a flowchart illustrating an exemplary method for treating venous disease using an ablation system. [Figure 35] 1 shows a flowchart illustrating a method for controlling a catheter, according to some examples. [Figure 36] 1 shows a flowchart illustrating a method for exposing a wire from a catheter, according to some examples. [Figure 37] 1 shows a flowchart illustrating an exemplary method for capturing a wire within a catheter. [Figure 38] 1 shows a flowchart illustrating a method for controlling a distal catheter tip, according to some examples. [Figure 39] 1 shows a flowchart illustrating a method for controlling a motor, according to some examples. [Figure 40] 1 shows a flowchart illustrating a method of delivering fluid through a catheter, according to some examples. [Figure 41] 1 shows a flowchart illustrating a method for segmental mechanical ablation, according to some examples. [Figure 42] 1 shows a flowchart illustrating a method for exposing and enclosing a wire within a sheath, according to some examples. [Figure 43] 1 shows a flowchart illustrating a method for limiting power flow to a motor, according to some examples. [Figure 44] 1 shows a flowchart illustrating a method for measuring distance in segment therapy, according to some examples. [Figure 45] 1 shows a flowchart illustrating a method for segmental mechanochemical ablation, according to some embodiments. [Figure 46] 1 shows a flowchart illustrating a method for tracking a catheter sheath separate from a wire, according to some examples. [Figure 47] 10 shows a flowchart illustrating an additional method for limiting power flow to a motor, according to some examples. [Figure 48] 1 shows a flowchart illustrating a method for stabilizing a controller body, according to some examples. [Figure 49] 10 shows a flowchart illustrating a method of using a controller with a sterilization pack, according to some examples. [Figure 50] 10 shows a flowchart illustrating a method for detachably coupling a catheter to a controller, according to some examples. DETAILED DESCRIPTION OF THE INVENTION

[0016] This disclosure describes systems and techniques for treating vascular disorders, such as varicose veins. Some existing prior art systems involve the use of highly complex interventional devices (e.g., ablation catheters) that require the user to multitask with the device while performing complex and dexterous techniques, requiring significant user training for accurate and effective use.

[0017] For example, certain sclerotherapy catheters require a user (e.g., a clinician) to operate a first manual control (e.g., a syringe plunger) to inject a chemical, such as a sclerosing agent, into a target vessel and simultaneously operate a second, separate manual control to longitudinally translate the catheter (e.g., advance distally and / or withdraw proximally) to distribute the chemical agent throughout the target vessel. In some such examples, the secondary control simply consists of the clinician manually pushing and / or pulling the catheter through the patient's vasculature. Such systems are not widely considered to be user- or patient-friendly.

[0018] Furthermore, some vascular treatment devices incorporate mechanical ablation features in addition to or as an alternative to solely chemical-based ablation. While mechanical ablation often improves the effectiveness of treatment, it significantly complicates device operation by incorporating yet another manual control to actuate the motion (e.g., rotation) of the ablation device's mechanical agitator, as well as requiring the clinician to consciously manage the relative speeds between the three aspects (i.e., longitudinal movement rate through the vessel, fluid injection rate, and mechanical agitation rate).

[0019] In other words, many conventional sclerotherapy treatments and devices require the clinician to manually inject a sclerosing agent at a "constant" flow, operate a separate control (e.g., squeeze a trigger), activate an abrasive element, mechanically disturb the vessel wall, and simultaneously manually withdraw the catheter at a constant speed. The cognitive load and skill required to simultaneously accomplish all of these steps is high, and the inconsistent catheter withdrawal speed increases the likelihood of error, as the amount of mechanical ablation performed does not match the amount of sclerosing agent delivered to the target treatment site. This not only results in the perception of a difficult device to use, but can also result in poor or incomplete vein ablation if, for example, an insufficient amount of sclerosing agent is delivered, or if the withdrawal speed is too fast and the amount of mechanical abrasion is insufficient.

[0020] Additionally, the present disclosure describes systems and methods for controlling catheters, possibly including wires. These controls include clearing the wire from a lumen within the catheter to expose the wire for treating a treatment site, and directional control of the catheter tip. Some existing solutions include the use of steerable catheter tips and electronic-based delivery / wire-clearance systems. The present disclosure allows for both manual control of wire clearance as well as directional control of the distal catheter tip.

[0021] 1 shows a schematic diagram of an ablation system 10 as it might appear during a procedure on a patient's leg. A sheath 40 and wire 30 are introduced to a treatment site 50 via direct access to the vein being treated. Here, the wire 30 is shown released from the sheath 40 before or during the procedure. An operator initiates the procedure from the controller 20.

[0022] Figure 2 shows a side view of wire 30 within a blood vessel, according to some examples. Figure 3 shows a cross-sectional view of an exemplary blood vessel to better illustrate the intima, media, and adventitia. As seen in Figure 2, wire 30 may extend through a working lumen of sheath 40. This view shows wire 30 penetrating and / or obstructing the intima and making physical contact with the media at treatment site 50. This disrupts the intima at the location affected by the rotating wire.

[0023] Because the length of wire 30 exposed at treatment site 50 can contact a length of the blood vessel rather than just its periphery, treatment site 50 is often referred to as treatment segment 55 throughout this disclosure. This ability to treat treatment segment 55 rather than just its periphery allows for the use of segmental mechanical or mechanochemical ablation. Now, because the operator can treat treatment segment 55 at a time, the need to inject agent into treatment site 50 while simultaneously withdrawing catheter 15 is obviated. Thus, the operator can now focus on injecting agent at an appropriate rate in isolation, and once the agent is infused, can then move catheter 15 during a period when no agent is being administered. This may exponentially reduce the difficulty of such procedures, as the operator no longer needs to divide their attention between controlling the rates of multiple administration procedures (i.e., injection rate and catheter 15 withdrawal rate), but rather only need to focus on the rate of one treatment administration at a time. In other words, this allows the procedure to be divided into injection and withdrawal actions, but by no means requires that both of these actions be performed simultaneously. Additionally, the terms "medication" or "sclerosing agent" are used throughout this disclosure. It should be understood that any fluid may be delivered in conjunction with any portion of this disclosure in which such a fluid may be delivered.

[0024] 4A and 4B show side views of an example ablation system 10. In some examples, ablation system 10 includes a controller 20, which is shown and described in detail in various embodiments in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C. The ablation system may also include a catheter 15, which in some examples includes a sheath 40 and a wire 30 extending through the sheath 40.

[0025] For purposes of this disclosure, in some instances, the terms "catheter" and "sheath" are used interchangeably, with the understanding that a catheter can be other than just a sheath, such as in examples that include a wire. It should be further understood that reference to a catheter can also include ablation systems without a sheath or wire.

[0026] The sheath 40 may extend from the controller 20. In some examples, the wire 30 extends through a working lumen within the sheath 40. The wire 30 may be stored within the sheath 40 while the catheter 15 traverses the patient's vasculature until it reaches the treatment site 50, at which point the sheath 40 may be pulled back or retracted to remove the wire 30. Various examples of the wire 30 are illustrated and discussed in more detail in FIGS. 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A. Also shown in FIG. 4A is a syringe 60 in fluid communication with the controller 20 at its distal end. Syringe 60 may deliver agents, such as sclerosing agents, through catheter 15, sheath 40, and / or wire 30.

[0027] FIG. 5A shows a perspective view of an example controller 20, and FIGS. 5B and 5C show side and top views, respectively, of the controller 20 of FIG. 5A. As seen in FIGS. 5A, 5B, and 5C, the controller 20 may include a proximal controller end 502 and a distal controller end 504 opposite the proximal controller end 502. The controller 20 may also include at least one actuator, seen in actuator 506a and actuator 506b. As shown, multiple actuators may be implemented in or on a single controller 20.

[0028] 5A, 5B, and 5C, actuator 506a is present at the base (proximal controller end 502) of controller 20. Another actuator 506b is shown at the top of controller 20 near the distal controller end 504. These actuators can act as a kind of "and" gate, where both actuators must be activated (i.e., switched to the "on" position) to turn on controller 20. This is useful as a safety precaution during transport of controller 20 to prevent it from being inadvertently turned on.

[0029] In some examples, either actuator 506a or actuator 506b may act as a power-activated actuator, providing power to any internal circuitry such as a motor. In such examples, the other actuator (i.e., if actuator 506a is a power-activated actuator, then actuator 506b) may be a rotation-activated actuator, thus commanding the motor to begin rotation in this example. However, if desired, use of a single actuator would also work, as explained and discussed in more detail in Figures 9A, 9B, and 9C. The actuator may be any type of actuator on a user interface, such as a button, switch, touchscreen, etc.

[0030] 5A and 5B also show a display 508. The display 508 may provide information to the operator of the controller 20, such as the amount of time that has elapsed during a procedure, or the amount of time remaining if the controller 20 is programmable to operate for a set duration.

[0031] Specifically, considering mechanochemical ablation (or simply mechanical ablation if no drug is delivered), the display 508 may facilitate segment ablation techniques. For example, once the catheter 15 is inserted and positioned at the correct treatment site 50 and the operator turns the device on using the actuator, the display may count down the time until the treatment site is sufficiently abraded to deliver the drug. Additionally or alternatively, the display 508 may also count down the time the drug should continue to be delivered, at which point the operator interrupts the drug infusion.

[0032] In examples where the treatment site 50 includes treatment segments 55, the display 508 can notify the operator when treatment for a treatment segment 55 is complete and inform the operator that it is time to move the catheter 15 to the next or subsequent treatment segment 55.

[0033] FIG. 6A shows a schematic side view showing the wire 30 enclosed within the sheath 40. FIG. 6B shows the schematic side view of FIG. 6A , but with the wire 30 exposed from the sheath 40. As seen in both FIGS. 6A and 6B , the controller 20 may include a slot 602 at the distal controller end 504. At the proximal end of the sheath 40, there may be an inflation tow 604. The wire 30 is delivered to the treatment site 50 (in some examples) enclosed within the sheath 40. In other examples, the sheath 40 can be separated from the controller 20 and delivered to the treatment site 50 before the wire 30 is delivered to the treatment site 50.

[0034] Once the wire 30 reaches the treatment site 50, the wire 30 may be exposed from the sheath 40. In this regard, the sheath 40 may be retracted from the wire 30, such that the sheath moves away from the treatment site 50 while leaving the wire 30 in place within the treatment site 50. The operator may manually perform this retraction or retraction motion on the sheath 40 (shown and discussed in FIGS. 7, 8, 9A, 9B, and 9C) and then rotate the sheath 40 to lock the expansion tooth 604 within the slot 602. Locking the expansion tooth 604 within the slot 602 may prevent axial movement of the sheath 40 during the procedure.

[0035] 6A and 6B, the controller 20 may include a motor 610, such as an electric motor, that may be actuated by an actuator 608. A power supply 606 is also included within the controller 20 (although the power supply 606 may be external to the controller 20, if desired). The power supply 606 enables the actuator 608 to provide power to the motor 610, thus causing rotation of the motor 610, which in turn causes rotation of the wire 30.

[0036] Throughout this specification, motor 610 may be described as being coupled to and rotating on wire 30 and / or catheter 15. These terms are used interchangeably throughout this specification, as either component may be coupled to and rotated by motor 610. Additionally, there may be intervening components between motor 610 and wire 30 and / or catheter 15. For example, wire 30 and / or catheter 15 may be detachably or fixedly coupled to one or more hypotubes. These hypotubes may then also be detachably or fixedly coupled to motor 610.

[0037] It should be understood that the side views of controller 20 shown in Figures 6A and 6B may be used in combination with any of the various examples of controller 20 shown and described above in Figures 5A, 5B, and 5C, and with any of the various examples of controller 20 shown and described below in Figures 7, 8, 9A, 9B, and 9C.

[0038] 7 shows a perspective view of the controller 20, according to some examples. The controller 20 may include a proximal body end 708 and a distal body end 710 opposite the proximal body end 708. Although not shown in FIG. 7, the controller 20 may be removably coupled to the catheter 15 at the distal body end 710.

[0039] As seen in FIG. 7 , the controller 20 may include a flat, or at least partially flat, bottom, allowing the controller 20 to be placed on a tabletop or other work surface to facilitate operation of the controller 20. While not shown in FIG. 7 , as seen and described above in FIGS. 5A, 5B, and 5C , the controller 20 may be handheld, allowing the controller 20 to be operated with both hands, with one hand providing support for the controller 20 and the other operating the controller 20. The controller 20 may also be removably coupled to any work surface not specifically described herein; i.e., the controller 20 does not need to be placed on a table or held in an operator's hand in order for the controller 20 to be operable.

[0040] As also seen in FIG. 7 , the controller may include a body 702 and a saddle 704 slidably coupled to the body 702. The saddle 704 may be slidably moved in a first direction 712 and opposite the first direction 712. As shown in FIG. 7 , the first direction 712 may be considered to be moving from the proximal body end 708 to the distal body end 710. A T-fitting 706 may be disposed within the body 106 of the controller 20 and at least partially surrounded by a central portion of the saddle 704. The T-fitting may be slidably moved in the first direction 712 and opposite the first direction 712 in response to movement of the saddle 704. In examples of controllers 20 that include a catheter 15 removably coupled to / through the distal body end 710, the catheter 15 may further be removably coupled to the T-fitting 706.

[0041] Such a catheter 15 may include a wire 30 for the purpose of abrading the vessel wall at a treatment site 50, as detailed in Figure 2. In some procedures, it may be desirable to keep the wire 30 within the catheter body or sheath 40 until the wire 30 is delivered to the treatment site 50 to prevent premature abrasion of the vessel wall, or in other words, abrasion of a vessel wall not intended for treatment. Once the catheter 15 reaches the desired treatment site, the saddle 705 may move along a first direction 712 to expose or enclose the wire 30.

[0042] In other examples, the catheter 15 is tracked or moved to the treatment site 50, thereby exposing the wire 30. This may allow for greater flexibility in designs where the wire 30 includes a shape that is larger than the opening in the sheath 40. In some examples, once the wire 30 is enclosed by the sheath 40, the sheath 40 responds by expanding slightly to accommodate the wire 30 within its confines. This may limit the flexibility of the sheath 40, and thus exposing the wire 30 while tracking the catheter 15 to the desired treatment site 50 may allow for greater flexibility to traverse a patient's tortuous vasculature.

[0043] Throughout this specification, catheter 15 is disclosed as including wire 30. However, it should be understood that this specification is not limited to the use of wire 30. This specification also allows for the use of a hypotube, a catheter shaft, or a combination thereof in combination with wire 30.

[0044] As shown in the exemplary controller 20 of Figure 7, the saddle 704 resides at the distal body end 710. In this position, the wire 30 remains within the lumen of the sheath 40. When the operator moves the saddle 704 opposite the first direction 712 toward the proximal body end 708, the sheath 40 is retracted around the wire 30, exposing the wire 30. At this point, the wire 30 may be used to abrade the vessel wall.

[0045] The body 702 may include an actuator (such as actuator 506a or 506b as illustrated and discussed in FIGS. 5A, 5B, and 5C, actuator 608 as illustrated and discussed in FIGS. 6A and 6B, and / or actuator 914 as discussed in further detail in FIGS. 9A, 9B, and 9C). In some examples, the actuators 506a, 506b, 608, and / or 914 control circuitry and / or a motor within the body 702 (such as motor 610 as illustrated and discussed in FIGS. 6A and 6B, and / or motor 3308 as discussed in further detail in FIG. 33). The actuators 506a, 506b, 608, and / or 914 may control rotation of the wire 30 to promote abrasion of the vessel wall. Once this abrasion is complete, the operator can move the saddle 704 in the first direction 712 to push the sheath 40 forward again, thereby re-enclosing (or capturing, re-sheathing, etc.) the wire 30 within the sheath 40 and allowing safe removal of the catheter 15 from the patient's vasculature.

[0046] 7 also shows syringe 60 removably coupled to T-fitting 706 via saddle 704. This syringe 60 may be in fluid communication with catheter 15, in instances where catheter 15 is present. In some instances, catheter 15 includes a fluid lumen (such as a working lumen through sheath 40) that allows fluid from syringe 60 to pass through catheter 15 when syringe 60 is depressed. This may be useful in procedures such as sclerotherapy, where it is recommended to deliver a fluid agent, such as a sclerosing agent, to treatment site 50 either before, concurrently with, or after abrasion of the vessel wall.

[0047] Syringe 60 is shown as extending perpendicular to first direction 712. This is by way of example only, and it should be understood that syringe 60 may be positioned at any angle to provide the best ergonomics and / or comfort to the operator. In some examples, syringe 60 acts as a type of handle for the operator, facilitating control of saddle 704 and T-fitting 706 when moving both in first direction 712 and opposite first direction 712.

[0048] Although the saddle 704 and T-fitting 706 may slide under manual control of the syringe 60, the T-fitting 706 may also be operated by direct control of the saddle 704, such as by an operator pushing the saddle 704 with one hand while operating the depression of the syringe 60 with the other hand. As discussed in Figures 9A, 9B, and 9C, the saddle 704 may further include a pull tab (such as pull tab 910 in Figures 9A, 9B, and 9C) to facilitate manual movement of the saddle 704. In these examples, the syringe 60 would move with the T-fitting 706 but would not be the cause of such movement.

[0049] 7, in some examples, syringe 60 may not be removably coupled to T-fitting 706. In such examples, a push / inject tube may connect syringe 60 to a removably coupled catheter 15. This allows syringe 60 to be uncoupled from T-fitting 706, and therefore uncoupled from controller 20. Instead, syringe 60 is coupled to flexible tubing, allowing greater freedom of movement of syringe 60 separate from controller 20, when desired.

[0050] 7 also shows a slot in saddle 704 that is perpendicular to first direction 712 and extends at least partially around saddle 704. This slot may enable syringe 60 to undergo rotational motion about body 702. In some examples, as the operator rotates syringe 60 about body 702, a torque is applied to wire 30, possibly within removably coupled catheter 15, providing manual control over the distal end of wire 30. This may enable the operator to perform such fine movement of the distal end of wire 30 within treatment site 50 to make better abrasive contact with the vessel wall and / or to facilitate traversal of the patient's tortuous vasculature.

[0051] Although not shown in FIG. 7, T-fitting 706 may include a luer (such as luer 3104 seen in FIG. 31 and described below) that may be configured to detachably couple syringe 60 to T-fitting 706. In examples that include such a luer, the luer may be configured to rotate about a direction perpendicular to first direction 712. This rotation may include any angle of rotation, including a full 360-degree circumferential rotation about body 702.

[0052] When syringe 60 is releasably coupled to the luer, this rotational movement will likely be limited to prevent over-rotation of syringe 60. In this configuration, syringe 60 may be configured to control the rotation of the luer. Similar to the disclosure above, rotating the luer creates a torque on wire 30, allowing manual control of the distal end of wire 30.

[0053] The luer may have an O-ring on its proximal side to facilitate preventing fluid leakage during injection, which can be gripped onto the wire 30 while also being attached to the catheter sheath 40, so that when the luer rotates, the catheter sheath 40 also rotates, and the O-ring on the luer simultaneously attempts to rotate the wire 30.

[0054] Although not shown in FIG. 7 , in some instances, the luer is not present within the device body. In such instances, the luer may be a prefabricated stopcock or three-way valve that accepts the catheter sheath 40. This allows the user to completely remove the sheath 40 from the device while leaving the wire 30 in place. This can facilitate use of the device in situations where another catheter sheath 40, such as a guidewire catheter, is in place. The second catheter sheath 40 may not fit within the vasculature next to the existing catheter sheath 40, and therefore, once the catheter sheath 40 is removed from the device, the wire 30 can still be inserted into the treatment site 50.

[0055] Another advantage of being able to remove the sheath 40 is that the sheath 40 can be tracked to the treatment site first. Also, removing the catheter sheath 40 from the wire 30 allows the sheath 40 to be tracked over an already placed guidewire. Once the catheter sheath 40 is in place, the guidewire, if present, can be removed and the device can be advanced further into the vasculature.

[0056] FIG. 8 shows a perspective view of the controller 20, according to some examples. The example controller of FIG. 8 shares many similarities with the example controller of FIG. 7, many of which are repeated here. The controller 20 may include a proximal body end 806 and a distal body end 808 opposite the proximal body end 806. Although not shown in FIG. 8, the controller 20 may be removably coupled to the catheter 20 at the distal body end 808.

[0057] As seen in FIG. 8 , the controller 20 may include an at least partially flat bottom, allowing the controller 20 to be placed on a tabletop or other work surface to facilitate use of the controller 20. Although not shown in FIG. 8 , as described above in FIGS. 5A, 5B, and 5C , the controller 20 may be handheld to allow for two-handed operation of the controller 20, with one hand providing support for the controller 20 and the other operating the controller 20. The controller 20 may also be removably coupled to any other work surface not described herein; i.e., the controller 20 does not need to be specifically placed on a tabletop or held in an operator's hand in order for the controller 20 to be operable.

[0058] As seen in FIG. 8 , the controller 20 may include a body 802. Unlike the example controller 20 of FIG. 7 , the example controller 20 of FIG. 8 does not include a saddle slidably coupled to the body 802. In this example, a T-fitting 804 may be disposed within the body 802 of the controller 20. The T-fitting 804 may be slidably movable in both a first direction 810 and opposite the first direction 810, where the first direction 810 is a direction of movement from the proximal body end 806 to the distal body end 808. In examples of the controller 20 that include a catheter removably coupled to and / or through the distal body end 808, the catheter may further be removably coupled to the T-fitting 804.

[0059] Also shown in Figure 8 is a T-fitting 804 residing at the point closest to the proximal body end 806. In this position, the sheath 40 is retracted around the wire 30, exposing the wire 30 to the treatment site 50. In some instances, the catheter may be delivered in this configuration, but the wire 30 will likely be delivered to the treatment site 50 while still within the sheath 40 to avoid unintentional abrasion of vascular locations other than the treatment site 50. After the treatment is performed, the operator may move the T-fitting 804 along the first direction 810 to re-sheath the wire 30, allowing the catheter to be safely removed from the patient's vasculature.

[0060] 8 also shows syringe 60 removably coupled to T-fitting 804. Syringe 60 may also be in fluid communication with a catheter, if / when one is present. In some examples, the catheter includes a fluid lumen, allowing fluid from syringe 60 to pass through the catheter when syringe 60 is depressed. As mentioned above, this is useful in procedures such as sclerotherapy, where a fluid agent, such as a sclerosing agent, is recommended for use either before, concurrently with, or after abrasion of the vessel wall.

[0061] Syringe 60 is shown as extending perpendicular to first direction 810. It should be understood that this is by way of example only, and syringe 60 may be positioned at any angle to provide the best ergonomics or comfort to the operator. In some examples, syringe 60 acts as a type of handle for the operator, facilitating control of T-fitting 804 as it slidably moves both in first direction 810 and opposite first direction 810.

[0062] Figure 9A shows a perspective view of an additional exemplary controller. Figure 9B shows the controller 20 of Figure 9A in a side view, and Figure 9C shows the controller of Figure 9A in a top view without the syringe 60 present. Similar to the controller 20 of Figures 7 and 8, the controller 20 of Figures 9A, 9B, and 9C includes a body 902 having a proximal body end 906 and a distal body end 908 opposite the proximal body end 906. The beginning of the catheter 15 is shown without being labeled, but can be seen to enter the body 902 through the distal body end 908.

[0063] In this example, a T-fitting 904 is shown at least partially disposed within body 902. T-fitting 904 may be or include a luer hub and luer for detachably receiving syringe 60, as previously described. This T-fitting may be coupled to a saddle, such as saddle 704 of FIG. 7. However, the saddle in FIGS. 9A, 9B, and 9C is largely obscured by body 902 because the saddle is at least partially, if not mostly, located within body 902. However, portions of the saddle protrude from the side of body 902, which are shown as pull tabs 910. It should be understood that the decision to use the term "pull tab" is merely a lexical choice and any other suitable term, such as "finger pad" or equivalent, may be substituted.

[0064] Similar to the disclosure of Figures 7 and 8, the controller 20 may be able to steer the sheath 40 around the wire 30. Figures 9A and 9B show the syringe 60 and T-fitting 904 positioned toward the proximal body end 906. Figure 9C does not show the syringe 60, but also shows the T-fitting 904 positioned toward the proximal body end 906. In all cases, this may indicate that the sheath 40 has fully retracted around the wire 30, exposing the wire 30. This likely, but not necessarily, indicates that the catheter 15 is positioned at the treatment site 50 and the wire 30 is exposed to provide treatment.

[0065] Once treatment is complete, the syringe 60 and T-fitting 904 may be pushed along a first direction 916 extending from the proximal body end 906 to the distal body end 908. In FIG. 7 , we discussed how the operator can manipulate the saddle 704 itself to push or pull the syringe 60 and T-fitting 904. Similarly, in FIGS. 9A , 9B, and 9C , the pull tab 910 may be manipulated either instead of or in addition to the syringe 60 and T-fitting 904. In this example, pushing the syringe 60, the T-fitting 904, and / or the pull tab 910 causes the sheath 40 to expand around the wire 30, thereby encapsulating or capturing the wire 30. In this configuration, the wire 30 is less expanded, making it easier or safer to remove the catheter 15 from the patient (or insert it into the patient, if this occurs before treatment is delivered).

[0066] To counter this pushing motion, once catheter 15 is delivered to treatment site 50, the operator may then pull on syringe 60, T-fitting 904, and / or pull tab 910 to retract sheath 40. This retraction of sheath 40 exposes wire 30, and in some cases, if the distal end of wire 30 includes a shaped profile, wire 30 may expand to this shaped profile (or in some cases may expand further to this shaped profile) to contact the vessel wall, allowing abrasion to occur during treatment.

[0067] Also included in Figures 9A, 9B, and 9C are light emitting diodes (LEDs) 912 (labeled in Figures 9A and 9C). The LEDs 912 may be used to communicate an array of information to the operator. For example, the LEDs 912 may indicate that the device is receiving power or is turned on. The LEDs 912 may indicate that the sheath 40 is fully retracted around the wire 30, indicating that the wire 30 is ready to be rotated to provide abrasion therapy.

[0068] Throughout this disclosure, reference is made to segment mechanical or mechanochemical ablation. The LED 912 may indicate the treatment time to the operator in these or other cases. For example, perhaps the operator desires to provide mechanical agitation of the treatment segment 55 for a set period of time before moving on to the subsequent treatment segment 55. In these cases, the LED 912 may illuminate to indicate that the treatment time has elapsed and it is time to move on to the subsequent treatment segment 55. Alternatively, perhaps the LED 912 may be illuminated constantly, with the LED 912 turning off to indicate that this treatment time has elapsed.

[0069] In mechanochemical ablation, it is often desirable to inject an agent, such as a sclerosing agent, at a particular rate. In these cases, the LED 912 may indicate, as the case may be, by turning on or off, that mechanical ablation has occurred for a desired amount of time and it is time to begin injecting the agent into the treatment segment 55. Similarly, the LED 912 may indicate that the injection time has elapsed and it is time to move the catheter 15 to a subsequent treatment segment 55.

[0070] While one LED 912 is shown in Figures 9A, 9B, and 9C, it should be understood that multiple LEDs 912 may be present in the device and may serve multiple different purposes. For example, although not explicitly labeled, Figure 8 shows two LEDs on the body 802 proximal to the location of the syringe 60 and T-fitting 804. These LEDs 912 may be labeled to prevent operator confusion.

[0071] Additionally or alternatively, the controller 20 may include a display (e.g., display 508 of FIGS. 5A, 5B, and 5C) or some type of alarm or other noise generator for the purpose of indicating treatment time to the operator. In the case of an alarm or another noise generator, operation is similar to that of the LED 912, and an alarm may sound to indicate the end of mechanical ablation of a treatment segment 55, the end of infusion of medication into a treatment segment 55, time to move to a subsequent treatment segment 55, and / or the end of overall treatment. The display may perform in much the same manner, also indicating the time remaining for each of these steps.

[0072] Finally, also seen in Figures 9A, 9B, and 9C (labeled only in Figures 9A and 9C) is an actuator 914. The actuator 914 may be any device capable of receiving input from an operator, such as a switch, button, lever, touchscreen, etc. The actuator 914 may serve one or more purposes, including, but not limited to, turning the device on and off and turning a motor within the device on and off. While one actuator 914 is shown in Figures 9A, 9B, and 9C, it should be understood that there may be multiple actuators 914 on a device for different purposes, such as actuators 506a and 506b in Figures 5A, 5B, and 5C.

[0073] Figure 10 shows a top view of the device contained within a sterilization pack 1002. It should be understood that any of the controllers 20 as shown and described in Figures 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C, as well as other potential exemplary controllers 20, may be operable in conjunction with the disclosure of the sterilization pack 1002. Likewise, it should be understood that any combination of catheters 15, wires 30, and sheaths 40 as shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as other potential wires 30, may be operable in conjunction with the disclosure of the sterilization pack 1002.

[0074] As can be seen in Figure 10, the controller 20 may fit within a cavity or recess in a sterilization pack 1002. Space is also provided within the sterilization pack 1002 to accommodate the catheter 15, but Figure 10 shows how the device may appear during use rather than storage. A slit 1004 may be provided in the sterilization pack 1002, through which the catheter 15 may fit. This may allow the controller 20 to be operated from within the sterilization pack 1002 while the catheter 15 is being removed from the sterilization pack 1002 and inserted into the patient's body.

[0075] Although the component "slit 1004" is used throughout this disclosure, it should be understood that any other equivalent void within the sterilization pack 1002 may be used, such as a channel or opening.

[0076] In some examples, the catheter 15 may be removable from the controller 20 to be placed through this slit 1004. In other examples, the slit 1004 slidably receives the catheter 15 while the catheter 15 is already coupled to the controller 20. In either case, the controller 20 may be operated from within the sterile pack 1002, allowing the operator to perform treatment without the need for a sterile drape.

[0077] In instances where catheter 15 is not detachably coupled to controller 20, the entire ablation system 10 may need to be sterilized between treatments. However, in instances where catheter 15 is detachably coupled to controller 20, catheter 15 may be sterilized separately without the need to sterilize controller 20 between treatments. This can help reduce waste, as it allows for the reuse of controller 20.

[0078] Additionally, the catheter 15 may be made to be disposable (which can mean that, if the catheter 15 includes the sheath 40 and wire 30, the sheath 40 and / or wire 30 are disposable). This can significantly reduce costs and waste generation, as the controller 20 may be reused between treatments and the catheter 15 may be discarded after use. Additionally, the operator may not need to use sterile drapes, and the surfaces on which the controller 20 is placed within the sterile pack 1002 may not need to be fully sterilized (simply wiped) because the controller 20 does not come into direct contact with these surfaces.

[0079] In any example in which the catheter 15 is detachably coupled to the controller 20, the controller 20 may be packaged by itself within the sterile pack 1002, thereby allowing the controller 20 to be sold separately from the catheter 15.

[0080] Additionally, whether or not the catheter 15 is detachably coupled to the controller 20, the sterilization pack 1002 may be "tip clipped" along the wall for quick and easy access. This allows the operator to quickly access the controller 20 without having to search through a storage cabinet or cardboard box of devices and catheters to find the device they need.

[0081] 11 shows a top view of an exemplary ablation system 10. As seen in FIG. 11, the controller 20 may include an extendable foot 1102. This extendable foot 1102 may be webbed or otherwise constructed to allow an operator to control the width of the extendable foot 1102 relative to the base of the controller 20. By extending the extendable foot 1102, the controller 20 may be provided with additional stability and may prevent the controller 20 from tipping on its side due to an external force.

[0082] It should be understood that the extendable foot 1102 as shown in FIG. 11 may be used in combination with any of the various examples of controller 20 shown in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C and described above, as well as any additional controller not specifically shown herein.

[0083] This may prove particularly useful in instances where the motor is located below the T-fitting / saddle position, shortening the length of the controller 20 but increasing its height. This shorter, taller footprint may result in a higher center of gravity for the controller 20, making it more susceptible to tipping, which can be prevented by the extendable feet 1102. In such cases where the motor is located below the T-fitting / saddle position, gears may be used to create a gear ratio such that the rotation of the catheter 15 and / or wire 30 can be controlled to a desired rotational speed.

[0084] Also shown in FIG. 11 is a torque knob 1104. The torque knob 1104 allows the operator to apply torque to the catheter 15 and / or wire 30, thereby adjusting the traverse direction of the distal end of the catheter 15 and / or wire 30. This is similar to the slot in the saddle 704 of FIG. 7. However, instead of having to rotate the syringe 60 about the body 702 as shown and described in FIG. 7, the torque knob 1104 can provide an easy way to control the distal end of the catheter 15 and / or wire 30 without adjusting the syringe 60 at all. Again, this newly generated torque can allow the operator to fine-tune the distal end of the catheter 15 and / or wire 30 out of the treatment site 50 to make better abrasive contact with the vessel wall and / or to facilitate traversing the patient's tortuous vasculature. Such a torque knob 1104 may function in conjunction with a controller, as described through the use of a dual-shaft motor or through the example where the motor is located under the T-fitting / saddle.

[0085] It should be understood that the torque knob 1104 as shown in FIG. 11 may be used in combination with any of the various example controllers 20 as shown in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C and described above, as well as any additional controllers not specifically shown herein.

[0086] Finally, as shown in FIG. 11 , the controller 20 may include an arm 1106. In instances where the controller 20 is positioned such that the catheter 15 and / or wire 30 are folded back on themselves before insertion into the patient, the arm 1106 can facilitate preventing kinking of the catheter 15 and / or wire 30, which may adversely affect any fluid delivery, such as fluid delivery of a medication. The arm 1106 may also set the radius at which the catheter 15 is spaced from the controller 20. Additionally or alternatively, the arm 1106 may act as a catheter clamp to keep the catheter 15 in a fixed position during treatment. The arm 1106 may also prevent the device from operating while at an aggressive radius, which may adversely affect device performance. The arm 1106 may also prevent the ablation system 10 from twisting. (i.e., while the motor is operating, the ablation system 10 may twist on itself, and the arm 1106 may prevent this.)

[0087] It should be understood that the arm 1106 shown in FIG. 11 may be used in combination with any of the various examples of controller 20 shown in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C and described above, as well as any additional controllers not specifically shown herein.

[0088] 12A, 12B, and 12C show exemplary side views of wire 30. Specifically, FIGS. 12A, 12B, and 12C show different examples of components for releasing an agent, such as a sclerosing agent, in ablation system 10 featuring wire 30. Wire 30 may include a proximal wire end 1202 and a distal wire end 1204 opposite proximal wire end 1202. Proximal wire end 1202 generally refers to the region proximal to any feature of distal wire end 1204. 12A, 12B, and 12C (and FIGS. 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A shown and described below) show only the distal-most portions of the wire, and therefore it is not possible to show the proximal wire end 1202 as beginning near any current controller 20. For this reason, throughout this disclosure, the proximal wire end 1202 will be understood to refer to the wire 30 proximal to the portion of the wire intended to abrade (or ablate or agitate) the vessel wall.

[0089] 12A, 12B, and 12C, wire 30 may include a sinusoidal shape that allows wire 30 to contact the wall of the blood vessel into which wire 30 is inserted. In some examples, wire 30 is made from nitinol (such as Nitinol #1 ASTM F2063) or a similar material that can return to its shape after compression, such as that which wire 30 may experience when retracted within sheath 40.

[0090] Any of the examples described and illustrated herein can also operate within a stent. In such examples, the wire 30 will contact both the stent and the tissue. Furthermore, many of the examples illustrated and described in this disclosure include three or four peaks. It should be understood that the number of peaks present in the figures and described in this disclosure are merely examples; any number of peaks in a sinusoidal shaped wire may be present as desired, and that a greater number of peaks may mean a longer treatment segment 55, or simply a greater number of contact points along such treatment segment 55.

[0091] Additionally, it should be understood that any dimensions for spacing or amplitude of wire 30 are merely exemplary, and that different sized wires may prove useful for different sized vasculature or treatment segments 55. For example, wire 30 may have an amplitude of approximately 12 millimeters. In this example, wire 30 is at least partially compressible so that wire 30 is operable within vasculature having a diameter smaller than the amplitude of wire 30. With such an exemplary wire 30 having an amplitude of approximately 12 millimeters, the working range, or range of vessel diameters that wire 30 may be able to treat, would be from approximately 4 millimeters to approximately 12 millimeters.

[0092] If the diameter of the vessel being treated is smaller than the amplitude of wire 30, wire 30 will be compressed, stretching the peaks of the sinusoidal waveform and providing longer contact with the vessel wall, thus effectively lengthening the length of treatment segment 55. Wire 30, in this example, can treat vessels of larger diameters as well, but will not be able to provide continuous contact with the vessel wall. Therefore, a wire 30 with a larger amplitude may be desirable for such applications.

[0093] In procedures such as sclerotherapy, it is sometimes desirable to damage or penetrate the intima of a blood vessel, leaving only the media of the vessel. Traditional wires in the prior art contact the vessel wall at their distal tip, making this contact point abrupt and sharp. This presents a problem in that they may penetrate the media in addition to the intima, potentially causing the wire to become embedded in the surrounding adventitia. Current solutions to this problem involve rotating the wire in the opposite direction in the hopes of reaching a point where the wire unwinds from the vessel and can be safely removed. Another solution involves pulling on the wire, often quite forcefully, to forcibly remove it from the patient. This solution can cause pain and discomfort to the patient and can even completely detach the vein.

[0094] 12A, 12B, and 12C, the contact points are much blunter or at obtuse angles than conventional wire 30. This significantly reduces the chance of penetrating the media into the adventitia, improving the safety and effectiveness of the sclerotherapy procedure.

[0095] A further problem with current sclerotherapy treatments is the simultaneous tracking of multiple functions by the operator. For example, in many prior art devices, a treatment may involve retracting a wire through the vessel being treated at a rate of approximately 1–2 millimeters per second. At the same time, the operator must inject a sclerosing agent or other agent from a manually operated syringe at a rate of approximately 0.1–0.2 milliliters per centimeter. This already requires the operator to keep an eye on two separate measurement gauges: the distance the wire is withdrawn and the distance the syringe plunger is depressed. Because the catheter retraction rate is time-dependent, the operator must also somehow track the passage of time, often by counting mentally—another item that is both error-prone and potentially distracting to the operator from the procedure. Treatments often approach 40 centimeters in length, which means that these treatments can take anywhere from 200 to 400 seconds, based on the parameters suggested above.

[0096] In many prior art devices, the distal tip of the wire is the only point of contact between the wire and the vessel wall. Therefore, there is no "treatment segment" involved in these prior art devices as described herein. This is the root cause of the procedure, which requires the operator to withdraw the wire at a specific rate while the agent is injected at a separate, distinct, and specific rate. The present disclosure seeks to remedy this shortcoming of the prior art by eliminating the need to simultaneously withdraw the catheter while injecting the agent.

[0097] Through the use of a sinusoidally shaped wire 30 (or other wire shaped and configured to contact a length of the vessel wall) to treat a length of vein at a time, methods may be configured for segmental treatment rather than continuous treatment. In these methods, the wire 30 is provided at the most distal portion of the treatment site 50 and then activated for a predetermined amount of time. According to the present invention, the operator only needs to worry about the amount of medication injected, which can be much more variable without causing adverse effects because it no longer depends on the distance the wire 30 is retracted. Once the prescribed amount of medication has been delivered to the treatment segment 55, the operator can then withdraw the catheter 15 to the subsequent treatment segment 55 at a specified rate, or any rate desired by the operator, without further medication needing to be injected until the catheter 15 reaches this subsequent treatment segment 55.

[0098] A display 508 such as that described in Figures 5A and 5B can also reduce additional operator burden by eliminating the need for the operator to keep count of time in their heads. Similarly, an LED 912 such as that described in Figures 9A and 9C can serve a similar purpose. Whether providing information to the operator via display 508, LED 912, or some other method, such as a noise from an alarm, such an indicator relieves the operator from having to keep track of time themselves, allowing them to focus their full attention on the finer details of the procedure.

[0099] In some examples, the syringe may be replaced with an Archimedes screw to deliver a set amount of agent per rotation of the wire 30. Additional features may include a torque limiter, which may indicate if the wire 30 is rotating through an unintended medium, such as if the wire 30 penetrates into the adventitia. A clutch may also be included. The clutch may automatically stop the rotation of the wire 30 if some parameter, such as torque, passes a certain threshold. If the wire 30 penetrates the adventitia, the automatic stopping of the rotation of the wire 30 may prevent the blood vessel from entangling itself.

[0100] FIG. 12A illustrates a wire 30 having at least one aperture 1206. As shown in FIG. 12A, the wire 30 may be a hypotube having multiple apertures 1206 along its length, with the distal wire end 1204 having a nozzle-type tip containing additional apertures 1206. The apertures 1206 are present for delivering agents, such as sclerosing agents, to the treatment site 50 during treatment. An arrow is present on the proximal wire end 1202 to indicate the rotation of the wire 30 during treatment. The wire 30 can rotate in either direction during treatment, allowing the sinusoidal peaks to fully contact the vessel wall and improving wear during treatment. In some, but not all, examples, the wire 30 only rotates in a single direction. A central axis 1208 about which the wire 30 rotates is also shown.

[0101] Figure 12B shows a wire 30 having at least one aperture 1206 similar to that shown in Figure 12A. However, unlike the example of Figure 12A, Figure 12B includes a weighted tip 1210 at the distal wire end 1204. The arrows indicate possible directions of rotation about the central axis 1208; the inclusion of the weighted tip 1210 can create a gyroscopic effect to help keep the wire 30 centered within the vessel and ensure consistent contact with the vessel wall.

[0102] 12C illustrates the wire 30 with a weighted tip 1210, however, the aperture 1206 is not present in this example. The sheath 40 is shown and acts as a fluid lumen while the wire 30 is exposed. In this example, an agent such as a sclerosing agent may be delivered to the treatment site 50 through the sheath and may contact the vessel wall proximal to the turns of the wire 30 along the treatment length.

[0103] Figures 13A, 13B, and 13C show several possible cross-sectional profiles for wire 30. Specifically, Figure 13A shows a circular cross-sectional profile 1302 for wire 30, Figure 13B shows a rectangular or flat bar cross-sectional profile 1304 for wire 30, and Figure 13C shows a triangular cross-sectional profile 1306 for wire 30.

[0104] It should be understood that the various cross-sectional profiles shown in Figures 13A, 13B, and 13C may be used in combination with any of the various examples of wire 30 shown in Figures 12A, 12B, and 12C and described above, in combination with any of the various examples of wire 30 shown in Figures 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A and described below, or in combination with any additional wire not specifically illustrated herein.

[0105] The circular cross-sectional profile 1302, as shown in Figure 13A, is the most traditional shape of the wire. Its rounded profile reduces the possibility of penetration through the media into the adventitia, as there are no sharp edges that could cause injury. If greater abrasion is desired, a surface roughness may be applied to the circular cross-sectional profile 1302.

[0106] The flat bar cross-sectional profile 1304 of Figure 13B and the triangular cross-sectional profile 1306 of Figure 13C have sharper edges than the circular cross-sectional profile 1302 of Figure 13A. These sharp edges can abrade the vessel wall more quickly than the circular cross-sectional profile 1302, but they are more likely to not only damage the tunica media, but also to penetrate it.

[0107] 14 shows a side view of an exemplary wire 30 that terminates at a point that is not along the central axis 1208. In this example, a weighted tip 1210 is included, and the off-axis position of the weighted tip 1210 creates an effect that is opposite, or at least counter to, the gyroscopic effect. The weighted tip 1210 causes the wire 30 to rotate more erratically, bringing the peaks of the sinusoidal wire 30 and the weighted tip 1210 into less frequent, but more forceful, contact with the vessel wall. In some examples, the weighted tip 1210 is not included, but the wire 30 still terminates off the central axis 1208.

[0108] FIG. 15 shows a side view of a wire 30 having a variable thickness. In the illustrated example, the proximal wire end 1202 has a thick diameter 1502, and the distal wire end 1204 has a thin diameter 1504. The thick diameter 1502 is larger than the thin diameter 1504. The thick diameter 1502 portion of the wire 30 may be stiffer than the thin diameter 1504 portion of the wire 30 due to its thickness. This may allow the thick diameter 1502 portion of the wire 30 to be "kicked off" from the vessel wall, allowing the thin diameter 1504 portion of the wire 30 to make stronger contact with the vessel wall. The thick diameter 1502 portion of the wire 30 may also have a greater surface roughness, which may improve the wear capability of the wire 30. Furthermore, the larger profile size of the thick diameter 1502 portion of the wire 30 allows for better contact with the vessel wall.

[0109] 15 shows a thicker diameter 1502 at the proximal wire end 1202 and a thinner diameter 1504 at the distal wire end 1204, these locations are exemplary only. Any portion of the wire 30 may include a thicker diameter 1502 or a thinner diameter 1504 based on the needs of the user, and thus different effects may be achieved.

[0110] 16 shows a side view of an additional exemplary wire 30 that forms a triangular sine wave profile 1602. In fact, any type of shaped sine wave may be used, depending on the user's desires. The triangular sine wave profile 1602 may result in sharper contact points with the vessel wall (as seen in FIG. 2), improving abrasion to these areas. These sharper points, or triangular peaks 1604, may scratch or cut into the intima and / or media, potentially causing more damage to the vessel wall than simple abrasion.

[0111] FIG. 17 shows a side view of an exemplary wire 30 including a stranded cable 1702 configuration. The surface of the stranded cable 1702 may be rougher than the surface of a monofilament wire or cable due to an increased number of ridges around its circumference. This increased roughness may allow the stranded cable 1702 to make stronger contact with the wall of the blood vessel within the treatment site 50. Additionally, the strands of the stranded cable 1702 can be loosened or tightened, allowing the operator to "dial in" or set the desired radius for treatment. For example, the looser the stranded cable 1702, the larger the radius and therefore the larger the overall diameter of the wire 30. In contrast, the tighter the stranded cable 1702, the smaller the radius and therefore the smaller the overall diameter of the wire 30.

[0112] 18 shows a side view of an exemplary wire 30 including a helical hollow strand 1802 structure. Similar to the stranded cable 1702 of FIG. 17, the helical hollow strand 1802 may be rougher than that of a monofilament wire or cable due to an increased number of ridges around its circumference. Again, this increased roughness may allow the helical hollow strand 1802 to make stronger contact with the wall of the blood vessel within the treatment site 50. The helical nature of the helical hollow strand 1802 makes it a candidate for a type of wire 50 that includes a lumen, perhaps for delivering a drug.

[0113] 18 , a pull string may be threaded through the hollow portion of the helical hollow strand 1802 and pulled to cause the helical hollow strand 1802 to form a different shaped profile, such as a sinusoidal profile. Such a pull string may allow the helical hollow strand 1802 to be delivered to the treatment site 50 with a lower profile (which may be completely straight), as well as a peak-to-peak distance or peak amplitude of the helical hollow strand 1802 in a sinusoidal profile. This may be useful in situations where the peak size or peak-to-peak distance may be optimized for a particular treatment segment 55.

[0114] Additionally, the agent delivered through the hollow portion of the helical hollow strand 1802 may not need to be delivered to the distal-most end of the helical hollow strand 1802. Instead, the agent may be delivered as a weeping agent through the individual coils.

[0115] 18, there may be a second helical hollow strand 1802 wound around the first helical hollow strand 1802, with the coils continuing in the same direction or in opposite directions. In such an example, a vibratory motion can be created by the helical hollow strand 1802 without the need for openings in the coils.

[0116] FIG. 19 shows a side view of an exemplary wire 30 including a spring-like structure 1902. In a straightened form, the spring-like structure 1902 may appear as a three-dimensional sine wave or helix. However, the spring-like structure 1902 is not limited to this, as shown in FIG. 19 , and the spring-like structure 1902 itself may form a sinusoidal profile. The benefit of this is similar to that discussed for the stranded cable 1702 of FIG. 17 and the helical hollow strand 1802 of FIG. 18 , in that the spring-like structure 1902 includes additional ridges around the periphery of the wire 30, which may increase the roughness of the wire 30. Again, this increased roughness may allow the spring-like structure 1902 to make stronger contact with the vessel wall within the treatment segment 55.

[0117] FIG. 20 shows a side view of an exemplary wire 30 including a cage-like structure 2002. The cage-like structure 2002 includes multiple individual components, such as strands of wire helically wrapped around one another, similar to the stranded cable 1702 of FIG. 17 and the helical hollow strand 1802 of FIG. 18. However, in the cage-like structure 2002, the individual strands may include gaps or spaces between them. The individual strands of the cage-like structure 2002 may allow the wire 30 to contact the wall of the vessel within the treatment segment 55 multiple times per rotation, thus increasing the wear characteristics of the wire 30. Although not shown in FIG. 20, the cage-like structure may also have a modified profile, such as a sinusoidal profile, if desired. The cage-like structure 2002 is revisited as a concept for both the proximal feature 2602 of FIG. 26C and the distal feature 2702 of FIG. 27B.

[0118] FIG. 21 shows a side view of an exemplary wire 30, similar to that of FIG. 14, that terminates at a point that is not along the central axis 1208. Also similar to FIG. 14, the wire 30 of FIG. 21 has a weighted tip 1210 that terminates off-axis, creating an opposite effect to the gyroscopic effect. The weighted tip 1210 causes the wire 30 to rotate more irregularly, bringing the peaks of the sinusoidal wire 30 and the weighted tip 1210 into stronger contact with the vessel wall. In some examples, the weighted tip 1210 is not included, but the wire 30 still terminates off-axis from the central axis 1208.

[0119] Unlike the example of FIG. 14 , the wire 30 of FIG. 21 continues the path of the sinusoidal profile of the wire 30. Advantages of this example may include a less irregular path at the distal-most tip of the wire 30 than in the example of FIG. 14 . Additionally, fewer bends of the wire 30 may be required to construct the example of FIG. 21 , reducing manufacturing costs. The weighted tip 1210 is shown terminating at a point that is equal to one of the peaks of the sinusoidal profile of the wire 30. This is not strictly necessary, and the end point of the weighted tip 1210 may be positioned as desired by the user (although an end point along the central axis 1208 may again result in a gyroscopic effect).

[0120] 22A, 22B, and 22C show various side views of an exemplary non-uniform amplitude wire 30. Specifically, FIG. 22A shows an exemplary wire 30 having a first peak and a fourth peak that are greater in amplitude than the second peak and the third peak. FIG. 22B shows an exemplary wire 30 having three peaks on one side of the central axis 1208 (not shown in this view). FIG. 22C shows an exemplary wire 30 having a first peak and a fourth peak that are less in amplitude than the second peak and the third peak. FIGS. 22A, 22B, and 22C are merely examples and not exhaustive, and any configuration of non-uniform amplitude wire 30 may be used as desired.

[0121] It should be understood that any of the exemplary non-uniform amplitude wires 30 shown and described in Figures 22A, 22B, and 22C may be used in combination with any of the various examples of wires 30 shown and described above in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, or with any additional wires not specifically shown herein.

[0122] The benefits of such non-uniform amplitude wires include drug dispersion effects and treatment segment wear effects. For example, the wire 30 in FIG. 22A may cause drug spraying in the midsection due to a low amplitude peak in the midsection. In contrast, the exemplary wire 30 in FIG. 22C may cause spraying away from the midsection due to a high amplitude peak in the midsection. Furthermore, the unilateral peak shown in FIG. 22B may result in differential wear due to simultaneous damage along one side of the vessel, rather than circumferentially distributed damage.

[0123] FIG. 23A shows an exemplary wire 30 having a two-dimensional sinusoidal profile. This is one possible profile shape for the wire 30, including peaks for abrading the treatment segment 55, as well as points around the treatment site 50. FIG. 23B is a front view of the exemplary wire 30 of FIG. 23A. As seen in FIG. 23B, a sinusoidal profile wire 30 existing in two dimensions would have a sinusoidal crossing profile 2302 that resembles a rectangle. When rotated, the sinusoidal crossing profile 2302 approximates a shape that abrades the vessel wall within the treatment segment 55.

[0124] While the exemplary wire 30 shapes are shown to be various interpretations of a sinusoidal profile, additional shape profiles may be realized by the present disclosure. Furthermore, the wire 30 described above is shown as lying on a two-dimensional plane. As Figures 24A and 25A illustrate below, any of the preceding disclosures and figures (i.e., Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23A) may also lie in a three-dimensional plane, such as a spiral (or spring shape) or variations in which the peaks alternately rotate about a central axis 1208.

[0125] FIG. 24A shows one such example three-dimensional wire 30. The wire 30 of FIG. 24A is similar to the spring-like structure 1902 of FIG. 19, except that in FIG. 24A, the wire 30 does not exhibit an additional sinusoidal profile in two dimensions. Rather, the wire 30 is a sinusoid that exists in three dimensions, thus forming a helical or spring-like shape. FIG. 24B is a front view of the example wire of FIG. 24A. As seen in FIG. 24B, the helical-shaped wire 30 has a spring-like crossing profile 2402 that resembles a circle. When rotated, the spring-like crossing profile 2402 approximates a shape that abrades the vessel wall within the treatment segment 55.

[0126] Figure 25A shows an exemplary wire 30 in which a sinusoidal profile is manipulated in three-dimensional space after each peak occurs. The possibilities for such configurations are endless, and therefore, for purposes of discussion, Figure 25A represents just one such exemplary configuration.

[0127] In FIG. 25A , each time the wire hits a peak along the sine wave and returns to the central axis 1208 (not shown), the sine wave shape rotates clockwise by approximately 90 degrees. Again, this angle is merely an example, and any angle may be selected. Furthermore, the decision to rotate clockwise when moving from proximal to distal along the wire 30 is also merely an example. Counterclockwise or a combination of clockwise and counterclockwise rotations may also be implemented. Because FIG. 25A includes four peaks, reaching the fourth peak results in a complete rotation in three-dimensional space. Again, the decision to use four peaks in this example is non-limiting, and any number of peaks along the wire may be included. Likewise, a complete rotation in three-dimensional space is not strictly required.

[0128] Figure 25B is a front view of the exemplary wire of Figure 25A. Because the exemplary wire 30 of Figure 25A includes four peaks and has been rotated approximately 90 degrees after each peak, the three-dimensional intersection profile 2502 appears as a cross or plus sign. In this example, the three-dimensional intersection profile 2502 approximates the shape that abrades the vessel wall within the treatment segment 55 as the wire 30 is rotated. The shape of this three-dimensional intersection profile 2502 can be affected by the number and degree of rotation of the wire 30 after each peak.

[0129] Finally, the location where the rotation occurs is not strictly necessary. For example, as shown in Figures 25A and 25B, wire 30 may rotate in three-dimensional space at each peak rather than at the base of each peak. Rotation may also occur at any point between the peaks and the base of the peaks. Furthermore, any combination of these rotation points may be used, such as a first rotation occurring at the base after the first peak and a subsequent rotation occurring at the second peak.

[0130] 26A, 26B, 26C, 26D, 26E, 26F, 26G, and 26H show side views of exemplary proximal features 2602 of wire 30. In FIGS. 26A, 26B, 26C, 26D, 26E, 26F, and 26G, proximal feature 2602 can at least partially occlude a blood vessel proximal to the treatment area. This occlusion, or stasis of blood flow, can help prevent blood from entering the treatment area. While blood entering the treatment site 50 does not interfere with the procedure, too much blood can dilute the medication or sclerosing agent, reducing its potency and the overall effectiveness of the treatment. This occlusion, or stasis of blood flow, also helps stop or slow blood flow, allowing the sclerosing agent to remain in the treatment site 50 longer, increasing the effectiveness of the sclerosing agent. This occlusion may also help prevent the agent from leaving the treatment site 50 proximally.

[0131] It should be understood that any of the proximal features 2602 shown in Figures 26A, 26B, 26C, 26D, 26E, 26F, 26G, and 26H may be used in combination with any of the various 30 example wires shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0132] 26A, balloon 2604 may be proximal to the exposed portion of wire 30 and reside on sheath 40. After wire 30 is deployed from sheath 40, balloon 2604 may be inflated through an inflation lumen, possibly a working lumen within sheath 40, to occlude the blood vessel. In some examples, balloon 2604 may include a weeping balloon, and an agent such as a sclerosing agent may be delivered through pores in the weeping balloon.

[0133] FIG. 26B is similar to FIG. 26A , except that an offset balloon 2606 may reside on the sheath 40 proximal to the exposed portion of the wire 30. Again, after the wire 30 is deployed from the sheath 40, the offset balloon 2606 may be inflated through an inflation lumen, possibly a working lumen within the sheath 40, to occlude the vessel. Similarly, the offset balloon 2606 may include a seepage balloon, and a drug, such as a sclerosing agent, may be delivered through the pores of the seepage balloon. However, unlike the balloon 2604 of FIG. 26A , the offset balloon 2606 of FIG. 26B may be biased toward one side of the sheath 40. In such an example, the offset balloon 2606 may relieve stress on the wire 30 while in an inflated state, thereby forcing the wire 30 into stronger contact with the vessel wall.

[0134] 26C and 26D show hollow and solid variations of the helical occlusion element. Specifically, FIG. 26C shows a cage 2608 that expands to approximately the same diameter as the blood vessel upon release from the sheath 40. In this example, the cage 2608 is made from a material, such as nitinol, that allows the cage 2608 to both expand and contract. When the cage 2608 rotates, it may act as a three-dimensional impeller, at least partially blocking the progression of blood to and / or the egress of agents from the treatment site 50. In some examples, the cage 2608 is made from a material that does not allow compression, and is then sized to fit within the sheath 40.

[0135] 26D shows a grooved solid portion 2610 that acts similarly to the cage of FIG. 26C. However, the grooved solid portion 2610 may be smaller in diameter than the cage 2608 because it cannot be compressed as much when not in its released state and must still fit within the sheath 40. The solid nature of the grooved solid portion 2610 prevents any blood from entering the treatment site 50 through the grooved solid portion 2610 and potentially escaping agents from said treatment site 50, and the grooves in the grooved solid portion 2610 act as a urging force to prevent at least some blood from passing around the grooved solid portion 2610 and into the treatment site 50.

[0136] FIG. 26E shows an impeller 2612 having three blades. The number of blades is not critical, and any desired number of blades may be used. The impeller 2612 may be made from a material, such as nitinol, that allows the impeller 2612 to both expand and contract. In this example, the impeller 2612 may be sized larger than the diameter of the sheath 40. The impeller 2612 may then expand to approximately the same diameter as the blood vessel when released from the sheath 40. In another example, the impeller 2612 is made from a material that does not expand and contract significantly, in which case the impeller 2612 is sized to fit within the sheath 40 when in its retracted state. As the wire 30 rotates, the impeller 2612 also rotates, thus impeding blood progression to the treatment site 50.

[0137] 26F and 26G show a sponge-like solid portion 2614 as the proximal feature 2602. Specifically, in FIG. 26F, the sponge-like solid portion 2614 is present on the wire 30. When in its retracted configuration, the sponge-like solid portion 2614 can be easily compressed within the sheath 40, and when released from the sheath 40, can expand to occlude the blood vessel proximal to the treatment site 50.

[0138] Similarly, in FIG. 26G, the sponge-like solid portion 2614 acts as the proximal feature 2602, but in this case, the sponge-like solid portion 2614 resides on the sheath 40. The sponge-like solid portion 2614 can be easily compressed within the patient's vasculature and, upon delivery, can expand to occlude blood vessels proximal to the treatment site 50. In both FIG. 26F and FIG. 26G, the sponge-like solid portion 2614 may prevent blood from entering the treatment site 50 during treatment and / or agents, such as sclerosing agents, from leaving the treatment site 50 during treatment.

[0139] 26H shows a sinusoidal urge 2616 on the wire 30 proximal to the distal wire end 1204 within the sheath 40. This sinusoidal urge 2616 may still be present within the sheath 40 when the sheath 40 is fully retracted around the wire 30. The sinusoidal urge 2616 is not intended to occlude blood flow, but rather may reduce the load on the wire 30, thereby allowing the wire 30 to make stronger contact with the vessel wall.

[0140] 27A, 27B, 27C, 27D, and 27E show side views of various potential distal features 2702 for the wire. In all cases, the distal feature 2702 at least partially occludes a blood vessel distal to the treatment area. This occlusion, i.e., stasis of blood flow, can help prevent an agent, such as a sclerosing agent, from migrating too far into the blood vessel, such as a junction with another, more major blood vessel, where it is not desirable to treat. This occlusion, i.e., stasis of blood flow, can also prevent blood from crossing distally into the treatment site 50, which could potentially dilute the delivered agent.

[0141] It should be understood that any of the distal features 2702 as shown in Figures 27A, 27B, 27C, 27D, and 27E may be used in combination with any of the various examples of wires 30 shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0142] 27A, the single-blade impeller 2704 may be distal to the wire 30. When the wire 30 is released from the sheath 40, the single-blade impeller 2704 can expand to a length approximately the same as the radius of the blood vessel. In these examples, the single-blade impeller 2704 is made from a material such as nitinol that allows for this expansion and contraction of the single-blade impeller 2704.

[0143] In other examples, the single-blade impeller 2704 may be sized to fit within the sheath 40 while in its fully expanded configuration and may be made of a material that is more rigid and does not allow for as much expansion or contraction. As the wire 30 rotates, the single-blade impeller 2704 also rotates, preventing agents such as sclerosing agents from leaving the treatment site 50. Because the single-blade impeller 2704 cannot be symmetrical around the wire 30 (as you cannot have symmetry around a circle with only one component), the single-blade impeller 2704 may not be usable with a gyroscopic effect. Similar to the off-axis terminated wire 30 of FIGS. 14 and 21, the single-blade impeller 2704 may cause the wire 30 to move eccentrically, resulting in stronger contact with the vessel wall.

[0144] 27B and 27C illustrate hollow and solid variations of the helical occlusion element at the distal wire end 1204. Specifically, FIG. 27B illustrates a cage 2706 that expands to approximately the same diameter as the blood vessel upon release from the sheath 40. In this example, the cage 2706 is made from a material, such as nitinol, that allows the cage 2706 to both expand and contract. When rotated, the cage 2706 can act as a three-dimensional impeller, which at least partially impedes the progression of an agent, such as a sclerosing agent, from the treatment site 50 and also prevents the unintended inflow of blood into the treatment site 50. In some examples, the cage 2706 is made from a material that does not allow for compression, and is then sized to fit within the sheath 40.

[0145] FIG. 27C shows a grooved solid portion 2708 that acts similarly to the cage 2706 of FIG. 27B. However, the grooved solid portion 2708 is smaller in diameter than the cage 1006 because it cannot compress as much and must still fit within the sheath 40 when not in its relaxed state. The solid nature of the grooved solid portion 2708 prevents any of the delivered agent, such as a sclerosing agent, from exiting the treatment site 50 through the grooved solid portion 2708, and the grooves in the grooved solid portion 2708 provide a urging action to prevent at least a portion of the agent from passing around the grooved solid portion 2708 and exiting the treatment site 50. As in FIG. 27B, the grooved solid portion 2708 may also prevent the unintended inflow of blood from the distal side into the treatment site 50.

[0146] FIG. 27D shows an impeller 2710 having three blades. The number of blades is not critical, and any desired number of blades may be used. The impeller 2710 may be made from a material, such as nitinol, that allows the impeller 2710 to both expand and contract. In this example, the impeller 2710 may be sized larger than the diameter of the sheath 40. The impeller 2710 can then expand to approximately the same diameter as the blood vessel when released from the sheath 40. In another example, the impeller 2710 is made from a material that does not expand or contract significantly, and thus, the impeller 2710 is sized to fit within the sheath 40 when in its retracted state. As the wire 30 rotates, the impeller 2710 also rotates, thus preventing agents, such as sclerosing agents, from exiting the treatment site 50. This obstruction effect also extends to preventing any unintended inflow of blood into the treatment site 50.

[0147] 27E shows the sponge-like solid portion 2712. When in its retracted configuration, the sponge-like solid portion 2712 can be easily compressed within the sheath 40, and when released from the sheath 40, can expand to occlude the blood vessel distal to the treatment site 50. Unlike the sponge-like solid portion 2614 of the proximal feature 2602, the sponge-like solid portion 2712 of the distal feature 2702 may not be present on the sheath 40 because once the sheath 40 is retracted around the wire 30 to expose it, the sponge-like solid portion 2712 may no longer be present at the distal end of the treatment site 50.

[0148] 28A, 28B, and 28C show side views of an example wire 30 that includes additional features at the distal-most tip of the wire 30. While many of the previous figures included a weighted tip 1210 at the distal-most tip of the wire 30, a weighted tip 1210 is not required (as seen in FIG. 12A where the tip includes an aperture 1206). FIGS. 28A, 28B, and 28C provide further examples of the distal-most tip of the wire 30 that are not necessarily intended to keep the wire gyroscopically stable during rotation.

[0149] It should be understood that any of the additional features at the distal-most tip of wire 30 as shown in Figures 28A, 28B, and 28C may be used in combination with any of the various examples of wire 30 as shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as with any additional wires not specifically shown herein.

[0150] 28A shows a hemispherical tip 2802 at the distal-most tip of the wire 30. This hemispherical tip 2802 may be weighted or unweighted. In either case, the hemispherical tip 2802, due to its lack of three-dimensional symmetry, may cause the distal-most tip of the wire 30 to become unbalanced, which may have an adverse effect on gyroscopic stability. This effect may cause the hemispherical tip 2802 to come into contact, and perhaps make stronger contact, with the vessel wall by adding additional wear points to the treatment segment 55 where the wire 30 is located.

[0151] FIG. 28B shows an offset weighted tip 2804 at the distal-most tip of the wire 30. The offset weighted tip 2804 does not necessarily need to be weighted, but weight can increase the effect this distal-most tip has on the wire 30. Similar to the hemispherical tip 2802 of FIG. 28A, this offset weighted tip 2804 does not have symmetry about its newly acquired central axis 1208 (not shown in this view), which can have an opposing effect on gyroscopic stability by throwing the wire off balance. This effect can bring the offset weighted tip 2804 into contact (again, possibly forceful contact) with the vessel wall by adding an additional point of wear to the treatment segment 55 where the wire 30 is located.

[0152] 28C shows a balloon tip 2806 at the distal-most tip of the wire 30. This balloon tip 2806 can be delivered to the treatment site 50 in an unexpanded (or non-inflated) configuration and then inflated to dilate and occlude the blood vessel distal to the treatment site 50. In such an example, the wire 30 would likely include a lumen, or be a hypotube, to deliver inflation fluid to the balloon tip 2806 so that the balloon tip 2806 can expand to its expanded configuration.

[0153] 29A shows an exemplary side view of wire 30 including auxiliary wire 2902. The auxiliary wire 2902 may add auxiliary geometry along different portions of wire 30, creating a rougher surface and "snag" points to promote greater abrasion of the vessel wall. While the auxiliary wire 2902 is shown wrapped around most of the wire 30, the auxiliary wire 2902 may be wrapped around only a small portion of the wire, such as near a peak, to reduce material usage (and possibly material cost).

[0154] 29A , in some examples, the auxiliary wire 2902 may be a hypotube that extends back to the controller 20, allowing the auxiliary wire 2902 to be used as a fluid lumen for delivery of agents such as sclerosing agents to the treatment site 50. In these examples, apertures may be present along the length of the auxiliary wire 2902, located along the treatment segment 55, or at the distal-most end of the auxiliary wire 2902 for distal injection of agents.

[0155] It should be understood that the auxiliary wire 2902 shown in FIG. 29A may be used in combination with any of the various examples of wire 30 as shown and described in FIGS. 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0156] Figure 29B shows a side view of an exemplary wire 30 including auxiliary geometry, which appears very similar to auxiliary wire 2902 of Figure 29A. However, unlike auxiliary wire 2902 of Figure 29A, this auxiliary geometry is a heated wire 2904. Heating wire 2904 may be capable of delivering heat to treatment segment 55, thereby increasing the temperature within said treatment segment 55. By heating this treatment segment 55, any medication infused therein may see improved medication diffusion.

[0157] It should be understood that the heating wire 2904 as shown in FIG. 29B may be used in combination with any of the various examples of wire 30 as shown and described in FIGS. 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0158] The heating wire 2904 may also be an additional wire made of a shape memory material such as nitinol, and the heating portion of the "heating wire" may be provided by the patient's body through which the wire 30 is inserted. In these cases, an austenite transformation finish temperature (A(f) temperature) may be set for the shape memory material so that the shape memory material will revert from its martensitic state to its austenitic state at a temperature provided by the body. In such an example, the wire 30 may be delivered to the treatment segment 55 in a somewhat straightened state, and the heating wire 2904 will begin heating during this delivery. Once the wire 30 is delivered to the processing segment 55 and exposed from the sheath 40, the heating wire 2904 will be allowed to reach its A(f) temperature, thereby reverting to its austenitic shape and forcing the wire 30 into the desired shape for abrading the vessel wall.

[0159] 29C illustrates a wire 30 including a porous surface geometry 2906, according to some embodiments. This porous surface geometry 2906 may add surface roughness to the wire, as suggested in FIGS. 13A and 15. The porous surface geometry 2906 may prevent smooth surface portions of the wire 30 from contacting the vessel wall within the treatment segment 55. Instead, the porous surface geometry 2906 may cause sharper edges and uneven surfaces to physically contact the vessel wall, thus causing greater abrasion of the vessel wall.

[0160] It should be understood that the porous surface geometry 2906 as shown in FIG. 29C may be used in combination with any of the various examples of wire 30 as shown and described in FIGS. 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0161] Figures 30A, 30B, 30C, and 30D show various embodiments of wires that include additional geometric shapes. For example, additional geometric shape 3002a in Figure 30A may consist of rounded protrusions in either two or three dimensions. Additional geometric shape 3002b in Figure 30B may be at least one ball-shaped object in either two or three dimensions. In some examples, additional geometric shape 3002c is a spike, again in either two or three dimensions, as seen in Figure 30C. Additional geometric shape 3002d in Figure 30D may be a brush or brush-like object.

[0162] Any of these additional geometries 3002a, 3002b, 3002c, and / or 3002d may be used in conjunction with one another. These additional geometries 3002a, 3002b, 3002c, and / or 3002d may promote abrasion of the vessel wall along the treatment segment 55. Furthermore, although the additional geometries 3002a, 3002b, 3002c, and / or 3002d are shown only at the peaks of the sinusoidal waveform of the wire 30 presented in FIGS. 30A, 30B, 30C, and 30D, it should be understood that these additional geometries 3002a, 3002b, 3002c, and / or 3002d may be included anywhere on the wire 30, including throughout the body of the wire 30, as desired by a user.

[0163] It should be understood that any of the additional geometric shapes 3002a, 3002b, 3002c, and / or 3002d shown in Figures 30A, 30B, 30C, and 30D may be used in combination with any of the various examples of wire 30 as shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0164] Figure 31 shows an exemplary luer hub 3102 that includes a luer 3104. This luer hub 3102 may be the mechanism by which syringe 60 is detachably coupled to T-fittings 706, 804, and / or 904 (of Figures 7, 8, 9A, 9B, and 9C) or saddle 704 of Figure 7 (or a saddle not shown but described in Figures 8, 9A, 9B, and 9C).

[0165] 32 shows a top view of an exemplary catheter 15 including a sheath 40 and a wire 30. Multiple marking devices are visible on the body of the sheath 40. Any of these marking devices may partially or completely surround the body of the sheath 40.

[0166] FIG. 32 includes a donut 3202 that resides around the sheath 40. While shown and described as a donut 3202, it should be understood that any type of slidable depth marker may be used and may perform the same function as the donut 3202. The donut 3202 may be slidably coupled to the sheath 40, allowing a user to move the donut 3202 along the sheath 40 to a desired position. For example, the donut 3202 may be positioned on the sheath 40 at a distance that corresponds to the distance from the distal end of the sheath 40 to the patient's deep venous system. This can indicate to the operator that, once the donut 3202 reaches the patient's insertion point, further insertion of the catheter 15 may cause the catheter 15 to enter the patient's deep venous system or other vascular system not intended for treatment.

[0167] Additionally or alternatively, the donut 3202 may be sized so that it cannot enter the patient's insertion point. As described in the previous paragraph, this can prevent the catheter 15 from accessing the patient's deep venous system. This may prove useful during procedures such as segmental mechanical or mechanochemical ablation as described throughout this specification. For example, once the operator reaches the target treatment segment 55 and initiates rotation of the wire 30, perhaps by applying power to a motor, the operator can slide the donut 3202 along the sheath 40 to the insertion point and then release the catheter 15.

[0168] The donut 3202 can hold the catheter 15 in a fixed position relative to the insertion point, allowing the operator to use both hands freely. In some instances, rotation of the wire 30 attempts to retract the catheter 15 further into the patient's body due to the forward thrust from the rotational motion. In such instances, the donut 3202 is sized such that when the donut 3202 is coupled to the sheath 40, frictional forces between the donut 3202 and the sheath 40 cause the donut 3202 to hold its position relative to the sheath 40. However, the donut 3202 is still configured to slide relative to the sheath 40 under the influence of an external force, such as manual manipulation by an operator, that overcomes any frictional forces between the donut 3202 and the sheath 40.

[0169] The donut 3202 may be sized such that it cannot enter the insertion point within the patient's body, so that the donut 3202 can prevent the sheath 40 from entering further into the patient's vasculature. In other examples, a catheter clamp may be included to serve a similar purpose.

[0170] Also seen in FIG. 32 are a plurality of distance markings 3204 along the sheath 40. The distance markings 3204 may be used by the operator to determine how far the catheter 15 is within the patient. This is particularly useful when withdrawing the catheter 15. For example, during segmental mechanical or mechanochemical ablation, the operator may treat a treatment segment 55 and then begin withdrawing the catheter 15 from the patient until a subsequent treatment segment 55 is reached. In this scenario, when the first treatment segment 55 is reached and aligned with the distance marking 3204, the operator can then treat the treatment segment 55 and then withdraw the catheter 15 until it reaches the subsequent distance marking 3204, indicating that the subsequent treatment segment 55 has also been reached.

[0171] For this reason, it may be beneficial to include distance markings 3204 that are approximately the same length as the treatment segment 55. As previously disclosed in this disclosure, the treatment segment 55 may be the same length as the distal wire tip 1204. Thus, the distance markings 3204 may also be the same length as the distal wire tip 1204. However, neither of these distance marking lengths is strictly necessary, and variations in distance may be used as desired by the user.

[0172] 32 also shows a warning track 3206 distal to the distance markings 3204. This warning track 3206 may appear as a series of closely spaced markings, although other markings or indicators may be used as well. In practice, the warning track 3206 may inform the operator that the end of the workable treatment length has been reached, i.e., further withdrawal of the catheter 15 from the patient will invalidate the treatment.

[0173] The length of the warning track 3206, the location of the warning track 3206, and the number of distance markings 3204 and the distance between the distance markings 3204 may be customized, and multiple catheters 15 may be utilized for specific purposes, such as longer or shorter lengths of treatment. Similarly, the length of the distal wire tip 1204 may be customizable to lengthen or shorten the length of the treatment segment 55.

[0174] It should be understood that the donut 3202, distance markings 3204, and warning track 3206 shown in Figure 32 may be used together, separately, or in any combination with one another. It should be understood that the donut 3202, distance markings 3204, and warning track 3206 shown in Figure 32 may be used in combination with any of the various examples of wire 30 as shown and described in Figures 12A, 12B, 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A, and 25A, as well as any additional wires not specifically shown herein.

[0175] FIG. 33 shows an exemplary block diagram for operating a controller 20, possibly any of the controllers 20 shown and described in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and / or 9C. As can be seen in this block diagram, a power source 3302 can be wired to receive input from an actuator 3304. As previously mentioned, the power source 3302 can be an internal power source, such as a battery or a wired power source. Similarly, the actuator 3304 can be a button, switch, or anything capable of receiving user input to operate the controller 20.

[0176] The actuator is wired to a limit switch 3306, which is wired to a motor 3308 and an LED 3310 (separated by a resistor 3312 to receive the correct amount of power). The limit switch 3306 either allows power to flow to the motor 3308 and LED 3310, or prevents power from flowing to the motor 3308 and LED 3310.

[0177] For example, consider an ablation system 10 that includes a controller 20 having a sheath 40 and a wire 30 disposed through a working lumen of the sheath 40. If the controller 20 is capable of moving the sheath such that retracting the sheath 40 exposes the wire 30 and extending the sheath 40 encloses the wire 30, it may be desirable to prevent the wire 30 from rotating unless it is fully exposed from the sheath 40.

[0178] In such an example, the limit switch 3306 may be provided to allow power to be provided to the motor 3308 and the LED 3310 only when the sheath 40 is fully retracted. Similarly, the limit switch 3306 may prevent power from being provided to the motor 3308 and the LED 3310 if the sheath 40 is extended even slightly from its fully retracted state.

[0179] This is just one example of how the limit switch 3306 may be implemented in the circuitry of the controller 20 to control when the motor 3308 receives power, and any implementation of the limit switch 3306 may be implemented as desired by the user. Also, as shown and described in Figures 9A and 9C, an LED 3310 may be present to communicate to the operator that the motor is on or ready to be turned on (i.e., in the example above, the sheath 40 has fully retracted). Other purposes for the LED 3310, such as use as a timer or indicator of treatment completion during segmental mechanical or mechanochemical ablation, can be similarly accomplished through this limit switch.

[0180] It should be understood that the entire block diagram as shown in FIG. 33, as well as other exemplary wiring configurations for the circuitry, may be used in combination with any of the various examples of controller 20 as shown in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C and described above, as well as any additional controllers not specifically shown herein.

[0181] 34 is a flowchart illustrating an exemplary method of treating venous disease using an ablation system. In some examples, the method includes using (at step 3400) a sclerotherapy device. A sclerotherapy device is understood to be any ablation device 10 and / or controller 20 and catheter 15 (or sheath 40 and wire 30) combination. As used throughout, a sclerotherapy device need not be capable of specifically delivering a sclerosing agent; any system capable of causing mechanical or mechanochemical ablation of a blood vessel is considered synonymous with this use of "sclerotherapy device."

[0182] According to some examples, the method includes determining (at step 3402) a first treatment site 50 within the patient's vasculature. As discussed above, the treatment site 50 (or first treatment site 50) may be a length along a blood vessel, otherwise described as a treatment segment 55 (or first treatment segment 55 as in this example).

[0183] The method may include (at step 3404) treating a first treatment site 50 by extending and expanding the wire 30 into the blood vessel. As also described above, the distal end of the wire 30 for treating each treatment site 50 may be the length of the segment to be treated (treatment segment 55), thus allowing the wire 30 to treat (or abrade) each treatment segment 55 simultaneously.

[0184] In some examples, the method includes repositioning (at step 3406) the sheath to a second treatment site 50. In examples such as those described above, the second treatment site 50 may also be a length along the vessel, otherwise described as a treatment segment 55 (or second treatment segment 55).

[0185] According to some examples, the method includes treating a second treatment site 50 (at step 3408). Also, as detailed above, the distal end of the wire 30 for treating each treatment site 50 may be the length of the segment being treated, thus allowing the wire 30 to simultaneously treat (or abrade) the entire second treatment segment 55. The use of "first" and "second" is merely exemplary, and there may be more steps or stages in the treatment. In these examples, any next step may be considered to be performed on a subsequent treatment site 50 or treatment segment 55.

[0186] The method may include (at step 3410) imaging the treatment 50 using ultrasound. This is just one way of positioning the catheter 15 within the patient while delivering the catheter to the treatment site 50, or at least partially retracting the catheter 15 to position the catheter 15 at a subsequent treatment site 50.

[0187] In some examples, the method includes providing (at step 3412) a sclerosing agent to at least one of the first treatment site 50 and the second treatment site 50 through the sheath 40. The sclerosing agent may be any agent and may be delivered through means other than the sheath 40, for example, through a lumen of the catheter 15 and / or a lumen of the wire 30. When delivered through the sheath 40, the agent may pass through a working lumen within the sheath 40.

[0188] Furthermore, according to some embodiments, because no agent is delivered while the catheter 15 (sheath 40) is removed from the first treatment site 50 and repositioned at the second treatment site 50, the operator has one less thing to worry about in that they no longer need to inject agent at a specific rate while simultaneously withdrawing the catheter 15 at a specific rate. In this manner, the method achieves segmental mechanical or mechanochemical ablation. It should be understood that any reference to segmental mechanical or mechanochemical ablation means segmental mechanical or segmental mechanochemical ablation.

[0189] 35 is a flowchart illustrating an exemplary method of controlling a catheter. In some examples, the method of controlling a catheter includes using (at step 3500) a controller. The controller may be the controller shown in FIGS. 5A, 5B, 5C, 7, 8, 9A, 9B, and 9C, or a similar controller that includes a sliding portion that can accept a syringe. According to some examples, the method of controlling a catheter includes (at step 3502) inserting the syringe into a T-fitting along a second direction perpendicular to the first direction.

[0190] The first direction, represented in Figures 7, 8, 9A, 9B, and 9C as first direction 712, first direction 810, and first direction 916, respectively, is the direction in which the saddle and T-fitting travel laterally around the device body. Stated another way, the first direction is the direction of travel between the proximal and distal body ends. In step 3502, the syringe is inserted into the T-fitting along a direction perpendicular to the first direction. It should be understood that, because the present invention exists in three-dimensional space, this second direction can be any direction circumferentially around the first direction. Furthermore, as depicted in Figures 7, 8, 9A, 9B, and 9C, the syringe need not be inserted perfectly perpendicularly; other directions and / or angles of inserting the syringe into the T-fitting can also be used.

[0191] The method of controlling a catheter may include directing the catheter to a treatment site on the patient (at step 3504). In examples including a catheter coupled to a distal body end, inserting a syringe into a T-fitting may cause the catheter to be delivered to the treatment site to begin treatment.

[0192] 36 is a flowchart illustrating a method of exposing a wire from a catheter, according to some examples. In some examples, the method of exposing a wire from a catheter includes (at step 3600) sliding a T-fitting from the distal body end toward the proximal body end. In examples including a catheter, the catheter may be coupled to the device body at the distal body end. By sliding the saddle and T-fitting from the distal body end to the proximal body end, the catheter is effectively "pulled back" with the movement of the saddle and T-fitting.

[0193] According to some examples, a method of exposing a wire from a catheter includes retracting a sheath around the wire (at step 3602). In examples including a wire within the catheter body, the catheter sheath surrounding the wire moves around the wire as the catheter is pulled back in response to movement of the saddle and T-fitting, as represented in step 3600. The wire either does not move in response to movement of the saddle and T-fitting, or moves at a speed slower than that of the catheter.

[0194] The method of exposing a wire from a catheter may include exposing the distal wire end (at step 3604). Once the saddle and T-fitting are fully moved from the distal body end to the proximal body end, the wire is exposed from the catheter sheath, allowing contact between the wire and the wall of the vasculature. This allows the wire to be used during a procedure, while also allowing delivery to the treatment site without exposing the wire.

[0195] 37 is a flowchart illustrating an exemplary method of capturing a wire in a catheter. In some examples, the method of capturing a wire with a catheter includes (at step 3700) sliding a T-fitting from a proximal body end to a distal body end. In embodiments including a catheter, the catheter may be coupled to the device body at the distal body end. By sliding the saddle and T-fitting from the proximal body end to the distal body end, the catheter is effectively "pushed forward" with the movement of the saddle and T-fitting.

[0196] According to some examples, a method of capturing a wire with a catheter includes extending a sheath around the wire (at step 3702). In examples including the wire within the catheter body, the catheter sheath surrounding the wire moves around the wire as the catheter is pushed forward in response to movement of the saddle and T-fitting, as represented in step 3700. The wire either does not move in response to movement of the saddle and T-fitting, or moves at a speed slower than that of the catheter.

[0197] The method of capturing a wire with a catheter may include capturing the distal wire end (at step 3704). Once the saddle and T-fitting have been fully moved from the proximal body end to the distal body end, the catheter sheath may completely cover the wire, effectively capturing or enclosing the distal wire end within the catheter sheath. This may help prevent damage to non-treated areas once the procedure is complete.

[0198] 38 is a flowchart illustrating a method of controlling a distal catheter tip, according to some examples. In some examples, the method of controlling a distal catheter tip includes rotating a syringe and a luer (at step 3800). Rotating the syringe and luer may also impart a rotational motion to a catheter coupled to the device body.

[0199] According to some examples, the method of controlling a distal catheter tip includes applying a torque to the catheter (at step 3802). The torque may be applied to the catheter by rotating the syringe and luer, and the torque may be either in the direction of rotation of the syringe and luer or opposite to the direction of rotation of the syringe and luer.

[0200] The method of controlling the distal catheter tip may include (in step 3804) controlling the direction of travel of the distal catheter tip. In response to an applied torque, the distal catheter tip moves. For example, if the torque applied to the catheter is in the same rotational direction as the syringe and luer, and this rotational direction is clockwise around the body of the device, the distal catheter tip may be steered toward the left (the length of the catheter from the proximal catheter tip to the distal catheter tip is a first direction, and left is based on this first direction). In contrast, if the torque applied to the catheter is opposite the rotational direction of the syringe and luer, the distal catheter tip may be steered toward the right. It should be understood that the use of "left" and "right" is merely exemplary, and the device may be configured to apply torque to the catheter to control the distal catheter tip in any direction desired by the operator.

[0201] 39 is a flowchart illustrating an exemplary method of controlling a motor. In some examples, the method of controlling the motor includes (at step 3900) pressing a button. The button may be mechanically coupled to the device body and electrically coupled to the motor, thereby enabling control of the motor. According to some examples, the method of controlling the motor includes (at step 3902) powering on the motor. In response to actuation of the button, power is provided to the motor, enabling it to rotate.

[0202] The method of controlling the motor may include pressing a button (at step 3904). The button can be activated again once the procedure is complete, or at any time when it is desired not to rotate the motor. In some examples, the method of controlling the motor includes powering the motor off (at step 3906). When the button is activated at a subsequent time, or at any time when the motor is currently powered on, the button removes access to power from the motor, thereby stopping the motor from rotating. While the use of "button" is used in FIG. 39, it should be understood that any toggleable mechanism or "actuator," such as a switch, as described above and shown in previous figures (see FIGS. 5A, 5B, 5C, 6A, 6B, 9A, 9B, and 9C), can be used to provide power to or remove power from the motor.

[0203] 40 is a flowchart illustrating a method of delivering fluid through a catheter, according to some examples. In some examples, the method of delivering fluid through a catheter includes depressing a plunger of a syringe (at step 4000). Depressing the plunger of the syringe causes any fluid in the syringe to be expelled from an opening in the tip of the syringe.

[0204] According to some examples, a method of delivering fluid through a catheter includes expelling fluid through the catheter (at step 4002). In examples where the catheter is in fluid communication with a syringe, the fluid ejected from the syringe at step 4000 is injected into the catheter body, possibly through a fluid lumen, which allows the fluid to travel along the length of the catheter to the treatment site.

[0205] FIG. 41 is a flowchart illustrating a method of segment mechanical ablation, according to some examples. In some examples, the method of segment mechanical ablation includes (at step 4100) inserting a catheter into a patient's vasculature. The catheter may then be delivered to a treatment site, also referred to as a treatment segment, with the length of treatment provided without the need for catheter movement. According to some examples, the method of segment mechanical ablation includes (at step 4102) moving the catheter to a first treatment segment. The first treatment segment may be the most distal location in the entire treatment length, allowing the operator to move the catheter throughout the entire treatment length by withdrawing the catheter from the patient rather than pushing the catheter further into the patient's body. However, it should be understood that either direction of movement is possible with this method, and the operator may choose how to perform such segment ablation treatment.

[0206] The method of segment mechanical ablation may include (at step 4104) activating a motor to rotate at least a portion of the catheter. Mechanical agitation (or abrasion, or ablation) of the vessel wall may result from rotating the catheter and physically contacting portions of the catheter with the intima and media of the vessel wall. This contact may be sufficient to damage these layers, and in some cases, this damage may be sufficient to kill the vessel, thereby completing treatment of the varicose vein in at least this treatment segment. In other examples, the catheter "scratches" the vessel wall to cause this damage by using less rotational motion and more reciprocating motion. This reciprocating motion may be caused by converting the rotational motion of the motor into linear motion of the catheter, or by other means if desired.

[0207] In some examples, the segment mechanical ablation method includes abrading the first treatment segment for a predetermined amount of time (in step 4106). The predetermined amount of time depends on the needs of the operator and the length of time that may be required to treat a particular vessel. The length of time may also vary based on whether the treatment is segment mechanical ablation, as described above in the method of FIG. 41, or segment mechanochemical ablation, as discussed later in FIG. 45. For segment mechanical ablation, the catheter may remain within the treatment segment (without moving longitudinally through the vein) for about 5 to about 30 seconds. Again, these values are merely examples, and the operator may choose to leave the catheter within the treatment segment for any length of time desired.

[0208] According to some examples, the method of segmental mechanical ablation includes moving the catheter to a second treatment segment (in step 4108). This second treatment segment may be adjacent or nearly adjacent to the first treatment segment, although this is not strictly necessary. By having the second treatment segment near or adjacent to the first treatment segment, the operator can be confident that the entire vessel is being treated.

[0209] The method of segment mechanical ablation may include abrading the second treatment segment for a predetermined amount of time (in step 4110). This abrasion (or, again, agitation or ablation) may be performed in the same manner as described above in step 4106. The predetermined amount of time may be the same as the predetermined amount of time discussed in step 4106, or may be a different predetermined amount of time depending on the needs of the operator for the particular segment of the vein being treated.

[0210] 42 is a flowchart illustrating a method of exposing and sheathing a wire, according to some examples. In some examples, the method of exposing and sheathing a wire includes indicating (at step 4200) that a predetermined amount of time has elapsed. This indication step is not strictly limited to the method of exposing and sheathing a wire and may be present in any of the other methods listed herein, or may not be included in the method if this indication step is not desired. This indication may occur through a component such as an LED, speaker, or display, likely located outside the body on a controller. The indication may be audible or visual.

[0211] According to some examples, the method of exposing and enclosing a wire within a sheath includes (at step 4202) retracting at least a portion of the sheath from the wire. The wire, which may pass through a working lumen of the sheath, may additionally be slidably disposed within the sheath. In some examples, this allows the sheath to be retracted around the wire.

[0212] The method of exposing and sheathing a wire may include exposing a distal wire tip (in step 4204). When the sheath is retracted, a portion of the wire, in this example the distal wire tip, may be exposed from the sheath, allowing the distal wire tip to contact the wall of the blood vessel in a treatment such as segmental mechanical ablation.

[0213] In some instances, the method of exposing and sheathing the wire includes extending the sheath around the wire (in step 4206). By slidably moving the sheath opposite the direction of step 4202, the operator can retract the sheath all the way, or at least partially, around the wire to its initial position. This can be useful in instances where the operator desires distal wire ends of different lengths to treat specific lengths of blood vessel.

[0214] According to some examples, the method of exposing and sheathing a wire includes at least partially sheathing the distal wire end (in step 4208). By extending the sheath, the operator can re-enclose the distal wire end, facilitating safe removal of the catheter from the patient. Again, the distal wire end may be only partially enclosed by the sheath, since the sheath may only partially extend around the wire. When the sheath is extended back to its initial position, the wire may again be fully enclosed.

[0215] FIG. 43 shows a flowchart illustrating a method for limiting power flow to a motor, according to some examples. The method for limiting power flow to a motor may include (at step 4300) allowing energization from a power source to the motor. In examples that include a limit switch, the limit switch may be a component that allows or prevents energization. As described in more detail in FIG. 47, the limit switch may be controlled by some other characteristic of the overall ablation system.

[0216] In some examples, the method of limiting power flow to the motor includes rotating the wire (at step 4302). As explored in Figure 41, rotation of the wire can cause ablation (or agitation, or abrasion) of the vessel wall. Motor rotation can also translate into longitudinal movement of the wire, allowing for a scratching effect rather than rotational ablation.

[0217] According to some examples, a method for limiting power flow to a motor includes preventing the power source from energizing the motor (at step 4304). As described in step 4300, this may be accomplished through the use of a limit switch. A method for limiting power flow to a motor may include terminating the rotation of the wire (at step 4306). When the motor is no longer permitted to be energized, the motor may also cease to have an effect on the movement of the wire.

[0218] FIG. 44 shows a flowchart illustrating a method for measuring distance during segment treatment, according to some examples. In some examples, the method for measuring distance during segment treatment includes (in step 4400) maintaining a longitudinal position of the catheter relative to a first treatment segment. As described in FIG. 41, the catheter may be held in a fixed longitudinal position within the vessel for a predetermined amount of time. In some examples, the shape of the distal wire tip allows the entire segment to be treated simultaneously, eliminating the need to move the catheter while treating such a segment. This allows the operator to track one less object at a time, freeing up one of the operator's hands to assist with other portions of the procedure.

[0219] According to some examples, a method for measuring distance in a segment treatment includes (in step 4402) moving a catheter out of a patient a distance approximately equal to the length from a first distance marking to a second distance marking. These distance markings may be located on the shaft of the catheter. As the catheter is withdrawn from the patient's body, subsequent distance markings become visible, indicating to the operator how far the catheter has moved from the patient overall. In some examples, the distance markings are separated by a distance approximately equal to the length of the treatment segments. In such examples, an operator withdrawing the catheter from the patient's body can identify when the distal end of the catheter has moved from one treatment segment to the subsequent treatment segment. This spacing of the distance markings, if any, between segments is minimized, reducing the likelihood that the operator will miss a portion of the vessel being treated, since each treatment segment is treated individually.

[0220] The method for measuring distance in a segment treatment may include (in step 4404) indicating that the end of the catheter's workable treatment length has been reached. A warning track or the like on the body of the catheter may display additional information to the operator. The warning track may be visually distinct from the distance markings in the previous paragraph to allow the operator to quickly identify differences between the information being communicated. Additionally, a warning track is likely to be present on the catheter distal to the distance markings. This is because, in some instances, the purpose of the warning track is to indicate that the operator has left the treatment area, i.e., that the operator has reached the end of the catheter's workable treatment length. This may indicate to the operator that treatment of the vessel is complete, at least for this instantaneous treatment.

[0221] FIG. 45 shows a flowchart illustrating a method of segmental mechanochemical ablation, according to some examples. According to some embodiments, the method of segmental mechanochemical ablation includes injecting (at step 4500) a drug into a first treatment segment. Similar to the disclosure of FIG. 41, this injection may occur for a predetermined amount of time. The predetermined amount of time may be the same as or different from the amount of time for which mechanical ablation is performed. Furthermore, the injection may occur before, after, or during the mechanical ablation portion of the treatment. For example, an operator may insert a catheter into the correct position for treatment and then energize the motor to begin abrading the vessel wall with the distal wire tip for 5 seconds. After the 5 seconds have elapsed, the operator may depress the syringe plunger to begin injecting the drug into the treatment site. This may occur for a period of time such that a specific rate of drug injection is achieved. During this injection, the distal wire tip may continue to rotate, abrading the vessel wall. This injection and mechanical ablation may occur over a period of approximately 5 seconds. Once injection is complete, the operator may allow the distal wire tip to continue mechanically ablating the vessel wall for an additional 10 seconds, thus further driving the agent into the damaged endothelium. It should be understood that the times listed herein are merely examples, and different times may be used for different treatments.

[0222] The segment mechanochemical ablation method may include (in step 4502) terminating the infusion of the agent before moving the catheter to the second treatment segment. In segment mechanochemical ablation, the agent only needs to be infused while the catheter is positioned within the treatment segment. This differs from prior art mechanochemical ablation methods in which the agent must be delivered continuously while the catheter is retracted through the patient's vasculature. Because the infusion of the agent is terminated before moving the catheter from the first treatment segment to the second treatment segment, the operator does not need to simultaneously focus on catheter movement and agent infusion. This may facilitate the elimination of human error when attempting to simultaneously measure two different rates (retraction rate and infusion rate).

[0223] In some examples, the method of segment mechanochemical ablation includes injecting (in step 4504) an agent into the second treatment segment. This injecting may be for a predetermined amount of time, also as described in step 4500. However, the predetermined amount of time for the injecting into the second treatment segment need not be the same length of time as the predetermined amount of time for the injecting into the first treatment segment.

[0224] According to some examples, the method of segment mechanochemical ablation includes (at step 4506) removing the catheter from the patient's vasculature. Once treatment is complete, the operator may remove the device from the patient. The method of segment mechanochemical ablation may include (at step 4508) terminating the infusion of agent before removing the catheter from the patient's vasculature. After the final treatment segment has been treated, the operator may discontinue injecting agent from the syringe through the catheter before removing the catheter from the patient.

[0225] 46 shows a flowchart illustrating a method for tracking a catheter sheath separate from a wire, according to some examples. In some examples, the method for tracking a catheter sheath separate from a wire includes (at step 4600) releasably coupling the sheath to a body of the controller. Releasably coupling the sheath to the body of the controller may allow the sheath to be manipulated longitudinally separately from the wire. According to some examples, the method for tracking a catheter sheath separate from the wire includes (at step 4602) removing the sheath from the body. In this example, because the sheath is releasably coupled to the body of the controller, the sheath may be separated or removed from the body while leaving the wire in place (still coupled in some way to the body of the controller).

[0226] A method for tracking a catheter sheath separate from a wire may include (in step 4604) directing the sheath to a treatment area on a patient. By separating the sheath from the body of the controller while leaving the wire in place, the sheath can be delivered to the treatment site ahead of the wire. In instances where the profile of the wire slightly affects the profile of the sheath while stored internally, it may be desirable to track the sheath to the treatment site without this effect on the crossover profile. Then, once the sheath is positioned in the correct location, the wire may be placed through the sheath to also reach the treatment site.

[0227] FIG. 47 is a flowchart illustrating an additional method for limiting power flow to a motor, according to some examples. In some examples, the additional method for limiting power flow to the motor includes retracting a sheath around the wire (in step 4700). This limiting function may be performed by a limit switch, as described in the method of FIG. 43. In such examples, the limit switch may be operably coupled to the sheath, such that the limit switch allows energization (from the power source through the limit switch to the motor) only when the sheath is in a fully retracted position. In other examples, the limit switch allows energization from the power source to the motor when the sheath is only partially retracted, thereby allowing the length of exposed wire to be varied. In either example, the limit switch prevents the motor from receiving power until the sheath is retracted, or at least partially retracted, so that the motor cannot be activated, intentionally or unintentionally, when the wire is not exposed. This may facilitate safe delivery of the catheter to the treatment site without concern for premature rotation of the wire.

[0228] According to some examples, an additional method of limiting power flow to the motor includes exposing the distal wire tip (in step 4702). As previously described in FIG. 42, when the sheath is retracted, a portion of the wire, in this example the distal wire tip, is exposed from the sheath, allowing the distal wire tip to contact the wall of the blood vessel in a treatment such as segmental mechanical ablation.

[0229] An additional method of limiting power flow to the motor may include rotating the motor (in step 4704). When the sheath is retracted, or at least partially retracted, a limit switch may allow the motor to receive power and thus rotate. As discussed above in FIGS. 41 and 43, rotation of the wire, and therefore rotation of the distal wire end, may cause ablation (or agitation, or abrasion) of the vessel wall. Again, motor rotation may also translate into longitudinal movement of the wire, allowing for a scratching effect through the distal wire end rather than rotational ablation.

[0230] In some examples, an additional method of limiting power flow to the motor includes extending a sheath around the wire (in step 4706). By slidably moving the sheath opposite the direction of step 4700, the operator can retract the sheath around the wire. Again, this movement may include moving the sheath completely back to its initial position (i.e., the position the sheath would have been in when the catheter was initially delivered to the treatment site), or only partially extending the sheath around the wire. Aside from the already-mentioned variable treatment length this provides, this may also affect a limit switch, thus preventing the motor from receiving further power, as discussed in step 4710.

[0231] According to some examples, an additional method of limiting power flow to the motor includes at least partially encapsulating the distal wire end (in step 4708). As previously discussed in FIG. 42, by extending the sheath, the operator may re-encapsulate the distal wire end, facilitating safe removal of the catheter from the patient. Again, the sheath may only partially extend around the wire, so the distal wire end may only partially be encapsulated by the sheath. When the sheath is extended back to its initial position, the wire may again be fully encapsulated. Furthermore, as noted in step 4706, this encapsulation of the distal wire end may also affect a limit switch, which may prevent power from flowing to the motor.

[0232] Additional methods of limiting power flow to the motor may include preventing the motor from rotating (in step 4710). Once the procedure is complete and the operator wishes to remove the catheter from the patient, the operator may also wish to stop the ablation mechanism, whether mechanical or chemical, so as not to damage healthy veins. Beyond simply turning the motor off, by tying the sheath position to a limit switch, the operator cannot accidentally start the motor again while retracting the catheter from the patient's body. Again, the limit switch can be adjusted to allow for variable length treatment segments at the distal wire end, only preventing the motor from receiving power when the sheath is fully extended.

[0233] FIG. 48 shows a flowchart illustrating a method for stabilizing a controller body, according to some examples. In some examples, the method for stabilizing a controller body includes (at step 4800) changing the rotational ratio between the motor and the catheter. While not necessary to stabilize the controller, in some cases, if the motor is located below the T-fitting and / or saddle rather than behind it, the controller may have a body that is taller but shorter in length. In such examples, the now higher center of gravity may increase the stability of the device. When the motor is located below the T-fitting and / or saddle, the motor is no longer aligned with the insertion point of the catheter, so a gear ratio may be required to convert the rotational motion of the motor into rotational motion of the catheter. These gear ratios may also be used in controllers where the motor is behind the T-fitting and / or saddle if the device user desires adjustable rotation options for the catheter.

[0234] According to some examples, a method of stabilizing a controller body includes (at step 4802) extending an extendable foot. An extendable foot on the bottom of the controller body, perhaps webbed as shown in FIG. 11, may be included in an ablation system. Extending the extendable foot may lower the center of gravity of the controller. This is particularly useful in example controllers, such as the controller in the previous paragraph, where the placement of the motors inherently increases the center of gravity of the controller and the user may wish to lower this center of gravity.

[0235] The method of stabilizing the controller body may include stabilizing the controller body (at step 4804). In step 4802, extending the extendable feet provides stability to the controller body by lowering the center of gravity of the controller, thereby reducing the likelihood that an operator will accidentally tip the controller during a procedure.

[0236] 49 is a flowchart illustrating a method of using a controller with a sterilization pack, according to some examples. In some examples, the method of using the controller with the sterilization pack includes (at step 4900) removing a catheter from the sterilization pack. In some examples, the controller and catheter are packaged together in the sterilization pack. The catheter must be at least partially removed from the sterilization pack for insertion into a patient. In some examples, the catheter is packaged separately from the controller.

[0237] According to some examples, a method of using a controller with a sterile pack includes (at step 4902) directing a catheter to a treatment site on a patient. The catheter may be directed to the treatment site on a patient while coupled to the controller, or the catheter may be detachable, and the operator may choose to direct the catheter to the treatment site before coupling the catheter to the controller. The present disclosure allows an operator to couple a catheter to a controller while the catheter is being delivered to the treatment site, if they wish to do so.

[0238] The method of using the controller with the sterile pack may include (at step 4904) operating the controller from within the sterile pack. A cavity or recess may be present within the sterile pack within which the controller resides while packaged. After removing the catheter from the sterile pack (in instances where the catheter and controller are packaged in the same sterile pack), the controller may be retained within the sterile pack. In this manner, the controller can maintain its sterility during use. This allows the operator to perform treatment without the need for a sterile drape. Furthermore, this may reduce the cost of the procedure because, while the catheter still needs to be sterilized or disposed of, the controller does not need to be sterilized after each use as long as its environment is kept sterile.

[0239] In some examples, a method of using a controller with a sterile pack includes (in step 4906) placing a catheter through a slit in the sterile pack. The sterile pack may include a slit distal to the controller (near the portion of the controller where the catheter is inserted to couple to the controller). This slit may also be an aperture or other hollow space in the sterile pack into which the catheter can be inserted. In this way, a catheter may be coupled to the controller without having to remove the controller from the sterile pack, thereby maintaining the sterility of the controller.

[0240] 50 is a flowchart illustrating a method of detachably coupling a catheter to a controller, according to some examples. According to some examples, the method of detachably coupling a catheter to a controller includes (at step 5000) detachably coupling the catheter to the controller. As previously discussed throughout this application, the catheter may be completely detachable from the controller, thereby providing a detachable coupling between the catheter and the controller. It is understood that this is not strictly necessary, and exemplary ablation systems may include a catheter that is fixedly coupled to the controller.

[0241] The method of detachably coupling a catheter to a controller may include (at step 5002) separating a sheath from the controller. In some examples, the catheter includes a sheath having a working lumen. In further examples, the sheath may be separable from the controller. In such examples, the sheath may be tracked to the treatment site before being coupled to the controller. In examples in which a wire is contained through the working lumen of the sheath, the sheath may be separated from the controller and tracked to the treatment site separate from the wire, as described in FIG. 46.

[0242] In some examples, the method of detachably coupling a catheter to a controller includes (at step 5004) sterilizing the sheath separately from the controller. According to some examples, the method of detachably coupling a catheter to a controller includes (at step 5006) discarding the sheath. In exemplary ablation systems in which the sheath is separable from the controller, the sheath may be sterilized while not connected to the controller. As described in FIG. 49, this may help reduce sterilization costs. Furthermore, the sheath may be completely discarded without having to discard the controller, and thus the controller may be reused more times than the catheter.

[0243] The method of detachably coupling a catheter to a controller may include (in step 5008) detaching the wire from the controller. In some exemplary ablation systems, the catheter further includes a wire passing through a working lumen of a sheath. The catheter may also include a wire without a sheath, if desired. In either case, the wire may be tracked to the treatment site (or a motor, e.g., an ablation system including a motor that rotates the wire) before being coupled to the controller.

[0244] In some examples, the method of detachably coupling a catheter to a controller includes (at step 5010) sterilizing the wire separately from the controller. According to some examples, the method of detachably coupling a catheter to a controller includes (at step 5012) disposing the wire. In exemplary ablation systems in which the wire is detachable from the controller, the wire may be sterilized while not connected to the controller. As also described in FIG. 49, this may help reduce sterilization costs. Furthermore, like the sheath in step 5006, the wire can be completely discarded without having to discard the controller; therefore, the controller can be reused more times than the catheter.

[0245] The present disclosure includes an ablation system 10 including a controller 20. In some examples, the ablation system 10 includes a sheath 40 having a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the controller 20, and the distal sheath end is configured for insertion into the patient's vasculature, the distal sheath end being located opposite the proximal sheath end. The ablation system 10 may include a wire 30 extending from the controller 20 through the working lumen to the distal sheath end. In some examples, the wire 30 includes a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202, the distal wire end 1204 being configured to engage a wall of a blood vessel within the treatment segment 55.

[0246] According to some examples, the sheath 40 is retractable to expose the distal wire tip 1204. The distal wire tip 1204 may be positioned and configured to define a compressed state when the distal wire tip 1204 is located within the sheath 40 and to define an uncompressed state when the sheath 40 is retracted from the distal wire tip 1204. In some examples, the wire 30 is configured to be delivered to the treatment segment 55 in a compressed state. According to some examples, the sheath 40 is variably retractable to expose a length of the distal wire tip 1204. The length of the distal wire tip 1204 may be configured to form a variable treatment length.

[0247] In some examples, the sheath 40 is detachably coupled to the controller 20. According to some examples, the sheath 40 is configured to follow the treatment segment 55 while the wire 30 remains stationary. The ablation system 10 may further include a motor 610 and / or 3308 configured to provide a rotational output, the wire 30 being coupled to the motor 610 and / or 3308.

[0248] In some examples, the sheath 40 includes an open distal end configured to deliver an agent to the treatment segment 55. According to some examples, the sheath 40 further includes a lumen for delivering an agent to the treatment segment 55. The sheath 40 may include an opening at the distal sheath end for delivering an agent to the treatment segment 55. In some examples, the agent is a sclerosing agent.

[0249] According to some examples, the sheath 40 includes a closed distal end and an opening at the distal sheath end for delivering a drug to the treatment segment 55. The drug may be a sclerosing agent.

[0250] In some examples, the distal wire tip 1204 includes a sinusoidal configuration. According to some examples, the distal wire tip 1204 includes a weighted tip 1210. The weighted tip 1210 may be attached to the distal-most end of the wire 30. In some examples, the distal wire tip 1204 defines a sinusoidal cross profile.

[0251] According to some examples, the sinusoidal wave configuration includes a non-uniform amplitude. The sheath 40 may include a closed distal end and holes at the distal sheath end to deliver the agent to the treatment segment 55. In some examples, the non-uniform amplitude is configured to cause a spraying effect of the agent.

[0252] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. According to some examples, the sinusoidal configuration is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0253] The wire 30 can define a central axis 1208. In some examples, the distal wire end 1204 includes a sinusoidal configuration. According to some examples, the distal wire end 1204 includes a weighted tip 1210. The weighted tip 1210 can be centered about the central axis 1208, with the weighted tip 1210 configured to create a gyroscopic effect. In some examples, the weighted tip 1210 is off-center and positioned parallel to the central axis 1208. According to some examples, the weighted tip 1210 is configured to contact a wall of a blood vessel. The weighted tip 1210 can be off-center and positioned at an angle relative to the central axis 1208. In some examples, the weighted tip 1210 is configured to contact a wall of a blood vessel.

[0254] According to some examples, the wire 30 includes a thickness gradient, allowing a thicker section at the distal wire end 1204 to improve contact with the wall of the blood vessel. The wire 30 may have a circular cross-sectional profile 1302. In some examples, the wire 30 has a flat bar cross-sectional profile 1304. According to some examples, the wire 30 has a triangular cross-sectional profile 1306.

[0255] The wire 30 may include a stranded cable 1702. In some examples, the stranded cable 1702 defines a radius, which is adjustable. According to some examples, the stranded cable 1702 is configured to enable a high contact force against the wall of a blood vessel. The stranded cable 1702 may define a sinusoidal profile.

[0256] In some examples, the controller 20 includes the motor 610 and / or 3308 and the power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. According to some examples, the motor 610 and / or 3308 is configured to provide a rotational output. The proximal wire end 1202 may be rotatably coupled to the motor 610 and / or 3308. In some examples, the stranded cable 1702 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0257] In some examples, the wire 30 comprises a helical hollow strand 1802 wire. According to some embodiments, the helical hollow strand 1802 wire is configured to deliver a drug to the treatment segment 55. The drug may be a sclerosing agent. In some examples, the drug is configured to permeate through the coils of the helical hollow strand 1802 wire. According to some examples, the helical hollow strand 1802 wire defines a sinusoidal profile. The amplitude of the sinusoidal profile may be adjustable. In some examples, the ablation system 10 further includes a pull string coupled to a distal end of the helical hollow strand 1802 wire, the pull string configured to adjust the amplitude of the sinusoidal profile.

[0258] According to some examples, the helical hollow strand 1802 wire defines a first helical hollow strand 1802 wire, and the wire 30 further includes a second helical hollow strand 1802 wire. The second helical hollow strand 1802 wire may at least partially surround the first helical hollow strand 1802 wire. In some examples, the first helical hollow strand 1802 wire and the second helical hollow strand 1802 wire generate a vibratory motion.

[0259] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. According to some examples, the helical hollow strand 1802 wire is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0260] The helical hollow strand 1802 wire may be configured to be positioned flat while inside the sheath 40. In some examples, the helical hollow strand 1802 wire is configured to expand when the sheath 40 is retracted.

[0261] According to some examples, the distal wire end 1204 includes a spring-like configuration. The distal wire end 1204 may define a spring-like cross profile 2402. In some examples, the spring-like configuration defines a sinusoidal profile.

[0262] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. According to some examples, the spring-like arrangement is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0263] The distal wire tip 1204 may include a three-dimensional cross-sectional profile. In some examples, the three-dimensional cross-sectional profile is a two-dimensional sinusoidal configuration, where the sinusoidal configuration defines a period. According to some examples, in each period, the sinusoidal configuration rotates in a third dimension.

[0264] The sinusoidal configuration may further define time segments that are part of a period. In some examples, during each time segment, the sinusoidal configuration rotates in a third dimension. According to some examples, each time segment is half a period.

[0265] The distal wire tip 1204 may define a three-dimensional cross-sectional profile. In some examples, the controller 20 includes a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. According to some examples, the motor 610 and / or 3308 is configured to provide a rotational output. The proximal wire tip 1202 may be rotatably coupled to the motor 610 and / or 3308. In some examples, the three-dimensional cross-sectional profile is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0266] According to some examples, the distal wire tip 1204 includes a triangular sinusoidal profile 1602. The triangular sinusoidal profile 1602 may include a triangular peak 1604. In some examples, the triangular peak 1604 is configured to contact the wall of a blood vessel.

[0267] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. According to some examples, the triangular sine wave profile 1602 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0268] The distal wire tip 1204 may include a basket-like shape. In some examples, the basket-like shape is configured to expand. According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the proximal wire tip 1202 is rotatably coupled to the motor 610 and / or 3308. According to some examples, the basket-like shape is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0269] The wire 30 may be made from a shapeable material. In some examples, the wire 30 is made from Nitinol.

[0270] According to some examples, the wire 30 includes a lumen from the proximal wire end 1202 to the distal wire end 1204. The wire 30 may further include an aperture 1206 at the distal-most end of the wire 30. In some examples, the lumen is configured to deliver a drug to the treatment segment 55 through the aperture 1206. According to some examples, the drug is a sclerosing agent. The wire 30 may include a hole at the distal wire end 1204. In some examples, the lumen is configured to deliver a drug to the treatment segment 55 through the hole.

[0271] According to some examples, the ablation system 10 further includes a proximal feature 2602 proximal to the distal wire end 1204. The proximal feature 2602 may be configured to prevent blood from entering the treatment segment 55. In some examples, the proximal feature 2602 is configured to prevent a drug from exiting the treatment segment 55. According to some examples, the drug is a sclerosing agent.

[0272] The proximal feature 2602 may be a balloon 2604 on the sheath 40. In some examples, the balloon 2604 at least partially surrounds the sheath 40. According to some examples, the balloon 2604 is an offset balloon 2606. The offset balloon 2606 may be biased toward a side of the sheath 40. In some examples, the offset balloon 2606 is configured to reduce the load on the wire 30 when the offset balloon 2606 is in an inflated state, thereby bringing the wire 30 into closer contact with the wall of the vessel. According to some examples, the sheath 40 is configured to provide inflation fluid to the balloon 2604, where the inflation fluid expands the balloon 2604.

[0273] The proximal feature 2602 may be a cage 2608 on the wire 30. In some examples, the proximal feature 2602 is a grooved solid portion 2610 on the wire 30. According to some examples, the proximal feature 2602 is an impeller 2612 on the wire 30. The proximal feature 2602 may be a sponge-like solid portion 2614 that at least partially surrounds the wire 30. In some examples, the proximal feature 2602 is a sponge-like solid portion 2614 that at least partially surrounds the sheath 40.

[0274] According to some examples, the proximal feature 2602 is a sinusoidal urge 2616 in the wire 30. The sinusoidal urge 2616 may be at least partially contained within the sheath 40 when the sheath 40 is retracted. In some examples, the sinusoidal urge 2616 is configured to reduce stress on the wire 30, thereby bringing the wire 30 into closer contact with the wall of the vessel.

[0275] According to some examples, the ablation system 10 further includes a distal feature 2702 proximal to a distal portion of the distal wire tip 1204. The distal feature 2702 may be configured to prevent blood from entering the treatment segment 55. In some examples, the distal feature 2702 is configured to prevent agent from exiting the treatment segment 55.

[0276] According to some examples, the distal feature 2702 is a single-blade impeller 2704 on the wire 30. The distal feature 2702 may be a cage 2706 on the wire 30. In some examples, the distal feature 2702 is a grooved solid portion 2708 on the wire 30. According to some examples, the distal feature 2702 is an impeller 2710 on the wire 30. The distal feature 2702 may be a spongy solid portion 2712 that at least partially surrounds the wire 30.

[0277] In some examples, the distal-most tip of wire 30 is a hemispherical tip 2802. According to some examples, hemispherical tip 2802 is weighted. Hemispherical tip 2802 may be configured to contact the wall of a blood vessel.

[0278] In some examples, the distal-most tip of wire 30 is an offset weighted tip 2804. According to some examples, offset weighted tip 2804 is weighted. Offset weighted tip 2804 may be configured to contact the wall of a blood vessel.

[0279] In some examples, wire 30 includes a lumen. According to some examples, the distal-most tip of wire 30 is balloon tip 2806. The lumen may be configured to provide inflation fluid to balloon tip 2806, where the inflation fluid is configured to expand balloon tip 2806. In some examples, balloon tip 2806 is configured to occlude a blood vessel when in an expanded state.

[0280] According to some examples, the ablation system 10 further includes an auxiliary wire 2902 wrapped around at least a portion of the distal wire tip 1204. The auxiliary wire 2902 may be a heating wire 2904. In some examples, the heating wire 2904 is configured to perforate the wire 30 into a predetermined shape in response to a temperature. According to some examples, the predetermined shape is a sinusoidal profile. The temperature may be human body temperature.

[0281] In some examples, the auxiliary wire 2902 is a hypotube. According to some embodiments, the hypotube is configured to deliver a drug to the treatment segment 55. The drug may be a sclerosing agent.

[0282] In some examples, at least a portion of the distal wire end 1204 includes a porous surface geometry 2906. According to some examples, the porous surface geometry 2906 is configured to make strong contact with the wall of the blood vessel.

[0283] At least a portion of distal wire end 1204 may include additional geometric shapes 3002a, 3002b, 3002c, and / or 3002d. In some examples, additional geometric shape 3002a includes a rounded protrusion. According to some examples, additional geometric shape 3002b includes a ball. Additional geometric shape 3002c may include a spike. In some examples, additional geometric shape 3002d includes a brush. According to some examples, additional geometric shapes 3002a, 3002b, 3002c, and / or 3002d are configured to make strong contact with the wall of a blood vessel. Wire 30 may include a sinusoidal profile. In some examples, the sinusoidal profile defines a peak. According to some examples, additional geometric shapes 3002a, 3002b, 3002c, and / or 3002d are located on the peak.

[0284] The ablation system 10 may further include a donut 3202 that at least partially surrounds the sheath 40. In some examples, the donut 3202 is slidably coupled to the sheath 40. According to some examples, the donut 3202 is sized so that it cannot enter an insertion point in a patient. The donut 3202 may be configured to maintain the sheath 40 and wire 30 in a fixed position during treatment. In some examples, the donut 3202 is configured to indicate the distance to the patient's deep venous system.

[0285] According to some embodiments, the ablation system 10 further includes at least one distance marking 3204 on the sheath 40. The at least one distance marking 3204 may be configured to indicate a distance to which the sheath 40 is removed from the patient. In some examples, the at least one distance marking 3204 is configured to notify a user that a subsequent treatment segment 55 has been reached. According to some examples, the space between the at least one distance marking 3204 and the subsequent at least one distance marking 3204 is approximately the same as the length of the distal wire tip 1204. The distal wire tip 1204 may define the treatment segment 55. In some examples, the at least one distance marking 3204 at least partially surrounds the sheath 40.

[0286] According to some examples, the ablation system 10 further includes a warning track 3206 on the sheath 40. The warning track 3206 may be configured to notify the user that the end of the workable treatment length has been reached. In some examples, the warning track 3206 at least partially surrounds the sheath 40.

[0287] The present disclosure also includes an ablation system 10 including a controller 20. In some examples, the ablation system 10 includes a sheath 40 including a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the controller 20, and the distal sheath end is configured for insertion into the patient's vasculature, the distal sheath end being located opposite the proximal sheath end. The ablation system 10 may include a wire 30 extending from the controller 20 through the working lumen to the distal sheath end. In some examples, the wire 30 includes a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202, the distal wire end 1204 configured to engage a wall of a blood vessel within the treatment segment 55.

[0288] According to some examples, the controller 20 includes the motor 610 and / or 3308 and the power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The controller 20 may further include an actuator 506a, 506b, 608, 914, and / or 3304 for actuating the motor 610 and / or 3308. In some examples, the motor 610 and / or 3308 is configured to provide a rotational output. According to some examples, the proximal wire-tip 1202 is rotatably coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 may rotate the distal wire-tip 1204 at about 1000 revolutions per minute (RPM) to about 4000 RPM. In some examples, the controller 20 includes a torque limiter and a clutch that stops rotation of the wire 30 if the torque limit is exceeded.

[0289] According to some examples, the controller 20 is a handle. The handle may include a slot 602, and the proximal sheath end includes an inflation towhee 604 that couples to the slot 602. In some examples, retraction of the inflation towhee 604 into the slot 602 retracts the sheath 40, exposing the distal wire end 1204. According to some examples, a flow path from the handle to the sheath 40 is established for injection of a sclerosing agent in the treatment segment 55.

[0290] The controller 20 may include a display 508. In some examples, the display 508 is configured to show a timer. According to some examples, the timer is configured to count down the remaining time of treatment.

[0291] The present disclosure also includes an ablation system 10 including a body 702, 802, and / or 902 defining a proximal body end 708, 806, and / or 906 and a distal body end 710, 808, and / or 908 opposite the proximal body end 708, 806, and / or 906. The ablation system 10 may include a saddle 704 slidably coupled to the body 702, 802, and / or 902 such that the saddle 704 moves along a first direction 712, 810, and / or 916 extending from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908. In some examples, the ablation system 10 includes a T-fitting 706, 804, and / or 904 slidably coupled to the body 702, 802, and / or 902 and at least partially surrounded by a central portion of the saddle 704, whereby the T-fitting 706, 804, and / or 904 moves along a first direction 712, 810, or 916 in response to movement of the saddle 704.

[0292] According to some examples, ablation system 10 further includes a syringe 60 configured to couple to T-fitting 706, 804, and / or 904. A component selected from the group consisting of syringe 60, saddle 704, and combinations thereof may be configured to control movement of T-fitting 706, 804, and / or 904. In some examples, syringe 60 is configured to be inserted into T-fitting 706, 804, and / or 904 along a second direction that is at an angle relative to first direction 712, 810, and / or 916. According to some examples, the angle is perpendicular.

[0293] Ablation system 10 may further include a syringe 60 configured to couple to T-fittings 706, 804, and / or 904. In some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fittings 706, 804, and / or 904. According to some examples, ablation system 10 further includes a sheath 40, where the sheath 40 includes a proximal sheath end, a distal sheath end opposite the proximal sheath end, and a working lumen therebetween. The proximal sheath end may be configured to couple to distal body ends 710, 808, and / or 908. In some examples, the working lumen is in fluid communication with syringe 60.

[0294] According to some examples, the sheath 40 is configured to receive the wire 30, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. By sliding the T-fittings 706, 804, and / or 904 from the distal body ends 710, 808, and / or 908 toward the proximal body ends 708, 806, and / or 906, the sheath 40 may be retracted around the wire 30 to expose the distal wire end 1204. In some examples, by sliding the T-fittings 706, 804, and / or 904 from the proximal body ends 708, 806, and / or 906 toward the distal body ends 710, 808, and / or 908, the sheath 40 extends around the wire 30 to at least partially enclose the distal wire end 1204.

[0295] According to some examples, the sheath 40 is configured to receive a hypotube, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. The sheath 40 may be retracted around the hypotube, exposing the distal hypotube end, by sliding the T-fittings 706, 804, and / or 904 from the distal body ends 710, 808, and / or 908 toward the proximal body ends 708, 806, and / or 906. In some examples, sliding the T-fittings 706, 804, and / or 904 from the proximal body ends 708, 806, and / or 906 toward the distal body ends 710, 808, and / or 908 extends the sheath 40 around the hypotube, at least partially enclosing the distal hypotube end.

[0296] According to some examples, the sheath 40 is configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. The sheath 40 may be retracted around the catheter shaft, exposing the distal catheter shaft end, by sliding the T-fittings 706, 804, and / or 904 from the distal body ends 710, 808, and / or 908 toward the proximal body ends 708, 806, and / or 906. In some examples, sliding the T-fittings 706, 804, and / or 904 from the proximal body ends 708, 806, and / or 906 toward the distal body ends 710, 808, and / or 908 extends the sheath 40 around the catheter shaft, at least partially enclosing the distal catheter shaft end.

[0297] According to some examples, T-fitting 706, 804, and / or 904 includes a luer hub 3102. Ablation system 10 may further include a syringe 60 configured to couple to T-fitting 706, 804, and / or 904. In some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fitting 706, 804, and / or 904. According to some examples, luer hub 3102 includes a luer 3104, which is configured to detachably couple syringe 60 to T-fitting 706, 804, and / or 904. Luer 3104 may be configured to rotate approximately 180 degrees about first direction 712, 810, and / or 916. In some examples, syringe 60 is configured to control rotation of luer 3104.

[0298] According to some examples, ablation system 10 further includes catheter 15 having a proximal catheter end and a distal catheter end opposite the proximal catheter end. The proximal catheter end may be configured to couple to distal body ends 710, 808, and / or 908. In some examples, catheter 15 is in fluid communication with syringe 60. According to some examples, luer 3104 is configured to apply a torque to catheter 15. The torque may be configured to control the direction of travel of the distal catheter end.

[0299] In some examples, the ablation system 10 further includes a sheath 40 including a proximal sheath end and a distal sheath end opposite the proximal sheath end. According to some examples, the proximal sheath end is configured to removably couple to a luer hub 3102. The sheath 40 may be in fluid communication with the syringe 60. In some examples, the luer 3104 is configured to apply a torque to the sheath 40. According to some examples, the torque is configured to control the direction of travel of the distal sheath end.

[0300] Sheath 40 may further include a working lumen. In some examples, ablation system 10 further includes a wire 30 extending from body 702, 802, and / or 902 through the working lumen to the distal sheath end, wire 30 having a proximal wire end 1202 and a distal wire end 1204 opposite proximal wire end 1202. According to some embodiments, distal wire end 1204 is configured to engage a vessel wall within treatment segment 55.

[0301] Ablation system 10 may further include a torque knob 1104 rotatably coupled to body 702, 802, and / or 902. In some examples, torque knob 1104 is located on proximal body end 708, 806, and / or 906.

[0302] According to some embodiments, ablation system 10 further includes a syringe 60 configured to couple to T-fitting 706, 804, and / or 904. A component selected from the group consisting of syringe 60, saddle 704, and combinations thereof may be configured to control movement of T-fitting 706, 804, and / or 904. In some examples, ablation system 10 further includes a catheter 15 having a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is configured to couple to distal body end 710, 808, and / or 908. Catheter 15 may be in fluid communication with syringe 60.

[0303] In some examples, the torque knob 1104 is configured to apply a torque to the catheter 15. According to some examples, the torque is configured to control the direction of travel of the distal catheter tip.

[0304] The ablation system 10 may further include a wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. In some examples, the proximal wire end 1202 is configured to couple to the distal body ends 710, 808, and / or 908. According to some examples, the torque knob 1104 is configured to apply a torque to the wire 30. The torque may be configured to control the direction of travel of the distal wire end 1204.

[0305] In some examples, ablation system 10 further includes motor 610 and / or 3308 that is at least partially enclosed within body 702, 802, and / or 902. According to some examples, motor 610 and / or 3308 is at least partially enclosed within proximal body end 708, 806, and / or 906. Ablation system 10 may further include actuators 506a, 506b, 608, 914, and / or 3304 coupled to body 702, 802, and / or 902 and electronically coupled to motor 610 and / or 3308, wherein actuators 506a, 506b, 608, 914, and / or 3304 are configured to turn electrical current to motor 610 and / or 3308 on and off.

[0306] In some examples, the ablation system 10 further includes a wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. According to some examples, the proximal wire end 1202 is configured to couple to a motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to effect rotation of the wire 30.

[0307] In some examples, the ablation system 10 further includes a hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. According to some examples, the proximal hypotube end is configured to couple to a motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to effect rotation to the hypotube.

[0308] In some examples, ablation system 10 further includes a catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. According to some examples, the proximal catheter shaft end is configured to couple to motor 610 and / or 3308. Motor 610 and / or 3308 may be configured to effect rotation on the catheter shaft.

[0309] In some examples, ablation system 10 further includes a limit switch 3306 electronically coupled to motor 610 and / or 3308. According to some examples, limit switch 3306 is configured to prevent motor 610 and / or 3308 from rotating when saddle 704 is positioned other than at proximal body end 708, 806, and / or 906. Limit switch 3306 may be configured to allow motor 610 and / or 3308 to rotate when saddle 704 is positioned at proximal body end 708, 806, and / or 906.

[0310] In some examples, ablation system 10 further includes LEDs 912 and / or 3310 electronically coupled to motors 610 and / or 3308. According to some examples, LEDs 912 and / or 3310 are configured to be powered off when saddle 704 is positioned at a location other than proximal body ends 708, 806, and / or 906. LEDs 912 and / or 3310 may be configured to be powered on when saddle 704 is positioned at proximal body ends 708, 806, and / or 906.

[0311] In some examples, saddle 704 is at least partially inside body 702, 802, and / or 902. According to some examples, saddle 704 includes a pull tab configured to facilitate movement of saddle 704. T-fittings 706, 804, and / or 904 may be fixedly coupled to saddle 704.

[0312] In some examples, ablation system 10 further includes a display 508 configured to display information. According to some examples, display 508 is configured to show a timer. The timer may be configured to count down the remaining time for treatment. In some examples, ablation system 10 further includes a catheter 15 coupled to distal body end 710, 808, and / or 908. According to some examples, the timer is configured to count down the time until treatment in treatment segment 55 is completed and catheter 15 is moved to a subsequent treatment segment 55.

[0313] Ablation system 10 may further include syringe 60 configured to couple to T-fittings 706, 804, and / or 904. In some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fittings 706, 804, and / or 904. According to some examples, a timer is configured to count down a time until an operator begins injecting agent from syringe 60. The timer may also be configured to count down a time until an operator stops injecting agent from syringe 60.

[0314] In some examples, ablation system 10 further includes an alarm configured to sound a noise when treatment is completed. According to some examples, ablation system 10 further includes a catheter 15 coupled to distal body end 710, 808, and / or 908. Ablation system 10 may further include an alarm configured to sound a noise when treatment in a treatment segment 55 is completed and the operator moves catheter 15 to a subsequent treatment segment 55.

[0315] In some examples, ablation system 10 further includes a syringe 60 configured to couple to T-fittings 706, 804, and / or 904. According to some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fittings 706, 804, and / or 904. Ablation system 10 may further include an alarm configured to sound a noise when an operator should begin injecting agent from syringe 60. In some examples, the alarm is configured to sound a noise when an operator should pause injecting agent from syringe 60.

[0316] According to some examples, ablation system 10 further includes LEDs 912 and / or 3310 configured to turn on when treatment is completed. Ablation system 10 may further include LEDs 912 and / or 3310 configured to turn off when treatment is completed. In some examples, ablation system 10 further includes a catheter 15 coupled to distal body end 710, 808, and / or 908, and LEDs 912 and / or 3310 configured to turn on when treatment in a treatment segment 55 is completed and the operator moves the catheter 15 to a subsequent treatment segment 55. According to some examples, ablation system 10 further includes a catheter 15 coupled to distal body end 710, 808, and / or 908, and LEDs 912 and / or 3310 configured to turn off when treatment in a treatment segment 55 is completed and the operator moves the catheter 15 to a subsequent treatment segment 55.

[0317] Ablation system 10 may further include a syringe 60 configured to couple to T-fittings 706, 804, and / or 904. In some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fittings 706, 804, and / or 904. According to some examples, ablation system 10 further includes LEDs 912 and / or 3310 configured to turn on when an operator should begin injecting agent from syringe 60. LEDs 912 and / or 3310 may be configured to turn off when an operator should pause injecting agent from syringe 60.

[0318] In some examples, ablation system 10 further includes a syringe 60 configured to couple to T-fitting 706, 804, and / or 904. According to some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-fitting 706, 804, and / or 904. Ablation system 10 may further include LEDs 912 and / or 3310 configured to turn off when an operator should begin injecting agent from syringe 60. In some examples, LEDs 912 and / or 3310 are configured to turn on when an operator should pause injecting agent from syringe 60.

[0319] According to some examples, ablation system 10 further includes motor 610 and / or 3308 located near the bottom of body 702, 802, and / or 902. Ablation system 10 may further include gears coupled to motor 610 and / or 3308. In some examples, the gears are configured to control the output rotational speed of motor 610 and / or 3308.

[0320] According to some examples, ablation system 10 further includes expandable feet 1102 at the base of body 702, 802, and / or 902. Expandable feet 1102 may be configured to promote stability of body 702, 802, and / or 902.

[0321] In some examples, ablation system 10 further includes a catheter 15 including a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is coupled to distal body end 710, 808, and / or 908. Ablation system 10 may further include an arm 1106 coupled to a side of body 702, 802, and / or 902.

[0322] In some examples, the arm 1106 is configured to maintain a distance between the catheter 15 and the body 702, 802, and / or 902 when the distal catheter tip is moved in a direction opposite the first direction 712, 810, and / or 916. According to some examples, the distance between the catheter 15 and the body 702, 802, and / or 902 is a radius. The arm 1106 may be configured to maintain the catheter 15 in a fixed position during treatment.

[0323] In some examples, ablation system 10 further includes a catheter 15 including a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is coupled to distal body ends 710, 808, and / or 908. Ablation system 10 may further include a catheter clamp configured to maintain catheter 15 in place during treatment.

[0324] In some examples, ablation system 10 further includes a sheath 40, which includes a working lumen, a proximal sheath end, and a distal sheath end. According to some embodiments, the proximal sheath end is coupled to distal body end 710, 808, and / or 908, with the distal sheath end configured for insertion into the patient's vasculature, the distal sheath end being located opposite the proximal sheath end. Ablation system 10 may further include a wire 30 extending from distal body end 710, 808, and / or 908 through the working lumen to the distal sheath end, the wire 30 having a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. In some examples, the distal wire end 1204 is configured to engage a vessel wall within treatment segment 55.

[0325] According to some examples, the sheath 40 is detachably coupled to the distal body end 710, 808, and / or 908. The sheath 40 may be configured to follow the treatment segment 55 while the wire 30 remains stationary.

[0326] In some examples, ablation system 10 further includes a sterilization pack 1002. According to some embodiments, body 702, 802, and / or 902, saddle 704, T-fittings 706, 804, and / or 904, sheath 40, and wire 30 are configured to fit within a cavity of sterilization pack 1002. Sheath 40 and wire 30 may be detachably coupled to distal body end 710, 808, and / or 908. In some examples, sheath 40 and wire 30 are configured to be sterilized separately from body 702, 802, and / or 902. According to some examples, sheath 40 and wire 30 are configured to be disposable. Ablation system 10 may be configured to be operated while within sterilization pack 1002.

[0327] In some examples, the sterilization pack 1002 includes a slit 1004. According to some examples, the slit 1004 is configured to slidably receive the sheath 40. The body 702, 802, and / or 902, the saddle 704, and the T-fittings 706, 804, and / or 904 may be configured to seat within a cavity of the sterilization pack 1002 during operation. In some examples, the sheath 40 and the wire 30 are configured to slidably couple to the slit 1004 during operation. According to some examples, the body 702, 802, and / or 902, the saddle 704, and the T-fittings 706, 804, and / or 904 are configured to be reusable.

[0328] Ablation system 10 may further include a sterile pack 1002, where body 702, 802, and / or 902, saddle 704, and T-fittings 706, 804, and / or 904 are configured to fit within a cavity of sterile pack 1002. In some examples, ablation system 10 is configured to be operated while within sterile pack 1002.

[0329] The present disclosure also includes methods that include inserting a syringe 60 into a T-fitting 706, 804, and / or 904 of a saddle 704 of a body 702, 802, and / or 902. In some examples, the body 702, 802, and / or 902 has a proximal body end 708, 806, and / or 906 and a distal body end 710, 808, and / or 908. According to some examples, the saddle 704 is slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. The first direction 712, 810, and / or 916 may extend from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908. In some examples, the T-fittings 706, 804, and / or 904 move along a first direction 712, 810, and / or 916 in response to movement of the saddle 704. According to some examples, the syringe 60 is inserted into the T-fittings 706, 804, and / or 904 along a second direction perpendicular to the first direction 712, 810, and / or 916. The method may include directing the catheter 15 toward a treatment site 50 of the patient.

[0330] In some examples, the catheter 1005 includes a sheath 40 configured to receive the wire 30, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 over the saddle 704. The method may further include retracting the sheath 40 around the wire 30 in response to sliding the T-fitting 706, 804, and / or 904. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40.

[0331] According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the syringe 60. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the pull tab.

[0332] According to some examples, the catheter 15 includes a sheath 40 configured to receive the wire 30, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. The method may further include sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 over the saddle 704. In some examples, the method further includes extending the sheath 40 around the wire 30 in response to sliding the T-fitting 706, 804, and / or 904. According to some examples, the method further includes at least partially encapsulating the distal wire end 1204 in response to extending the sheath 40.

[0333] The method may further include sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the syringe 60. In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the pull tab.

[0334] The catheter 15 may include a sheath 40 configured to receive a hypotube, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the saddle 704. According to some examples, the method further includes retracting the sheath 40 around the hypotube in response to sliding the T-fitting 706, 804, and / or 904. The method may further include exposing the distal hypotube end in response to retracting the sheath 40.

[0335] In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the syringe 60. According to some examples, the saddle 704 includes a pull tab. The method may further include sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the pull tab.

[0336] In some examples, the catheter 15 includes a sheath 40 configured to receive a hypotube, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. According to some embodiments, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the saddle 704. The method may further include extending the sheath 40 around the hypotube in response to sliding the T-fitting 706, 804, and / or 904. In some examples, the method further includes at least partially enclosing the distal hypotube end in response to extending the sheath 40.

[0337] According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the syringe 60. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the pull tab.

[0338] According to some examples, the catheter 15 includes a sheath 40 configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. The method may further include sliding a T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the saddle 704. In some examples, the method further includes retracting the sheath 40 around the catheter shaft in response to sliding the T-fitting 706, 804, and / or 904. According to some examples, the method further includes exposing the distal catheter shaft end in response to retracting the sheath 40.

[0339] The method may further include sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the syringe 60. In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 toward the proximal body end 708, 806, and / or 906 via the pull tab.

[0340] The catheter 15 may include a sheath 40 configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. In some examples, the method includes sliding a T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via a saddle 704. According to some examples, the method further includes extending the sheath 40 around the catheter shaft in response to sliding the T-fitting 706, 804, and / or 904. The method may further include at least partially enclosing the distal catheter shaft end in response to extending the sheath 40.

[0341] In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the syringe 60. According to some examples, the saddle 704 includes a pull tab. The method may further include sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 toward the distal body end 710, 808, and / or 908 via the pull tab.

[0342] In some examples, the T-fitting 706, 804, and / or 904 further includes a luer 3104 configured to receive the syringe 60. According to some examples, the method further includes inserting the syringe 60 into the luer 3104. The luer 3104 may be configured to rotate approximately 180 degrees about the first direction 712, 810, and / or 916. In some examples, the method further includes rotating the syringe 60 and the luer 3104. According to some examples, the method further includes applying a torque to the catheter 15 in response to the rotation of the syringe 60 and the luer 3104. The method may further include controlling a direction of travel of the distal catheter shaft end in response to applying the torque to the catheter 15.

[0343] In some examples, the luer 3104 includes a connector configured to removably couple the sheath 40 to the body 702, 802, and / or 902. According to some examples, the method further includes removably coupling the sheath 40 to the body 702, 802, and / or 902. The method may further include removing the sheath 40 from the body 702, 802, and / or 902. In some examples, the method further includes directing the sheath 40 to the treatment site 50 of the patient.

[0344] According to some examples, motor 610 and / or 3308 is at least partially enclosed within body 702, 802, and / or 902. Catheter 15 may at least partially surround wire 30 including proximal wire end 1202 and distal wire end 1204 opposite proximal wire end 1202. In some examples, proximal wire end 1202 is configured to couple to motor 610 and / or 3308. According to some examples, the method further includes rotating wire 30 via motor 610 and / or 3308.

[0345] Actuators 506a, 506b, 608, 914, and / or 3304 may be coupled to body 702, 802, and / or 902 and electronically coupled to motors 610 and / or 3308. In some examples, the method further includes interacting with actuators 506a, 506b, 608, 914, and / or 3304. According to some examples, the method further includes powering on motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304. The method may further include powering off motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304.

[0346] In some examples, motor 610 and / or 3308 is at least partially enclosed within body 702, 802, and / or 902. According to some examples, catheter 15 at least partially surrounds a hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. The proximal hypotube end may be configured to couple to motor 610 and / or 3308. In some examples, the method further includes rotating the hypotube via motor 610 and / or 3308.

[0347] According to some examples, actuators 506a, 506b, 608, 914, and / or 3304 are coupled to body 702, 802, and / or 902 and are electronically coupled to motors 610 and / or 3308. The method may further include interacting with actuators 506a, 506b, 608, 914, and / or 3304. In some examples, the method further includes powering on motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304. According to some examples, the method further includes powering off motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304.

[0348] Motor 610 and / or 3308 may be at least partially enclosed within body 702, 802, and / or 902. In some examples, catheter 15 at least partially encloses a catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. According to some examples, the proximal catheter shaft end is configured to couple to motor 610 and / or 3308. The method may further include rotating the catheter shaft via motor 610 and / or 3308.

[0349] In some examples, actuators 506a, 506b, 608, 914, and / or 3304 are coupled to body 702, 802, and / or 902 and are electronically coupled to motors 610 and / or 3308. According to some examples, the method further includes interacting with actuators 506a, 506b, 608, 914, and / or 3304. The method may further include powering on motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304. In some examples, the method further includes powering off motors 610 and / or 3308 in response to interacting with actuators 506a, 506b, 608, 914, and / or 3304.

[0350] According to some examples, syringe 60 includes a syringe body and a plunger. The method may further include depressing the plunger of syringe 60. In some examples, the method further includes expelling fluid through catheter 15 in response to depressing the plunger.

[0351] The present disclosure also includes a method that includes directing a wire 30 to a treatment site 50 on a patient. In some examples, the wire 30 includes a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. According to some examples, the wire 30 is coupled to a motor 610 and / or 3308 that is at least partially enclosed by a body 702, 802, and / or 902. The method may include providing power to the motor 610 and / or 3308. According to some examples, the method includes rotating the wire 30 in response to providing power to the motor 610 and / or 3308.

[0352] The method may further include extending the wire 30 through a sheath 40 coupled to the body 702, 802, and / or 902. In some examples, the method includes detachably coupling the sheath 40 to the body 702, 802, and / or 902. According to some examples, the method further includes directing the sheath 40 toward the treatment site 50 on the patient while the sheath 40 is detached from the body 702, 802, and / or 902.

[0353] The method may further include retracting the sheath 40 around the wire 30. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40. According to some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. The method may further include allowing the motor 610 and / or 3308 to rotate in response to retracting the sheath 40 around the wire 30.

[0354] In some examples, body 702, 802, and / or 902 includes a proximal body end 708, 806, and / or 906 and a distal body end 710, 808, and / or 908. According to some examples, saddle 704 is slidably coupled to body 702, 802, and / or 902, whereby saddle 704 moves along a first direction 712, 810, and / or 916. First direction 712, 810, and / or 916 may extend from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. In some examples, the method further includes sliding saddle 704 from distal body end 710, 808, and / or 908 to proximal body end 708, 806, and / or 906. According to some examples, retraction of the sheath 40 around the wire 30 occurs in response to sliding the saddle 704 from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906.

[0355] The saddle 704 may include a T-fitting 706, 804, and / or 904. In some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906. According to some examples, the T-fitting 706, 804, and / or 904 includes a luer 3104. The method may further include inserting the syringe 60 into the luer 3104. In some examples, the method further includes sliding the syringe 60 from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906.

[0356] According to some examples, syringe 60 includes a syringe body and a plunger. The method may further include depressing the plunger of syringe 60. In some examples, the method may further include expelling fluid through sheath 40 in response to depressing the plunger. According to some examples, wire 30 includes a lumen. The method may further include expelling fluid through wire 30 in response to depressing the plunger.

[0357] In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the pull tab from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906. The method may further include partially retracting the sheath 40 around the wire 30. In some examples, the method further includes partially exposing the distal wire end 1204 in response to partially retracting the sheath 40 around the wire 30.

[0358] According to some examples, the method further includes extending the sheath 40 around the wire 30. The method may further include at least partially encapsulating the distal wire end 1204 in response to extending the sheath 40. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes preventing the motor 610 and / or 3308 from rotating in response to extending the sheath 40 around the wire 30.

[0359] Body 702, 802, and / or 902 may include proximal body end 708, 806, and / or 906 and distal body end 710, 808, and / or 908. In some examples, saddle 704 is slidably coupled to body 702, 802, and / or 902, whereby saddle 704 moves along first direction 712, 810, and / or 916. According to some examples, first direction 712, 810, and / or 916 extends from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. The method may further include sliding saddle 704 from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. In some examples, the extending of the sheath 40 around the wire 30 occurs in response to sliding the saddle 704 from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908.

[0360] According to some examples, saddle 704 includes T-fitting 706, 804, and / or 904. The method further includes sliding T-fitting 706, 804, and / or 904 from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. In some examples, T-fitting 706, 804, and / or 904 includes luer 3104. According to some examples, the method further includes inserting syringe 60 into luer 3104. The method may further include sliding syringe 60 from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908.

[0361] In some examples, the syringe 60 includes a syringe body and a plunger. According to some examples, the method further includes depressing the plunger of the syringe 60. The method may further include expelling fluid through the sheath 40 in response to depressing the plunger. In some examples, the wire 30 includes a lumen. According to some examples, the method further includes expelling fluid through the wire 30 in response to depressing the plunger.

[0362] The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908. According to some examples, the method further includes partially extending the sheath 40 around the wire 30. The method may further include at least partially encapsulating the distal wire end 1204 in response to partially extending the sheath 40 around the wire 30.

[0363] In some examples, the body 702, 802, and / or 902 includes a torque knob 1104. According to some examples, the method further includes applying a torque to the wire 30. The method may further include controlling a direction of travel of the distal wire tip 1204 in response to applying the torque to the wire 30.

[0364] In some examples, motor 610 and / or 3308 is located near the bottom of body 702, 802, and / or 902. According to some examples, the method further includes changing the rotation ratio between motor 610 and / or 3308 and wire 30 via gears.

[0365] Body 702, 802, and / or 902 may include expandable feet 1102 at a bottom of body 702, 802, and / or 902. In some examples, the method further includes expanding expandable feet 1102. According to some examples, the method further includes stabilizing body 702, 802, and / or 902 in response to expanding expandable feet 1102.

[0366] The present disclosure also includes a method that includes directing a hypotube toward a treatment site 50 on a patient, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. In some examples, the hypotube is coupled to a motor 610 and / or 3308 that is at least partially enclosed by body 702, 802, and / or 902. According to some examples, the method includes providing power to motor 610 and / or 3308. The method may include rotating the hypotube in response to providing power to motor 610 and / or 3308.

[0367] In some examples, the method further includes extending a hypotube through the catheter 15 coupled to the body 702, 802, and / or 902. According to some examples, the method further includes detachably coupling the catheter 15 to the body 702, 802, and / or 902. The method may further include directing the catheter 15 toward the treatment site 50 of the patient while the catheter 15 is detached from the body 702, 802, and / or 902.

[0368] In some examples, the method further includes retracting the catheter 15 around the hypotube. According to some examples, the method further includes exposing the distal hypotube end in response to retracting the catheter 15. The limit switch 3306 may be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes allowing the motor 610 and / or 3308 to rotate in response to retracting the catheter 15 around the hypotube.

[0369] According to some examples, body 702, 802, and / or 902 includes proximal body end 708, 806, and / or 906 and distal body end 710, 808, and / or 908. Saddle 704 may be slidably coupled to body 702, 802, and / or 902 such that saddle 704 moves along first direction 712, 810, and / or 916. In some examples, first direction 712, 810, and / or 916 extends from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. According to some examples, the method further includes sliding saddle 704 from distal body end 710, 808, and / or 908 to proximal body end 708, 806, and / or 906. Retraction of the catheter 15 around the hypotube can occur in response to sliding the saddle 704 from the distal body end 710 , 808 , and / or 908 to the proximal body end 708 , 806 , and / or 906 .

[0370] In some examples, the saddle 704 includes a T-fitting 706, 804, and / or 904. According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906. The T-fitting 706, 804, and / or 904 may include a luer 3104. In some examples, the method further includes inserting the syringe 60 into the luer 3104. According to some examples, the method includes sliding the syringe 60 from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906.

[0371] The syringe 60 may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe 60. According to some examples, the method further includes expelling fluid through a lumen in the hypotube in response to depressing the plunger. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the distal body end 710, 808, and / or 908 to the proximal body end 708, 806, and / or 906.

[0372] According to some examples, the method includes partially retracting the catheter 15 around the hypotube. The method may include partially exposing the distal hypotube end in response to partially retracting the catheter 15 around the hypotube.

[0373] In some examples, the method further includes extending the catheter 15 around the hypotube. According to some examples, the method further includes at least partially enclosing the distal hypotube end in response to extending the catheter 15. The limit switch 3306 may be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes preventing the motor 610 and / or 3308 from rotating in response to extending the catheter 15 around the hypotube.

[0374] According to some examples, body 702, 802, and / or 902 includes proximal body end 708, 806, and / or 906 and distal body end 710, 808, and / or 908. Saddle 704 may be slidably coupled to body 702, 802, and / or 902 such that saddle 704 moves along first direction 712, 810, and / or 916. In some examples, first direction 712, 810, and / or 916 extends from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. According to some examples, the method further includes sliding saddle 704 from proximal body end 708, 806, and / or 906 to distal body end 710, 808, and / or 908. Extending the catheter 15 around the hypotube may occur in response to sliding the saddle 704 from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908.

[0375] In some examples, the saddle 704 includes a T-fitting 706, 804, and / or 904. According to some examples, the method further includes sliding the T-fitting 706, 804, and / or 904 from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908. The T-fitting 706, 804, and / or 904 may include a luer 3104. In some examples, the method further includes inserting the syringe 60 into the luer 3104. According to some examples, the method further includes sliding the syringe 60 from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908.

[0376] The syringe 60 may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe 60. In some examples, the method further includes expelling fluid through a lumen within the hypotube in response to depressing the plunger.

[0377] The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the proximal body end 708, 806, and / or 906 to the distal body end 710, 808, and / or 908. According to some examples, the method further includes partially extending the catheter 15 around the hypotube. The method may further include at least partially encapsulating the distal hypotube end in response to partially extending the catheter 15 around the hypotube.

[0378] In some examples, the body 702, 802, and / or 902 includes a torque knob 1104. According to some examples, the method further includes applying a torque to the hypotube. The method may further include controlling a direction of travel of the distal hypotube end in response to applying a torque to the hypotube.

[0379] In some examples, the motor 610 and / or 3308 is located near a bottom of the body 702, 802, and / or 902. According to some examples, the method further includes changing a rotational ratio between the motor 610 and / or 3308 and the hypotube via gears. The body 702, 802, and / or 902 may include an expandable foot 1102 at a bottom of the body 702, 802, and / or 902. In some examples, the method further includes expanding the expandable foot 1102. According to some examples, the method further includes stabilizing the body 702, 802, and / or 902 in response to expanding the expandable foot 1102.

[0380] The present disclosure also includes a method that includes removing the catheter 15 from the sterilization pack 1002. In some examples, the method includes directing the catheter 15 to a treatment site 50 on a patient. According to some examples, the method includes operating a controller 20 from within the sterilization pack 1002. The catheter 15 may be coupled to the controller 20.

[0381] In some examples, the method further includes releasably coupling the catheter 15 to the controller 20. According to some examples, the sterilization pack 1002 includes a slit 1004. The method may further include placing the catheter 15 through the slit 1004 in the sterilization pack 1002.

[0382] In some examples, the method further includes removing the catheter 15 from the patient's treatment site 50. According to some examples, the catheter 15 includes a sheath 40 and a wire 30. The method may further include discarding the sheath 40. In some examples, the method further includes discarding the wire 30.

[0383] According to some examples, the catheter 15 includes a sheath 40 and a wire 30. The method may further include separating the sheath 40 from the controller 20. In some examples, the method may further include sterilizing the sheath 40 separately from the controller 20. According to some examples, the method may further include separating the wire 30 from the controller 20. The method may further include sterilizing the wire 30 separately from the controller 20.

[0384] The present disclosure also includes an ablation system 10 including a controller 20. In some examples, the ablation system 10 includes a sheath 40 including an open proximal sheath end, an open distal sheath end, and a working lumen extending from the open proximal sheath end to the open distal sheath end. According to some examples, the open proximal sheath end is coupled to the controller 20, the open distal sheath end is configured for insertion into a patient's vasculature, and the open distal sheath end is located opposite the open proximal sheath end. The ablation system 10 may include a wire 30 extending from the controller 20, through the open proximal sheath end, through the working lumen, and to the open distal sheath end. In some examples, the wire 30 has a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202, the distal wire end 1204 configured to mechanically treat the vessel wall in the treatment segment 55, whereby the length of the distal wire end 1204 defines the length of the treatment segment 55. Mechanical treatment should be construed as equivalent to any term that defines a type of disruption, including, but not limited to, abrasion, ablation, disruption, agitation, modification, etc.

[0385] According to some examples, the working lumen is configured to slidably receive the wire 30 and allow passage of a fluid therethrough around the wire 30 to chemically treat the treatment segment 55. Chemical treatment should be construed as equivalent to any term defining treatment with a chemical substance, such as ablation, occlusion, ablation, etc. When the ablation system 10 receives a first input, the distal wire end 1204 can mechanically treat the vessel wall. In some examples, when the ablation system 10 receives a second input, the ablation system 10 delivers a fluid into the treatment segment 55. According to some examples, when the ablation system 10 receives a third input, the ablation system 10 delivers a fluid into the subsequent treatment segment 55.

[0386] The sheath 40 may be retractable to expose the distal wire tip 1204. In some examples, the controller 20 includes the motor 610 and / or 3308, the power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power source 606 and / or 3302. According to some examples, the limit switch 3306 allows electricity to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308 when the sheath 40 is fully retracted. The sheath 40 may be variably retractable to expose at least a portion of the length of the distal wire tip 1204. In some examples, the portion of the length of the distal wire tip 1204 is configured to form a variable treatment length.

[0387] According to some examples, the sheath 40 is extendable to enclose at least a portion of the distal wire tip 1204. The controller 20 may include the motor 610 and / or 3308, the power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power source 606 and / or 3302. In some examples, the limit switch 3306 prevents electricity from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308 when the sheath 40 is at least partially extended.

[0388] According to some examples, the ablation system 10 further includes at least one distance marking 3204 located on the sheath 40 between the open proximal sheath end and the open distal sheath end. The at least one distance marking 3204 may be positioned and configured according to the length of the treatment segment 55. In some examples, the ablation system 10 further includes a warning track 3206 located on the sheath 40 between the at least one distance marking 3204 and the open distal sheath end. According to some examples, the warning track 3206 is configured to indicate that the end of the workable treatment length has been reached.

[0389] Ablation system 10 may further include a slidable depth marker (i.e., donut 3202) that at least partially surrounds sheath 40. In some examples, the slidable depth marker is slidably coupled to sheath 40. According to some examples, the slidable depth marker is sized and configured such that it cannot enter the patient's insertion point. The slidable depth marker may be positioned and configured to maintain the position of sheath 40 and wire 30 during treatment. In some examples, the slidable depth marker is positioned along sheath 40 and configured to indicate the distance to the patient's deep venous system.

[0390] According to some examples, the controller 20 includes an actuator 506a, 506b, 608, 914, and / or 3304 configured to receive a first input. The controller 20 may include a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. In some examples, the proximal wire tip 1202 is operably coupled to the motor 610 and / or 3308. According to some examples, the motor 610 and / or 3308 is configured to rotate the wire 30. The distal wire tip 1204 may be configured to rotate in response to the motor 610 and / or 3308 rotating the wire 30. In some examples, the ablation system 10 includes a syringe 60 fluidly coupled to the working lumen. According to some examples, the syringe 60 is configured to receive a second input and a third input.

[0391] The present disclosure also includes methods that include inserting a catheter 15 into a patient's vasculature. In some examples, the method includes moving the catheter 15 to a first treatment segment 55. According to some examples, the method includes treating the first treatment segment 55 via the catheter 15. The method may include moving the catheter 15 to a second treatment segment 55. In some examples, the method includes treating the second treatment segment 55 via the catheter 15.

[0392] According to some examples, the catheter 15 includes a sheath 40 having a working lumen and a wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. The method may further include abrading the first treatment segment 55 via the distal wire end 1204. In some examples, the method further includes moving the wire 30 to the second treatment segment 55 in response to moving the catheter 15 to the second treatment segment 55. According to some examples, the method further includes abrading the second treatment segment 55 via the distal wire end 1204.

[0393] The wire 30 may be electrically coupled to the motor 610 and / or 3308. In some examples, the method further includes rotating the wire 30 via the motor 610 and / or 3308. According to some examples, the method further includes abrading the first treatment segment 55 by rotating the wire 30. The method may further include abrading the second treatment segment 55 by rotating the wire 30.

[0394] In some examples, the method further includes retracting the sheath 40 around the wire 30. According to some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40 around the wire 30.

[0395] The wire 30 may be electrically coupled to the motor 610 and / or 3308. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes enabling the motor 610 and / or 3308 to receive power via the limit switch 3306 in response to the sheath 40 being fully retracted. The method may further include providing a rotational output to the wire 30 via the motor 610 and / or 3308. In some examples, the method further includes rotating the wire 30 via the rotational output. According to some examples, the method further includes abrading the first treatment segment 55 by rotating the wire 30. The method may further include abrading the second treatment segment 55 by rotating the wire 30.

[0396] In some examples, wire 30 is electrically coupled to motor 610 and / or 3308. According to some examples, LED 912 and / or 3310 is electrically coupled to motor 610 and / or 3308. The method may further include providing power to the LED. In some examples, the method further includes providing power to the LED to indicate that motor 610 and / or 3308 is receiving power.

[0397] According to certain examples, the method further includes extending the sheath 40 around the wire 30. The method may further include at least partially encapsulating the distal wire end 1204 in response to retracting the sheath 40 around the wire 30.

[0398] In some examples, wire 30 is electrically coupled to motor 610 and / or 3308. According to some examples, limit switch 3306 is electronically coupled to motor 610 and / or 3308. The method may further include preventing motor 610 and / or 3308 from receiving power in response to sheath 40 being at least partially extended via limit switch 3306. In some examples, the method further includes preventing motor 610 and / or 3308 from providing a rotational output. According to some examples, the method further includes preventing rotation of wire 30 in response to preventing motor 610 and / or 3308 from providing a rotational output.

[0399] The LEDs 912 and / or 3310 may be electrically coupled to the motors 610 and / or 3308. In some examples, the method further includes preventing the LEDs 912 and / or 3310 from receiving power. According to some examples, the method further includes indicating that the motors 610 and / or 3308 are not receiving power by preventing the LEDs 912 and / or 3310 from receiving power.

[0400] The syringe 60 may be fluidly coupled to the catheter 15. In some examples, the method further includes injecting a drug into the first treatment segment 55 via the syringe 60. According to some examples, the method includes injecting a drug into the second treatment segment 55 via the syringe 60. The method may further include preventing the injection of the drug while repositioning the catheter 15 into the second treatment segment 55.

[0401] In some examples, the sheath 40 includes a first distance marking 3204 and a second distance marking 3204. According to some examples, the method further includes withdrawing the catheter 15 from the patient from the first distance marking 3204 to the second distance marking 3204. The method may further include repositioning the distal wire tip 1204 by withdrawing the catheter 15 from the patient. In some examples, the distance from the first distance marking 3204 to the second distance marking 3204 is approximately equal to the treatment length of the distal wire tip 1204. According to some examples, the method further includes repositioning the distal wire tip 1204 by the treatment length.

[0402] The catheter 15 may include a warning track 3206. In some examples, the method further includes indicating, via the warning track 3206, that the end of the workable treatment length of the catheter 15 has been reached. According to some examples, the catheter 15 includes a donut 3202 that at least partially surrounds the catheter 15. The method may further include indicating, via the donut 3202, the distance to the patient's deep venous system.

[0403] The present disclosure also includes methods that include determining a first treatment segment 55 and a second treatment segment 55 in a patient's vasculature. In some examples, the method includes inserting a catheter 15 into the patient's vasculature. According to some examples, the method includes positioning the catheter 15 in the first treatment segment 55. The method may include injecting a fluid (e.g., saline or a medication such as a sclerosing agent) into the first treatment segment 55 via a syringe 60. In some examples, the method includes repositioning the catheter 15 to a second treatment segment 55. According to some examples, the method includes injecting a fluid into the second treatment segment 55 via a syringe 60.

[0404] The method may further include preventing fluid injection while repositioning the catheter 15 to the second treatment segment 55. In some examples, the catheter 15 includes a sheath 40 having a working lumen and a wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. According to some examples, the method further includes abrading the first treatment segment 55 via the distal wire end 1204. The method may further include repositioning the wire 30 to the second treatment segment 55 in response to repositioning the catheter 15 to the second treatment segment 55. In some examples, the method further includes abrading the second treatment segment 55 via the distal wire end 1204.

[0405] According to some examples, the wire 30 is electrically coupled to the motor 610 and / or 3308. The method may further include rotating the wire 30 via the motor 610 and / or 3308. In some examples, the method further includes abrading the first treatment segment 55 by rotating the wire 30. According to some examples, the method further includes abrading the second treatment segment 55 by rotating the wire 30.

[0406] The method may further include retracting the sheath 40 around the wire 30. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40 around the wire 30.

[0407] According to some examples, the wire 30 is electrically coupled to the motor 610 and / or 3308. The limit switch 3306 may be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes enabling the motor 610 and / or 3308 to receive power via the limit switch 3306 in response to the sheath 40 being fully retracted. According to some examples, the method further includes providing a rotational output to the wire 30 via the motor 610 and / or 3308. The method may further include rotating the wire 30 via the rotational output. In some examples, the method further includes abrading the first treatment segment 55 by rotating the wire 30. According to some examples, the method further includes abrading the second treatment segment 55 by rotating the wire 30.

[0408] Wire 30 may be electrically coupled to motor 610 and / or 3308. In some examples, LED 912 and / or 3310 are electrically coupled to motor 610 and / or 3308. According to some examples, the method further includes providing power to the LED. The method may further include indicating that motor 610 and / or 3308 is receiving power by providing power to the LED.

[0409] In some examples, the method further includes extending the sheath 40 around the wire 30. According to some examples, the method further includes at least partially encapsulating the distal wire end 1204 in response to retracting the sheath 40 around the wire 30.

[0410] The wire 30 may be electrically coupled to the motor 610 and / or 3308. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes preventing the motor 610 and / or 3308 from receiving power in response to the sheath 40 being at least partially extended via the limit switch 3306. The method may further include preventing the motor 610 and / or 3308 from providing a rotational output. In some examples, the method further includes preventing rotation of the wire 30 in response to preventing the motor 610 and / or 3308 from providing a rotational output.

[0411] According to some examples, LED 912 and / or 3310 are electrically coupled to motor 610 and / or 3308. The method may further include preventing LED 912 and / or 3310 from receiving power. In some examples, the method further includes indicating that motor 610 and / or 3308 is not receiving power by preventing LED 912 and / or 3310 from receiving power.

[0412] According to some examples, the sheath 40 includes a first distance marking 3204 and a second distance marking 3204. The method may further include withdrawing the catheter 15 from the patient from the first distance marking 3204 to the second distance marking 3204. In some examples, the method further includes repositioning the distal wire tip 1204 by withdrawing the catheter 15 from the patient.

[0413] According to some examples, the distance from the first distance marking 3204 to the second distance marking 3204 is approximately equal to the treatment length of the distal wire tip 1204. The method may further include repositioning the distal wire tip 1204 by the treatment length.

[0414] In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method further includes indicating, via the warning track 3206, that the end of the workable treatment length of the catheter 15 has been reached.

[0415] The catheter 15 may include a donut 3202 that at least partially surrounds the catheter 15. In some examples, the method further includes displaying a distance to the patient's deep venous system through the donut 3202.

[0416] The present disclosure also includes methods that include inserting a catheter 15 into a patient's vasculature. In some examples, the method includes moving the catheter 15 to a first treatment segment 55. According to some examples, the method includes actuating a motor 610 and / or 3308 and rotating at least a portion of the catheter 15 in response to actuating the motor 610 and / or 3308. The method may include abrading the first treatment segment 55 over a predetermined amount of time in response to the rotation of at least a portion of the catheter 15. In some examples, the method includes moving the catheter 15 to a second treatment segment 55. According to some examples, the method includes abrading the second treatment segment 55 over a predetermined amount of time in response to the rotation of at least a portion of the catheter 15.

[0417] The method may further include indicating that the predetermined amount of time has elapsed via a component selected from the group consisting of an LED 912 and / or 3310, a speaker, a display 508, and combinations thereof. In some examples, the component is electrically coupled to a power source 606 and / or 3302 that provides electricity to the motor 610 and / or 3308.

[0418] According to some examples, the catheter 15 includes a sheath 40 including a working lumen and a wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202, the wire 30 extending through the working lumen. The method may further include retracting at least a portion of the sheath 40 from the wire 30. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the portion of the sheath 40 from the wire 30. According to some examples, the method further includes extending the sheath 40 around the wire 30. The method may further include at least partially enclosing the distal wire end 1204 in response to extending the sheath 40 around the wire 30.

[0419] In some examples, the wire 30 is operably coupled to the motor 610 and / or 3308, and the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes, in response to the sheath 40 being fully retracted, allowing electrical current to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306. The method may further include, in response to the power source 606 and / or 3302 allowing electrical current to flow to the motor 610 and / or 3308, rotating the wire 30. In some examples, the method further includes, in response to the sheath 40 not being fully retracted, preventing electrical current from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306. According to some examples, the method further includes terminating rotation of wire 30 in response to preventing electricity from flowing from power source 606 and / or 3302 to motor 610 and / or 3308.

[0420] The catheter 15 may include a sheath 40 having a working lumen, the sheath 40 including a first distance marking 3204 and a second distance marking 3204, and a wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method further includes maintaining a longitudinal position of the catheter 15 relative to the first treatment segment 55, the longitudinal position being defined by the distal end of the catheter 15 relative to the first treatment segment 55. The method may further include moving the catheter 15 out of the patient a distance approximately equal to a length from the first distance marking 3204 to the second distance marking 3204, the length approximately equal to a treatment length of the distal wire end 1204. In some examples, the method further includes indicating, via a warning track 3206, that the end of the workable treatment length of the catheter 15 has been reached.

[0421] According to some examples, the catheter 15 includes a sheath 40 including a working lumen, the sheath 40 including a first distance marking 3204 and a second distance marking 3204, and a wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. The method may further include moving the catheter 15 out of the patient a distance approximately equal to the length from the first distance marking 3204 to the second distance marking 3204, which length is approximately equal to the treatment length of the distal wire end 1204.

[0422] In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method further includes indicating, via the warning track 3206, that the end of the workable treatment length of the catheter 15 has been reached.

[0423] The syringe 60 may be fluidly coupled to the catheter 15. In some examples, the method further includes injecting a fluid into the first treatment segment 55 via the syringe 60. According to some examples, the method further includes terminating the injection of the fluid before moving the catheter 15 to the second treatment segment 55. The method may further include injecting a fluid into the second treatment segment 55 via the syringe 60. In some examples, the method further includes removing the catheter 15 from the patient's vasculature. According to some examples, the method further includes terminating the injection of the fluid before removing the catheter 15 from the patient's vasculature.

[0424] The catheter 15 may include a sheath 40 including a working lumen, and a wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. In some examples, the wire 30 is operably coupled to the motor 610 and / or 3308, and the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the catheter 15 includes a sheath 40 including a working lumen, the sheath 40 including the first distance marking 3204 and the second distance marking 3204, and the wire 30 extending through the working lumen, the wire 30 including a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202.

[0425] The catheter 15 may include a warning track 3206. In some examples, the method further includes maintaining a longitudinal position of the catheter 15 relative to the first treatment segment 55, the longitudinal position being defined by a distal end of the catheter 15 relative to the first treatment segment 55. According to some examples, the method further includes retracting at least a portion of the sheath 40 from the wire 30. The method may further include exposing the distal wire tip 1204 in response to retracting the portion of the sheath 40 from the wire 30. In some examples, the method further includes allowing energization from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 in response to the sheath 40 being in a fully retracted state.

[0426] According to some examples, the method further includes activating the motor 610 and / or 3308 and rotating at least a portion of the catheter 15 in response to activating the motor 610 and / or 3308. The method may further include rotating the wire 30 in response to allowing energization from the power source 606 and / or 3302 to the motor 610 and / or 3308. In some examples, the method further includes moving the catheter 15 out of the patient a distance approximately equal to a length from the first distance marking 3204 to the second distance marking 3204, which length is approximately equal to a treatment length of the distal wire tip 1204.

[0427] In some examples, the method further includes extending the sheath 40 around the wire 30. According to some examples, the method further includes at least partially enclosing the distal wire end 1204 in response to extending the sheath 40 around the wire 30. The method may further include preventing, via the limit switch 3306, the flow of electricity from the power source 606 and / or 3302 to the motor 610 and / or 3308 in response to the sheath 40 not being fully retracted. In some examples, the method further includes terminating rotation of the wire 30 in response to preventing the flow of electricity from the power source 606 and / or 3302 to the motor 610 and / or 3308. According to some examples, the method further includes indicating, via the warning track 3206, that the end of the workable treatment length of the catheter 15 has been reached.

[0428] None of the steps described herein are necessary or essential. Any of the steps can be adjusted or modified. Other or additional steps can also be used. Any portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in an embodiment, flowchart, or example herein can be combined with or used in place of any other portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be separate and distinct from one another.

[0429] The section headings and subheadings provided herein are non-limiting. The section headings and subheadings do not represent the complete scope or limit the embodiments described in the section to which they relate. For example, a section entitled "Topic 1" may include embodiments unrelated to Topic 1, and embodiments described in other sections may be applied to or combined with embodiments described within the "Topic 1" section.

[0430] To make the various features more clear, other features are not labeled in each figure.

[0431] The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of the present disclosure. Furthermore, certain methods, events, states, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular order, and the associated blocks, steps, or states may be performed in any other order as appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined into a single block or state. Example tasks or events may be performed serially, in parallel, or in some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

[0432] In particular, any of the various catheter components and features included in the ablation system 10 described herein and shown in the drawings may be used independently of one another or may be combined in various ways in any of the embodiments disclosed herein.

[0433] Additionally, some of the components listed herein, including but not limited to, catheter 15, controller 20, wire 30, sheath 40, syringe 60, proximal wire end 1202, distal wire end 1204, weighted tip 1210, proximal feature 2602, and distal feature 2702, use the same numbers from one figure to the next. It should be understood that these components use the same numbers for ease of reference only and to facilitate understanding by the reader. Although these components may use the same numbers, there may be differences in these components as shown in the various figures in which they appear and as described herein.

[0434] As used herein, conditional language, such as "can," "could," "could," "may," "for example," and the like, is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps that are not included in other embodiments, unless expressly stated otherwise or understood within the context of use. Such conditional language is not generally used to imply that features, elements, and / or steps are required in one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, that determines whether those features, elements, and / or steps are included or performed in a particular embodiment. Terms such as "comprise," "include," "have," and the like are synonymous and used inclusively without limitation and do not exclude additional elements, features, activities, operations, etc. Additionally, the term "or" is used in its inclusive sense (not exclusive), so that, for example, when used in connection with a list of elements, "or" means one, some, or all of the elements in the list. It is understood that connective language such as the phrase "at least one of X, Y, and Z," unless expressly stated otherwise, is generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such connective language is not intended to imply that at least one of X, at least one of Y, and at least one of Z must each be present in a particular embodiment.

[0435] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Thus, A, B, and / or C can be substituted for A, B, and C in one sentence and A, B, or C in another sentence. A, B, and / or C means that some embodiments can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can include only A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term "and / or" is used to avoid unnecessary redundancy.

[0436] While specific embodiments of the present invention have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the invention disclosed herein. Accordingly, nothing in the foregoing description should be construed as implying that any particular feature, characteristic, step, module, or block is necessary or essential. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms, and various omissions, substitutions, and changes may be made in the form of the methods and systems described herein without departing from the spirit of the invention disclosed herein. [Explanation of symbols]

[0437] 10-Ablation System 15-catheter 20-Controller 30-wire 40-Sheath 50-Treatment area 55-Treatment Segment 60-syringe 502 - Proximal Controller End 504 - Distal Controller End 506a-switch 506b-switch 508-Display 602-Slot 604-Expansion Tooey 606-Power supply 608-Actuator 610-Motor 702-Main body 704-Saddle 706-T fitting 708-Proximal Body End 710-Distal body end 712-First Direction 802-Main body 804-T fitting 806-Proximal Body End 808-Distal Body End 810-First Direction 902-Main body 904-T fitting 906-Proximal Body End 908-Distal Body End 910-Pull Tab 912-Light Emitting Diode (LED) 914-Actuator 916-First Direction 1002-Sterilized Pack 1004-Slit 1102-Expandable foot 1104-Torque knob 1106-Arm 1202-Proximal Wire End 1204-Distal Wire End 1206-Aperture 1208-Central axis 1210-Weighted tip 1302-Circular Section Profile 1304-Flat Bar Sectional Profile 1306-Triangular Section Profile 1502-thick diameter 1504-thin diameter 1602-Sinusoidal Profile 1604-Triangle Peak 1702-Stranded Cable 1802-Spiral Hollow Strand 1902-Spring-like structure 2002-Cage-like structure 2302 - Sine wave cross profile 2402-Spring Cross Profile 2502-3D Intersection Profile 2602-Proximal Features 2604-Balloon 2606-Offset Balloon 2608-Cage 2610-Grooved solid 2612-Impeller 2614-Sponge-like solid 2616-Sinusoidal urge 2702-Distal Features 2704-Single Blade Impeller 2706-Cage 2708-Grooved solid section 2710-Impeller 2712-Sponge-like solid part 2802-Semispherical tip 2804 - Offset Weighted Tip 2806-Balloon Tip 2902-Auxiliary Wire 2904-Heating Wire 2906-Porous surface geometry 3002a-Additional geometry 3002b-Additional geometry 3002c-Additional geometric shapes 3002d-Additional geometric shapes 3102-Lure Hub 3104-Lure 3202-Donut 3204-Distance Marking 3206-Warning Truck 3302-Power supply 3304-Actuator 3306-Limit Switch 3308-Motor 3310-LED 3312-Resistor 3400, 3402, 3304, 3406, 3408, 3410, and 3412—Method steps 3500, 3502, and 3504—Method steps 3600, 3602, and 3604—Method steps 3700, 3702, and 3704—Method steps 3800, 3802, and 3804—Method steps 3900, 3902, 3904, and 3906—Method steps 4000 and 4002 - Method steps 4100, 4102, 4104, 4106, 4108, and 4110—Method steps 4200, 4202, 4204, 4206, and 4208—Method steps 4300, 4302, 4304, and 4306—Method steps 4400, 4402, and 4404—Method steps 4500, 4502, 4504, 4506, and 4508—Method steps 4600, 4602, and 4604—Method steps 4700, 4702, 4704, 4706, 4708, and 4710—Method steps 4800, 4802, and 4804—Method steps 4900, 4902, 4904, and 4906—Method steps 5000, 5002, 5004, 5006, 5008, 5010, and 5012—Method steps

Claims

1. 1. A system comprising: A controller; a sheath including an open proximal sheath end, an open distal sheath end, and a working lumen extending from the open proximal sheath end to the open distal sheath end, the open proximal sheath end coupled to the controller, the open distal sheath end configured for insertion into a patient's vascular system, the open distal sheath end located opposite the open proximal sheath end; a wire extending from the controller through the open proximal sheath end, through the working lumen, and to the open distal sheath end, the wire having a proximal wire end and a distal wire end opposite the proximal wire end, the distal wire end configured to mechanically treat a vessel wall of a treatment segment, whereby a length of the distal wire end defines a length of the treatment segment; Equipped with the working lumen is configured to slidably receive the wire and permit passage of fluid therethrough and around the wire to chemically treat the treatment segment; When the system receives a first input, the distal wire tip mechanically treats the vessel wall, when the system receives a second input, the system delivers the fluid to the treatment segment, and when the system receives a third input, the system delivers the fluid to a subsequent treatment segment.

2. The system of claim 1 , wherein the sheath is retractable to expose the distal wire end.

3. 3. The system of claim 2, wherein the controller includes a motor, a power source configured to provide power to the motor, and a limit switch electrically coupled to the motor and the power source, whereby the limit switch allows electricity to flow from the power source to the motor when the sheath is fully retracted.

4. the sheath is variably retractable to expose at least a portion of the length of the distal wire end; The system of claim 2 , wherein the portion of the length of the distal wire tip is configured to form a variable treatment length.

5. The system of claim 1 , wherein the sheath is extendable to enclose at least a portion of the distal wire end.

6. 6. The system of claim 5, wherein the controller includes a motor, a power source configured to provide power to the motor, and a limit switch electrically coupled to the motor and the power source, whereby the limit switch prevents electricity from flowing from the power source to the motor when the sheath is at least partially extended.

7. The system of claim 1 , further comprising at least one distance marking located on the sheath between the open proximal sheath end and the open distal sheath end.

8. The system of claim 7 , wherein the at least one distance marking is positioned and configured according to a length of the treatment segment.

9. The system of claim 7 , further comprising a warning track located on the sheath between the at least one distance marking and the open distal sheath end.

10. 10. The system of claim 9, wherein the warning track is configured to indicate that the end of a workable treatment length has been reached.

11. The system of claim 1 , further comprising a slidable depth marker at least partially surrounding the sheath.

12. The system of claim 11 , wherein the slidable depth marker is slidably coupled to the sheath.

13. The system of claim 11 , wherein the slidable depth marker is sized and configured so that it cannot enter an insertion point on the patient.

14. The system of claim 13 , wherein the slidable depth marker is positioned and configured to maintain the position of the sheath and the wire during treatment.

15. The system of claim 11 , wherein the slidable depth marker is positioned along the sheath and configured to indicate a distance to the patient's deep venous system.

16. The system of claim 1 , wherein the controller includes an actuator configured to receive the first input.

17. The system of claim 16 , wherein the controller includes a motor and a power supply configured to provide power to the motor.

18. The system of claim 17 , wherein the proximal wire end is operably coupled to the motor, the motor configured to rotate the wire.

19. 20. The system of claim 18, wherein the distal wire end is configured to rotate in response to the motor rotating the wire.

20. The system of claim 1 , wherein the system comprises a syringe fluidly coupled to the working lumen, the syringe configured to receive the second input and the third input.

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