SEGMENTAL VASCULAR ABLATION

Abstract

The disclosure includes a controller and a sheath having 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, wherein a length of the distal wire end defines a length of the treatment segment. The working lumen may be configured to slidably receive the wire and allow passage of a fluid 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 can supply the fluid.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 396,176; filed August 8, 2022; entitled VASCULAR ABLATION.

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

[0003] The entire contents of the following application are incorporated herein by reference: Provisional Patent Application No. 63 / 476,156; filed December 19, 2022; entitled CATHETER WIRE CONTROLLER. INTRODUCTIONTechnical area

[0004] The present disclosure relates to systems and methods for treating varicose veins. background

[0005] Mechanochemical ablation (MOCA) is a medical procedure used to treat varicose veins, i.e., enlarged 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 scrapes or ablates) the inner lining of the vein, damaging the endothelium. Simultaneously, a drug, such as a sclerosant, is delivered through the catheter as a chemical solution that irritates and closes the vein. This combination of mechanical agitation (or abrasion or ablation) and chemical irritation induces closure of the varicose vein, causing it to shrink and eventually be reabsorbed by the body.

[0007] Mechanochemical ablation is considered a safe and effective alternative to conventional surgical treatments for varicose veins, such as vein stripping or ligation, as well as to currently available endovascular alternatives, such as radiofrequency ablation, laser ablation, or adhesive closure. It is typically performed as an outpatient procedure, and patients can often resume normal activities shortly after treatment. SUMMARY

[0008] The present disclosure includes an ablation system (see, for example, the one disclosed in Fig. 1), including a control system (see, for example, the one shown in Fig. 1). In some examples, the system includes a shell (see, for example, the 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, and the open distal sheath end is configured for insertion into a patient's vasculature, with the open distal sheath end opposite the open proximal sheath end.

[0009] The ablation system may include a wire (see, for example, the one in Fig. 2) extending from the control through the open proximal sheath end through the working lumen to the open distal sheath end. In some examples, the wire has a proximal wire end (see, e.g., the wire shown in Fig. 12 shown proximal wire end 1202) and a distal wire end (see e.g. the one shown in Fig. 12) opposite the proximal wire end, wherein the distal wire end is configured to contact a vessel wall of a treatment segment (see, for example, the Fig. 2) is mechanically treated, wherein a length of the distal wire end defines a length of the treatment segment.

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

[0011] The present disclosure also includes a method that includes inserting a catheter (see, e.g., the method described in Fig. 1) into a vascular system of a patient. In some examples, the method includes moving the catheter to a first treatment segment (e.g., see the Fig. 2). According to some examples, the method includes actuating a motor (see, e.g., the treatment segment 55 shown in Fig. 6A) and rotating at least a portion of the catheter in response to actuation of the motor.

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

[0013] The foregoing and other features and advantages of the invention will become apparent from the following more particular description of the preferred embodiments of the invention, the accompanying drawings, and the claims. BRIEF DESCRIPTION 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 limit, the invention. In the drawings, like reference numerals designate corresponding features that are common to all similar embodiments. Fig. Figure 1 illustrates a schematic view of an ablation system as it may appear in a patient. Fig. Figure 2 illustrates a side view of an exemplary wire in a vessel. Fig. Figure 3 illustrates a cross-section through an exemplary vessel. Fig. 4A and Fig. 4B illustrate side views of an ablation system, according to some examples. Fig. Figure 5A illustrates a perspective view of an exemplary controller. Fig. Figure 5B illustrates a side view of the control of Fig. 5A, according to some examples. Fig. Figure 5C illustrates a top view of the exemplary control of Fig. 5A. Fig. Figure 6A illustrates a schematic side view of an exemplary ablation system. Fig. Figure 6B illustrates a schematic side view of the ablation system of Fig. 6A with exposed wire. Fig. 7 illustrates a profile view of another exemplary controller, according to some examples. Fig. 8 illustrates a profile view of another exemplary controller, according to some examples. Fig. 9A illustrates a profile view of another exemplary controller, according to some examples. Fig. Figure 9B illustrates a side view of the control of Fig. 9A, according to some examples. Fig. Figure 9C illustrates a top view of the control of Fig. 9A without syringe, according to some examples. Fig. 10 illustrates a top view of a controller in a sterile package, according to some examples. Fig. 11 illustrates a controller including additional features, according to some examples. Fig. 12A, Fig. 12B and Fig. 12C illustrate side views of exemplary wires. Fig. 13A, Fig. 13B and Fig. 13C illustrate exemplary cross-sectional views of a wire. Fig. Figure 14 illustrates a side view of an exemplary off-axis wire. Fig. Figure 15 illustrates a side view of a variable gauge wire according to some examples. Fig. Figure 16 illustrates a side view of an exemplary wire having an angle profile. Fig. 17 illustrates a side view of a wire having a stranded cable construction, according to some examples. Fig. Figure 18 illustrates a perspective view and an inside view of an exemplary wire incorporating a spiral hollow strand construction. Fig. Figure 19 illustrates a perspective view of an exemplary wire incorporating a spring-like construction. Fig. 20 illustrates a side view of a wire incorporating a cage-like construction, according to some examples. Fig. 21 illustrates a side view of a filler wire ending off-axis, according to some examples. Fig. 22A, Fig. 22B and Fig. 22C illustrate several examples of wires that contain non-uniform amplitude profiles. Fig. Figure 23A illustrates an exemplary wire incorporating a sinusoidal profile. Fig. Figure 23B illustrates a front view of the wire of Fig. 23A, according to some examples. Fig. Figure 24A illustrates an exemplary wire incorporating a spring-like profile. Fig. Figure 24B illustrates a front view of the wire of Fig. 24A, according to some examples. Fig. Figure 25A illustrates an exemplary wire that includes a profile extending into a third dimension. Fig. 25B illustrates a front view of the wire of Fig. 25A, according to some examples. Fig. 26A, Fig. 26B, Fig. 26C, Fig. 26D, Fig. 26E, Fig. 26F, Fig. 26G and Fig. 26H illustrate side views of exemplary proximal features for a wire and / or sheath. Fig. 27A, Fig. 27B, Fig. 27C, Fig. 27D and Fig. 27E illustrate side views of exemplary distal features of a wire. Fig. 28A, Fig. 28B and Fig. 28C illustrate several exemplary wires that include multiple features at a distalmost tip. Fig. 29A, Fig. 29B and Fig. 29C illustrate side views of exemplary wires having additional features at a distal wire end. Fig. 30A, Fig. 30B, Fig. 30C and Fig. 30D illustrate side views of example wires that include additional geometry around a wire. Fig. 31 illustrates an exemplary Luer hub. Fig. 32 illustrates a shell including multiple features and a wire, according to some examples. Fig. Figure 33 illustrates an exemplary block diagram for providing power to a motor via a limit switch. Fig. Figure 34 illustrates a flowchart depicting an exemplary method for treating venous disease with an ablation system. Fig. 35 illustrates a flowchart illustrating a method of controlling, according to some examples. Fig. 36 illustrates a flowchart depicting a method for releasing a wire from a catheter, according to some examples. Fig. Figure 37 illustrates a flowchart depicting an exemplary method for enclosing a wire in a catheter. Fig. 38 illustrates a flowchart depicting a method for controlling a distal catheter end, according to some examples. Fig. 39 illustrates a flowchart depicting a method of controlling a motor, according to some examples. Fig. 40 illustrates a flow diagram depicting a method for delivering fluid through a catheter, according to some examples. Fig. 41 illustrates a flowchart depicting a method of segmental mechanical ablation, according to some examples. Fig. 42 illustrates a flowchart depicting a method for exposing and enclosing a wire in a sheath, according to some examples. Fig. 43 illustrates a flowchart depicting a method for limiting current flow to a motor, according to some examples. Fig. 44 illustrates a flowchart depicting a method for measuring distances in a segmental treatment, according to some examples. Fig. 45 illustrates a flowchart depicting a method of segmental mechanochemical ablation, according to some examples. Fig. 46 illustrates a flowchart depicting a method for tracking a catheter sheath separately from the wire, according to some examples. Fig. 47 illustrates a flowchart depicting an additional method for limiting current flow to a motor, according to some examples. Fig. 48 illustrates a flowchart depicting a method for stabilizing a control housing, according to some examples. Fig. 49 illustrates a flowchart depicting a method of using a controller with a sterile package, according to some examples. Fig. 50 illustrates a flowchart depicting a method for removably coupling a catheter to a controller, according to some examples. COMPONENT LIST 10 Ablation system 15 catheters 20 Control 30 wire 40 cover 50 treatment centers 55 Treatment segment 60 syringes 502 Proximal control end 504 Distal control end 506a switch 506b switch 508 ad 602 slot 604 Inflatable Tuohy 606 Power supply 608 Actuator 610 engine 702 housing 704 trailers 706 T-piece 708 Proximal housing end 710 Distal housing end 712 First Direction 802 housing 804 T-piece 806 Proximal housing end 808 Distal housing end 810 First Direction 902 housing 904 T-piece 906 Proximal housing end 908 Distal housing end 910 pull tab 912 light-emitting diode (LED) 914 Actuator 916 First Direction 1002 Sterile packaging 1004 Slot 1102 Extendable foot 1104 Torque knob 1106 Arm 1202 Proximal wire end 1204 Distal wire end 1206 aperture 1208 central axis 1210 Weighted Tip 1302 Circular cross-sectional profile 1304 Flat bar cross-sectional profile 1306 Triangular cross-sectional profile 1502 Thick Diameter 1504 Thin Diameter 1602 Triangular sinusoidal profile 1604 Triangular Peak 1702 Stranded cable 1802 Spiral hollow strand 1902 Spring-like construction 2002 Cage-like construction 2302 Sinusoidal crossing profile 2402 Spring-like crossing profile 2502 Three-dimensional crossing profile 2602 Proximal feature 2604 Balloon 2606 Balloon Offset 2608 Cage 2610 Grooved solid 2612 impeller 2614 Sponge-like solid 2616 Sinusoidal Urge 2702 Distal feature 2704 Single-blade impeller 2706 Cage 2708 Grooved solid 2710 impeller 2712 Sponge-like solid 2802 Hemispherical tip 2804 offset weighted tip 2806 Balloon tip 2902 filler wire 2904 Heated Wire 2906 Geometry porous surface 3002a Additional geometry 3002b Additional geometry 3002c Additional Geometry 3002d Additional Geometry 3102 Luer hub 3104 Luer 3202 Ring 3204 Distance marking 3206 warning lane 3302 Power supply 3304 Actuator 3306 limit switch 3308 engine 3310 LED 3312 resistance 3400, 3402, 3304, 3406, 3408, 3410 and 3412 process steps 3500, 3502 and 3504 process steps 3600, 3602 and 3604 process steps 3700, 3702 and 3704 process steps 3800, 3802 and 3804 process steps 3900, 3902 3904, and 3906 process steps 4000 and 4002 process steps 4100, 4102, 4104, 4106, 4108 and 4110 process steps 4200, 4202, 4204, 4206 and 4208 process steps 4300, 4302, 4304 and 4306 process steps 4400, 4402 and 4404 process steps 4500, 4502, 4504, 4506 and 4508 process steps 4600, 4602 and 4604 process steps 4700, 4702, 4704, 4706, 4708 and 4710 process steps 4800, 4802 and 4804 process steps 4900, 4902, 4904 and 4906 process steps 5000, 5002, 5004, 5006, 5008, 5010 and 5012 process steps DETAILED DESCRIPTION

[0015] The present disclosure describes systems and techniques for treating vascular diseases, such as varicose veins. Some prior art systems involve the use of highly sophisticated interventional devices (e.g., ablation catheters) that require extensive user training to enable proper and effective use, as the devices require the user to multitask while performing complex, dexterous techniques.

[0016] Certain sclerotherapy catheters require the user (e.g., a physician) to operate a first manual control (e.g., a syringe plunger) to infuse a chemical agent, such as a sclerosant, into a target vessel while simultaneously operating a second, different manual control to translate the catheter longitudinally (e.g., advance distally and / or retract proximally) to distribute the chemical agent within the target vessel. In some such examples, the secondary control consists solely of the physician manually pushing and / or pulling the catheter through the patient's vasculature. Such systems are not considered particularly user- or patient-friendly.

[0017] In addition, some vascular treatment devices integrate mechanical ablation functions in addition to, or instead of, purely chemical ablation. In many cases, mechanical ablation improves treatment effectiveness but significantly complicates device operation because not only is additional manual control required to actuate a movement (e.g., rotation) of a mechanical drive of the ablation device, but the physician must also consciously control the relative speeds between all three aspects—i.e., a speed of longitudinal translation through the vessel, a speed of fluid infusion, and a speed of mechanical agitation.

[0018] In other words, many conventional sclerotherapy treatments and devices require the physician to manually initiate a "steady" flow of sclerosant, operate a separate control (e.g., pressing a trigger) to activate an abrasive element that mechanically impacts the vessel wall, and simultaneously manually withdraw the catheter at a steady pace. The cognitive load and skill required for the user to perform all these steps simultaneously is high, leading to a higher likelihood of error due to a mismatch between the amount of mechanical ablation performed and the amount of sclerosant delivered to the target treatment site, as well as a mismatch between the catheter withdrawal speed and the amount of mechanical ablation performed. This not only makes the device difficult to handle, but can also lead to inadequate or incomplete vein ablation, e.g.,if an insufficient amount of sclerosant is administered or an insufficient amount of mechanical abrasion is performed with too fast a retraction speed.

[0019] Additionally, the present disclosure describes systems and methods for controlling a catheter, such as a catheter that includes a wire. These controls include exposing a wire from a lumen within a catheter and exposing the wire to treat a treatment site, as well as directional control of a catheter tip. Some existing solutions include steerable catheter tips and electronically controlled delivery / wire disclosure systems. The present disclosure enables manual control of wire disclosure as well as directional control of the distal catheter tip.

[0020] Fig. Figure 1 illustrates a schematic view of an ablation system 10 as it may appear during a procedure on a patient's leg. A sheath 40 and a wire 30 are inserted into the treatment site 50 via direct access to the vein to be treated. Here, the wire 30 is shown being released from the sheath 40 before or during the procedure. The operator initiates the procedure from the controller 20.

[0021] Fig. Figure 2 shows a side view of a wire 30 in a vessel, according to some examples. Fig. Figure 3 illustrates a cross-section through an exemplary vessel to better show the intima, media, and adventitia. As in Fig. As can be seen in Figure 2, the wire 30 may extend through a working lumen of a sheath 40. This figure shows how the wire 30 penetrates and / or impacts the intima and comes into physical contact with the medium at a treatment site 50. This disrupts the intima at the sites affected by the rotating wire.

[0022] Because the length of wire 30 exposed at treatment site 50 is capable of contacting a length of the vessel, rather than just a circumference of the vessel, treatment site 50 is often referred to in this disclosure as a treatment segment 55. The ability to treat a treatment segment 55, rather than just the circumference of treatment site 50, enables the use of segmental mechanical or mechanochemical ablation. Because an operator would now be able to treat a treatment segment 55 at a time, the need to withdraw catheter 15 and simultaneously inject drug into treatment site 50 is eliminated. The operator can now focus on injecting the drug in isolation at an appropriate rate and, after injecting the drug, move catheter 15 during periods when the drug is not being administered.This can exponentially reduce the difficulty of such an intervention, as the operator no longer needs to divide their attention between controlling multiple delivery rates (i.e., injection rate and withdrawal rate of catheter 15), but rather only needs to control one delivery rate at a time. In other words, this allows interventions to be divided into the acts of injecting and withdrawing without requiring these two acts to be performed simultaneously. Additionally, the term "drug" or "sclerosing agent" is used throughout this disclosure. It is to be understood that any fluid may be delivered in combination with any portion of this disclosure where such a fluid may be delivered.

[0023] Fig. 4A and Fig. 4B illustrate side views of an example of an ablation system 10. In some examples, in several embodiments, the ablation system 10 includes a controller 20 that is Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C and described in more detail. The ablation system may also include a catheter 15, and in some examples, the catheter 15 includes a sheath 40 and a wire 30 extending through the sheath 40.

[0024] For purposes of this disclosure, the terms "catheter" and "sheath" are used interchangeably in some cases, and it is understood that the catheter may be more than just a sheath, such as examples that include a wire. It is understood that references to the term "catheter" may also include ablation systems without a sheath or wire.

[0025] The sheath 40 may extend from the controller 20. In some examples, the wire 30 extends through a working lumen in the sheath 40. The wire 30 may be stored in the sheath 40 while the catheter 15 traverses the patient's vasculature until it reaches a treatment site 50, at which the sheath 40 may be retracted to expose the wire 30. Several examples of the wire 30 are shown in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A illustrates and explains in more detail. Fig. 4A, a syringe 60 is shown in fluid communication with the controller 20 at a distal end of the controller 20. The syringe 60 can deliver a drug, e.g., a sclerosing agent, through the catheter 15, the sheath 40, and / or the wire 30.

[0026] Fig. 5A illustrates a perspective view of an example of a controller 20, and Fig. 5B and Fig. 5C show a side view and a top view of the controller 20 of Fig. 5A. As it is in Fig. 5A, Fig. 5B and Fig. 5C, the controller 20 may include a proximal control end 502 and a distal control end 504 opposite the proximal control end 502. The controller 20 may also include at least one actuator, as seen in actuator 506a and actuator 506b. As illustrated, multiple actuators may be implemented in or on a single controller 20.

[0027] In Fig. 5A, Fig. 5B and Fig. 5C, actuator 506a is present at the base (proximal control end 502) of controller 20. Another actuator 506b is shown at the top of controller 20 near distal control end 504. These actuators may operate as a type of "and" gate, where both actuators must be activated (i.e., switched to an "on" position) for controller 20 to turn on. This is useful as a safety precaution during transport of controller 20 to prevent controller 20 from accidentally turning on.

[0028] In some examples, either actuator 506a or actuator 506b may function as a power enable actuator, providing power to all internal circuitry, such as a motor. In such examples, the other actuator (i.e., actuator 506b if actuator 506a is the power enable actuator) may be a rotation enable actuator, telling the motor, in this example, to rotate. If desired, and as described in Fig. 9A, Fig. 9B and Fig. As further described and discussed in Figure 9C, using a single actuator would also work. The actuator can be any type of actuator, such as a button, a switch, a touchscreen on a user interface, etc.

[0029] In Fig. 5A and Fig. 5B also shows a display 508. The display 508 may provide information to the operator of the controller 20, such as the amount of time elapsed during a procedure or the amount of time remaining if the controller 20 can be programmed to operate for a set duration.

[0030] Particularly with regard to mechanochemical ablation (or just mechanical ablation in cases where no drug is being administered), the display 508 can facilitate a segmental ablation technique. For example, once a catheter 15 has been inserted and placed at the correct treatment site 50 and an operator has operated an actuator to turn on a device, the display can count down the time until the treatment site is abraded enough for drug to be delivered. Additionally or alternatively, the display 508 can also display a countdown indicating the time for which drug delivery should continue, after which the operator stops injecting a drug.

[0031] In examples where the treatment site 50 includes a treatment segment 55, the display 508 may inform an operator when the treatment segment 55 is finished being treated, which would tell the operator that it is time to move the catheter 15 to the next or a subsequent treatment segment 55.

[0032] Fig. 6A illustrates a schematic side view showing the wire 30 enclosed in the sheath 40. Fig. Figure 6B illustrates the schematic side view of Fig. 6A, but with the wire 30 exposed from the sheath 40. As in both Fig. 6A and Fig. As can be seen in FIG. 6B, the controller 20 may have a slot 602 at the distal end of the controller 504. At the proximal end of the sheath 40, an inflatable Tuohy 604 may be present. The wire 30 is fed to a treatment site 50 while being enclosed by the sheath 40 (in some examples). In other examples, the sheath 40 is removable from the controller 20 and can be fed to the treatment site 50 before the wire 30 is fed to the treatment site 50.

[0033] Once the wire 30 reaches the treatment site 50, the wire 30 can be exposed from the sheath 40. In this context, the sheath 40 can be withdrawn from the wire 30, whereby the sheath is removed from the treatment site 50 while the wire 30 remains in the treatment site 50. The operator can manually perform this withdrawal movement on the sheath 40 (as shown in Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C) and then rotate the sheath 40 to lock the inflation tuohy 604 in the slot 602. This locking of the inflation tuohy 604 in the slot 602 may prevent the sheath 40 from moving axially during a procedure.

[0034] As it is in Fig. 6A and Fig. 6B, the controller 20 may include a motor 610, e.g., an electric motor, that may be activated by an actuator 608. A power supply 606 is also included in the controller 20 (although the power supply 606 may be external to the controller 20 if desired). This power supply 606 enables the actuator 608 to connect power to the motor 610, thereby causing rotation of the motor 610 and, in turn, rotation of the wire 30.

[0035] In the present description, the motor 610 may be described as being coupled to the wire 30 and / or the catheter 15 and causing rotation thereon. These terms are used interchangeably in this description, as both components may be coupled to the motor 610 and thereby rotate. Additionally, there may be intermediate components between the motor 610 and the wire 30 and / or the catheter 15. For example, the wire 30 and / or the catheter 15 may be removably or fixedly coupled to one or more hypotubes. These hypotubes, in turn, may be either removably or fixedly coupled to the motor 610.

[0036] It is to be understood that the schematic side views of the controller 20 as shown in Fig. 6A and Fig. 6B, in combination with any of the various examples of control 20 as previously described in Fig. 5A, Fig. 5B, Fig. 5C, as well as with each of the plurality of controllers 20 as shown in Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C can be used.

[0037] Fig. 7 illustrates a profile view of a controller 20, according to some examples. The controller 20 may include a proximal housing end 708 and a distal housing end 710 opposite the proximal housing end 708. Although in Fig. 7, the controller 20 may be removably coupled to a catheter 15 at the distal housing end 710.

[0038] As it is in Fig. 7, the controller 20 may include a flat or at least partially flat bottom portion that allows the controller 20 to be placed on a tabletop or other work surface to facilitate operation of the controller 20. Although in Fig. 7 is not shown, but as in previous Fig. 5A, Fig. 5B and Fig. 5C, the controller 20 may be handheld. This may result in the controller 20 being operated ambidextrous, with one hand holding the controller 20 and the other hand operating the controller 20. The controller 20 may also be removably coupled to any work surface not further described herein; that is, the controller 20 does not need to be placed on a table or held in the hand of an operator for the controller 20 to be operational.

[0039] As is also the case in Fig. 7, the controller may include a housing 702 and a trailer 704 slidably coupled to the housing 702. The trailer 704 is capable of slidably moving both in a first direction 712 and opposite to this first direction 712. As shown in Fig. 7, the first direction 712 is considered to be the direction from the proximal housing end 708 to the distal housing end 710. A T-piece 706 may be disposed within the housing 106 of the controller 20 and at least partially surrounded by a central portion of the trailer 704. The T-piece may be capable of slidably moving in the first direction 712, as well as opposite to the first direction 712, in response to movements of the trailer 704. In examples where the controller 20 includes a catheter 15 removably connected to the distal housing end 710, the catheter 15 may be further removably coupled to the T-piece 706.

[0040] Such a catheter 15 may include a wire 30 to scrape a vessel wall at a treatment site 50, as shown in Fig. 2. In some procedures, it is desirable to leave the wire 30 within the catheter housing or sheath 40 until the wire 30 has been delivered to the treatment site 50 to prevent premature abrasion of vessel walls or, in other words, abrasion of vessel walls not intended for treatment. Once the catheter 15 reaches the desired treatment site, the trailer 705 can move along the first direction 712 to expose or enclose the wire 30.

[0041] In other examples, the catheter 15 is guided or moved to a treatment site 50, causing the catheter to expose the wire 30. This may allow for greater flexibility in designs where the wire 30 has a shape larger than the opening of 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 therefore, 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.

[0042] Throughout this specification, catheter 15 is disclosed as being provided with a wire 30. However, it should be understood that the present description is not limited to the use of a wire 30. The present specification also allows for the use of a hypotube, a catheter shaft, or combinations thereof, and in combination with a wire 30.

[0043] As shown in the exemplary control 20 in Fig. As illustrated in Figure 7, the trailer 704 is present at the distal housing end 710. At this point, the wire 30 remains within a lumen of the sheath 40. When an operator moves the trailer 704 opposite the first direction 712 toward the proximal housing end 708, the sheath 40 can be retracted onto the wire 30, exposing the wire 30. At this point, the wire 30 can be used to scrape the vessel wall.

[0044] The housing 702 may include an actuator (e.g., actuator 506a or 506b as shown in Fig. 5A, Fig. 5B and Fig. 5C, actuator 608, as in Fig. 6A and Fig. 6B, and / or actuator 914 as described and discussed in Fig. 9A, Fig. 9B and Fig. 9C). In some examples, this actuator 506a, 506b, 608, and / or 914 controls a circuit and / or a motor (such as motor 610 shown in Fig. 6A and Fig. 6B, and / or the motor 3308 described in Fig. 33 is discussed in more detail) within the housing 702. This actuator 506a, 506b, 608, and / or 914 can control the rotation of the wire 30 and facilitate abrasion of the vessel wall. Once this abrasion is complete, the operator can move the trailer 704 in the first direction 712 to advance the sheath 40 forward again, thereby re-enclosing the wire 30 within the sheath 40 (or capturing, wrapping, etc.) and allowing safe removal of the catheter 15 from the patient's vasculature.

[0045] Fig. 7 also shows a syringe 60 removably connected to the T-piece 706 via the trailer 704. This syringe 60 may be in fluid communication with the catheter 15 if the catheter 15 is present. In some examples, the catheter 15 includes a fluid lumen (e.g., a working lumen through the sheath 40) that allows fluid from the syringe 60 to flow through the catheter 15 when the syringe 60 is depressed. This may be useful in procedures such as sclerotherapy, where a liquid drug, e.g., a sclerosing agent, is to be delivered to the treatment site 50 either before, simultaneously with, or after abrading the vessel wall.

[0046] The sprayer 60 is illustrated extending perpendicular to the first direction 712. This is only an example, and it should be understood that the sprayer 60 can be positioned at any angle to provide the best ergonomics and / or comfort for the operator. In some examples, the sprayer 60 acts as a handle for the operator, allowing easy control of the trailer 704 and the tee 706 when moving both in the first direction 712 and opposite to the first direction 712.

[0047] The trailer 704 and the T-piece 706 can slide by manual actuation of the sprayer 60, but the T-piece 706 can also be actuated by direct actuation of the trailer 704, e.g., by the operator pressing on the trailer 704 with one hand while actuating the recess of the sprayer 60 with the other hand. As shown in the Fig. 9A, Fig. 9B and Fig. 9C, the trailer 704 may further include pull tabs (such as the pull tabs 910 of Fig. 9A, Fig. 9B and Fig. 9C) to facilitate manual movement of the trailer 704. In these examples, the sprayer 60 would move along with the tee 706, but would not be the cause of such movement.

[0048] Additionally, in some examples shown in Fig. 7 are not explicitly shown, may be non-removably connected to the T-piece 706. In such examples, an extrusion tube / infusion tube may connect the syringe 60 to a removably coupled catheter 15. This would allow the syringe 60 to be uncoupled from the T-piece 706 and thus also uncoupled from the controller 20. Instead, the syringe 60 would be connected to a flexible tube, allowing greater freedom of movement of the syringe 60 independent of the controller 20, if desired.

[0049] In Fig. Also illustrated in Figure 7 is a slot in the trailer 704 perpendicular to the first direction 712 and extending at least partially around the trailer 704. This slot may allow the syringe 60 to perform a rotational movement about the housing 702. In some examples, when an operator rotates the syringe 60 about the housing 702, the operator creates a torque on a wire 30, perhaps a wire 30 in a detachably coupled catheter 15, allowing manual control of a distal end of the wire 30. This may allow the operator to perform subtle movements of such a distal end of the wire 30 at the treatment site 50 to establish better abrasive contact with the vessel walls and / or facilitate traversing the patient's tortuous vasculature.

[0050] Although it is in Fig. 7, the T-piece 706 may have a Luer (such as the Luer 3104 as shown in Fig. 31). This Luer may be configured to removably couple the syringe 60 to the T-piece 706. In examples with such a Luer, the Luer may be configured to rotate about a direction perpendicular to the first direction 712. This rotation may include any angle of rotation, including a full 360-degree rotation around the housing 702.

[0051] Once a syringe 60 is removably connected to the Luer, this rotational movement would likely be restricted to prevent over-rotation of the syringe 60. In this configuration, the syringe 60 may be configured to control rotation of the Luer. Similar to the above disclosure, rotation of the Luer may generate torque on a wire 30, allowing manual control of the distal end of the wire 30.

[0052] The Luer may have an O-ring on a proximal side to prevent fluid leakage during infusion. This O-ring may also engage the wire 30 while simultaneously being attached to the catheter sheath 40, so that when the Luer rotates, the catheter sheath 40 also rotates, and the Luer's O-ring attempts to rotate the wire 30 at the same time.

[0053] In some examples shown in Fig. 7, the Luer is not present within the device housing. In such examples, the Luer could be a commercially available stopcock or three-way valve that receives 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 may facilitate use of the device in situations where another catheter sheath 40 is in situ—such as a guidewire catheter. A second catheter sheath 40 may not fit into the vasculature adjacent to a pre-existing catheter sheath 40, so the wire 30 can still be introduced into the treatment site 50 by removing the catheter sheath 40 from the present device.

[0054] Another advantage of being able to remove the sheath 40 is that the sheath 40 can be guided to the treatment site first. Removing the catheter sheath 40 from the wire 30 may also allow the sheath 40 to be guided over a previously placed guidewire. Once the catheter sheath 40 is in place, the guidewire, if present, can be removed, allowing the device to be advanced further into the vasculature.

[0055] Fig. Figure 8 illustrates a profile view of a controller 20 according to some examples. The exemplary controller of Fig. 8 shares many similarities with the exemplary control of Fig. 7, many of which are to be repeated herein. The controller 20 may include a proximal housing end 806 and a distal housing end 808 opposite the proximal housing end 806. Although in Fig. 8, the controller 20 may be removably coupled to a catheter 20 at the distal housing end 808.

[0056] As it is in Fig. 8, the controller 20 may include an at least partially flat bottom portion that allows the controller 20 to be placed on a tabletop or other work surface to facilitate operation of the controller 20. Although in Fig. 8 is not shown, but as previously in Fig. 5A, Fig. 5B and Fig. 5C, the controller 20 may be handheld, making use of the controller 20 a two-handed operation, with one hand providing support for the controller 20 and the other hand operating the controller 20. The controller 20 may also be removably coupled to any work surface not described herein; that is, the controller 20 does not need to be specifically placed on a tabletop or held in the hands of an operator for the controller 20 to be operational.

[0057] As in Fig. 8, the controller 20 may include a housing 802. In contrast to the exemplary controller 20 of Fig. 7 contains the exemplary control 20 of Fig. 8 does not include a trailer slidably coupled to the housing 802. In this example, a T-piece 804 may be disposed within the housing 802 of the controller 20. The T-piece 804 may be capable of slidably moving both in a first direction 810 and opposite to the first direction 810, where the first direction 810 is the direction of movement from the proximal housing end 806 to the distal housing end 808. In examples of the controller 20 that include a catheter removably coupled to and / or through the distal housing end 808, the catheter may further be removably coupled to the T-piece 804.

[0058] In Fig. 8 also illustrates the T-piece 804 present at a point near the proximal housing end 806. At this point, the sheath 40 is retracted over the wire 30, exposing the wire 30 at a treatment site 50. In some examples, the catheter may be inserted in this configuration, but it is likely that the wire 30 will be delivered to the treatment site 50 while still within the sheath 40 to avoid inadvertent abrasion of vascular sites other than the treatment site 50. After treatment, the operator may move the T-piece 804 along the first direction 810 to re-sheath the wire 30, allowing safe removal of the catheter from the patient's vasculature.

[0059] Fig. 8 also shows a syringe 60 removably coupled to the T-piece 804. The syringe 60 may also be in fluid communication with the catheter if a catheter is present. In some examples, the catheter includes a fluid lumen that allows fluid to flow from the syringe 60 through the catheter when the syringe 60 is depressed. As previously described, this is useful in procedures such as sclerotherapy, where a fluid drug, such as a sclerosant, should be used either before, simultaneously with, or after abrading the vessel wall.

[0060] The syringe 60 is shown extending perpendicular to the first direction 810. This is only an example, and it should be understood that the syringe 60 can be positioned at any angle to provide the best ergonomics or comfort for the operator. In some examples, the syringe 60 acts as a handle for the operator, allowing easy control of the T-piece 804 while slidably moving both in the first direction 810 and opposite to the first direction 810.

[0061] Fig. Figure 9A illustrates a profile view of another exemplary controller. Fig. 9B shows the control 20 of Fig. 9A in a side view, and Fig. Figure 9C shows the control of Figure 9A in a top view without the syringe 60 present. Similar to the controls 20 of Fig. 7 and Fig. 8 includes the control 20 of Fig. 9A, Fig. 9B and Fig. 9C illustrates a housing 902 including a proximal housing end 906 and a distal housing end 908 opposite the proximal housing end 906. The unlabeled but shown initial portion of a catheter 15 is shown inserted into the housing 902 through the distal housing end 908.

[0062] In this example, a T-piece 904 is illustrated that is at least partially located within the housing 902. The T-piece 904 may be or include a Luer hub and a Luer for removably receiving a syringe 60, as previously described. This T-piece may be connected to a trailer, such as the trailer 704 in Fig. 7, be coupled. The trailer in Fig. 9A, Fig. 9B and Fig. 9C is largely obscured by the housing 902, as this trailer is at least partially, if not mostly, contained within the housing 902. However, portions of the trailer protrude from the sides of the housing 902, and these are shown as pull tab(s) 910. It should be understood that the decision to use the term "pull tab(s)" is solely a lexicographical decision, and any other appropriate term, such as "fingerpad(s)" or an equivalent, may be substituted.

[0063] Similar to Fig. 7 and Fig. 8, the controller 20 may be able to maneuver a sheath 40 around a wire 30. Fig. 9A and Fig. 9B show the syringe 60 and the T-piece 904 located towards the proximal housing end 906. Fig. While not illustrating syringe 60, Figure 9C also shows T-piece 904 positioned toward proximal housing end 906. In all cases, this may indicate that sheath 40 is fully retracted onto wire 30, exposing wire 30. This is likely, but not necessarily, an indication that catheter 15 is at a treatment site 50 and wire 30 has been exposed to provide treatment.

[0064] Once a treatment is completed, the syringe 60 and the T-piece 904 can be pushed along the first direction 916, which runs from the proximal housing end 906 to the distal housing end 908. In Fig. 7, it was discussed how the trailer 704 itself can be manipulated by the operator to push and pull the sprayer 60 and the T-piece 904. Similarly, in FIG. Fig. 9A, Fig. 9B and Fig. 9C, the pull tab(s) 910 may be actuated either instead of or in addition to the syringe 60 and the T-piece 904. In this example, pressing the syringe 60, the T-piece 904, and / or the pull tab(s) 910 causes the sheath 40 to expand on the wire 30, thereby enclosing or encompassing the wire 30. In this configuration, the wire 30 may be in a less expanded state, making removal of the catheter 15 from the patient (or insertion into the patient, if done prior to treatment) easier or safer.

[0065] In contrast to this sliding motion, once a catheter 15 has been brought to a treatment site 50, the operator can pull on the syringe 60, the T-piece 904, and / or the pull tab(s) 910 to retract the sheath 40. This retraction of the sheath 40 exposes the wire 30, and in cases where a distal end of the wire 30 includes a shaped profile, the wire 30 can expand into this shaped profile (or expand further into this shaped profile, as the case may be) to contact the vessel walls so that abrasion can occur during a treatment.

[0066] In Fig. 9A, Fig. 9B and Fig. Also included in Figure 9C is a light-emitting diode (LED) 912 (labeled in Figures 9A and 9C). The LED 912 can be used to convey a variety of information to the operator. For example, the LED 912 can indicate that the device is receiving power or is turned on. The LED 912 can indicate that the sheath 40 is fully retracted onto the wire 30, meaning that the wire 30 is ready to be rotated to provide an abrasive treatment.

[0067] Throughout this disclosure, reference is made to segmental mechanical or mechanochemical ablation. The LED 912 may indicate treatment times to the operator in these or other cases. For example, the operator may wish to provide mechanical agitation to a treatment segment 55 for a set period of time before moving on to a 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 next treatment segment 55. Or, the LED 912 may illuminate steadily, and the LED 912 may turn off to indicate that this treatment time has elapsed.

[0068] During mechanochemical ablation, it is often desirable to inject a drug, such as a sclerosant, at a specific rate. In these cases, the LED 912 may illuminate or turn off to indicate that mechanical ablation has occurred for a desired period of time and it is time to begin injecting the drug into the treatment segment 55. Likewise, the LED 912 may indicate that the injection time has elapsed and it is time to advance the catheter 15 to a subsequent treatment segment 55.

[0069] In Fig. 9A, Fig. 9B and Fig. 9C, one LED 912 is shown, but it should be understood that multiple LEDs 912 may be present in the device and may serve multiple different purposes. Although not explicitly labeled, Fig. 8, for example, two LEDs on the housing 802 near the syringe 60 and the T-piece 804. These LEDs 912 may be labeled to avoid confusion by the operator.

[0070] Additionally or alternatively, the controller 20 may include a display (such as the display 508 in Fig. 5A, Fig. 5B and Fig. 5C) or some type of alarm or other sounder to indicate treatment times to the operator. In the case of an alarm or other sounder, the operation would be similar to that of LED 912—the alarm may sound to indicate the end of a mechanical ablation of a treatment segment 55, the end of an injection of a drug in the treatment segment 55, the time to transition to a subsequent treatment segment 55, and / or the end of an overall treatment. The indication may be provided in the same manner, also indicating the remaining time for each of these steps.

[0071] Finally, in Fig. 9A, Fig. 9B and Fig. 9C (only labeled in FIGS. 9A and 9C), an actuator 914 can be seen. The actuator 914 may be any device capable of receiving input from an operator, such as a switch, a button, a lever, a 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. In Fig. 9A, Fig. 9B and Fig. 9C, one actuator 914 is shown, but multiple actuators 914 for different purposes may be present on the device, such as the actuators 506a and 506b of Fig. 5A, Fig. 5B, and Fig. 5C.

[0072] Fig. Figure 10 illustrates a top view of a device contained within a sterile package 1002. It is understood that each controller 20, as shown in Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, as well as other possible exemplary controls 20 may be operable in connection with the disclosure of the sterile package 1002. Similarly, it is to be understood that any combination of catheter 15, wire 30, and sheath 40 as shown in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as other possible exemplary wires 30 may be operable in connection with the disclosure of the sterile package 1002.

[0073] As it is in Fig. 10, a controller 20 can fit into a cavity or recess of the sterile package 1002. Space is also provided in the sterile package 1002 for the catheter 15, but Fig. Figure 10 illustrates what the device may look like in use and not in storage. A slot 1004 may be provided in the sterile package 1002 through which the catheter 15 may pass. This may allow the controller 20 to be operated from within the sterile package 1002 while the catheter 15 is exiting the sterile package 1002 to be inserted into a patient's body.

[0074] Although the term "slit 1004" is used throughout this disclosure, any other equivalent vacant location in the sterile package 1002, such as a channel or opening, may be used.

[0075] In some examples, the catheter 15 may be removable from the controller 20 to be placed through this slot 1004. In other examples, the slot 1004 slidably receives the catheter 15 while the catheter 15 is already coupled to the controller 20. In both cases, the controller 20 may be operated from the sterile package 1002, allowing operators to perform treatment without the need for a sterile drape.

[0076] In examples where the catheter 15 is non-removably coupled to the controller 20, the entire ablation system 10 must be sterilized between treatments. However, in examples where the catheter 15 is removably coupled to the controller 20, the catheter 15 can be sterilized separately without requiring the controller 20 to be sterilized between treatments. Reusing the controller 20 can help reduce waste.

[0077] Additionally, the catheter 15 may be manufactured as a disposable device (this could mean that the sheath 40 and / or the wire 30 are disposable if the catheter 15 includes a sheath 40 and a wire 30). This can significantly reduce costs and waste, as the controller 20 can be reused between treatments and the catheter 15 can be discarded after use. Additionally, the operator may not need to use sterile wipes, and the surface on which the controller 20 is placed within the sterile package 1002 may not need to be fully sterilized (it can simply be wiped clean) because the controller 20 does not come into direct contact with these surfaces.

[0078] In an example where the catheter 15 is removably coupled to the controller 20, the controller 20 itself may be packaged in the sterile package 1002 so that the controller 20 may be sold separately from the catheter 15.

[0079] Regardless of whether the catheter 15 is removably coupled to the controller 20, the sterile package 1002 may be "hung" on a wall for quick and easy access. This would allow operators to quickly access the controller 20 without having to rummage through storage or boxes of devices and catheters to find the required device.

[0080] Fig. 11 illustrates a top view of an exemplary ablation system 10. As shown in Fig. As can be seen in Figure 11, the controller 20 may include an extendable foot 1102. This extendable foot 1102 may be provided with a web or otherwise constructed to allow the operator to control how wide the extendable foot 1102 is relative to the base of the controller 20. By extending the extendable foot 1102, additional stability may be provided to the controller 20 so that the controller 20 cannot tip over on its side due to an external force.

[0081] It is to be understood that the expandable foot 1102, as shown in Fig. 11, can be used in combination with one of the various controls 20 previously described in Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, as well as any additional control not specifically illustrated herein.

[0082] This can be particularly useful in cases where the motor is located beneath the tee / trailer, making the controller 20 shorter but taller. This shorter length and taller footprint can result in the controller 20 having a higher center of gravity, making it more prone to tipping, but the expandable base 1102 can prevent this. In such cases where the motor is located beneath the tee / trailer, gears could be used to create a gear ratio so that the rotation of the catheter 15 and / or the wire 30 can be controlled to a desired rotational speed.

[0083] In Fig. 11, a torque knob 1104 is also shown. The torque knob 1104 may allow an operator to provide torque to the catheter 15 and / or the wire 30 and thereby adjust the direction of movement of a distal end of the catheter 15 and / or the wire 30. This is comparable to the slot in the trailer 704 in Fig. 7. However, instead of having to rotate the syringe 60 around the housing 702 as shown in Fig. 7, the torque knob 1104 can provide a simple method for controlling these distal ends of the catheter 15 and / or the wire 30 without adjusting the syringe 60 at all. Also, this newly generated torque can allow the operator to perform subtle movements of the distal end of the catheter 15 and / or the wire 30 at the treatment site 50 to achieve better abrasive contact with the vessel walls and / or facilitate traversing the patient's tortuous vasculature. Such a torque knob 1104 can be operated in conjunction with the controller, as described through the use of a dual-shaft motor, or in the example where the motor is under the T-piece / trailer.

[0084] It is to be understood that the torque knob 1104 as shown in Fig. 11, can be used in combination with one of the various controls 20 previously described in Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, as well as any additional control not specifically illustrated herein.

[0085] Finally, the controller 20 can, as in Fig. 11, include an arm 1106. In examples where the controller 20 is positioned so that the catheter 15 and / or the wire 30 is rotated back on itself prior to insertion into a patient, the arm 1106 may help prevent the catheter 15 and / or the wire 30 from kinking, which may be detrimental to fluid delivery, e.g., a drug. The arm 1106 may further define a radius at which the catheter 15 is held away from the controller 20. Additionally or alternatively, the arm 1106 may serve as a catheter clamp, holding the catheter 15 in position during a treatment. The arm 1106 may further prevent the device from being operated in an aggressive radius, which may negatively impact device performance. The arm 1106 may also prevent the ablation system 10 from twisting (i.e.,while the motor is running, the ablation system 10 could rotate around itself, and the arm 1106 can prevent this).

[0086] It is to be understood that the Fig. 11 can be used in combination with one of the various controllers 20 previously described in Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, as well as with additional control not specifically illustrated herein.

[0087] Fig. 12A, Fig. 12B and Fig. 12C illustrate exemplary side views of a wire 30. Fig. 12A, Fig. 12B and Fig. 12C illustrate various examples of components for delivering a drug, such as a sclerosant, in an ablation system 10 having a wire 30. The wire 30 may include a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. The proximal wire end 1202 generally points to a region proximal to any feature of the distal wire end 1204. Since Fig. 12A, Fig. 12B and Fig. 12C (as well as Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as shown and described below) show only a distalmost portion of the wire, it is not possible to show the proximal wire end 1202 where it begins near an existing controller 20. For this reason, in this disclosure, the proximal wire end 1202 should be understood to refer to the wire 30 that is proximal to the portion of the wire that is intended to scrape (or ablate or move) the vessel walls.

[0088] As it is in Fig. 12A, Fig. 12B and Fig. 12C, the wire 30 may have a sinusoidal shape. This sinusoidal shape allows the wire 30 to contact the walls of a vessel into which the wire 30 has been inserted. In some examples, the wire 30 is made of nitinol (e.g., Nitinol No. 1 ASTM F2063) or a similar material that can return to its shape after compression, such as the compression the wire 30 may experience when stored in the sheath 40.

[0089] Any of the examples described and shown herein are also functional in a stent. In such examples, the wire 30 would contact both the stent and the tissue. Additionally, many of the examples shown and described in the present disclosure include either three or four peaks. It is understood that the number of peaks present in FIG. 1 and described in the disclosure is only an example, and that any number of peaks may be present in a sinusoidally shaped wire, as desired, and a greater number of peaks could mean a greater length of the treatment segment 55, or simply a greater number of contact points along such treatment segment 55.

[0090] Additionally, any dimensions regarding the spacing or amplitude of the wire 30 are also merely exemplary, and it should be understood that wires of different sizes may prove useful for vessels or treatment segments 55 of different sizes. For example, the wire 30 may have an amplitude of about 12 millimeters. Because the wire 30 is at least partially compressible in this example, the wire 30 may be used in vessels having a smaller diameter than the amplitude of the wire 30. In such an exemplary wire 30 having an amplitude of about 12 millimeters, the working range or range of vessel diameters that the wire 30 may treat would be from about 4 millimeters to about 12 millimeters.

[0091] In cases where the diameter of the vessel to be treated is smaller than the amplitude of wire 30, wire 30 is compressed, broadening the peaks of the sinusoid and lengthening contact with the vessel walls, which in turn effectively increases the length of treatment segment 55. Wire 30, in this example, could also treat larger diameter vessels, but would not be able to maintain continuous contact with the vessel walls. Therefore, a larger amplitude wire 30 may be desirable for such an application.

[0092] During a procedure such as sclerotherapy, it may be desirable to either damage the intima of a vessel or to penetrate it and damage only the media of the vessel. Conventional state-of-the-art wires contact the vessel wall at the distal tip, resulting in this contact point being abrupt and sharp. This creates the potential for the wire to penetrate not only the intima but also the media, allowing it to enter the surrounding adventitia. Current solutions to this problem involve twisting the wire in the opposite direction in the hope that the wire will disengage from the vessel enough to be safely removed. Another solution is to forcibly remove the wire from the patient by pulling on it—often quite forcefully. This solution can be painful or uncomfortable for the patient or even result in complete stripping of the vein.

[0093] For a sinusoidal shape, as in the examples in Fig. 12A, Fig. 12B and Fig. 12C, the contact point is much blunter or more blunt than with conventional wires 30. This significantly reduces the likelihood of penetrating the media and entering the adventitia, increasing the safety and effectiveness of sclerotherapy procedures.

[0094] Another problem with current sclerotherapy treatments is the multitude of functions the operator must simultaneously monitor. For example, with many state-of-the-art devices, a treatment might consist of retracting the wire through the vessel being treated at a speed of approximately 1 to 2 millimeters per second. At the same time, the operator must inject a drug, such as a sclerosant, from a manually operated syringe at a rate of approximately 0.1 to 0.2 milliliters per centimeter. Already, the operator must monitor two separate measuring devices—the distance the wire is retracted and the distance the syringe plunger has been depressed.Because the catheter's retraction rate is time-dependent, the operator must keep track of the elapsed time somehow—often through mental counting, which is both error-prone and can distract the operator from the procedure. Treatments are often nearly 40 centimeters long, meaning these treatments can last between 200 and 400 seconds, based on the parameters mentioned above.

[0095] 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, these prior art devices lack a "treatment segment" as described in the present specification. This causes procedures that require the operator to withdraw the wire at a specific rate while injecting the drug at a separate, distinct, and specific rate. The present disclosure seeks to address this deficiency of the prior art by eliminating the need to withdraw the catheter while simultaneously injecting the drug.

[0096] By using a sinusoidal wire 30 (or other wire shaped and configured to contact a length of the vessel wall) that treats a length of vein at once, methods for segmental treatment rather than continuous treatment can be developed. In these methods, the wire 30 is delivered to the most distal portion of the treatment site 50 and then activated for a predetermined period of time. With the present invention, the operator only needs to worry about the amount of drug injected, which, since it no longer depends on the length of the retracted wire 30, can be much more variable without causing side effects.Once a prescribed amount of drug has entered the treatment segment 55, the operator can withdraw the catheter 15 into a subsequent treatment segment 55, either at a predetermined speed or at any speed desired by the operator, without having to inject further drug until the catheter 15 reaches that subsequent treatment segment 55.

[0097] The Fig. 5A and Fig. The display 508 described in Figure 5B can further reduce the operator's workload by eliminating the need to count the time in his head. Similarly, the LED 912, as described in Fig. 9A and Fig. 9C, may serve a similar purpose. Such an indicator, whether the display 508, the LED 912, or another method of providing information to an operator, such as an alarm tone, may allow the operator to stop keeping track of the passage of time, allowing them to focus their full attention on smaller details of the procedure.

[0098] In some examples, the syringe can even be replaced with an Archimedes screw to deliver a specific amount of drug per rotation of the wire 30. Additional features can include a torque limiter, which can indicate when the wire 30 is rotating through an unintended medium, such as when the wire 30 has penetrated the adventitia. A clutch can also be included. If a parameter, such as torque, exceeds a certain threshold, the clutch can automatically stop rotation of the wire 30. If the wire 30 has penetrated the adventitia, this automatic interruption of rotation of the wire 30 can help prevent the vessel from becoming tangled in on itself.

[0099] Fig. 12A illustrates a wire 30 having at least one opening 1206. As shown in Fig. 12A, the wire 30 may be a hypotube having multiple apertures 1206 along its housing, as well as a nozzle-like tip at the distal wire end 1204 that includes an additional aperture 1206. The apertures 1206 are provided to deliver a drug, such as a sclerosant, to a treatment site 50 during a procedure. An arrow is provided at the proximal wire end 1202 to show the rotation of the wire 30 during a procedure. The wire 30 may rotate in either direction during a procedure, and this rotation allows the peaks of the sinusoid to make full peripheral contact with the vessel walls, enhancing abrasion during the procedure. In some, but not all, examples, the wire 30 rotates in only one direction. Also shown is a central axis 1208 about which the wire 30 rotates.

[0100] Fig. Figure 12B illustrates a wire 30 having at least one opening 1206, similar to those shown in Fig. 12A. In contrast to the example of Fig. 12A includes Fig. 12B, however, a weighted tip 1210 at the distal wire end 1204. An arrow shows a possible direction of rotation about a central axis 1208, but the inclusion of a weighted tip 1210 creates a gyroscopic effect that may facilitate keeping the wire 30 centered in the vessel and ensuring uniform contact with the vessel walls.

[0101] Fig. Figure 12C illustrates a wire 30 with a weighted tip 1210, in this example without apertures 1206. Sheath 40 is shown serving as a fluid lumen while wire 30 is exposed. In this example, a drug, such as a sclerosant, can be delivered through the sheath to treatment site 50 and contact the vessel walls proximal to the rotation of wire 30 along the treatment length.

[0102] Fig. 13A, Fig. 13B and Fig. 13C illustrate some possible cross-sectional profiles of a wire 30. In particular, Fig. 13A a circular cross-sectional profile 1302 of a wire 30, Fig. 13B a ​​rectangular or flat flat bar cross-sectional profile 1304 of a wire 30 and Fig. 13C a triangular cross-sectional profile 1306 of a wire 30.

[0103] It is to be understood that the different cross-sectional profiles as shown in Fig. 13A, Fig. 13B and Fig. 13C, in combination with any of the plurality of exemplary wires 30 as previously described in Fig. 12A, Fig. 12B and Fig. 12C, and in combination with any of the plurality of exemplary wires 30 as shown in Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, or with any filler wire not specifically illustrated herein.

[0104] A circular cross-sectional profile 1302, as shown in Fig. The circular cross-sectional profile shown in Figure 13A is the most conventional shape for a wire. Its rounded profile can cause damage, but the lack of sharp edges reduces the likelihood of it penetrating the medium and into the adventitia. If greater abrasion is desired, the circular cross-sectional profile 1302 can be provided with a surface roughness.

[0105] The flat bar cross-sectional profile 1304 from Fig. 13B and the triangular cross-sectional profile 1306 of Fig. 13C have sharper edges than the circular cross-sectional profile 1302 of Fig. 13A. These sharp edges can scrape the vessel walls faster than the circular cross-sectional profile 1302, but with a greater chance of penetrating the medium rather than just damaging it.

[0106] Fig. 14 illustrates a side view of an exemplary wire 30 terminating at a point not along the central axis 1208. In this example, a weighted tip 1210 is included, which achieves the opposite of a gyroscopic effect, or at least an opposite effect, due to the off-axis location of the weighted tip 1210. The weighted tip 1210 causes the wire 30 to rotate more erratically, causing the peaks of the sinusoidal wire 30, as well as the weighted tip 1210, to contact the vessel walls harder, albeit less frequently. In some examples, no weighted tip 1210 is included, but the wire 30 still terminates off-axis from the central axis 1208.

[0107] Fig. 15 illustrates a side view of a wire 30 having a variable gauge. In the example shown, 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 portion 1502 of the wire 30 may be stiffer than the thin diameter portion 1504 of the wire 30 due to its thickness. This may allow the thick diameter portion 1502 of the wire 30 to "bounce" off the vessel walls, thereby increasing the contact of the thin diameter portion 1504 of the wire 30 with the vessel walls. The thick diameter portion 1502 of the wire 30 may also allow for a higher surface roughness, which may improve the abrasion resistance of the wire 30.In addition, due to the larger profile size of a thick diameter section 1502 of the wire 30, better contact with the vessel walls can be made.

[0108] While Fig. While Figure 15 shows the thick diameter 1502 at the proximal wire end 1202 and the thin diameter 1504 at the distal wire end 1204, these positions are only exemplary. Each portion of the wire 30 may include a thick diameter 1502 or a thin diameter 1504 depending on the user's needs, allowing different effects to be achieved.

[0109] Fig. Figure 16 illustrates a side view of another exemplary wire 30 forming a triangular sinusoidal profile 1602. Depending on the user's preference, any type of shaped sinusoidal wave may be used. A triangular sinusoidal profile 1602 creates sharper contact points with the vessel walls (as shown in Fig. 2), which can enhance abrasion in these areas. These sharper points or triangular peaks 1604 can scratch or cut the intima and / or media, causing more damage to the vessel wall than simple abrasion.

[0110] Fig. 17 illustrates a side view of an exemplary wire 30 incorporating a stranded cable 1702 construction. The surface of the stranded cable 1702 may be rougher than that of a monofilament wire or cable due to the greater number of ridges around the circumference. This increased roughness may allow the stranded cable 1702 to make more aggressive contact with the walls of a vessel within a treatment site 50. Additionally, the strands of the stranded cable 1702 may be loosened or tightened, allowing the operator to "dial" the radius desired for a treatment. For example, a looser stranded cable 1702 would have a larger radius, and thus the overall diameter of the wire 30 would increase. Conversely, a tighter stranded cable 1702 would have a smaller radius, thereby decreasing the diameter of the entire cable 30.

[0111] Fig. Figure 18 illustrates a side view of an exemplary wire 30 having a helical hollow strand construction 1802. Similar to the stranded cable 1702 in Fig. 17, the helical hollow strand 1802 may be rougher than a monofilament wire or cable due to the increased number of ridges around its circumference. Again, this increased roughness may allow the helical hollow strand 1802 to make more aggressive contact with the walls of a vessel within a 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.

[0112] Additionally or alternatively, although in Fig. 18, a pull cord could be threaded through the hollow portion of the helical hollow strand 1802 and pulled, causing the helical hollow strand 1802 to form a differently shaped profile, such as a sinusoidal profile. In addition to allowing the helical hollow strand 1802 to be delivered to a treatment site 50 with a lower profile (perhaps even completely straightened), such a pull cord may allow for the peak-to-peak spacing or peak amplitude of a sinusoidal profile helical hollow strand 1802 to be adjusted. This may prove useful in situations where the peak size or peak-to-peak spacing can be optimized for a particular treatment segment 55.

[0113] Furthermore, a drug delivered through the hollow portion of the helical hollow strand 1802 need not necessarily be delivered to the distalmost end of the helical hollow strand 1802. Instead, the drug may be delivered as an enema agent through the individual coils.

[0114] Finally, even if this is Fig. 18, a second helical hollow strand 1802 may be wound around the first helical hollow strand 1802, with the turns either continuing in the same direction or opposing each other. In such an example, an oscillating motion may be created by the helical hollow strands 1802 without having to open the coils.

[0115] Fig. 19 illustrates a side view of an exemplary wire 30 having a spring-like structure 1902. In extended form, the spring-like structure 1902 may appear as a three-dimensional sinusoid or spiral. However, the spring-like structure 1902 is not limited to Fig. 19, and the spring-like structure 1902 can form a sinusoidal profile. The advantages are similar to the stranded cable 1702 in Fig. 17 and the spiral hollow strand 1802 in Fig. 18 in that the spring-like structure 1902 has additional ridges around the circumference 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 more aggressive contact with the vessel wall in the treatment segment 55.

[0116] Fig. Figure 20 illustrates a side view of an exemplary wire 30 having a cage-like construction 2002. The cage-like construction 2002 includes several individual components, such as strands, that are spirally wound around each other, similar to the stranded cable 1702 in Fig. 17 and the spiral hollow strand 1802 in Fig. 18. However, in the cage-like construction 2002, the individual strands may include gaps or spaces. The individual strands of the cage-like construction 2002 may allow the wire 30 to contact the wall of a vessel in a treatment segment 55 multiple times per revolution, thereby increasing the abrasive properties of the wire 30. The cage-like construction used in Fig. 20 is not shown, could also be modified in the shape of its profile, e.g., by a sinusoidal profile, if desired. The cage-like construction 2002 is used as a concept both as a proximal feature 2602 in Fig. 26C as well as distal feature 2702 in Fig. 27B taken up again.

[0117] Fig. Figure 21 illustrates a side view of an exemplary wire 30 terminating at a point not along the central axis 1208, similar to that in Fig. 14. Similar to Fig. 14 the wire 30 can be Fig. 21 may include a weighted tip 1210, and due to the off-axis endpoint of this weighted tip 1210, an effect opposite to a gyroscopic effect is caused. The weighted tip 1210 may cause the wire 30 to rotate more erratically, causing the peaks of the sinusoidal wire 30, as well as the weighted tip 1210, to contact the vessel walls more aggressively. In some examples, no weighted tip 1210 is included, but the wire 30 still ends off-axis from the central axis 1208.

[0118] In contrast to the example of Fig. 14 sets the wire 30 of Fig. 21 continues the path of the sinusoidal profile of the wire 30. Advantages in this example may include a less irregular course of the distal tip of the wire 30 than in the example of Fig. 14. In addition, fewer bends of the wire 30 are required to make the example in Fig. 21, which can reduce manufacturing costs. The weighted tip 1210 is shown ending at a point that coincides with one of the peaks of the sinusoidal profile of the wire 30. This is not strictly necessary, and the endpoint of the weighted tip 1210 can be positioned anywhere desired by the user (although an endpoint along the central axis 1208 may cause the gyroscopic effect to reappear).

[0119] Fig. 22A, Fig. 22B and Fig. 22C illustrate several side views of exemplary wires with non-uniform amplitude 30. Fig. Figure 22A shows an exemplary wire 30 having a first peak and a fourth peak whose amplitude is greater than that of the second and third peaks. Fig. Figure 22B illustrates an exemplary wire 30 having three peaks on one side of the central axis 1208 (not shown in this figure). Fig. Figure 22C shows an exemplary wire 30 having a first peak and a fourth peak whose amplitude is smaller than that of the second and third peaks. Fig. 22A, Fig. 22B and Fig. 22C are only examples and not exhaustive - any formation of the wire 30 of uneven amplitudes can be used as desired.

[0120] It is to be understood that any of the Fig. 22A, Fig. 22B and Fig. 22C in combination with any of the several examples of wires 30 as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, or with any filler wire not specifically illustrated herein.

[0121] The advantages of such wires with uneven amplitude include drug distribution effects and abrasion effects on treatment segments. For example, wire 30 can be Fig. 22A may cause a spray effect of a drug due to the lower amplitude peaks in the middle section. In contrast, the exemplary wire 30 in Fig. 22C may cause the spray effect to be distant from the central section due to the higher amplitude peaks there. In addition, the one-sided peaks, as seen in Fig. 22B, cause a different pattern of abrasion because the damage occurs all at once along one side of the vessel rather than being distributed circumferentially.

[0122] Fig. Figure 23A illustrates an exemplary wire 30 having a sinusoidal profile in two dimensions. This is one possible profile shape for a wire 30 that includes peaks for scraping a treatment segment 55 rather than just a point around a treatment site 50. Fig. 23B illustrates a front view of the exemplary wire 30 of Fig. 23A. As it is in Fig. As can be seen in Figure 23B, a sinusoidal profile wire 30, which exists in two dimensions, has a sinusoidal crossing profile 2302 that resembles a rectangle. When rotated, the sinusoidal crossing profile 2302 is approximately the shape that would abrade the walls of the vessel within the treatment segment 55.

[0123] While the shape of the exemplary wires 30 has been shown as several interpretations of a sinusoidal profile, other shaped profiles may be realized by the present disclosure. In addition, the projecting wires 30 have been shown as lying in a two-dimensional plane. Fig. 24A and Fig. 25A, any of the above disclosures and FIG. (ie Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22 and Fig. 23A) may also exist in a three-dimensional plane, such as a spiral (or spring shape) or variations where the peaks alternately rotate around the central axis 1208.

[0124] Fig. 24A illustrates such a three-dimensional exemplary wire 30. The wire 30 of Fig. 24A resembles the spring-like construction 1902 by Fig. 19, but in Fig. 24A, the wire 30 does not have an additional sinusoidal profile in two dimensions. Rather, the wire 30 is a sinusoidal shape that exists in three dimensions, thus forming a helical or spring-like shape. Fig. Figure 24B illustrates a front view of the exemplary wire of Fig. 24A. As it is in Fig. As shown in Figure 24B, a helical wire 30 has a spring-like crossing profile 2402 that resembles a circle. When twisted, the spring-like crossing profile 2402 is approximately the shape that would abrade the walls of the vessel within the treatment segment 55.

[0125] Fig. Figure 25A illustrates an exemplary wire 30 in which a sinusoidal profile is maneuvered in three-dimensional space after the occurrence of each peak. The possibilities of such a configuration are almost endless, so Fig. 25A represents only one such exemplary configuration for the purposes of discussion.

[0126] In Fig. 25A rotates the sinusoidal shape clockwise by approximately ninety degrees each time the wire encounters a peak along a sinusoid and returns to the central axis 1208 (not shown). Again, this angle is only an example, and any angle may be chosen. In addition, the decision for a clockwise rotation when moving from proximal to distal along the wire 30 is also only an example. A counterclockwise rotation or a combination of right and left rotation may also be implemented. Since Fig. 25A includes four peaks, a complete rotation in three-dimensional space has occurred upon reaching the fourth peak. Again, the decision to use four peaks in this example is not a restriction, and any number of peaks along the wire can be included. A complete rotation in three-dimensional space is also not strictly required.

[0127] Fig. 25B illustrates a front view of the exemplary wire of Fig. 25A. Since in the exemplary wire 30 of Fig. 25A included four peaks and the rotation after each peak was approximately ninety degrees, the three-dimensional crossing profile 2502 appears as a cross or plus sign. In this example, the three-dimensional crossing profile 2502 approximately corresponds to the shape that would abrade the walls of the vessel within the treatment segment 55 when the wire 30 is rotated. The shape of this three-dimensional crossing profile 2502 can be influenced by the number of revolutions and the degree of rotation of the wire 30 after the occurrence of each peak.

[0128] Finally, the location at which the rotation takes place is not essential. For example, the wire 30 can be rotated in three-dimensional space at each peak instead of at the base of each peak, as in Fig. 25A and Fig. 25B. The rotation can also occur at any point between the peak and the base of the peak. Additionally, any combination of these rotation points can be used, e.g., the first rotation occurs at the base after the first peak appears, and the next rotation occurs at the second peak.

[0129] Fig. 26A, Fig. 26B, Fig. 26C, Fig. 26D, Fig. 26E, Fig. 26F, Fig. 26G and Fig. 26H illustrate side views of exemplary proximal features 2602 for the wire 30. In the cases of Fig. 26A, Fig. 26B, Fig. 26C, Fig. 26D, Fig. 26E, Fig. 26F and Fig.26G, the proximal features 2602 may be capable of at least partially occluding the vessel proximal to the treatment area. This occlusion or interruption of blood flow may help prevent blood from entering the treatment area. While blood entering the treatment site 50 is not detrimental to the procedure, there is a risk that too much blood may dilute the drug or sclerosant, thereby reducing its effectiveness and the overall effectiveness of the treatment. This occlusion or interruption of blood flow may also help stop or slow blood flow, allowing the sclerosant to remain at the treatment site 50 longer, increasing the effectiveness of the sclerosant. This occlusion may further help prevent the drug from leaving the treatment site 50 in a proximal direction.

[0130] It is to be understood that each of the proximal features 2602 as shown in Fig. 26A, Fig. 26B, Fig. 26C, Fig. 26D, Fig. 26E, Fig. 26F, Fig. 26G and Fig. 26H, in combination with any of the various exemplary wires 30, as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, and may be used with any filler wire not specifically illustrated herein.

[0131] In relation to Fig. 26A, a balloon 2604 may be proximal to the exposed portion of the wire 30 and resting on the sheath 40. After the wire 30 is extended from the sheath 40, the balloon 2604 may be inflated via an inflation lumen, possibly a working lumen in the sheath 40, to occlude the vessel. In some examples, the balloon 2604 may include an oozing balloon, and a drug, such as a sclerosant, may be delivered through the micropores of the oozing balloon.

[0132] Fig. 26B resembles Fig. 26A in that an offset balloon 2606 may lie on the sheath 40 proximal to the exposed portion of the wire 30. After the wire 30 is extended from the sheath 40, the offset balloon 2606 may be inflated via an inflation lumen, possibly a working lumen in the sheath 40, to occlude the vessel. Similarly, the offset balloon 2606 may include an oozing balloon through whose micropores a drug, e.g., a sclerosing agent, may be delivered. Unlike the balloon 2604 of Fig. 26A, the offset balloon 2606 can be Fig. 26B, however, may be biased toward one side of the sheath 40. In such examples, the offset balloon 2606 may relieve pressure on the wire 30 when inflated, allowing the wire 30 to make more aggressive contact with the vessel wall.

[0133] Fig. 26C and Fig. 26D show hollow and solid variants of a spiral closure element. Fig. 26C shows a cage 2608 that, when released from the sheath 40, expands to approximately the same diameter as the vessel. In this example, the cage 2608 is made of a material, such as nitinol, that allows for expansion and contraction of the cage 2608. The cage 2608, as it rotates, can act as a three-dimensional impeller that at least partially obstructs the entry of blood into the treatment site 50 and / or the exit of a drug from the treatment site 50. In some examples, the cage 2608 is made of a material that does not allow for compression and, as such, is sized to fit within the sheath 40.

[0134] Fig. Figure 26D illustrates a grooved solid 2610 formed in a similar manner to the cage in Fig. 26C. However, the grooved solid 2610 may be of a smaller diameter than the cage 2608 because it cannot be compressed as far and must still fit within the sheath 40 even in its unlocked state. The rigid nature of the grooved solid 2610 prevents blood from penetrating through the grooved solid 2610 into the treatment site 50, as well as any possible leaching of a drug from the treatment site 50, and the grooves in the grooved solid 2610 exert a driving effect to prevent at least some blood from passing around the grooved solid 2610 and into the treatment site 50.

[0135] Fig. 26E shows an impeller 2612 having three blades. The number of blades is not important; as many blades as desired can be used. The impeller 2612 can be made of a material, such as nitinol, that allows for expansion and contraction of the impeller 2612. In this example, the impeller 2612 can be sized larger than the diameter of the sheath 40. The impeller 2612 can then expand to approximately the same diameter as the vessel when released from the sheath 40. In other examples, the impeller 2612 is made of a material that does not expand and contract greatly, and as such, the impeller 2612 would be sized to fit within the sheath 40 in its retracted state. As the wire 30 rotates, the impeller 2612 would also rotate, thus impeding blood flow to the treatment site 50.

[0136] Fig. 26F and Fig. 26G show a sponge-like solid 2614 as the proximal feature 2602. In Fig. 26F, the spongy solid 2614 is located on the wire 30. The spongy solid 2614 can be easily compressed within the sheath 40 when in its retracted configuration and can expand to occlude the vessel proximal to the treatment site 50 when released from the sheath 40.

[0137] In a similar way, Fig. 26G, the spongy solid 2614 is like the proximal feature 2602, but in this case, the spongy solid 2614 is located on the sheath 40. The spongy solid 2614 is easily compressed within the patient's vasculature and, after delivery, can expand to occlude the vessel proximal to the treatment site 50. In both Fig. 26F as well as Fig. 26G, the spongy solid 2614 can prevent blood from entering the treatment site 50 during treatment and / or a drug, such as a sclerosant, from leaving the treatment site 50 during treatment.

[0138] Fig. Figure 26H illustrates a sinusoidal pressure 2616 in the wire 30 proximal to the distal wire end 1204 within the sheath 40. This sinusoidal pressure 2616 may still be present in the sheath 40 even when the sheath 40 is fully retracted onto the wire 30. The sinusoidal pressure 2616 is not intended to occlude blood flow, but may relieve the wire 30 to cause the wire 30 to make more aggressive contact with the vessel wall.

[0139] Fig. 27A, Fig. 27B, Fig. 27C, Fig. 27D and Fig. 27E illustrate side views of several possible distal features 2702 for a wire. In all cases, the distal features 2702 at least partially occlude the vessel distal to the treatment area. This occlusion or flow disruption can help prevent a drug, such as a sclerosant, from penetrating too far into a vessel, for example, into an intersection with another, larger vessel that is not to be treated. This occlusion or flow disruption of blood flow can also prevent blood from entering the treatment site 50 from the distal side, potentially diluting the delivered drug.

[0140] It is to be understood that any of the distal features 2702 as shown in Fig. 27A, Fig. 27B, Fig. 27C, Fig. 27D and Fig. 27E can be used in combination with any of the various exemplary wires 30 as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0141] In relation to Fig. 27A, a single-bladed impeller 2704 may be distal from the wire 30. When the wire 30 is exposed from the sheath 40, the single-bladed impeller 2704 may expand to be approximately equal in length to the radius of the vessel. In these examples, the single-bladed impeller 2704 is made of a material, such as nitinol, that allows for this expansion and contraction of the single-bladed impeller 2704.

[0142] In other examples, the single-bladed impeller 2704 may be sized to fit within the sheath 40 in its fully expanded configuration and is made of a material that is stiffer and does not allow as much expansion or contraction. As the wire 30 rotates, the single-bladed impeller 2704 also rotates and impedes the progression of a drug, e.g., a sclerosant, from the treatment site 50. Because the single-bladed impeller 2704 cannot be symmetrical on the wire 30 (since symmetry around a circle with only one component is not possible), the single-bladed impeller 2704 cannot be used with a gyroscopic effect. Similar to the off-axis terminated wire 30 in Fig. 14 and Fig. 21, the single-blade impeller 2704 can cause the wire 30 to move eccentrically, resulting in more aggressive contact with the vessel walls.

[0143] Fig. 27B and Fig. 27C illustrate hollow and solid variants of a spiral occlusion element at the distal wire end 1204. Fig. 27B shows a cage 2706 that, when released from the sheath 40, expands to approximately the same diameter as the vessel. In this example, the cage 2706 is made of a material, such as nitinol, that allows for expansion and contraction of the cage 2706. The cage 2706, as it rotates, can act as a three-dimensional impeller, at least partially impeding the progression of a drug, such as a sclerosant, from the treatment site 50 while preventing the inadvertent inflow of blood into the treatment site 50. In some examples, the cage 2706 is made of a material that does not allow for compression and, as such, is sized to fit within the sheath 40.

[0144] Fig. Figure 27C illustrates a grooved solid 2708 formed in a similar manner to the cage 2706 in Fig. 27B. However, the grooved solid 2708 is of a smaller diameter than the cage 1006 because it cannot be compressed as far and must still fit within the shell 40 even in its non-released state. The solid nature of the grooved solid 2708 prevents a delivered drug, such as a sclerosant, from leaving the treatment site 50 through the grooved solid 2708, and the grooves in the grooved solid 2708 exert a driving action to prevent at least a portion of the drug from leaking around the grooved solid 2708 and out of the treatment site 50. Similar to Fig. 27B, the grooved solid 2708 can also prevent inadvertent penetration of blood into the treatment site 50 from the distal side.

[0145] Fig. 27D shows an impeller 2710 having three blades. The number of blades is not important; as many blades as desired can be used. The impeller 2710 can be made of a material, such as nitinol, that allows for expansion and contraction of the impeller 2710. In this example, the impeller 2710 can be sized larger than the diameter of the sheath 40. The impeller 2710 can then expand to approximately the same diameter as the vessel when released from the sheath 40. In other examples, the impeller 2710 is made of a material that does not expand and contract very much, and as such, the impeller 2710 would be sized to fit within the sheath 40 in its retracted state. As the wire 30 rotates, the impeller 2710 would also rotate, allowing progression of a drug, e.g., a drug. B. a sclerosing agent, from the treatment site 50.This inhibitory effect may also extend to preventing an unintentional inflow of blood into the treatment site 50.

[0146] Fig. 27E shows a spongy solid 2712. The spongy solid 2712 can be slightly compressed within the sheath 40 when in its retracted configuration and can expand to occlude the vessel distal to the treatment site 50 when released from the sheath 40. Unlike the proximal feature 2602 of the spongy solid 2614, the distal feature 2702 of the spongy solid 2712 cannot lie on the sheath 40 because the spongy solid 2712 can no longer lie at the distal end of the treatment site 50 once the sheath 40 is retracted onto the wire 30 to expose the wire 30.

[0147] Fig. 28A, Fig. 28B and Fig. 28C illustrate side views of exemplary wires 30, including additional features at the distalmost tip of the wire 30. While many of the previous figures included a weighted tip 1210 at the distalmost tip of the wire 30, the weighted tip 1210 is not necessary (as in Fig. 12A, where the tip included an opening 1206). Fig. 28A, Fig. 28B and Fig. 28C provide further examples of distalmost tips of the wire 30 that are not necessarily intended to keep the wire gyroscopically stable during rotation.

[0148] It is to be understood that any of the additional features at the distalmost tip of the wire 30, as shown in Fig. 28A, Fig. 28B and Fig. 28C, in combination with any of the various exemplary wires 30 as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any filler wire not specifically illustrated herein.

[0149] Fig. Figure 28A illustrates a hemispherical tip 2802 at the distalmost tip of wire 30. This hemispherical tip 2802 can be weighted or unweighted. In either case, due to its lack of three-dimensional symmetry, the hemispherical tip 2802 can unbalance the distalmost tip of wire 30, counteracting gyroscopic stability. This effect can cause the hemispherical tip 2802 to contact, perhaps even aggressively, the vessel wall, creating an additional abrasion point in the treatment segment 55 in which the wire 30 is located.

[0150] Fig. 28B illustrates an offset weighted tip 2804 at the distalmost tip of the wire 30. The offset weighted tip 2804 does not necessarily have to be weighted, but the weight can increase the effect that this distalmost tip has on the wire 30. Similar to the hemispherical tip 2802 of Fig. 28A, this offset weighted tip 2804 may have an adverse effect on gyroscopic stability by unbalancing the wire due to its newly acquired lack of symmetry about the central axis 1208 (not shown in this figure). This effect may cause the offset weighted tip 2804 to contact the vessel wall (again, possibly in aggressive contact) by adding an additional abrasion point to the treatment segment 55 in which the wire 30 is located.

[0151] Fig. 28C illustrates a balloon tip 2806 at the distalmost tip of the wire 30. This balloon tip 2806 can be delivered to a treatment site 50 in an unexpanded (or uninflated) configuration and then inflated to expand and occlude the vessel distal to the treatment site 50. In such examples, the wire 30 is likely to include a lumen or be a hypotube to deliver inflation fluid to the balloon tip 2806 to enable inflation of the balloon tip 2806 to its expanded configuration.

[0152] Fig. 29A illustrates an exemplary side view of a wire 30 including a filler wire 2902. The filler wire 2902 may have additional geometry along various portions of the wire 30, creating a rougher surface and "catch points" to enable greater abrasion of the vessel wall. While the filler wire 2902 is wrapped around most of the wire 30, the filler wire 2902 may also be wrapped around only small portions of the wire, such as near the peaks, to reduce material consumption (and potentially material costs).

[0153] Although it is in Fig. 29A, in some examples, the supplemental wire 2902 may be a hypotube that extends back to the controller 20 so that the supplemental wire 2902 may be used as a fluid lumen for delivering a drug, such as a sclerosant, to the treatment site 50. In these examples, apertures may be present along the length of the supplemental wire 2902 at the location where it would be located in a treatment segment 55 or at the distalmost end of the supplemental wire 2902 for distal injection of the drug.

[0154] It is to be understood that the filler wire 2902, as described in Fig. 29A, may be used in combination with any of the various exemplary wires 30 as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0155] Fig. Figure 29B illustrates a side view of an exemplary wire 30 incorporating additional geometry similar to that of filler wire 2902 in Fig. 29A is quite similar. In contrast to the additional wire 2902 of Fig. 29A, however, this additional geometry is a heated wire 2904. The heated wire 2904 may be capable of conducting heat into the treatment segment 55, thereby increasing the temperature in that treatment segment 55. By heating that treatment segment 55, the drug injected therein may be better distributed.

[0156] It is to be understood that the heated wire 2904 as shown in Fig. 29B, may be used in combination with any of the various exemplary wires 30 previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0157] The heated wire 2904 may also be a filler wire made of a shape memory material, such as Nitinol, and the heat portion of the "heated wire" may be provided by the patient's body into which the wire 30 is inserted. In these cases, the austenite transformation end temperature (A(f) temperature) of the shape memory material may be adjusted to return from the martensite state to the austenite state at these body-provided temperatures. In such examples, the wire 30 may be fed to a treatment segment 55 in a reasonably straight state, and the heated wire 2904 begins to heat up during this feeding. After the wire 30 is fed into the treatment segment 55 and released from the sheath 40, the heated wire 2904 can reach its A(f) temperature, so that it returns to its austenite shape and forces the wire 30 into the desired profile for scraping the vessel wall.

[0158] Fig. 29C illustrates a wire 30 including a porous surface geometry 2906, according to some examples. This porous surface geometry 2906 may impart a surface roughness to the wire, as shown in Fig. 13A and Fig. 15. The porous surface geometry 2906 may prevent smooth surface portions of the wire 30 from contacting the vessel walls in a treatment segment 55. Instead, the porous surface geometry 2906 may cause sharper edges and uneven surfaces to contact the vessel walls, thereby more aggressively abrading the vessel walls.

[0159] It is understood that the porous surface geometry 2906 as shown in Fig. 29C, may be used in combination with any of the various exemplary wires 30 previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0160] Fig. 30A, Fig. 30B, Fig. 30C and Fig. 30D illustrate several examples of wires, including additional geometry. For example, the additional geometry 3002a of Fig. 30A consist of rounded studs, either in two or three dimensions. The additional geometry 3002b of Fig. 30B may be at least a spherical object, either in two or three dimensions. In some examples, the additional geometry 3002c is as shown in Fig. 30C, a spike - again either in two or three dimensions. The additional geometry 3002d in Fig. 30D can be a brush or a brush-like object.

[0161] 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 facilitate abrasion of the vessel wall along a treatment segment 55. While the additional geometries 3002a, 3002b, 3002c, and / or 3002d may additionally only be used at the peaks of the sinusoidal shape of the Fig. 30A, Fig. 30B, Fig. 30C and Fig. 30D, these additional geometries 3002a, 3002b, 3002c and / or 3002d may be included at any location on the wire 30, including the entire housing of the wire 30, as desired by the user.

[0162] It is to be understood that any of the additional geometries 3002a, 3002b, 3002c and / or 3002d as shown in Fig. 30A, Fig. 30B, Fig. 30C and Fig. 30D can be used in combination with any of the various exemplary wires 30 as previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0163] Fig. 31 illustrates an exemplary Luer hub 3102, including a Luer 3104. This Luer hub 3102 may be the mechanism by which the syringe 60 is releasably connected to the T-piece 706, 804 and / or 904 ( Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C) or the trailer 704 Fig. 7 (or the one not shown, but in Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C described saddles).

[0164] Fig. Figure 32 illustrates a top view of an exemplary catheter 15, including a sheath 40 and a wire 30. Several marker devices are shown on the body of the sheath 40. Each of these marker devices may partially or completely surround the body of the sheath 40.

[0165] In Fig. 32 includes a ring 3202 located on the sheath 40. Although shown and described as ring 3202, any type of slidable depth marker may be used and perform the same functions as ring 3202. Ring 3202 may be slidably coupled to the sheath 40 so that a user can move the ring 3202 to a desired location along the sheath 40. For example, ring 3202 may be placed on the sheath 40 at a distance from the distal end of the sheath 40 such that the distance corresponds to the distance to a patient's deep venous system. This could indicate to an operator that once the ring 3202 reaches the patient's insertion site, further insertion of the catheter 15 could cause it to penetrate the patient's deep venous system or other vessels not intended for treatment.

[0166] Additionally or alternatively, the ring 3202 may be sized so that it cannot penetrate the patient's insertion site. As described in the previous section, this may prevent the catheter 15 from entering the patient's deep venous system. This may also prove useful during a procedure, such as segmental mechanical or mechanochemical ablation as described herein. For example, once an operator has reached a treatment segment 55 and begun rotating the wire 30, such as by energizing a motor, the operator may slide the ring 3202 along the sheath 40 to the insertion point and then release the catheter 15.

[0167] The ring 3202 can hold the catheter 15 in position relative to the insertion site, allowing the operator to use both hands freely. In some examples, rotation of the wire 30 attempts to pull the catheter 15 further into the patient's body due to the forward propulsion provided by the rotational motion. In such examples, the ring 3202 is sized so that when the ring 3202 is coupled to the sheath 40, the ring 3202 maintains its position relative to the sheath 40 due to frictional forces between the ring 3202 and the sheath 40. However, the ring 3202 is still configured to be translated relative to the sheath 40 under the influence of external forces, such as manual manipulation by an operator, that overcomes any frictional forces between the ring 3202 and the sheath 40.

[0168] Because the ring 3202 may be sized so that it cannot penetrate the insertion site in a patient's housing, the ring 3202 may thereby prevent the sheath 40 from further penetrating the patient's vasculature. In other examples, a catheter clamp may be included for a similar purpose.

[0169] Also in Fig. 32 shows a plurality of distance markers 3204 along the sheath 40. Using the distance markers 3204, an operator can determine how far the catheter 15 is within the patient. This is particularly useful in cases involving withdrawal of the catheter 15. For example, in segmental mechanical or mechanochemical ablation, the operator may treat a treatment segment 55 and then begin withdrawing the catheter 15 from the patient until reaching a subsequent treatment segment 55. In this scenario, once the first treatment segment 55 is reached and aligned with a distance marker 3204, after treating the treatment segment 55, the operator may withdraw the catheter 15 until a subsequent distance marker 3204 is reached, indicating that a subsequent treatment segment 55 has also been reached.

[0170] For this reason, it may be advantageous to include distance markers 3204 that are approximately the same length as the treatment segment 55. As previously described in this disclosure, the treatment segment 55 may be the same length as the distal wire end 1204. Thus, the distance markers 3204 may also be the same length as the distal wire end 1204. However, neither length of the distance markers is mandatory, and the user may vary the spacing as desired.

[0171] Finally, Fig. 32 also includes a warning track 3206 distal from the distance markers 3204. This warning track 3206 may consist of a series of closely spaced markers, but other markers or indicators may also be used. In practice, the warning track 3206 may indicate to an operator that the end of a practical treatment length has been reached, meaning that further withdrawal of the catheter 15 from the patient would result in ineffective treatment.

[0172] The length of the warning track 3206, the position of the warning track 3206, as well as the number of distance markers 3204 and the spacing between the distance markers 3204 are individually adjustable, and multiple catheters 15 can be used for specific purposes—for example, for longer or shorter treatment times. Likewise, the length of the distal wire end 1204 can be individually adjusted to increase or decrease the length of the treatment segment 55.

[0173] It is to be understood that the ring 3202, the distance markings 3204 and the warning track 3206 as shown in Fig. 32 may be used together, separately, or in any combination. It is additionally understood that the ring 3202, the distance markings 3204, and the warning track 3206, as shown in Fig. 32 can be used in combination with any of the various exemplary wires 30 previously described in Fig. 12A, Fig. 12B, Fig. 12C, Fig. 14, Fig. 15, Fig. 16, Fig. 17, Fig. 18, Fig. 19, Fig. 20, Fig. 21, Fig. 22A, Fig. 22B, Fig. 22C, Fig. 23A, Fig. 24A and Fig. 25A, as well as with any additional wire not specifically illustrated herein.

[0174] Fig. 33 illustrates an exemplary block diagram for operating a controller 20, possibly one of the Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and / or 9C. As seen in this block diagram, a power supply 3302 may be wired to receive input from an actuator 3304. As previously described, the power supply 3302 may be a self-contained power supply, such as a battery or a wired power supply. Likewise, the actuator 3304 may be a button, switch, or other device capable of receiving user input to operate the controller 20.

[0175] The actuator is wired to a limit switch 3306, which in turn is wired to a motor 3308 and an LED 3310 (separated by a resistor 3312 to maintain the correct current). The limit switch 3306 either allows current to flow to the motor 3308 and the LED 3310 or prevents current from flowing to the motor 3308 and the LED 3310.

[0176] For example, considering an ablation system 10 that includes a controller 20 having a sheath 40 and a wire 30 extending through a working lumen of the sheath 40, if the controller 20 is capable of moving the sheath such that retraction of the sheath 40 exposes the wire 30 and expansion of the sheath 40 encloses the wire 30, it may be desirable to prevent rotation of the wire until the wire 30 is completely exposed from the sheath 40.

[0177] In such an example, the limit switch 3306 may be provided to energize the motor 3308 and the LED 3310 only when the sheath 40 is fully retracted. Likewise, the limit switch 3306 may prevent the motor 3308 and the LED 3310 from being energized if the sheath 40 is extended from its fully retracted state at all.

[0178] This is just one example of how a limit switch 3306 may be implemented in the circuitry of a 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. As shown in Fig. 9A and Fig. 9C, the LED 3310 may also be present to indicate to the operator that the motor is on or that the motor is ready to be turned on (i.e., in the example above, that the sheath 40 is fully retracted). The LED 3310 may also be used for other purposes, such as as a timer or treatment completion indicator during segmental mechanical or mechanochemical ablation, via this limit switch.

[0179] It is to be understood that the totality of the Fig. 33, as well as other exemplary wiring configurations for a circuit in combination with one of the various examples for the controller 20, as previously described in Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, as well as any additional control not specifically illustrated herein.

[0180] Fig. 34 illustrates a flowchart depicting an exemplary method for treating venous disease with an ablation system. In some examples, the method includes use of a sclerotherapy device (at step 3400). The sclerotherapy device is understood to be any ablation device 10 and / or combination of controller 20 and catheter 15 (or sheath 40 and wire 30). As used herein, a sclerotherapy device need not necessarily be capable of delivering sclerosing agent, and a system capable of effecting mechanical or mechanochemical ablation of a vessel is considered synonymous with this use of the term "sclerotherapy device."

[0181] According to some examples, the method includes determining a first treatment site 50 in the patient's vasculature (at step 3402). As previously discussed, the treatment site 50 (or first treatment site 50) may be a length along a vessel, also referred to as a treatment segment 55 (or first treatment segment 55 as in this specific example).

[0182] The method may include treating the first treatment site 50 by inserting the wire 30 into the blood vessel and allowing it to expand (step 3404). As previously described, for treating each treatment site 50, the distal end of the wire 30 may correspond to the length of the segment to be treated (the treatment segment 55) so that the wire 30 can treat (or abrade) each treatment segment 55 at once.

[0183] In some examples, the method includes repositioning the sheath to a second treatment location 50 (at step 3406). In the examples described above, the second treatment location 50 may also be a length along a vessel, also referred to as a treatment segment 55 (or second treatment segment 55).

[0184] According to some examples, the method includes treating the second treatment site 50 (in step 3408). As also described above, the distal end of the wire 30 for treating each treatment site 50 may correspond to the length of the segment to be treated, such that the wire 30 can treat (or scrape) the entire second treatment segment 55 at once. The use of the terms "first" and "second" is merely an example; there may be more treatment steps or stages. In these examples, each next step could be considered to be performed at a subsequent treatment site 50 or a subsequent treatment segment 55.

[0185] The method may include imaging the treatment 50 with ultrasound (at step 3410). This is merely a method for placing the catheter 15 within the patient while advancing the catheter to a treatment site 50 or at least partially retracting the catheter 15 to place the catheter 15 at a subsequent treatment site 50.

[0186] In some examples, the method includes providing sclerosant through a sheath 40 to at least one of the first treatment site 50 and the second treatment site 50 (in step 3412). The sclerosant may be any drug that can be delivered through means other than the sheath 40, e.g., through a lumen of the catheter 15 and / or a lumen of the wire 30. When delivered through the sheath 40, the drug may pass through a working lumen within the sheath 40.

[0187] Additionally, according to some examples, the drug is not delivered while the catheter 15 (sheath 40) is removed from the first treatment site 50 and moved to the second treatment site 50, thus eliminating the need for the operator to inject the drug at a specific rate while simultaneously withdrawing the catheter 15 at a specific rate. In this way, the method achieves segmental mechanical or mechanochemical ablation. The term "segmental mechanical or mechanochemical ablation" means segmental mechanical or segmental mechanochemical ablation.

[0188] Fig. 35 illustrates a flowchart depicting an exemplary method for controlling a catheter. In some examples, the method for controlling a catheter includes using a controller (in step 3500). This controller may include the Fig. 5A, Fig. 5B, Fig. 5C, Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C or a similar controller that includes a slidable portion for receiving a syringe. According to some examples, the method for controlling a catheter includes inserting a syringe into a T-piece along a second direction perpendicular to a first direction (at step 3502).

[0189] The first direction is in Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C as first direction 712, first direction 810, and first direction 916, respectively, but to reiterate, it is the direction of lateral movement of the trailer and the T-piece on the device body. In other words, the first direction is a direction of movement between the proximal and distal housing ends. In step 3502, the syringe is inserted into a T-piece in a direction perpendicular to the first direction. Since the invention exists in three-dimensional space, this second direction can be any direction circumferentially around the first direction. Additionally, as in Fig. 7, Fig. 8, Fig. 9A, Fig. 9B and Fig. 9C, a perfectly vertical insertion of the syringe is not required, and other directions and / or angles of insertion of the syringe into the T-piece can also be used.

[0190] The method for controlling a catheter may include guiding the catheter to a treatment site of a patient (at step 3504). In examples including a catheter coupled to the distal housing end, after inserting the syringe into the T-piece, the catheter may be guided to the treatment site to begin a procedure.

[0191] Fig. 36 illustrates a flowchart depicting a method for exposing a wire from a catheter, according to some examples. In some examples, the method for exposing a wire from a catheter includes translating a T-connector from a distal housing end to a proximal housing end (at step 3600). In examples involving a catheter, the catheter may be coupled to the device housing at the distal housing end. By translating the trailer and T-connector from the distal housing end to the proximal housing end, the catheter is effectively "retracted" along with the movement of the trailer and T-connector.

[0192] According to some examples, the method for exposing a wire from a catheter includes retracting a sheath on the wire (at step 3602). In examples involving a wire within the catheter housing, the catheter sheath surrounding the wire moves on the wire as the catheter is retracted in response to movement of the trailer and T-piece, as expressed at step 3600. The wire either does not move in response to movement of the trailer and T-piece, or it moves at a slower speed than the catheter.

[0193] The method of exposing a wire from a catheter may include exposing a distal wire end (in step 3604). Once the abutment and the T-piece have moved from the distal housing end to the proximal housing end, the wire can be exposed from the catheter sheath, which enables contact between the wire and the vessel walls. Thereby, the wire can be used during a procedure while it can be simultaneously brought to the treatment site without being exposed.

[0194] Fig. 37 illustrates a flowchart depicting an exemplary method for capturing a wire within a catheter. In some examples, the method for capturing a wire with a catheter includes translating a T-connector from a proximal housing end to a distal housing end (at step 3700). In examples involving a catheter, the catheter may be coupled to the device housing at the distal housing end. By translating the trailer and T-connector from the proximal housing end to the distal housing end, the catheter is effectively "pushed forward" along with the movement of the trailer and T-connector.

[0195] According to some examples, the method for encompassing a wire with a catheter includes expanding a sheath on the wire (at step 3702). In examples including a wire within the catheter housing, the catheter sheath surrounding the wire moves on the wire as the catheter is advanced in response to moving the trailer and T-piece, as expressed at step 3700. The wire either does not move in response to moving the trailer and T-piece, or it moves at a slower speed than the catheter.

[0196] The method of encasing a wire with a catheter may include encasing a distal wire end (at step 3704). Once the trailer and T-piece travel all the way from the proximal housing end to the distal housing end, the catheter sheath may completely cover the wire, effectively encasing or enclosing the distal wire end within the catheter sheath. Once a procedure is complete, this may facilitate the prevention of damage to non-treatment areas.

[0197] Fig. 38 illustrates a flowchart depicting a method for controlling a distal catheter end, according to some examples. In some examples, the method for controlling a distal catheter end includes rotating a syringe and a Luer (at step 3800). Rotating the syringe and the Luer may also apply rotational motion to a catheter coupled to the device housing.

[0198] According to some examples, the method for controlling a distal catheter end includes providing torque to a catheter (at step 3802). The rotational movement of the syringe and Luer can apply torque to the catheter either in the direction of rotation of the syringe and Luer or opposite to the direction of rotation of the syringe and Luer.

[0199] The method for controlling a distal catheter end may include controlling a direction of movement of the distal catheter end (in step 3804). In response to the applied torque, the distal catheter end 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 housing of the device, the distal catheter end may be steered to the left (where the length of the catheter from the proximal catheter end to the distal catheter end is a first direction, and the left direction is based on this first direction). Conversely, if the torque applied to the catheter is opposite to the rotational direction of the syringe and Luer, the distal catheter end may be steered to the right.The use of "left" and "right" is for example purposes only, and it is to be understood that the device can be configured to apply torque to the catheter to steer the distal end of the catheter in any direction desired by the operator.

[0200] Fig. 39 illustrates a flowchart depicting an exemplary method for controlling a motor. In some examples, the method for controlling a motor includes pressing a button (at step 3900). The button may be mechanically coupled to the device housing and electrically coupled to the motor, thereby allowing the motor to be controlled. According to some examples, the method for controlling a motor includes turning on the motor (at step 3902). Upon actuation of the button, the motor is supplied with power, allowing it to rotate.

[0201] The method for controlling a motor may include pressing the button (in step 3904). When an intervention is complete or the motor is no longer to rotate, the button may be pressed again. In some examples, the method for controlling a motor includes turning the motor off (in step 3906). If the button is pressed a further time, or if the motor is currently turned on, the button interrupts power to the motor, thus stopping rotation of the motor. Although in Fig. 39 the term “button” is used, any switchable mechanism or “actuator” as described and shown in the previous FIG. (see Fig. 5A, Fig. 5B, Fig. 5C, Fig. 6A, Fig. 6B, Fig. 9A, Fig. 9B and Fig. 9C), such as a switch, may be used to supply or disconnect power to the motor.

[0202] Fig. 40 illustrates a flowchart depicting a method for delivering fluid through a catheter, according to some examples. In some examples, the method for delivering fluid through a catheter includes depressing the plunger of a syringe (at step 4000). Depressing the syringe plunger expels the fluid in the syringe from the opening in the tip of the syringe.

[0203] According to some examples, the method for providing a fluid through a catheter includes releasing a fluid through the catheter (at step 4002). In examples where a catheter is in fluid communication with the syringe, the fluid expelled from the syringe at step 4000 is injected into the catheter housing, possibly through a fluid lumen. In this way, the fluid can travel along the length of the catheter to a treatment site.

[0204] Fig. 41 illustrates a flowchart depicting a method of segmental mechanical ablation, according to some examples. In some examples, the method of segmental mechanical ablation includes inserting a catheter into a patient's vasculature (at step 4100). The catheter may then be delivered to a treatment site, also referred to as a treatment segment due to the length of the treatment, without requiring catheter movement. According to some examples, the method of segmental mechanical ablation includes moving the catheter to a first treatment segment (at step 4102). The first treatment segment may be the most distal location of the entire treatment length, allowing an operator to move the catheter through the entire treatment length by pulling the catheter out of the patient rather than pushing it further into the patient.However, it should be understood that both directions of movement are possible with this procedure, and the operator can choose how to perform such segmental ablation treatment.

[0205] The method of segmental mechanical ablation may include actuating a motor and rotating at least a portion of the catheter (in step 4104). The mechanical agitation (or abrasion or ablation) of the vessel wall may be accomplished by 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, thus completing treatment of a varicose vein, at least in that treatment segment. In other examples, the catheter performs a reciprocating motion rather than a rotating motion, "scraping" against the vessel walls to perform this damage. This reciprocating motion may be accomplished either by converting the rotary motion of the motor into linear motion of the catheter or by other means.

[0206] In some examples, the method of segmental mechanical ablation includes scraping the first treatment segment for a predetermined period of time (in step 4106). The predetermined period of time depends on the needs of the operator and the amount of time required for the vessel to be treated. The length of time may also depend on whether the procedure is a segmental mechanical ablation, as in the method of Fig. 41, or a segmental mechanochemical ablation, as described in Fig. 45. In the case of segmental mechanical ablation, the catheter can be left in the treatment segment (stationary along the length of the vein) for approximately five to thirty seconds. Again, these figures are only examples, and the operator can leave the catheter in the treatment segment for as long as desired.

[0207] According to some examples, the method of segmental mechanical ablation includes moving the catheter to a second treatment segment (at step 4108). This second treatment segment may be adjacent to or approximately adjacent to the first treatment segment, but this is not required. By having the second treatment segment near or adjacent to the first treatment segment, the operator can be assured that the entire vessel is treated.

[0208] The segmental mechanical ablation procedure may involve scraping the second treatment segment over the predetermined period 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 period of time may be the same as the predetermined period of time discussed in step 4106, or it may be a different predetermined period of time, depending on the operator's needs for a particular segment of a vein to be treated.

[0209] Fig. 42 illustrates a flowchart depicting a method for exposing and enclosing a wire in a sleeve, according to some examples. In some examples, the method for exposing and enclosing a wire in a sleeve includes indicating that the predetermined amount of time has elapsed (in step 4200). This indicating step is not strictly limited to methods for exposing and enclosing a wire in a sleeve and may be present in any of the other methods listed herein or may not be included in the present method if this indicating step is not desired. This indication may be provided by a component likely external to the housing, such as an LED, speaker, or display, perhaps on the controller. The indication may be audible or visual.

[0210] According to some examples, the method of exposing and enclosing a wire in a sheath includes retracting at least a portion of the sheath from the wire (in step 4202). The wire, which may extend through a working lumen of the sheath, may additionally be slidably disposed within the sheath. In some examples, the sheath may be retracted onto the wire.

[0211] The method of exposing and enclosing a wire in a sheath may include exposing the distal end of the wire (at step 4204). Once the sheath is retracted, a portion of the wire, in this example, the distal end of the wire, may be exposed from the sheath so that the distal end of the wire can contact the walls of a vessel during treatments such as segmental mechanical ablation.

[0212] In some examples, the method for exposing and enclosing a wire in a sheath includes extending the sheath onto the wire (in step 4206). By slidably moving the sheath opposite the direction of step 4202, an operator can fully or at least partially expand the sheath back around the wire to its original position. This may prove useful in cases where the operator desires a different length of the distal wire end to treat a particular vessel length.

[0213] According to some examples, the method for exposing and enclosing a wire in a sheath includes at least partially enclosing the distal end of the wire (in step 4208). By expanding the sheath, the operator can re-enclose the distal end of the wire, thus facilitating safe removal of the catheter from the patient. Because the sheath only extends partially around the wire, the distal end of the wire may also be only partially enclosed by the sheath. By expanding the sheath to its original position, the wire may be fully re-enclosed.

[0214] Fig. 43 illustrates a flowchart depicting a method for limiting current flow to a motor, according to some examples. The method for limiting current flow to a motor may include allowing current to flow from a power supply to a motor (in step 4300). In examples that include a limit switch, the limit switch may be the component through which current is either allowed or prohibited to flow. As shown in Fig. As described in more detail in Figure 47, the limit switch may be controlled by another property of the ablation system as a whole.

[0215] In some examples, the method for limiting current flow to a motor includes rotating the wire (in step 4302). As described in Fig. As shown in Figure 41, the rotation of the wire can cause ablation (or agitation or abrasion) of the vessel wall. The rotation of the motor can also be translated into the longitudinal movement of the wire, allowing for a scraping effect rather than rotational ablation.

[0216] According to some examples, the method for limiting current flow to a motor includes preventing current flow from the power supply to the motor (in step 4304). As described in step 4300, this may be achieved using a limit switch. The method for limiting current flow to a motor may include stopping rotation of the wire (in step 4306). Once no more current is allowed to flow to the motor, any effects of the motor on the movement of the wire may cease.

[0217] Fig. 44 illustrates a flowchart depicting a method for measuring distances in a segmental treatment, according to some examples. In some examples, the method for measuring distances in a segmental treatment includes maintaining a longitudinal position of the catheter relative to the first treatment segment (in step 4400). As shown in Fig. 41, the catheter can remain longitudinally within a vessel for a specified period of time. In some examples, a shape of the distal wire end allows for treatment of the entire segment at once, eliminating the need to move the catheter while treating such a segment. This frees up one less thing for the operator to keep an eye on and leaves a hand free to assist with other portions of the procedure.

[0218] According to some examples, the method for measuring distances in a segmental treatment includes moving the catheter out of the patient a distance approximately equal to the length between the first distance marker and the second distance marker (at step 4402). These distance markers may be located on the shaft of the catheter. As the catheter is withdrawn from the patient's housing, subsequent distance markers may become visible, indicating to the operator how far the catheter as a whole has been removed from the patient. In some examples, the distance markers are spaced at a distance approximately equal to the length of the treatment segment. In such examples, an operator withdrawing the catheter from the patient's housing could detect when the distal end of the catheter has been moved from one treatment segment to a subsequent treatment segment.This spacing of the distance markers also makes it unlikely that the operator will miss a section of the vessel being treated, as each treatment segment is treated individually and the distances between the segments are minimal, if any.

[0219] The method for measuring distances in a segmental treatment may include indicating that an end of a workable treatment length of the catheter has been reached (in step 4404). A warning track or the like on the catheter housing may provide additional information to the operator. The warning track may be visually distinct from the distance markers of the previous paragraph, allowing an operator to quickly recognize the difference between the conveyed information. Additionally, the warning track would likely be located on the catheter distal to the distance markers. In some examples, the purpose of the warning track is to indicate that the operator is leaving the treatment area, i.e., that they have reached the end of the treatment length of the catheter. This may indicate to the operator that treatment of the vessel is complete, at least at that moment.

[0220] Fig. 45 illustrates a flowchart depicting a method of segmental mechanochemical ablation, according to some examples. According to some examples, the method of segmental mechanochemical ablation includes injecting a drug into the first treatment segment (in step 4500). Similar to Fig. 41 This injection can occur over a predetermined period of time. The predetermined period of time can be the same as or different from the period of mechanical ablation. Additionally, the injection can occur before, after, or during the mechanical ablation portion of the treatment. For example, an operator can insert the catheter into the correct treatment site and then turn on the motor to scrape the vessel wall with a distal wire end for five seconds. After these five seconds have elapsed, the operator can begin depressing the syringe plunger to inject the drug into the treatment site. This can occur over a specific period of time so that a specific infusion rate is achieved. During this injection, the distal wire end can continue to rotate and scrape the vessel wall. This injection and the mechanical ablation can occur for approximately five seconds.After the injection is complete, the operator can allow the distal end of the wire to mechanically ablate the vessel wall for another ten seconds, allowing the drug to penetrate further into the damaged endothelium. It should be understood that the times listed here are only examples, and different times may be used for different treatments.

[0221] The method of segmental mechanochemical ablation may involve stopping injection of a drug before moving the catheter to the second treatment segment (at step 4502). With segmental mechanochemical ablation, the drug only needs to be injected while the catheter is in a treatment segment. This differs from previous mechanochemical ablation methods, in which the drug must be continuously delivered while the catheter is withdrawn through the patient's vasculature. Because the injection of a drug stops before moving the catheter from the first treatment segment to the second treatment segment, the operator does not need to focus their attention on simultaneously injecting a drug and moving the catheter.This helps avoid human error when trying to measure two different speeds - a retraction speed and an injection speed - at the same time.

[0222] In some examples, the method of segmental mechanochemical ablation includes injecting the drug into the second treatment segment (at step 4504). This injection may also occur over a predetermined period of time, as described in step 4500. However, the predetermined period of time for the injection into the second treatment segment need not be the same as the predetermined period of time for the injection into the first treatment segment.

[0223] According to some examples, the method of segmental mechanochemical ablation includes removing the catheter from the patient's vasculature (at step 4506). After completing a treatment, the operator may remove the device from the patient. The method of segmental mechanochemical ablation may include stopping injecting a drug before removing the catheter from the patient's vasculature (at step 4508). After a final treatment segment has been treated, the operator may stop injecting drug from the syringe through the catheter before removing the catheter from the patient.

[0224] Fig. 46 illustrates a flowchart depicting a method for tracking a catheter sheath separate from the wire, according to some examples. In some examples, the method for tracking a catheter sheath separated from a wire includes removably coupling a sheath to a housing of a controller (at step 4600). By removably coupling the sheath to the housing of the controller, the sheath can be handled longitudinally separately from the wire. According to some examples, the method for tracking a catheter sheath separated from the wire includes removing the sheath from the housing (at step 4602). Because the sheath is removably coupled to the housing of the controller in this example, the sheath can be detached or removed from the housing while leaving a wire in place (still coupled in some manner to the housing of the controller).

[0225] The method for tracking a catheter sheath separate from a wire may involve guiding the sheath to a treatment area of ​​a patient (at step 4604). By releasing the sheath from the controller housing while the wire remains in place, the sheath can be delivered to the treatment site ahead of the wire. In cases where the profile of the wire is such that it will even slightly interfere with the profile of the sheath while stored internally, it may be desirable to guide the sheath to the treatment site without changing its crossing profile. Once the sheath is in place, the wire can be guided through the sheath to also reach the treatment site.

[0226] Fig. 47 illustrates a flowchart depicting an additional method for limiting current flow to a motor, according to some examples. In some examples, the additional method for limiting current flow to a motor includes retracting a sheath on a wire (in step 4700). This limiting feature may be accomplished by a limit switch, as in the method of Fig. 43. In such examples, the limit switch may be operatively coupled to the sheath such that the limit switch permits current flow (from the power supply, through the limit switch, to the motor) only when the sheath is in a fully retracted position. In other examples, the limit switch permits current to flow from the power supply to the motor when the sheath is only partially retracted, thereby allowing variable treatment lengths of the exposed wire. In either case, because the limit switch prevents power from being supplied to the motor unless the sheath is partially retracted, the motor cannot be operated, either intentionally or inadvertently, unless the wire is exposed. This may facilitate safe introduction of the catheter into the treatment site without the risk of premature rotation of the wire.

[0227] According to some examples, the additional method for limiting current flow to a motor includes exposing a distal wire end (in step 4702). As already described in Fig. 42, after retraction of the sheath, a portion of the wire, in this example the distal wire end, may be exposed from the sheath so that the distal wire end may come into contact with the walls of a vessel during treatments such as segmental mechanical ablation.

[0228] The additional method for limiting current flow to a motor may include allowing a motor to rotate (in step 4704). Once the sheath is retracted, or at least partially retracted, the limit switch may allow the motor to receive current and rotate. As described in Fig. 41 and Fig. 43 above, the rotation of the wire and thus the rotation of the distal wire end can cause ablation (or agitation or abrasion) of the vessel wall. Again, the rotation of the motor can be translated into the longitudinal movement of the wire, allowing a scraping action via the distal wire end instead of rotational ablation.

[0229] In some examples, the additional method for limiting current flow to a motor includes extending the sheath on the wire (in step 4706). By slidably moving the sheath opposite the direction of step 4700, an operator can extend the sheath on the wire. Again, this movement may include the sheath moving completely back to its home position (i.e., the position it was in when the catheter was originally delivered to the treatment site) or the sheath only partially extending around the wire. Aside from the variable treatment length already mentioned, this may also affect the limit switch so that the motor no longer receives any further current, as discussed in step 4710.

[0230] According to some examples, the additional method for limiting current flow to a motor includes at least partially enclosing the distal wire end (in step 4708). As in Fig. 42 above, by expanding the sheath, the operator can re-enclose the distal end of the wire, thus facilitating safe removal of the catheter from the patient. Since the sheath only extends partially around the wire, the distal end of the wire may also only be partially enclosed by the sheath. By expanding the sheath to its original position, the wire may be fully re-enclosed. As mentioned in step 4706, this enclosing of the distal end of the wire may also additionally affect a limit switch to prevent current from flowing to the motor.

[0231] The additional method for limiting current flow to a motor may involve preventing the motor from rotating (in step 4710). When a procedure is complete and the operator wishes to remove the catheter from the patient, they may also wish to stop the mechanical or chemical ablation mechanism to avoid damaging the healthy veins. Beyond simply turning the motor off, the operator can prevent the motor from accidentally turning it back on when withdrawing the catheter from the patient's enclosure by linking the position of the sheath to a limit switch. Again, the limit switch can be set to vary the length of the treatment segment of the distal wire end by only energizing the motor when the sheath is fully expanded.

[0232] Fig. 48 illustrates a flowchart depicting a method for stabilizing a controller housing, according to some examples. In some examples, the method for stabilizing a controller housing includes changing the rotational relationship between a motor and a catheter (at step 4800). Although not required for stabilizing a controller, in some cases where the motor is located below the tee and / or trailer rather than behind it, the controller may have a taller but shorter housing. In such examples, it may be necessary to increase stability of the device due to its now higher center of gravity.If the motor is located below the T-piece and / or trailer, a gear ratio may be required to convert the motor's rotational motion into a rotational motion of the catheter, as the motor would no longer be in line with the catheter insertion point. These gear ratios can also be used in controllers where the motor is located behind the T-piece and / or trailer if the device user desires adjustable rotation options for the catheter.

[0233] According to some examples, the method for stabilizing a controller housing includes extending an expandable foot (in step 4802). The ablation system may include an expandable foot on the underside of the controller, perhaps with a mesh, as shown in Fig. 11. This extendable foot can lower the center of gravity of the controller when extended. This is particularly useful for controllers like the one described in the previous paragraph, where the placement of the motor gives the controller a higher center of gravity, and the user wishes to lower this center of gravity.

[0234] The method for stabilizing a controller housing may include stabilizing a controller housing (at step 4804). By lowering the center of gravity of the controller by extending the extendable foot at step 4802, the controller housing gains stability. This reduces the risk of an operator accidentally knocking over the controller during a procedure.

[0235] Fig. 49 illustrates a flowchart depicting a method of using a controller with sterile packaging, according to some examples. In some examples, the method of using a controller with sterile packaging includes removing a catheter from a sterile package (at step 4900). In some examples, the controller and the catheter are packaged together in the sterile package. The catheter would need to be at least partially removed from the sterile package to be inserted into a patient's body. In some examples, the catheter is packaged separately from the controller.

[0236] According to some examples, the method of using a controller with sterile packaging includes guiding the catheter to a patient treatment site (at step 4902). The catheter may be guided to the patient treatment site while coupled to the controller, or the catheter may be detachable, and an operator may guide the catheter to the treatment site before coupling it to the controller. The present disclosure also allows the operator to couple the catheter to the controller while delivering the catheter to the treatment site, if desired.

[0237] The method of using a controller with a sterile package may include operating a controller from within the sterile package (at step 4904). The sterile package may contain a cavity or recess in which the controller resides while packaged. After removing the catheter from the sterile package (in examples where the catheter and controller are packaged in the same sterile package), the controller may be stored within the sterile package. In this way, the controller may maintain its sterility during use. This allows an operator to perform a procedure without the need for a sterile drape. Additionally, this may reduce the cost of a procedure because, while the catheter still needs to be either sterilized or discarded, the controller does not need to be sterilized after each use as long as its environment is kept sterile.

[0238] In some examples, the method of using a controller with a sterile package includes placing the catheter through a slit in the sterile package (in step 4906). The sterile package may include a slit distal to the controller (near the portion of the controller into which the catheter is inserted to couple to the controller). This slit could also be an aperture or other lumen-like cavity in the sterile package through which the catheter could be inserted. In this way, the catheter can be connected to the controller without having to remove the controller from the sterile package, thereby maintaining the sterility of the controller.

[0239] Fig. 50 illustrates a flowchart depicting a method for removably coupling a catheter to a controller, according to some examples. According to some examples, the method for removably coupling a catheter to a controller includes removably coupling a catheter to a controller (in step 5000). As previously described in the application, the catheter may be completely removed from the controller, thereby providing a removably coupling between the catheter and the controller. However, this is not required, and ablation systems may also be provided in which the catheter is fixedly coupled to the controller.

[0240] The method for detachably coupling a catheter to a controller may include detaching a sheath from the controller (in step 5002). In some examples, the catheter includes a sheath having a working lumen. In further examples, the sheath may be detachable from the controller. In such examples, the sheath may be tracked to a treatment site before being coupled to the controller. In examples where a wire is included through the working lumen of the sheath, the sheath may be detachable from the controller and tracked to a treatment site separately from the wire, as described in Fig. 46 is described.

[0241] In some examples, the method for releasably coupling a catheter to a controller includes sterilizing the sheath separately from the controller (in step 5004). According to some examples, the method for releasably coupling a catheter to a controller includes detaching the sheath (in step 5006). For ablation systems where the sheath is detachable from the controller, the sheath may be sterilized while disconnected from the controller. As described in Fig. 49, this could help reduce sterilization costs. Additionally, the sheath can be completely disposed of without the need to dispose of the controller, meaning the controller can be reused more frequently than the catheter.

[0242] The method for releasably coupling a catheter to a controller may include detaching a wire from the controller (in step 5008). In some exemplary ablation systems, the catheter further includes a wire that is passed through the working lumen of a sheath. The catheter may also include an unsheathed wire, if desired. In either case, the wire may be passed to a treatment site before being coupled to the controller (or motor, e.g., in ablation systems with a motor to rotate the wire).

[0243] In some examples, the method for releasably coupling a catheter to a controller includes sterilizing the wire separately from the controller (in step 5010). According to some examples, the method for releasably connecting a catheter to a controller includes disposing the wire (in step 5012). For ablation systems where the wire is releasable from the controller, the wire can be sterilized while not connected to the controller. As also described in Fig. 49, this could help reduce sterilization costs. Additionally, like the sheath of step 5006, the wire can be completely disposed of without the need to dispose of the controller, meaning the controller can be reused more frequently than the catheter.

[0244] The present disclosure includes an ablation system 10 that includes a controller 20. In some examples, the ablation system 10 includes a sheath 40 that includes 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 a patient's vasculature, with the distal sheath end 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, with the distal wire end 1204 configured to engage a vessel wall in a treatment segment 55.

[0245] According to some examples, the sheath 40 is retractable to expose the distal wire end 1204. The distal wire end 1204 can be arranged and configured to define a compressed state when the distal wire end 1204 is within the sheath 40 and an uncompressed state when the sheath 40 is retracted from the distal wire end 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 end 1204. The length of the distal wire end 1204 can be configured to form a variable treatment length.

[0246] In some examples, the sheath 40 is releasably 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 rotary output, with the wire 30 coupled to the motor 610 and / or 3308.

[0247] In some examples, sheath 40 includes an open distal end configured to deliver a drug to treatment segment 55. In some examples, sheath 40 further includes a lumen for delivering the drug into treatment segment 55. Sheath 40 may include an opening at the sheath distal end for delivering the drug into treatment segment 55. In some examples, the drug is a sclerosing agent.

[0248] According to some examples, sheath 40 includes a closed distal end and an opening at the distal end of the sheath for delivering a drug to treatment segment 55. The drug may be a sclerosing agent.

[0249] 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 may be attached to one of the distalmost ends of the wire 30. In some examples, the distal wire end 1204 defines a sinusoidal crossing profile.

[0250] According to some examples, the sinusoidal configuration includes a non-uniform amplitude. Sheath 40 may include a closed distal end and a hole at the distal sheath end for delivering a drug into treatment segment 55. In some examples, the non-uniform amplitude is configured to create a spray effect of the drug.

[0251] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotary 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 rotary output of the motor 610 and / or 3308.

[0252] The wire 30 may 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 may be centered on the central axis 1208, with the weighted tip 1210 configured to create a gyroscopic effect. In some examples, the weighted tip 1210 is off-axis and parallel to the central axis 1208. In some examples, the weighted tip 1210 is configured to contact the wall of the vessel. The weighted tip 1210 may be off-center and at an angle to the central axis 1208. In some examples, the weighted tip 1210 is configured to contact the wall of the vessel.

[0253] According to some examples, the wire 30 includes a thickness gradient to allow thicker portions of the distal wire end 1204 to have better contact with the vessel wall. 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.

[0254] The wire 30 may include a stranded cable 1702. In some examples, the stranded cable 1702 defines a radius, and the radius is adjustable. According to some examples, the stranded cable 1702 is configured to enable a high contact force on the vessel wall. The stranded cable 1702 may define a sinusoidal profile.

[0255] In 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. In some examples, the motor 610 and / or 3308 is configured to provide a rotary output. The proximal wire end 1202 can 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 rotary output of the motor 610 and / or 3308.

[0256] In some examples, the wire 30 includes a helical hollow strand 1802. In some examples, the helical hollow strand 1802 is configured to deliver a drug to the treatment segment 55. The drug may be a sclerosant. In some examples, the drug is configured to seep through a turn of the helical hollow strand 1802. In some examples, the helical hollow strand 1802 defines a sinusoidal profile. The amplitude of the sinusoidal profile may be adjustable. In some examples, the ablation system 10 further includes a pull cord coupled to a distal end of the helical hollow strand 1802, the pull cord configured to adjust the amplitude of the sinusoidal profile.

[0257] According to some examples, the helical hollow strand 1802 defines a first wire of helical hollow strand 1802, wherein the wire 30 further includes a second wire of helical hollow strand 1802. The second wire of helical hollow strand 1802 may at least partially surround the first wire of helical hollow strand 1802. In some examples, the first wire of helical hollow strand 1802 and the second wire of helical hollow strand 1802 produce an oscillating motion.

[0258] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power 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 wire 1802 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0259] The helical hollow strand wire 1802 may be configured to lie flat within the sheath 40. In some examples, the helical hollow strand wire 1802 is configured to expand when the sheath 40 is retracted.

[0260] According to some examples, the distal wire end 1204 includes a spring-like configuration. The distal wire end 1204 may define a spring-like crossing profile 2402. In some examples, the spring-like configuration defines a sinusoidal profile.

[0261] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power 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. In some examples, the spring-like configuration is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0262] The distal wire end 1204 may include a three-dimensional cross-sectional profile. In some examples, the three-dimensional cross-sectional profile is a sinusoidal configuration in two dimensions, where the sinusoidal configuration defines a period. According to some examples, the sinusoidal configuration rotates in a third dimension in each period.

[0263] The sinusoidal configuration may further define a time segment that is a portion of a period. In some examples, the sinusoidal configuration rotates in a third dimension during each time segment. In some examples, each time segment corresponds to half of the time period.

[0264] The distal wire end 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 supply 606 and / or 3302 configured to power the motor 610 and / or 3308. In 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 three-dimensional cross-sectional profile is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0265] According to some examples, the distal wire end 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 the vessel.

[0266] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power 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 sinusoidal profile 1602 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0267] The distal wire end 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 supply 606 and / or 3302 configured to power the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotary output. In some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. In some examples, the basket-like shape is configured to rotate in response to the rotary output of the motor 610 and / or 3308.

[0268] Wire 30 may be made of a material that can be shaped. In some examples, wire 30 is made of Nitinol.

[0269] 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 distalmost end of the wire 30. In some examples, the lumen is configured to deliver a drug to the treatment segment 55 through the opening 1206. According to some examples, the drug is a sclerosant. 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.

[0270] 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 leaving the treatment segment 55. According to some examples, the drug is a sclerosing agent.

[0271] 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 one side of the sheath 40. In some examples, the offset balloon 2606 is configured to relieve pressure on the wire 30 when the offset balloon 2606 is in an inflated state, thereby more aggressively contacting the wire 30 with the vessel wall. According to some examples, the sheath 40 provides an inflation fluid to the balloon 2604, wherein the inflation fluid is configured to expand the balloon 2604.

[0272] The proximal feature 2602 may be a cage 2608 on the wire 30. In some examples, the proximal feature 2602 is a grooved solid 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 2614 that at least partially surrounds the wire 30. In some examples, the proximal feature 2602 is a sponge-like solid 2614 that at least partially surrounds the sheath 40.

[0273] 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 unload the wire 30, thereby causing the wire 30 to more aggressively contact the vessel wall.

[0274] According to some examples, the ablation system 10 further includes a distal feature 2702 proximal to a distal portion of the distal wire end 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 a drug from exiting the treatment segment 55.

[0275] According to some examples, the distal feature 2702 is a single-bladed 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 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 sponge-like solid 2712 that at least partially surrounds the wire 30.

[0276] In some examples, the distalmost tip of the wire 30 is a hemispherical tip 2802. In some examples, the hemispherical tip 2802 is weighted. The hemispherical tip 2802 may be configured to contact the vessel wall.

[0277] In some examples, the distalmost tip of the wire 30 is an offset weighted tip 2804. In some examples, the offset weighted tip 2804 is weighted. The offset weighted tip 2804 may be configured to contact the wall of the vessel.

[0278] In some examples, the wire 30 includes a lumen. According to some examples, the distalmost tip of the wire 30 is a balloon tip 2806. The lumen may be configured to provide an inflation fluid to the balloon tip 2806, wherein the inflation fluid is configured to expand the balloon tip 2806. In some examples, the balloon tip 2806 is configured to occlude the vessel in an expanded state.

[0279] According to some examples, the ablation system 10 further includes a supplementary wire 2902 wrapped around at least a portion of the distal wire end 1204. The supplementary wire 2902 may be a heated wire 2904. In some examples, the heated wire 2904 is configured to constrain the wire 30 into a predetermined shape in response to a temperature. In some examples, the predetermined shape is a sinusoidal profile. The temperature may correspond to human body temperature.

[0280] In some examples, the supplemental wire 2902 is a hypotube. According to some examples, the hypotube is configured to deliver a drug to a treatment segment 55. The drug may be a sclerosant.

[0281] 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 aggressive contact with the wall of the vessel.

[0282] At least a portion of the distal wire end 1204 may include additional geometry 3002a, 3002b, 3002c, and / or 3002d. In some examples, the additional geometry 3002a includes a rounded nub. In some examples, the additional geometry 3002b includes a sphere. The additional geometry 3002c may include a spike. In some examples, the additional geometry 3002d includes a brush. According to some examples, the additional geometry 3002a, 3002b, 3002c, and / or 3002d is configured to make aggressive contact with the wall of the vessel. The wire 30 may include a sinusoidal profile. In some examples, the sinusoidal profile defines a peak. According to some examples, the additional geometry 3002a, 3002b, 3002c, and / or 3002d is located on the peak.

[0283] The ablation system 10 may further include a ring 3202 at least partially surrounding the sheath 40. In some examples, the ring 3202 is slidably coupled to the sheath 40. According to some examples, the ring 3202 is sized so that it cannot penetrate an insertion site in the patient. The ring 3202 may be configured to hold the sheath 40 and the wire 30 in position during a treatment. In some examples, the ring 3202 is configured to indicate a distance from a deep venous system of the patient.

[0284] According to some examples, the ablation system 10 further includes at least one distance marker 3204 on the sheath 40. The at least one distance marker 3204 may be configured to indicate a distance that the sheath 40 is removed from the patient. In some examples, the at least one distance marker 3204 is configured to inform a user that a subsequent treatment segment 55 has been reached. According to some examples, the distance between the at least one distance marker 3204 and a subsequent at least one distance marker 3204 is approximately equal to the length of the distal wire end 1204. The distal wire end 1204 may define a treatment segment 55. In some examples, the at least one distance marker 3204 at least partially surrounds the sheath 40.

[0285] 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 inform the user that the end of the processable treatment length has been reached. In some examples, the warning track 3206 at least partially surrounds the sheath 40.

[0286] The present disclosure also includes an ablation system 10 that includes a controller 20. In some examples, the ablation system 10 includes a sheath 40 that includes 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 a patient's vasculature, with the distal sheath end 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, with the distal wire end 1204 configured to engage a vessel wall in a treatment segment 55.

[0287] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power the motor 610 and / or 3308. The controller 20 may further include an actuator 506a, 506b, 608, 914, and / or 3304 to activate the motor 610 and / or 3308. In some examples, the motor 610 and / or 3308 is configured to provide a rotary output. According to some examples, the proximal wire end 1202 is rotatably coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 can rotate the distal wire end 1204 at a speed between about 1000 revolutions per minute (RPM) and about 4000 RPM. In some examples, the controller 20 includes a torque limiter and a clutch to stop rotation of the wire 30 when a torque limit is exceeded.

[0288] 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 tuohy 604 coupled to the slot 602. In some examples, retracting the inflation tuohy 604 into the slot 602 retracts the sheath 40 and exposes the distal wire end 1204. According to some examples, a flow path from the handle into the sheath 40 is created for the injection of the sclerosant at the treatment segment 55.

[0289] The controller 20 may include a display 508. In some examples, the display 508 is configured to display a timer. According to some examples, the timer is configured to count down the remaining time of a treatment.

[0290] The present disclosure also includes an ablation system 10 that includes a housing 702, 802, and / or 902 defining a proximal housing end 708, 806, and / or 906 and a distal housing end 710, 808, and / or 908 opposite the proximal housing end 708, 806, and / or 906. The ablation system 10 may include a trailer 704 slidably coupled to the housing 702, 802, and / or 902, wherein the trailer 704 moves along a first direction 712, 810, and / or 916 extending from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.In some examples, the ablation system 10 includes a T-piece 706, 804 and / or 904 slidably coupled to the housing 702, 802 and / or 902 and at least partially surrounded by a mid-portion of the trailer 704, wherein the T-piece 706, 804 and / or 904 moves in response to movement of the trailer 704 along the first direction 712, 810 and / or 916.

[0291] According to some examples, the ablation system 10 further includes a syringe 60 configured to be coupled to the T-piece 706, 804, and / or 904. A component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof may be configured to control movement of the T-piece 706, 804, and / or 904. In some examples, the syringe 60 is configured to be inserted into the T-piece 706, 804, and / or 904 along a second direction that is at an angle to the first direction 712, 810, and / or 916. According to some examples, the angle is perpendicular.

[0292] The ablation system 10 may further include a syringe 60 configured to couple to the T-piece 706, 804, and / or 904. In some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. According to some examples, the ablation system 10 further includes a sheath 40 including 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 the distal housing end 710, 808, and / or 908. In some examples, the working lumen is in fluid communication with the syringe 60.

[0293] According to some examples, the sheath 40 is configured to receive a 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-piece 706, 804, and / or 904 from the distal housing end 710, 808, and / or 908 toward the proximal housing end 708, 806, and / or 906, the sheath 40 can be retracted onto the wire 30, exposing the distal wire end 1204. In some examples, by sliding the T-piece 706, 804 and / or 904 from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908, the sheath 40 is extended around the wire 30, thereby at least partially enclosing the distal wire end 1204.

[0294] 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. By sliding the T-piece 706, 804, and / or 904 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906, the sheath 40 can be retracted onto the hypotube, thereby exposing the distal hypotube end. In some examples, by sliding the T-piece 706, 804 and / or 904 from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908, the sheath 40 is extended around the hypotube, thereby at least partially enclosing the distal hypotube end.

[0295] 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. By sliding the T-piece 706, 804, and / or 904 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906, the sheath 40 can be retracted onto the catheter shaft, thereby exposing the distal catheter shaft end. In some examples, by sliding the T-piece 706, 804 and / or 904 from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908, the sheath 40 is extended around the catheter shaft, thereby at least partially enclosing the distal catheter shaft end.

[0296] According to some examples, the T-piece 706, 804, and / or 904 includes a Luer hub 3102. The ablation system 10 may further include a syringe 60 configured to couple to the T-piece 706, 804, and / or 904. In some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. According to some examples, the Luer hub 3102 includes a Luer 3104, wherein the Luer 3104 is configured to releasably couple the syringe 60 to the T-piece 706, 804, and / or 904. The Luer 3104 may be configured to rotate approximately 180 degrees about the first direction 712, 810, and / or 916. In some examples, the syringe 60 is configured to control rotation of the Luer 3104.

[0297] According to some examples, the ablation system 10 further includes a 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 the distal housing end 710, 808, and / or 908. In some examples, the catheter 15 is in fluid communication with the syringe 60. According to some examples, the Luer 3104 is configured to apply torque to the catheter 15. The torque may be configured to control a direction of movement of the distal catheter end.

[0298] 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. In some examples, the proximal sheath end is configured to be removably coupled to the 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 torque to the sheath 40. In some examples, the torque is configured to control a direction of movement of the distal sheath end.

[0299] Sheath 40 may further include a working lumen. In some examples, ablation system 10 further includes a wire 30 extending from housing 702, 802, and / or 902 through the working lumen to the sheath distal end, wherein wire 30 has a proximal wire end 1202 and a distal wire end 1204 opposite proximal wire end 1202. According to some examples, distal wire end 1204 is configured to engage a vessel wall in treatment segment 55.

[0300] The ablation system 10 may further include a torque knob 1104 rotatably coupled to the housing 702, 802, and / or 902. In some examples, the torque knob 1104 is located at the proximal housing end 708, 806, and / or 906.

[0301] According to some examples, the ablation system 10 further includes a syringe 60 configured to couple to the T-piece 706, 804, and / or 904. A component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof may be configured to control movement of the T-piece 706, 804, and / or 904. In some examples, the 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 the distal housing end 710, 808, and / or 908. The catheter 15 may be in fluid communication with the syringe 60.

[0302] In some examples, torque knob 1104 is configured to apply torque to catheter 15. According to some examples, the torque is configured to control a direction of movement of the distal catheter end.

[0303] The ablation system 10 may further include a wire 30 having 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 housing distal end 710, 808, and / or 908. According to some examples, the torque knob 1104 is configured to provide torque to the wire 30. The torque may be configured to control a direction of movement of the distal wire end 1204.

[0304] In some examples, the ablation system 10 further includes a motor 610 and / or 3308 at least partially enclosed within the housing 702, 802, and / or 902. According to some examples, the motor 610 and / or 3308 is at least partially enclosed within the proximal housing end 708, 806, and / or 906. The ablation system 10 may further include an actuator 506a, 506b, 608, 914, and / or 3304 coupled to the housing 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308, wherein the actuator 506a, 506b, 608, 914, and / or 3304 is configured to turn the motor 610 and / or 3308 on and off.

[0305] In some examples, the ablation system 10 further includes a wire 30 having 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 be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to cause rotation of the wire 30.

[0306] 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 be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to cause rotation of the hypotube.

[0307] In some examples, the 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 be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to cause rotation of the catheter shaft.

[0308] In some examples, the ablation system 10 further includes a limit switch 3306 electronically coupled to the motor 610 and / or 3308. According to some examples, the limit switch 3306 is configured to prevent the motor 610 and / or 3308 from rotating when the trailer 704 is positioned at a location other than the proximal housing end 708, 806, and / or 906. The limit switch 3306 may be configured to allow the motor 610 and / or 3308 to rotate when the trailer 704 is positioned at the proximal housing end 708, 806, and / or 906.

[0309] In some examples, the ablation system 10 further includes an LED 912 and / or 3310 electronically coupled to the motor 610 and / or 3308. According to some examples, the LED 912 and / or 3310 is configured to turn off when the trailer 704 is positioned at a location other than the proximal housing end 708, 806, and / or 906. The LED 912 and / or 3310 may be configured to turn on when the trailer 704 is positioned at the proximal housing end 708, 806, and / or 906.

[0310] In some examples, the trailer 704 is at least partially within the housing 702, 802, and / or 902. According to some examples, the trailer 704 includes a pull tab configured to facilitate movement of the trailer 704. The tee 706, 804, and / or 904 may be fixedly coupled to the trailer 704.

[0311] In some examples, the ablation system 10 further includes a display 508 configured to display information. According to some examples, the display 508 is configured to display a timer. The timer may be configured to count down the remaining time of a treatment. In some examples, the ablation system 10 further includes a catheter 15 coupled to the distal housing end 710, 808, and / or 908. According to some examples, the timer is configured to count down the time until a treatment in a treatment segment 55 is completed and the catheter 15 is to be moved to a subsequent treatment segment 55.

[0312] The ablation system 10 may further include a syringe 60 configured to be coupled to the T-piece 706, 804, and / or 904. In some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. According to some examples, the timer is configured to count down the time until an operator is to begin injecting a drug from the syringe 60. The timer may be configured to count down the time until the operator is to finish injecting the drug from the syringe 60.

[0313] In some examples, the ablation system 10 further includes an alarm configured to sound at the end of a treatment. According to some examples, the ablation system 10 further includes a catheter 15 coupled to the distal housing end 710, 808, and / or 908. The ablation system 10 may further include an alarm configured to sound when a treatment in a treatment segment 55 is completed and an operator is to move the catheter 15 to a subsequent treatment segment 55.

[0314] In some examples, the ablation system 10 further includes a syringe 60 configured to be coupled to the T-piece 706, 804, and / or 904. According to some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. The ablation system 10 may further include an alarm configured to sound when an operator is to begin injecting a drug from the syringe 60. In some examples, the alarm is configured to sound when the operator is to stop injecting a drug from the syringe 60.

[0315] According to some examples, the ablation system 10 further includes an LED 912 and / or 3310 configured to turn on at the end of a treatment. The ablation system 10 may further include an LED 912 and / or 3310 configured to turn off at the end of a treatment. In some examples, the ablation system 10 further includes a catheter 15 coupled to the distal housing end 710, 808, and / or 908 and an LED 912 and / or 3310 configured to turn off when a treatment in a treatment segment 55 is completed and an operator is to move the catheter 15 to a subsequent treatment segment 55.According to some examples, the ablation system 10 further includes a catheter 15 coupled to the distal housing end 710, 808 and / or 908 and an LED 912 and / or 3310 configured to turn off when a treatment in a treatment segment 55 is completed and an operator is to move the catheter 15 to a subsequent treatment segment 55.

[0316] The ablation system 10 may further include a syringe 60 configured to be coupled to the T-piece 706, 804, and / or 904. In some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. According to some examples, the ablation system 10 further includes an LED 912 and / or 3310 configured to turn on when an operator is to begin injecting a drug from the syringe 60. The LED 912 and / or 3310 may be configured to turn off when the operator is to stop injecting a drug from the syringe 60.

[0317] In some examples, the ablation system 10 further includes a syringe 60 configured to be coupled to the T-piece 706, 804, and / or 904. According to some examples, a component selected from the group consisting of the syringe 60, the trailer 704, and combinations thereof is configured to control movement of the T-piece 706, 804, and / or 904. The ablation system 10 may further include an LED 912 and / or 3310 configured to turn off when an operator is to begin injecting a drug from the syringe 60. In some examples, the LED 912 and / or 3310 is configured to turn on when the operator is to stop injecting a drug from the syringe 60.

[0318] According to some examples, the ablation system 10 further includes a motor 610 and / or 3308 located near a bottom of the housing 702, 802, and / or 902. The ablation system 10 may further include a gearbox coupled to the motor 610 and / or 3308. In some examples, the gearbox is configured to control an output speed of the motor 610 and / or 3308.

[0319] According to some examples, the ablation system 10 further includes an expandable foot 1102 at a base of the housing 702, 802, and / or 902. The expandable foot 1102 may be configured to facilitate stability of the housing 702, 802, and / or 902.

[0320] In some examples, the 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 coupled to the distal housing end 710, 808, and / or 908. The ablation system 10 may further include an arm 1106 coupled to one side of the housing 702, 802, and / or 902.

[0321] In some examples, arm 1106 is configured to maintain a distance between catheter 15 and housing 702, 802, or 902 when the distal catheter end moves in a direction opposite to first direction 712, 810, or 916. According to some examples, the distance between catheter 15 and housing 702, 802, and / or 902 is a radius. Arm 1106 may be configured to hold catheter 15 in position during a treatment.

[0322] In some examples, the ablation system 10 further includes a catheter 15 having a proximal catheter end and a distal catheter end opposite the proximal catheter end. In some examples, the proximal catheter end is coupled to the distal housing end 710, 808, and / or 908. The ablation system 10 may further include a catheter clamp configured to hold the catheter 15 in position during a treatment.

[0323] In some examples, the ablation system 10 further includes a sheath 40 that includes a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the distal housing end 710, 808, and / or 908, and the distal sheath end is configured for insertion into a patient's vasculature, with the distal sheath end located opposite the proximal sheath end. The ablation system 10 may further include a wire 30 extending from the distal housing 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 in a treatment segment 55.

[0324] According to some examples, the sheath 40 is removably coupled to the distal housing end 710, 808, and / or 908. The sheath 40 may be configured to follow the treatment segment 55 while the wire 30 remains stationary.

[0325] In some examples, the ablation system 10 further includes a sterile package 1002. According to some examples, the housing 702, 802, and / or 902, the trailer 704, the T-piece 706, 804, and / or 904, the sheath 40, and the wire 30 are configured to fit within a lumen of the sterile package 1002. The sheath 40 and the wire 30 can be releasably coupled to the distal housing end 710, 808, and / or 908. In some examples, the sheath 40 and the wire 30 are configured to be sterilized separately from the housing 702, 802, and / or 902. According to some examples, the sheath 40 and the wire 30 are configured to be disposable. The ablation system 10 may be configured to operate while in the sterile package 1002.

[0326] In some examples, the sterile package 1002 includes a slot 1004. According to some examples, the slot 1004 is configured to slidably receive the sheath 40. The housing 702, 802, and / or 902, the trailer 704, and the tee 706, 804, and / or 904 may be configured to be within the cavity of the sterile package 1002 during a procedure. In some examples, the sheath 40 and the wire 30 are configured to be slidably coupled to the slot 1004 during a procedure. According to some examples, the housing 702, 802, and / or 902, the trailer 704, and the tee 706, 804, and / or 904 are configured to be reusable.

[0327] The ablation system 10 may further include a sterile package 1002, wherein the housing 702, 802, and / or 902, the trailer 704, and the tee 706, 804, and / or 904 are configured to fit within a lumen of the sterile package 1002. In some examples, the ablation system 10 is configured to operate while within the sterile package 1002.

[0328] The present disclosure also includes a method in which a syringe 60 is inserted into a T-piece 706, 804, and / or 904 of a trailer 704 of a housing 702, 802, and / or 902. In some examples, the housing 702, 802, and / or 902 includes a proximal housing end 708, 806, and / or 906 and a distal housing end 710, 808, and / or 908. According to some examples, the trailer 704 is slidably coupled to the housing 702, 802, or 902, whereby the trailer 704 moves along a first direction 712, 810, or 916. The first direction 712, 810, and / or 916 may extend from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, the tee 706, 804, and / or 904 moves in response to moving the trailer 704 along the first direction 712, 810, and / or 916.According to some examples, the syringe 60 is inserted into the T-piece 706, 804, and / or 904 along a second direction that is perpendicular to the first direction 712, 810, and / or 916. The method may include guiding a catheter 15 to a treatment site 50 of a patient.

[0329] In some examples, the catheter 15 includes a sheath 40 configured to receive a 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 translating the T-piece 706, 804, and / or 904 over the trailer 704 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. The method may further include retracting the sheath 40 onto the wire 30 in response to translating the T-piece 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.

[0330] According to some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the distal housing end 710, 808, and / or 908 toward the proximal housing end 708, 806, and / or 906. The trailer 704 may include a pull tab. In some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the pull tab from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0331] According to some examples, the catheter 15 includes a sheath 40 configured to receive a wire 30, wherein the wire 30 includes a proximal wire end 1202 and a distal wire end 1204 opposite the proximal wire end 1202. The method may further include translating the T-piece 706, 804, and / or 904 over the trailer 704 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, the method further includes expanding the sheath 40 on the wire 30 in response to displacement of the T-piece 706, 804, and / or 904. According to some examples, the method further includes at least partially enclosing the distal wire end 1204 in response to expanding the sheath 40.

[0332] The method may further include sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, the trailer 704 includes a pull tab. According to some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the pull tab from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0333] 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 translating the T-piece 706, 804, and / or 904 over the trailer 704 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. According to some examples, the method further includes retracting the sheath 40 onto the hypotube in response to translating the T-piece 706, 804, and / or 904. The method may further include exposing the distal hypotube end in response to retracting the sheath 40.

[0334] In some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. According to some examples, the trailer 704 includes a pull tab. The method may further include sliding the T-piece 706, 804, and / or 904 over the pull tab from the distal housing end 710, 808, and / or 908 toward the proximal housing end 708, 806, and / or 906.

[0335] 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 examples, the method further includes translating the T-piece 706, 804, and / or 904 over the trailer 704 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. The method may further include expanding the sheath 40 onto the hypotube in response to translating the T-piece 706, 804, and / or 904. In some examples, the method further includes at least partially enclosing the distal hypotube end in response to expanding the sheath 40.

[0336] According to some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the proximal housing end 708, 806, and / or 906 toward the distal housing end 710, 808, and / or 908. The trailer 704 may include a pull tab. In some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the pull tab from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0337] 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 translating the T-piece 706, 804, and / or 904 over the trailer 704 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. In some examples, the method further includes retracting the sheath 40 onto the catheter shaft in response to translating the T-piece 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.

[0338] The method may further include sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. In some examples, the trailer 704 includes a pull tab. According to some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the pull tab from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0339] 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 translating the T-piece 706, 804, and / or 904 over the trailer 704 from the proximal housing end 708, 806, and / or 906 toward the distal housing end 710, 808, and / or 908. According to some examples, the method further includes expanding the sheath 40 on the catheter shaft in response to translating the T-piece 706, 804, and / or 904. The method may further include at least partially enclosing the distal catheter shaft end in response to expanding the sheath 40.

[0340] In some examples, the method further includes sliding the T-piece 706, 804, and / or 904 over the syringe 60 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. According to some examples, the trailer 704 includes a pull tab. The method may further include sliding the T-piece 706, 804, and / or 904 over the pull tab from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0341] In some examples, the T-piece 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 providing torque to the catheter 15 in response to rotating the syringe 60 and the Luer 3104. The method may further include controlling the direction of movement of the distal catheter shaft in response to applying torque to the catheter 15.

[0342] In some examples, the Luer 3104 includes a connection configured to removably couple a sheath 40 to the housing 702, 802, and / or 902. According to some examples, the method further includes removably coupling the sheath 40 to the housing 702, 802, and / or 902. The method may further include removing the sheath 40 from the housing 702, 802, and / or 902. In some examples, the method further includes guiding the sheath 40 to the patient's treatment site 50.

[0343] According to some examples, a motor 610 and / or 3308 is at least partially enclosed within the housing 702, 802, and / or 902. The catheter 15 may at least partially surround 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 be coupled to the motor 610 and / or 3308. According to some examples, the method further includes rotating the wire 30 via the motor 610 and / or 3308.

[0344] An actuator 506a, 506b, 608, 914 and / or 3304 may be coupled to the housing 702, 802 and / or 902 and electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes interacting with the actuator 506a, 506b, 608, 914, and / or 3304. According to some examples, in response to interacting with the actuator 506a, 506b, 608, 914, and / or 3304, the method further includes turning on the motor 610 and / or 3308. The method may further include turning off the motor 610 and / or 3308 in response to interacting with the actuator 506a, 506b, 608, 914, and / or 3304.

[0345] In some examples, a motor 610 and / or 3308 is at least partially enclosed within the housing 702, 802, and / or 902. According to some examples, the 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 be coupled to the motor 610 and / or 3308. In some examples, the method further includes rotating the hypotube via the motor 610 and / or 3308.

[0346] According to some examples, an actuator 506a, 506b, 608, 914, and / or 3304 is coupled to the housing 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308. The method may further include interacting with the actuator 506a, 506b, 608, 914, and / or 3304. In some examples, the method further includes, in response to interacting with actuator 506a, 506b, 608, 914, and / or 3304, turning on motor 610 and / or 3308. According to some examples, the method further includes, in response to interacting with actuator 506a, 506b, 608, 914, and / or 3304, turning off motor 610 and / or 3308.

[0347] A motor 610 and / or 3308 may be at least partially enclosed within the housing 702, 802, and / or 902. In some examples, the catheter 15 at least partially surrounds a catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. In some examples, the proximal catheter shaft end is configured to be coupled to the motor 610 and / or 3308. The method may further include rotating the catheter shaft via the motor 610 and / or 3308.

[0348] In some examples, an actuator 506a, 506b, 608, 914, and / or 3304 is coupled to the housing 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes interacting with the actuator 506a, 506b, 608, 914, and / or 3304. The method may further include energizing the motor 610 and / or 3308 in response to interacting with the actuator 506a, 506b, 608, 914, and / or 3304. In some examples, the method further includes turning off the motor 610 and / or 3308 in response to interacting with the actuator 506a, 506b, 608, 914 and / or 3304.

[0349] According to some examples, syringe 60 includes a syringe barrel and a plunger. The method may further include depressing the plunger of syringe 60. In some examples, the method further includes releasing a fluid through catheter 15 in response to depressing the plunger.

[0350] The present disclosure also includes a method in which a wire 30 is guided to a treatment site 50 of 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 housing 702, 802, and / or 902. The method may include supplying power to the motor 610 and / or 3308. According to some examples, the method includes rotating the wire 30 in response to energizing the motor 610 and / or 3308.

[0351] The method may further include extending the wire 30 through a sheath 40 coupled to the housing 702, 802, and / or 902. In some examples, the method includes releasably coupling the sheath 40 to the housing 702, 802, and / or 902. According to some examples, the method further includes guiding the sheath 40 to the patient's treatment site 50 while the sheath 40 is detached from the housing 702, 802, and / or 902.

[0352] The method may further include retracting the sheath 40 onto 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, a limit switch 3306 is electronically coupled to the motor 610 and / or 3308. The method may further include enabling the motor 610 and / or 3308 to rotate in response to retracting the sheath 40 onto the wire 30.

[0353] In some examples, the housing 702, 802, and / or 902 includes a proximal housing end 708, 806, and / or 906 and a distal housing end 710, 808, and / or 908. According to some examples, a trailer 704 is slidably coupled to the housing 702, 802, or 902, with the trailer 704 moving along a first direction 712, 810, or 916. The first direction 712, 810, and / or 916 may extend from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, the method further includes translating the trailer 704 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. According to some examples, retracting the sheath 40 on the wire 30 occurs in response to translating the trailer 704 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0354] The trailer 704 may include a T-piece 706, 804, and / or 904. In some examples, the method further includes moving the T-piece 706, 804, and / or 904 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. According to some examples, the T-piece 706, 804, and / or 904 includes a Luer 3104. The method may also include inserting a syringe 60 into the Luer 3104. In some examples, the method further includes moving the syringe 60 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0355] According to some examples, syringe 60 includes a syringe barrel and a plunger. The method may further include depressing the plunger of syringe 60. In some examples, the method may further include releasing a fluid through sheath 40 in response to depressing the plunger. In some examples, wire 30 includes a lumen. The method may further include releasing a fluid through wire 30 in response to depressing the plunger.

[0356] In some examples, the trailer 704 includes a pull tab. According to some examples, the method further includes translating the pull tab from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. The method may further include partially retracting the sheath 40 onto the wire 30. In some examples, in response to partially retracting the sheath 40 onto the wire 30, the method further includes partially exposing the distal wire end 1204.

[0357] According to some examples, the method further includes expanding the sheath 40 on the wire 30. The method may further include, in response to expanding the sheath 40, at least partially enclosing the distal wire end 1204. In some examples, a limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes preventing rotation of the motor 610 and / or 3308 in response to expanding the sheath 40 on the wire 30.

[0358] The housing 702, 802, and / or 902 may include a proximal housing end 708, 806, and / or 906 and a distal housing end 710, 808, and / or 908. In some examples, a trailer 704 is slidably coupled to the housing 702, 802, or 902, with the trailer 704 moving along a first direction 712, 810, or 916. According to some examples, the first direction 712, 810, and / or 916 extends from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. The method may further include translating the trailer 704 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, expansion of the sheath 40 on the wire 30 occurs in response to translating the trailer 704 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0359] According to some examples, the trailer 704 includes a T-piece 706, 804, and / or 904. The method further includes translating the T-piece 706, 804, and / or 904 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. In some examples, the T-piece 706, 804, and / or 904 includes a Luer 3104. According to some examples, the method further includes inserting a syringe 60 into the Luer 3104. The method may further include translating the syringe 60 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0360] In some examples, syringe 60 includes a syringe barrel and a plunger. In some examples, the method further includes depressing the plunger of syringe 60. The method may further include releasing a fluid through sheath 40 in response to depressing the plunger. In some examples, wire 30 includes a lumen. In some examples, the method further includes releasing a fluid through wire 30 in response to depressing the plunger.

[0361] The trailer 704 may include a pull tab. In some examples, the method further includes translating the pull tab from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. According to some examples, the method further includes partially expanding the sheath 40 on the wire 30. The method may further include at least partially enclosing the distal wire end 1204 in response to partially expanding the sheath 40 on the wire 30.

[0362] In some examples, the housing 702, 802, and / or 902 includes a torque knob 1104. In some examples, the method further includes providing torque to the wire 30. The method may further include controlling the direction of movement of the distal wire end 1204 in response to applying torque to the wire 30.

[0363] In some examples, the motor 610 and / or 3308 is located near the bottom of the housing 702, 802 and / or 902. According to some examples, the method further includes changing the rotational relationship between the motor 610 and / or 3308 and the wire 30 via a gearing.

[0364] The housing 702, 802, and / or 902 may include an expandable foot 1102 at a bottom of the housing 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 housing 702, 802, and / or 902 in response to expanding the expandable foot 1102.

[0365] The present disclosure also includes a method of delivering a hypotube to a treatment site 50 of 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 a housing 702, 802, and / or 902. According to some examples, the method includes supplying power to the motor 610 and / or 3308. The method may include rotating the hypotube in response to energizing the motor 610 and / or 3308.

[0366] In some examples, the method further includes expanding the hypotube through a catheter 15 coupled to the housing 702, 802, and / or 902. According to some examples, the method further includes removably coupling the catheter 15 to the housing 702, 802, and / or 902. The method may further include guiding the catheter 15 to the patient's treatment site 50 while the catheter 15 is detached from the housing 702, 802, and / or 902.

[0367] In some examples, the method further includes retracting the catheter 15 onto the hypotube. According to some examples, in response to retracting the catheter 15, the method further includes exposing the distal hypotube end. A 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 rotate in response to retracting the catheter 15 onto the hypotube.

[0368] According to some examples, the housing 702, 802 and / or 902 includes a proximal housing end 708, 806 and / or 906 and a distal housing end 710, 808 and / or 908. A trailer 704 may be slidably coupled to the housing 702, 802 or 902, with the trailer 704 moving along a first direction 712, 810 or 916. In some examples, the first direction 712, 810 and / or 916 extends from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908. According to some examples, the method further includes translating the trailer 704 from the distal housing end 710, 808 and / or 908 to the proximal housing end 708, 806 and / or 906. Retraction of the catheter 15 on the hypotube may occur in response to translating the trailer 704 from the distal housing end 710, 808 and / or 908 to the proximal housing end 708, 806 and / or 906.

[0369] In some examples, the trailer 704 includes a T-piece 706, 804, and / or 904. According to some examples, the method further includes translating the T-piece 706, 804, and / or 904 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906. The T-piece 706, 804, and / or 904 may include a Luer 3104. In some examples, the method further includes inserting a syringe 60 into the Luer 3104. According to some examples, the method further includes translating the syringe 60 from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0370] The syringe 60 may include a syringe housing 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 releasing a fluid through a lumen in the hypotube in response to depressing the plunger. The trailer 704 may include a pull tab. In some examples, the method further includes translating the pull tab from the distal housing end 710, 808, and / or 908 to the proximal housing end 708, 806, and / or 906.

[0371] According to some examples, the method includes partially withdrawing the catheter 15 onto the hypotube. The method may include partially exposing the distal end of the hypotube onto the hypotube in response to partially withdrawing the catheter 15.

[0372] In some examples, the method further includes expanding the catheter 15 onto the hypotube. In some examples, the method further includes at least partially enclosing the distal hypotube end in response to expanding the catheter 15. A limit switch 3306 may be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes preventing rotation of the motor 610 and / or 3308 in response to expanding the catheter 15 onto the hypotube.

[0373] According to some examples, the housing 702, 802 and / or 902 includes a proximal housing end 708, 806 and / or 906 and a distal housing end 710, 808 and / or 908. A trailer 704 may be slidably coupled to the housing 702, 802 or 902, with the trailer 704 moving along a first direction 712, 810 or 916. In some examples, the first direction 712, 810 and / or 916 extends from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908. According to some examples, the method further includes translating the trailer 704 from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908. Expanding the catheter 15 on the hypotube may occur in response to translating the trailer 704 from the proximal housing end 708, 806 and / or 906 to the distal housing end 710, 808 and / or 908.

[0374] In some examples, the trailer 704 includes a T-piece 706, 804, and / or 904. According to some examples, the method further includes translating the T-piece 706, 804, and / or 904 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. The T-piece 706, 804, and / or 904 may include a Luer 3104. In some examples, the method further includes inserting a syringe 60 into the Luer 3104. According to some examples, the method further includes translating the syringe 60 from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908.

[0375] The syringe 60 may include a syringe barrel and a plunger. In some examples, the method further includes depressing the plunger of the syringe 60. In some examples, the method further includes releasing a fluid through a lumen in the hypotube in response to depressing the plunger.

[0376] The trailer 704 may include a pull tab. In some examples, the method further includes moving the pull tab from the proximal housing end 708, 806, and / or 906 to the distal housing end 710, 808, and / or 908. According to some examples, the method further includes partially expanding the catheter 15 onto the hypotube. The method may further include, in response to partially expanding the catheter 15 onto the hypotube, at least partially enclosing the distal hypotube end.

[0377] In some examples, the housing 702, 802, and / or 902 includes a torque knob 1104. In some examples, the method further includes providing torque to the hypotube. The method may further include controlling the direction of movement of the distal hypotube in response to applying torque to the hypotube.

[0378] In some examples, the motor 610 and / or 3308 is located near the bottom of the housing 702, 802, and / or 902. According to some examples, the method further includes changing the rotational relationship between the motor 610 and / or 3308 and the hypotube via a gear train. The housing 702, 802, and / or 902 may include an expandable foot 1102 at a bottom of the housing 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 housing 702, 802, and / or 902 in response to expanding the expandable foot 1102.

[0379] The present disclosure also includes a method that includes removing a catheter 15 from a sterile package 1002. In some examples, the method includes guiding the catheter 15 to a patient treatment site 50. According to some examples, the method includes operating a controller 20 from within the sterile package 1002. The catheter 15 may be coupled to the controller 20.

[0380] In some examples, the method further includes releasably coupling the catheter 15 to the controller 20. According to some examples, the sterile package 1002 includes a slit 1004. The method may further include placing the catheter 15 through the slit 1004 into the sterile package 1002.

[0381] 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 also include disposing of the sheath 40. In some examples, the method further includes disposing of the wire 30.

[0382] According to some examples, the catheter 15 includes a sheath 40 and a wire 30. The method may further include detaching 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 detaching the wire 30 from the controller 20. The method may further include sterilizing the wire 30 separately from the controller 20.

[0383] The present disclosure also includes an ablation system 10 that includes a controller 20. In some examples, the ablation system 10 includes a sheath 40 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 20, and the open distal sheath end is configured for insertion into a patient's vasculature with the open distal sheath end opposite the open proximal sheath end. The ablation system 10 may include a wire 30 that extends from the controller 20 through the open proximal sheath end, through the working lumen, to the open 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, wherein the distal wire end 1204 is configured to mechanically treat a vessel wall of a treatment segment 55, wherein a length of the distal wire end 1204 defines a length of the treatment segment 55. Mechanical treatment should be interpreted as equivalent to any term that defines a type of disruption, including, but not limited to, scraping, ablating, disrupting, agitating, modifying, etc.

[0384] According to some examples, the working lumen is configured to slidably receive the wire 30 and allow passage of a fluid around the wire 30 to chemically treat the treatment segment 55. The term "chemically treat" is synonymous with any term that refers to treatment with chemicals, such as ablating, occluding, denuding, etc. When the ablation system 10 receives a first input, the distal wire end 1204 can mechanically treat the vessel wall. In some examples, the ablation system 10 delivers the fluid to the treatment segment 55 when the ablation system 10 receives a second input. According to some examples, the ablation system 10 delivers the fluid to a subsequent treatment segment 55 when the ablation system 10 receives a third input.

[0385] The sheath 40 may be retractable to expose the distal wire end 1204. In some examples, the controller 20 includes a motor 610 and / or 3308, a power supply 606 and / or 3302 configured to power the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power supply 606 and / or 3302. According to some examples, the limit switch 3306 allows current to flow from the power supply 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 end 1204. In some examples, the portion of the length of the distal wire end 1204 is configured to form a variable treatment length.

[0386] According to some examples, the sheath 40 is expandable to enclose at least a portion of the distal wire end 1204. The controller 20 may include a motor 610 and / or 3308, a power supply 606 and / or 3302 configured to power the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power supply 606 and / or 3302. In some examples, the limit switch 3306 prevents power from flowing from the power supply 606 and / or 3302 to the motor 610 and / or 3308 when the sheath 40 is at least partially expanded.

[0387] According to some examples, the ablation system 10 further includes at least one distance marker 3204 located on the sheath 40 between the open proximal sheath end and the open distal sheath end. The at least one distance marker 3204 can be arranged 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 marker 3204 and the open distal sheath end. According to some examples, the warning track 3206 is configured to indicate that the end of a processable treatment length has been reached.

[0388] The ablation system 10 may further include a movable depth marker (i.e., ring 3202) that at least partially surrounds the sheath 40. In some examples, the movable depth marker is slidably coupled to the sheath 40. According to some examples, the movable depth marker is sized and configured not to intrude into an insertion point into the patient. The movable depth marker may be positioned and configured to maintain the position of the sheath 40 and the wire 30 during a treatment. In some examples, the movable depth marker is positioned along the sheath 40 and configured to indicate a distance to a deep venous system in the patient.

[0389] According to some examples, the controller 20 includes an actuator 506a, 506b, 608, 914, and / or 3304 configured to receive the first input. The controller 20 may include a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to power the motor 610 and / or 3308. In some examples, the proximal wire end 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 end 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 coupled to the working lumen. According to some examples, the syringe 60 is configured to receive the second port and the third port.

[0390] The present disclosure also includes a method in which a catheter 15 is inserted 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.

[0391] 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 scraping the first treatment segment 55 over 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 scraping the second treatment segment 55 over the distal wire end 1204.

[0392] The wire 30 may be electrically coupled to a 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 scraping the first treatment segment 55 by rotating the wire 30. The method may further include scraping the second treatment segment 55 by rotating the wire 30.

[0393] In some examples, the method further includes retracting the sheath 40 on the wire 30. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40 on the wire 30.

[0394] The wire 30 may be electrically coupled to a motor 610 and / or 3308. In some examples, a limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes enabling, via the limit switch 3306, the motor 610 and / or 3308 to receive power in response to the sheath 40 being fully retracted. The method may further include providing a rotary 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 rotary output. According to some examples, the method further includes scraping the first treatment segment 55 by rotating the wire 30. The method may further include scraping the second treatment segment 55 by rotating the wire 30.

[0395] In some examples, the wire 30 is electrically coupled to a motor 610 and / or 3308. According to some examples, an LED 912 and / or 3310 is electrically coupled to the motor 610 and / or 3308. The method may also include powering the LED. In some examples, the method further includes indicating that the motor 610 and / or 3308 is powered by turning on the LED.

[0396] According to some examples, the method further includes expanding the sheath 40 on the wire 30. The method may further include at least partially enclosing the distal wire end 1204 in response to retracting the sheath 40 on the wire 30.

[0397] In some examples, the wire 30 is electrically coupled to a motor 610 and / or 3308. According to some examples, a limit switch 3306 is electronically coupled to the motor 610 and / or 3308. The method may further include preventing the motor 610 and / or 3308 from receiving power via the limit switch 3306 when the sheath 40 is at least partially expanded. In some examples, the method further includes preventing the motor 610 and / or 3308 from providing a rotational output. According to 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.

[0398] An LED 912 and / or 3310 may be electrically coupled to the motor 610 and / or 3308. In some examples, the method also includes preventing the LED 912 and / or 3310 from receiving power. According to some examples, the method further includes indicating that the motor 610 and / or 3308 is not receiving power by preventing the LED 912 and / or 3310 from receiving power.

[0399] A syringe 60 may be fluidly coupled to the catheter 15. In some examples, the method further includes injecting a drug via the syringe 60 into the first treatment segment 55. According to some examples, the method further includes injecting a drug via the syringe 60 into the second treatment segment 55. The method may further include preventing injection of a drug while repositioning the catheter 15 into the second treatment segment 55.

[0400] In some examples, the sheath 40 includes a first distance marker 3204 and a second distance marker 3204. According to some examples, the method further includes withdrawing the catheter 15 from the patient from the first distance marker 3204 to the second distance marker 3204. The method may further include repositioning the distal wire end 1204 by withdrawing the catheter 15 from the patient. In some examples, the distance between the first distance marker 3204 and the second distance marker 3204 is approximately equal to the treatment length of the distal wire end 1204. According to some examples, the method further includes repositioning the distal wire end 1204 by the treatment length.

[0401] 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 a treatable treatment length of the catheter 15 has been reached. According to some examples, the catheter 15 includes a ring 3202 at least partially surrounding the catheter 15. The method may further include indicating via the ring 3202 a distance to a deep venous system of the patient.

[0402] The present disclosure also includes a method that includes 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 at the first treatment segment 55. The method may include injecting a fluid (e.g., saline or a drug, such as a sclerosant) via a syringe 60 into the first treatment segment 55. In some examples, the method includes repositioning the catheter 15 to the second treatment segment 55. According to some examples, the method includes injecting the fluid via the syringe 60 into the second treatment segment 55.

[0403] The method may further include preventing injection of a fluid 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 scraping the first treatment segment 55 over 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 scraping the second treatment segment 55 over the distal wire end 1204.

[0404] In some examples, the wire 30 is electrically coupled to a 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 scraping the first treatment segment 55 by rotating the wire 30. According to some examples, the method further includes scraping the second treatment segment 55 by rotating the wire 30.

[0405] The method may further include retracting the sheath 40 onto the wire 30. In some examples, the method further includes exposing the distal wire end 1204 in response to retracting the sheath 40 onto the wire 30.

[0406] In some examples, the wire 30 is electrically coupled to a motor 610 and / or 3308. A limit switch 3306 may be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes enabling, via the limit switch 3306, the motor 610 and / or 3308 to receive power 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 scraping the first treatment segment 55 by rotating the wire 30. According to some examples, the method further includes scraping the second treatment segment 55 by rotating the wire 30.

[0407] The wire 30 may be electrically coupled to a motor 610 and / or 3308. In some examples, an LED 912 and / or 3310 is electrically coupled to the motor 610 and / or 3308. According to some examples, the method further includes turning on the LED. The method may further include indicating that the motor 610 and / or 3308 is powered via a power supply to the LED.

[0408] In some examples, the method further includes expanding the sheath 40 on the wire 30. According to some examples, in response to retracting the sheath 40 on the wire 30, the method further includes at least partially enclosing the distal wire end 1204.

[0409] The wire 30 may be electrically coupled to a motor 610 and / or 3308. In some examples, a 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 via the limit switch 3306 when the sheath 40 is at least partially expanded. 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 the motor 610 and / or 3308 being prevented from providing a rotational output.

[0410] According to some examples, an LED 912 and / or 3310 is electrically coupled to the motor 610 and / or 3308. The method may further include preventing the LED 912 and / or 3310 from receiving power. In some examples, the method further includes indicating that the motor 610 and / or 3308 is not receiving power by preventing the LED 912 and / or 3310 from receiving power.

[0411] According to some examples, the sheath 40 includes a first distance marker 3204 and a second distance marker 3204. The method may further include withdrawing the catheter 15 from the patient from the first distance marker 3204 to the second distance marker 3204. In some examples, the method further includes repositioning the distal wire end 1204 by withdrawing the catheter 15 from the patient.

[0412] According to some examples, the distance between the first distance marker 3204 and the second distance marker 3204 is approximately equal to the treatment length of the distal wire end 1204. The method may further include repositioning the distal wire end 1204 by the treatment length.

[0413] 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 a processable treatment length of the catheter 15 has been reached.

[0414] The catheter 15 may include a ring 3202 that at least partially surrounds the catheter 15. In some examples, the method further includes indicating a distance to a deep venous system of the patient via the ring 3202.

[0415] The present disclosure also includes a method in which a catheter 15 is inserted 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 scraping the first treatment segment 55 for a predetermined period of time in response to rotating at least the 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 scraping the second treatment segment 55 for the predetermined period of time in response to rotating at least the portion of the catheter 15.

[0416] The method may further include indicating that the predetermined time period 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 supply 606 and / or 3302 that supplies power to the motor 610 and / or 3308.

[0417] 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 expanding the sheath 40 onto the wire 30. The method may further include at least partially enclosing the distal wire end 1204 in response to expanding the sheath 40 onto the wire 30.

[0418] In some examples, the wire 30 is operatively coupled to a motor 610 and / or 3308, and a limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes allowing current to flow from a power supply 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. The method may further include rotating the wire 30 in response to current flowing from the power supply 606 and / or 3302 to the motor 610 and / or 3308. In some examples, the method further includes preventing current flow from the power supply 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 not fully retracted state.According to some examples, the method further includes ceasing rotation of the wire 30 in response to preventing current flow from the power supply 606 and / or 3302 to the motor 610 and / or 3308.

[0419] The catheter 15 may include a sheath 40 having a working lumen, the sheath 40 including a first distance marker 3204 and a second distance marker 3204, 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. 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 a 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 marker 3204 to the second distance marker 3204, wherein the length is approximately equal to a treatment length of the distal wire end 1204. In some examples, the method further includes indicating via the warning track 3206 that the end of a workable treatment length of the catheter 15 has been reached.

[0420] According to some examples, the catheter 15 includes a sheath 40 including a working lumen, the sheath 40 including a first distance marker 3204 and a second distance marker 3204, 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 extending the catheter 15 out of the patient a distance approximately equal to a length from the first distance marker 3204 to the second distance marker 3204, the length being approximately equal to a treatment length of the distal wire end 1204.

[0421] 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 a processable treatment length of the catheter 15 has been reached.

[0422] A syringe 60 may be fluidly coupled to the catheter 15. In some examples, the method further includes injecting a fluid via the syringe 60 into the first treatment segment 55. According to some examples, the method further includes stopping an injection of the fluid before moving the catheter 15 to the second treatment segment 55. The method may further include injecting the fluid via the syringe 60 into the second treatment segment 55. In some examples, the method further includes removing the catheter 15 from the patient's vasculature. According to some examples, the method further includes stopping an injection of the fluid before removing the catheter 15 from the patient's vasculature.

[0423] Catheter 15 may include a sheath 40 having a working lumen and a wire 30 having a proximal wire end 1202 and a distal wire end 1204 opposite proximal wire end 1202, with wire 30 extending through the working lumen. In some examples, wire 30 is operably coupled to a motor 610 and / or 3308, and a limit switch 3306 is electronically coupled to motor 610 and / or 3308. According to some examples, the catheter 15 includes a sheath 40 including a working lumen, the sheath 40 including a first distance marker 3204 and a second distance marker 3204, 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.

[0424] 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 end 1204 in response to retracting the portion of the sheath 40 from the wire 30. In some examples, the method further includes allowing current to flow from a power supply 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.

[0425] According to some examples, the method further includes actuating a motor 610 and / or 3308 and rotating at least a portion of the catheter 15 in response to actuation of the motor 610 and / or 3308. The method may further include rotating the wire 30 in response to power flowing from the power supply 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 marker 3204 to the second distance marker 3204, wherein the length is approximately equal to a treatment length of the distal wire end 1204.

[0426] In some examples, the method further includes extending the sheath 40 on 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 on the wire 30. The method may further include preventing current flow from the power supply 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 when the sheath 40 is in a not fully retracted state. In some examples, the method further includes terminating rotation of the wire 30 in response to preventing current flow from the power supply 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 a processable treatment length of the catheter 15 has been reached.

[0427] None of the steps described herein are essential or essential. Any of the steps may be adapted or modified. Other or additional steps may also be used. Any portion of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification may be combined with, or used in place of, any other portion of the steps, processes, structures, and / or devices disclosed or illustrated in another embodiment, flowchart, or example. The embodiments and examples provided herein are not to be considered standalone and separate from one another.

[0428] Section headings and subheadings are not limiting. Chapter headings and subheadings do not represent the full scope of the embodiments described in the chapters to which the headings and subheadings belong. For example, a chapter titled "Topic 1" may include embodiments that do not belong to Topic 1, and embodiments described in other chapters may apply to and be combined with the embodiments described in the "Topic 1" chapter.

[0429] To increase the clarity of the various features, other features are not labeled in each figure.

[0430] The various features and methods described above may be used independently or combined in a variety of ways. All possible combinations and sub-combinations are intended to be within the scope of this disclosure. In addition, certain method, event, state, 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 related blocks, steps, or states may be performed in other suitable orders. For example, the described tasks or events may be performed in a different order than the specified order. Multiple steps may be combined in a single block or state. The exemplary tasks or events may be performed in series, in parallel, or otherwise.Tasks or events may be added to or removed from the disclosed examples. The exemplary systems and components described herein may be configured differently than described. For example, elements may be added, removed, or rearranged compared to the disclosed embodiments.

[0431] In particular, the various catheter components and features included in the ablation system 10 described herein and illustrated in FIG. may be used independently or combined in various ways in each of the examples disclosed herein.

[0432] In addition, some of the components listed herein use the same number from figure to figure, 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. It should be noted that these components are numbered the same only for the sake of clarity and understanding for the reader. Although these components bear the same numbers, they may still differ, as illustrated in the various figures and described in this specification.

[0433] Conditional phrases such as "may," "could," "might," "might," "e.g.," and the like, unless expressly stated otherwise or understood differently in the relevant context, are generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not include them. Therefore, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required of one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without input or prompting from the author, whether those features, elements, and / or steps are included or should be performed in a particular embodiment.The terms "comprising," "including," "having," and the like are synonymous and are used inclusively and openly, not excluding additional elements, features, acts, operations, etc. Also, the term "or" is used in its inclusive (rather than exclusive) sense, so that, for example, when used to join a list of items, the term "or" refers to one, some, or all of the items in the list. Conjunctive expressions such as "at least one of X, Y, and Z," unless explicitly stated otherwise, are generally understood to mean that an element, term, etc., can be either X, Y, or Z. Therefore, such conjunctive expressions do not generally imply that at least one of X, at least one of Y, and at least one of Z must be present in particular embodiments.

[0434] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Thus, A, B, and / or C may be replaced by A, B, and C in one sentence and A, B, or C in another sentence. A, B, and / or C means that some embodiments may include A and B, some embodiments may include A and C, some embodiments may include B and C, some embodiments may include only A, some embodiments may include only B, some embodiments may include only C, and some embodiments may include A, B, and C. The term "and / or" is used to avoid unnecessary redundancy.

[0435] While certain embodiments have been described, they have been presented only by way of example and are not intended to limit the scope of the inventions disclosed herein. Thus, the foregoing description does not imply 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; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 396,176

[0001] US 63 / 396,586

[0002] WO 63 / 476,156

[0003]

Claims

[1] 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 being coupled to the controller, the open distal sheath end being configured for insertion into a vasculature of a patient, the open distal sheath end being opposite the open proximal sheath end; and a wire extending from the controller through the open proximal sheath end through the working lumen 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 being 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, wherein the working lumen is configured to slidably receive the wire and to allow passage of a fluid around the wire to chemically treat the treatment segment, wherein, when the system receives a first input, the distal wire end mechanically treats the vessel wall, when the system receives a second input, the system delivers the fluid into the treatment segment, and when the system receives a third input, the system delivers the fluid into a subsequent treatment segment. [2] The system of claim 1, wherein the sheath is retractable to expose the distal wire end. [3] The system of claim 2, wherein the controller includes a motor, a power supply configured to power the motor, and a limit switch electrically coupled to the motor and the power supply, the limit switch enabling power to flow from the power supply to the motor when the sheath is fully retracted. [4] The system of claim 2, wherein the sheath is variably retractable to expose at least a portion of the length of the distal wire end, and wherein the portion of the length of the distal wire end 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] The system of claim 5, wherein the controller includes a motor, a power supply configured to power the motor, and a limit switch electrically coupled to the motor and the power supply, whereby the limit switch prevents power from flowing from the power supply to the motor when the sheath is at least partially extended. [7] The system of claim 1, further comprising at least one distance marker 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 marker is arranged and configured according to the 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 marker and the open distal sheath end. [10] The system of claim 9, wherein the warning track is configured to indicate that the end of a processable treatment length has been reached. [11] The system of claim 1, further comprising a displaceable 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 movable depth marker is sized and configured so that it cannot penetrate an insertion point in the patient. [14] The system of claim 13, wherein the movable depth marker is positioned and configured to maintain a position of the sheath and 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 a deep venous system in the patient. [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 power the motor. [18] The system of claim 17, wherein the proximal wire end is operatively coupled to the motor and the motor is configured to rotate the wire. [19] 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 fluidically coupled to the working lumen, the syringe configured to receive the second input and the third input.

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