Segmented vascular ablation

Abstract

The present disclosure includes a controller and a sheath having a sheath proximal end opening coupled to the controller, a sheath open distal end configured to be inserted into a vascular system of a patient, and a working lumen extending through the sheath. The system may include a guidewire extending from the controller through the working lumen, the guidewire having a guidewire distal end configured to mechanically treat a vascular wall of the treatment segment, a length of the guidewire distal end defining a length of the treatment segment. The working lumen may be configured to slidably receive the guidewire and allow fluid to pass therethrough around the guidewire to chemically treat the treatment segment. The distal end of the guidewire may mechanically treat the vessel wall when the system receives a first input. The system may deliver a fluid when the system receives a second input and / or a third input.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 396,176; filed on August 8, 2022; entitled "Vascular Ablation".

[0003] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 396,586; filed on August 9, 2022; entitled "Vascular Ablation".

[0004] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 476,156; filed on December 19, 2022; entitled "Catheter Guidewire Controller." Technical Field

[0005] The present disclosure relates to systems and methods for treating varicose veins. Background Art

[0006] Mechanochemical ablation (MOCA) is a medical procedure used to treat varicose veins, which are enlarged and twisted veins that usually occur in the legs. This minimally invasive procedure aims to close the affected veins by using mechanical and / or chemical ablation techniques.

[0007] During the procedure, a specialized catheter is inserted through a small incision into the vein with the varicose vein. The catheter has a rotating tip that mechanically agitates (or scrapes, or ablates) the lining of the vein, causing endothelial damage. At the same time, medication is delivered through the catheter, such as a sclerosant, a chemical solution that irritates and closes the vein. This combination of mechanical agitation (or scraping, or ablation) and chemical stimulation induces the closure of the varicose vein, causing it to shrink and eventually be absorbed by the body.

[0008] Mechanochemical ablation is considered a safe and effective alternative to traditional surgical treatments for varicose veins, such as vein stripping or ligation, as well as currently available endovascular alternatives, such as radiofrequency ablation, laser ablation, or glue closure. It is usually performed as an outpatient procedure, and patients can usually resume normal activities shortly after treatment. Summary of the invention

[0009] The present disclosure includes ablation systems (see, for example, Figure 1 ablation system 10 as shown), which includes a controller (see, for example, Figure 1 In some examples, the system includes a sheath (e.g., see Figure 2The sheath 40 shown in the figure comprises an open sheath proximal end, an open sheath distal end, and a working lumen extending from the open sheath proximal end to the open sheath distal end. According to some examples, the sheath proximal end opening is connected to a controller, and the sheath distal end opening is configured to be inserted into the patient's vascular system, and the sheath distal end opening is opposite to the sheath proximal end opening.

[0010] The ablation system may include a guide wire (see, for example, Figure 2 In some examples, the guidewire has a guidewire proximal end (e.g., see guidewire proximal end 1202 as shown in FIG. 12 ) and a guidewire distal end (e.g., see guidewire distal end 1204 as shown in FIG. 12 ) opposite to the guidewire proximal end, and the guidewire distal end is configured to mechanically process the treatment segment (e.g., see guidewire distal end 1204 as shown in FIG. 12 ). Figure 2 The vascular wall of the treatment segment 55 shown, whereby the length of the distal end of the guidewire defines the length of the treatment segment.

[0011] According to some examples, the working lumen is configured to slidably receive a guidewire and allow a fluid to pass therethrough around the guidewire to chemically treat the treatment segment. When the system receives a first input, the distal end of the guidewire can mechanically treat the vessel wall. In some examples, when the system receives a second input, the system delivers the fluid to the treatment segment. According to some examples, when the system receives a third input, the system delivers the fluid to a subsequent treatment segment.

[0012] The present disclosure also includes a method comprising placing a catheter (e.g., see Figure 1 In some examples, the method includes moving the catheter to a first treatment segment (e.g., see FIG. Figure 2 According to some examples, the method includes controlling a motor (e.g., see Fig. 6A A motor 610 is shown being actuated and rotating at least a portion of the catheter in response to actuation of the motor.

[0013] The method may include scraping the first treatment segment for a predetermined amount of time in response to rotating at least a portion of the catheter. In some examples, the method includes moving the catheter to the second treatment segment. According to some examples, the method includes scraping the second treatment segment for a predetermined amount of time in response to rotating at least a portion of the catheter.

[0014] The foregoing and other features and advantages of the invention will be 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

[0015] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate rather than limit the present invention. In the accompanying drawings, like characters consistently represent corresponding features throughout similar embodiments.

[0016] Figure 1 A schematic diagram of an ablation system as it might appear within a patient is shown.

[0017] Figure 2 A side view of an exemplary guidewire within a blood vessel is shown.

[0018] Figure 3 A cross-sectional view of an exemplary blood vessel is shown.

[0019] Figure 4A and Figure 4B A side view of an ablation system according to some examples is shown.

[0020] Figure 5A A perspective view of an example controller is shown.

[0021] Figure 5B According to some examples Figure 5A Side view of the controller.

[0022] Figure 5C Shows Figure 5A A top view of the example controller.

[0023] Fig. 6A A schematic side view of an example ablation system is shown.

[0024] Figure 6B Shows the guidewire exposed Fig. 6A Schematic side view of an ablation system.

[0025] Figure 7 A cross-sectional view of another example controller is shown according to some examples.

[0026] Figure 8 A cross-sectional view of another example controller is shown according to some examples.

[0027] Fig. 9A A cross-sectional view of another example controller is shown according to some examples.

[0028] Fig. 9B According to some examples Fig. 9A Side view of the controller.

[0029] Fig. 9C Shown is a syringe without a syringe according to some examples Fig. 9A A top view of the controller.

[0030] Fig.10A top view of a controller within a sterile package is shown according to some examples.

[0031] Fig.11 A controller including additional features according to some examples is shown.

[0032] Fig. 12A , Fig. 12B and Fig. 12C A side view of an example guidewire is shown.

[0033] Fig.13A , 13B and 13C show exemplary cross-sectional views of the guidewire.

[0034] Fig.14 An exemplary off-axis side view is shown.

[0035] Fig.15 A side view of a guidewire of varying thickness is shown according to some examples.

[0036] Fig.16 A side view of an example guidewire having an angled profile is shown.

[0037] Fig.17 A side view of a guidewire including a twisted wire configuration is shown according to some examples.

[0038] Fig.18 A perspective illustration of an example guidewire including a helical hollow strand configuration is shown.

[0039] Fig.19 A perspective view of an example guidewire including a spring-like configuration is shown.

[0040] Fig. 20 A side view of a guidewire including a cage structure is shown according to some examples.

[0041] Fig.21 A side view of an additional guidewire with the tip off-axis is shown according to some examples.

[0042] Fig.22A , 22B and 22C show various examples of guidewires including non-uniform amplitude profiles.

[0043] Fig.23A An exemplary guidewire comprising a sinusoidal profile is shown.

[0044] Fig. 23B According to some examples Fig.23A Front view of the guidewire.

[0045] Fig.24A An example guidewire comprising a spring-like profile is shown.

[0046] Fig. 24B According to some examples Fig.24A Front view of the guidewire.

[0047] Fig.25A An example guidewire including a profile extending into a third dimension is shown.

[0048] Fig.25B According to some examples Fig.25A Front view of the guidewire.

[0049] Fig.26A , 26B , 26C, 26D, 26E, 26F, 26G and 26H illustrate side views of exemplary proximal features of a guidewire and / or sheath.

[0050] Fig.27A , Fig.27B , Fig.27C , Fig.27D and Fig.27E A side view of exemplary distal features of a guidewire is shown.

[0051] Fig.28A , 28B and 28C show various examples of guidewires including various features at the distal-most end.

[0052] Fig.29A , Fig.29B and Fig.29C A side view of an example guidewire having additional features at the distal end of the guidewire is shown.

[0053] Fig. 30A , 30B , 30C and 30D show side views of example guidewires having additional geometries surrounding the guidewire.

[0054] Fig.31 An exemplary Luer connector is shown.

[0055] Fig.32 A sheath including various features and a guidewire is shown according to some examples.

[0056] Fig.33 An exemplary block diagram for providing power to a motor through a limit switch is shown.

[0057] Fig.34 A flow chart describing an exemplary method of treating venous disease using an ablation system is shown.

[0058] Fig.35 A flow chart depicting a method of controlling a catheter according to some examples is shown.

[0059] Fig.36A flow chart depicting a method of exposing a guidewire from a catheter according to some examples is shown.

[0060] Fig.37 A flow chart depicting an example method of capturing a guidewire into a catheter is shown.

[0061] Fig.38 A flow chart depicting a method of controlling a distal end of a catheter according to some examples is shown.

[0062] Fig.39 A flow chart depicting a method of controlling a motor according to some examples is shown.

[0063] Fig.40 A flow chart depicting a method of providing a fluid through a catheter according to some examples is shown.

[0064] Fig.41 A flow chart depicting a method of segmented mechanical ablation according to some examples is shown.

[0065] Fig.42 A flow chart depicting a method of exposing and enclosing a guidewire in a sheath according to some examples is shown.

[0066] Fig.43 A flow chart is shown depicting a method of limiting motor power input according to some examples.

[0067] Fig.44 A flow chart depicting a method of metering distance in fractionated treatment according to some examples is shown.

[0068] Fig.45 A flow chart depicting a method of segmented mechanochemical ablation according to some examples is shown.

[0069] Fig.46 A flow chart depicting a method for tracking a catheter sheath-to-guidewire separation according to some examples is shown.

[0070] Fig.47 A flow chart is shown depicting additional methods of limiting motor power input according to some examples.

[0071] Fig.48 A flow chart depicting a method of stabilizing a controller body according to some examples is shown.

[0072] Fig.49 A flow chart depicting a method of using a controller with a sterilization package according to some examples is shown.

[0073] Fig.50 A flow chart depicting a method of removably coupling a catheter to a controller according to some examples is shown.

[0074] Component Index

[0075] 10-Ablation System

[0076] 15-Catheter

[0077] 20-Controller

[0078] 30-Guidewire

[0079] 40-Sheath

[0080] 50- Treatment area

[0081] 55-Treatment segment

[0082] 60-Syringe

[0083] 502-Controller Nearside

[0084] 504-Controller Remote

[0085] 506a-Switch

[0086] 506b-Switch

[0087] 508-Display

[0088] 602-Slot

[0089] 604 - Inflatable Tuohy Needle

[0090] 606-Power Supply

[0091] 608-Actuator

[0092] 610-Motor

[0093] 702-Main

[0094] 704-Saddle

[0095] 706-T-joint

[0096] 708-Proximal end of the body

[0097] 710-Main body far end

[0098] 712-First Direction

[0099] 802-Main

[0100] 804-T-joint

[0101] 806-Proximal end of the body

[0102] 808-Main remote

[0103] 810-First Direction

[0104] 902-Main

[0105] 904-T-joint

[0106] 906-Proximal end of the body

[0107] 908-Main remote end

[0108] 910-Pull Tab

[0109] 912-Light Emitting Diode (LED)

[0110] 914-Actuator

[0111] 916-First Direction

[0112] 1002-Sterile Package

[0113] 1004-Slit

[0114] 1102-Extendable feet

[0115] 1104-Torque knob

[0116] 1106-arm

[0117] 1202-Proximal end of guidewire

[0118] 1204-distal end of guidewire

[0119] 1206-Hole

[0120] 1208-Middle axis

[0121] 1210-Counterweight end

[0122] 1302-Circular cross-section profile

[0123] 1304 – Flat bar cross section profile

[0124] 1306-Triangular cross-section profile

[0125] 1502-thick diameter

[0126] 1504-thin diameter

[0127] 1602-Triangle Sinusoidal Profile

[0128] 1604-Triangle Peak

[0129] 1702-Stranded Wire

[0130] 1802-Spiral Hollow Strand

[0131] 1902-Spring-like structure

[0132] 2002-Cage Structure

[0133] 2302-Sinusoidal Section Profile

[0134] 2402-Spring-like cross-section profile

[0135] 2502-3D Section Profile

[0136] 2602-Proximal characteristic structure

[0137] 2604-Balloon

[0138] 2606-Biased Balloon

[0139] 2608-Cage

[0140] 2610-Slotted Entity

[0141] 2612-Impeller

[0142] 2614-Sponge Entity

[0143] 2616-Sine Actuator

[0144] 2702-Remote characteristic structure

[0145] 2704-Single Blade Impeller

[0146] 2706-Cage

[0147] 2708-Slotted Entity

[0148] 2710-Impeller

[0149] 2712-Sponge Entity

[0150] 2802-hemispherical end

[0151] 2804-Offset weight end

[0152] 2806-Balloon end

[0153] 2902-Assisted Guide Wire

[0154] 2904-Heating Guide Wire

[0155] 2906-Porous Surface Geometry

[0156] 3002a - Additional Geometry

[0157] 3002b-Additional Geometry

[0158] 3002c-Additional Geometry

[0159] 3002d-Additional Geometry

[0160] 3102-Luer connector

[0161] 3104-Luer port

[0162] 3202-Donut

[0163] 3204-Distance Marker

[0164] 3206-Warning Track

[0165] 3302-Power Supply

[0166] 3304-Actuator

[0167] 3306-Limit switch

[0168] 3308-Motor

[0169] 3310-LED

[0170] 3312-Resistors

[0171] 3400, 3402, 3304, 3406, 3408, 3410 and 3412 - method steps 3500, 3502 and 3504 - method steps 3600, 3602 and 3604 - method steps 3700, 3702 and 3704 - method steps 3800, 3802 and 3804 - method steps 3900, 3902, 3904 and 3906 - method steps 4000 and 4002 - method steps 4100, 4102, 4104, 4106, 4108 and 4110 - method steps 4200, 4202, 4204, 4206 and 4208 - Method steps 4300, 4302, 4304 and 4306 - Method steps 4400, 4402 and 4404 - Method steps 4500, 4502, 4504, 4506 and 4508 - Method steps 4600, 4602 and 4604 - Method steps 4700, 4702, 4704, 4706, 4708 and 4710 - Method steps 4800, 4802 and 4804 - Method steps 4900, 4902, 4904 and 4906 - Method steps 5000, 5002, 5004, 5006, 5008, 5010 and 5012 - Method steps DETAILED DESCRIPTION

[0172] The present disclosure describes systems and techniques for treating vascular disease such as varicose veins. Some existing prior art systems involve the use of highly complex interventional devices (e.g., ablation catheters) that require extensive user training for correct and effective use due to the device's requirements for the user to multitask while performing complex dexterity techniques.

[0173] For example, some sclerotherapy catheters require a user (e.g., a clinician) 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 operating a second, different manual control to longitudinally translate (e.g., advance distally and / or withdraw proximally) the catheter to disperse the chemical agent throughout the target vessel. In some such examples, the auxiliary control includes only the clinician manually pushing and / or pulling the catheter through the patient's vasculature. Such systems are not widely considered to be user-friendly or patient-friendly.

[0174] In addition, some vascular treatment devices incorporate mechanical-based ablation features in addition to or in lieu of chemical-based ablation alone. In many cases, mechanical ablation improves the effectiveness of the treatment, but greatly complicates the operation of the device by not only incorporating another manual control to actuate the movement (e.g., rotation) of the ablation device's mechanical agitator, but also requiring the clinician to consciously manage the relative rates between all three aspects - i.e., the rate of longitudinal translation through the vessel, the rate of fluid infusion, and the rate of mechanical agitation.

[0175] In other words, many conventional sclerotherapy treatments and devices require the clinician to manually inject a "steady" stream of sclerotherapy agent, manipulate a separate controller (e.g., squeeze a trigger) to actuate a scraping element to mechanically disturb the vessel wall, and also simultaneously and manually withdraw the catheter at a consistent rate. The cognitive load and skill required of the user to complete all of these steps simultaneously is high, resulting in a greater potential for error due to a mismatch between the amount of mechanical ablation performed and the amount of sclerotherapy agent delivered to the target treatment site and the inconsistent withdrawal rate of the catheter. This not only creates a perception that the device is difficult to use, but can also result in inferior or incomplete vein ablations, for example, if an insufficient amount of sclerotherapy is delivered, or if an insufficient amount of mechanical scraping is performed with a withdrawal rate that is too fast.

[0176] In addition, the disclosure describes systems and methods for controlling a catheter (which may be a catheter including a guidewire). These controls include exposing the guidewire from the catheter lumen and exposing the guidewire to handle the treatment site, and the directional control of the catheter head. Some existing solutions include using a steerable catheter tip and an electronically based delivery / guidewire deployment system. The disclosure allows manual control of the deployment of the guidewire, as well as the directional control of the distal catheter head.

[0177] Figure 1 A schematic diagram of an ablation system 10 is shown as it may occur during a procedure on a patient's leg. A sheath 40 and a guidewire 30 are introduced into a treatment site 50 via direct access to the vein being treated. Here, the guidewire 30 is shown released from the sheath 40 prior to or during the procedure. The operator initiates the procedure from the controller 20.

[0178] Figure 2 A side view of a guidewire 30 within a blood vessel is shown, according to some examples. Figure 3 An exemplary cross-sectional view of a blood vessel is shown to better illustrate the intima, media, and adventitia. Figure 2 As shown, the guidewire 30 may extend through the working lumen of the sheath 40. The figure shows that the guidewire 30 penetrates and / or disturbs the intima and physically contacts the media at the treatment site 50. The intima at the location affected by the guidewire rotation is thereby disrupted.

[0179] Because the length of the guidewire 30 exposed to the treatment site 50 is able to contact the length of the blood vessel, rather than just the periphery of the blood vessel, the treatment site 50 is generally referred to as the treatment segment 55 throughout this disclosure. This ability to treat the treatment segment 55 rather than just the periphery of the treatment site 50 enables segmented mechanical or mechanochemical ablation. Since the operator is now able to treat the treatment segment 55 at a time, there is no need to withdraw the catheter 15 while injecting the drug into the treatment site 50. Therefore, the operator can now focus on injecting the drug alone at an appropriate rate, and after injecting the drug, move the catheter 15 again during the period when the drug is not administered. This can exponentially reduce the difficulty of such a procedure because the operator no longer needs to control multiple application treatment rates (i.e., injection rate and catheter 15 withdrawal rate) to divide their attention, but only one treatment application rate at a time. In other words, this allows the procedure to be divided into injection and withdrawal actions, and never needs to perform these two actions at the same time. In addition, throughout this disclosure, the term "drug" or "hardening agent" is used. It should be understood that any fluid can be delivered in combination with any part of the present disclosure that can deliver such a fluid.

[0180] Figure 4A and Figure 4B A side view of an example of an ablation system 10 is shown. In some examples, the ablation system 10 includes a controller 20, which in various embodiments Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C The ablation system may further include a catheter 15 , and in some examples, the catheter 15 includes a sheath 40 and a guidewire 30 extending through the sheath 40 .

[0181] For the purpose of this disclosure, in some examples, the terms "catheter" and "sheath" are used interchangeably, and it should be understood that a catheter can be more than just a sheath, such as an example including a guidewire. In addition, it should be understood that the description of a catheter can also include an ablation system without a sheath or a guidewire.

[0182] The sheath 40 may extend from the controller 20. In some examples, the guidewire 30 extends through a working lumen in the sheath 40. The guidewire 30 may be stored within the sheath 40 while the catheter 15 is passed through the patient's vasculature until it reaches the treatment site 50, at which time the sheath 40 may be pulled back or retracted to expose the guidewire 30. 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 Various examples of guidewire 30 are shown and discussed in more detail in . Figure 4A Also shown is a syringe 60 in fluid communication with the controller 20 at the distal end of the controller 20. The syringe 60 can provide a drug, such as a sclerosant, through the catheter 15, the sheath 40, and / or the guidewire 30.

[0183] Figure 5A A perspective view of an example of the controller 20 is shown, and Figure 5B and 5C They are shown respectively Figure 5A The side view and top view of the controller 20 are shown in FIG. Figure 5A , 5B 5C, the controller 20 may include a controller proximal end 502 and a controller distal end 504 opposite the controller proximal end 502. The controller 20 may also include at least one actuator, as seen in actuator 506a and actuator 506b. As shown, multiple actuators may be implemented in or on a single controller 20.

[0184] exist Figure 5A , 5B 5C, actuator 506a is present at the base of controller 20 (controller proximal end 502). Another actuator 506b is shown at the top of controller 20 near controller distal end 504. These actuators can operate as a kind of "AND" gate, where both actuators must be activated (i.e., switched to the "on" position) in order for controller 20 to turn on. This is useful as a safety precaution during transportation of controller 20 so that controller 20 is not accidentally turned on.

[0185] In some examples, actuator 506a or actuator 506b can be used as a power-activated actuator, thereby providing power to any internal circuits (such as a motor). In such an example, the other actuator (i.e., actuator 506b, if actuator 506a is a power-activated actuator) can be a rotation-activated actuator, thereby telling the motor to start rotating in the described example. However, if desired, and as will be described in Fig. 9A , Fig. 9B and Fig. 9C As further described and discussed in detail in , using a single actuator will also work. The actuator can be any type of actuator, such as a button, a switch, a touch screen on a user interface, etc.

[0186] Figure 5A and 5B Also shown is a display 508. Display 508 may provide information to the operator of controller 20, such as the amount of time that has elapsed during the procedure, or the amount of time remaining if controller 20 is programmable for a set duration for the operation.

[0187] Specifically, in view of mechanochemical ablation (or only mechanical ablation without drug delivery), the display 508 can facilitate the segmented ablation technique. For example, once the catheter 15 has been inserted and positioned at the correct treatment site 50, and the operator has opened the device using the actuator, the display can count down the time until the treatment site has been sufficiently abraded so that the drug should be delivered. Additionally or alternatively, the display 508 can also count down the time during which the drug should continue to be delivered, at the end of which the operator interrupts the injection of the drug.

[0188] In examples where the treatment site 50 includes a treatment segment 55 , the display 508 may inform the operator when treatment of the treatment segment 55 is complete, which would inform the operator that it is time to move the catheter 15 to the next or subsequent treatment segment 55 .

[0189] Fig. 6A A schematic side view is shown showing the guidewire 30 enclosed in a sheath 40 . Figure 6B Shows Fig. 6A , but with the guidewire 30 exposed from the sheath 40. Fig. 6A and Figure 6B As seen in both, the controller 20 can include a slot 602 in the distal end 504 of the controller. At the proximal end of the sheath 40, there can be an inflatable Tuohy needle 604. The guidewire 30 is delivered to the treatment site 50 while being enclosed in the sheath 40 (in some examples). In other examples, the sheath 40 is detachable from the controller 20 and can be delivered to the treatment site 50 before the guidewire 30 is delivered to the treatment site 50.

[0190] Once the guidewire 30 reaches the treatment site 50, the guidewire 30 can be exposed from the sheath 40. In this regard, the sheath 40 can be retracted from the guidewire 30, whereby the sheath moves away from the treatment site 50 while leaving the guidewire 30 in place in the treatment site 50. The operator can manually perform the pulling or retracting action on the sheath 40 (e.g., Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C ), the sheath 40 is then rotated to lock the inflatable Tuohy needle 604 in the slot 602. This locking of the inflatable Tuohy needle 604 in the slot 602 can prevent the sheath 40 from moving axially during surgery.

[0191] If you can also Fig. 6A and Figure 6B As seen in FIG. 6 , the controller 20 may include a motor 610, such as an electric motor, that may be activated by an actuator 608. A power source 606 is also included within the controller 20 (although the power source 606 may be external to the controller 20 if desired). The power source 606 allows the actuator 608 to connect power to the motor 610, thereby causing rotation of the motor 610, and thereby causing rotation of the guidewire 30.

[0192] Throughout this specification, the motor 610 may be described as being coupled to the guidewire 30 and / or the catheter 15 and rotating on the guidewire 30 and / or the catheter 15. These are used interchangeably in this specification because any component may be a component that is coupled to the motor 610 and rotates thereby. In addition, there may be an intervening component between the motor 610 and the guidewire 30 and / or the catheter 15. For example, the guidewire 30 and / or the catheter 15 may be detachably or fixedly coupled to one or more hypotubes. Furthermore, these hypotubes may again be detachably or fixedly coupled to the motor 610.

[0193] It should be understood that Fig. 6A and 6B The schematic side view of the controller 20 shown in FIG. Figure 5A , 5B , any of the various controller 20 examples shown and described in 5C and as will be described in Figure 7 , 8 , 9A, 9B and 9C are used in combination with any of the various controllers 20 shown and described.

[0194] Figure 7 2 shows a cross-sectional view of a controller 20 according to some examples. The controller 20 may include a body proximal end 708 and a body distal end 710 opposite the body proximal end 708. Figure 7, but the controller 20 may be removably coupled to the catheter 15 at the distal end 710 of the body.

[0195] like Figure 7 As seen in FIG. 1 , the controller 20 may include a flat or at least partially flat bottom portion, thereby permitting the controller 20 to be placed on a desktop or other work surface to facilitate operation of the controller 20. Figure 7 As shown in Figure 5A , 5B 5C, the controller 20 may be handheld. This may allow the controller 20 to be operated in a two-handed manner, where one hand would provide support for the controller 20 and the other hand would operate the controller 20. The controller 20 may also be removably coupled to any work surface not specifically described herein, i.e., the controller 20 need not be placed on a table or held in the operator's hand in order for the controller 20 to be operable.

[0196] If you can also Figure 7 As seen in FIG. 1 , the controller may include a body 702 and a saddle 704 slidably coupled to the body 702. The saddle 704 is slidably movable in a first direction 712 and in a direction opposite to the first direction 712. Figure 7 As shown, the first direction 712 is considered to be the direction of movement from the body proximal end 708 to the body distal end 710. The T-joint 706 can be disposed within the body 106 of the controller 20 and at least partially surrounded by the central portion of the saddle 704. The T-joint can be slidably movable in the first direction 712 and opposite to the first direction 712 in response to movement of the saddle 704. In the example of the controller 20 including the catheter 15, the catheter 15 is removably coupled to / through the body distal end 710, and the catheter 15 can also be removably coupled to the T-joint 706.

[0197] Such a catheter 15 may include a guide wire 30 for scraping the vessel wall at the treatment site 50, such as Figure 2 In some procedures, it is desirable to keep the guidewire 30 contained within the catheter body or sheath 40 until the guidewire 30 has been delivered to the treatment site 50 to prevent premature scraping of the vessel wall, or in other words, to prevent scraping of the vessel wall that is not intended for treatment. Once the catheter 15 reaches the desired treatment location, the saddle 705 can be moved along the first direction 712 to expose or surround the guidewire 30.

[0198] In other examples, the catheter 15 is tracked or moved to the treatment site 50, whereby the catheter exposes the guidewire 30. This can allow for greater design flexibility, wherein the guidewire 30 comprises a shape that is larger than the opening of the sheath 40. In some examples, once the guidewire 30 is surrounded by the sheath 40, the sheath 40 responds by expanding slightly to receive the guidewire 30 within its confines. This can limit the flexibility of the sheath 40, and therefore, exposing the guidewire 30 while routing the catheter 15 to the desired treatment site 50 can allow for greater flexibility to pass through the tortuous vasculature of the patient.

[0199] Throughout the specification, the catheter 15 is disclosed as including a guidewire 30. However, it should be understood that the present description is not limited to the use of a guidewire 30. The present description also enables the use of a hypotube, a catheter shaft, or a combination thereof, and in combination with a guidewire 30.

[0200] like Figure 7 As shown in the example controller 20 of FIG. 1 , the saddle 704 is present at the distal end 710 of the body. At the position, the guidewire 30 is held within the lumen of the sheath 40. When the operator moves the saddle 704 toward the proximal end 708 of the body opposite to the first direction 712, the sheath 40 can be pulled back around the guidewire 30, thereby exposing the guidewire 30. At this point, the guidewire 30 can be used to scrape the vessel wall.

[0201] The body 702 may include an actuator (such as Figure 5A , 5B and 5C described and discussed actuator 506a or 506b, such as Fig. 6A and 6B The actuator 608 described and discussed in Fig. 9A , 9B In some examples, the actuators 506a, 506b, 608, and / or 914 control circuits and / or motors within the body 702 (such as, for example, Fig. 6A and Figure 6B The motor 610 described and discussed in the Fig.33 308 discussed in further detail in the present invention). The actuators 506a, 506b, 608 and / or 914 can control the rotation of the guidewire 30 to promote scraping of the vessel wall. When scraping is completed, the operator can move the saddle 704 in the first direction 712 to push the sheath 40 forward again, thereby enclosing (or capturing, re-inserting, etc.) the guidewire 30 within the sheath 40 again, thereby allowing the catheter 15 to be safely removed from the patient's vascular system.

[0202] Figure 7Also shown is a syringe 60 removably coupled to a T-joint 706 via a saddle 704. In examples where a catheter 15 is present, the syringe 60 may be in fluid communication with the catheter 15. In some examples, the catheter 15 includes a fluid lumen (such as a working lumen through the sheath 40) to allow fluid from the syringe 60 to pass through the catheter 15 when the syringe 60 is depressed. This may be useful in procedures such as sclerotherapy, where it is advisable to deliver a fluid medication such as a sclerosant to the treatment site 50 before, simultaneously with, or after scraping the vessel wall.

[0203] The syringe 60 is depicted as extending perpendicular to the first direction 712. This is by way of example only, and it should be understood that the syringe 60 may be positioned at any angle to provide optimal ergonomics and / or comfort for the operator. In some examples, the syringe 60 serves as a type of handle for the operator, allowing easy control of movement of the saddle 704 and the T-joint 706 in the first direction 712 and in a direction opposite to the first direction 712.

[0204] The saddle 704 and the T-joint 706 can slide due to manual control of the syringe 60, but the T-joint 706 can also be operated by directly controlling the saddle 704, such as by the operator pushing the saddle 704 with one of their hands while operating the depression of the syringe 60 with their other hand. Fig. 9A , Fig. 9B and Fig. 9C As explored in, the saddle 704 may also include a pull tab (such as Fig. 9A , Fig. 9B and Fig. 9C The pull tab 910 of the embodiment of the present invention is provided to facilitate manual movement of the saddle 704. In these examples, the syringe 60 will move with the T-connector 706, but will not be the cause of such movement.

[0205] In addition, although not in Figure 7 706, but in some examples, the syringe 60 may be non-removably coupled to the T-joint 706. In such an example, a squeeze tube / infusion tube may connect the syringe 60 to the removably coupled catheter 15. This would allow the syringe 60 to not be coupled to the T-joint 706, and therefore not be coupled to the controller 20. Instead, the syringe 60 would be coupled to the flexible tube, allowing greater freedom of movement to separate the syringe 60 from the controller 20 when desired.

[0206] Figure 7Also shown is a slot in the saddle 704, which is perpendicular to the first direction 712 and extends at least partially around the saddle 704. The slot can allow the syringe 60 to perform a rotational motion around the body 702. In some examples, when the operator rotates the syringe 60 around the body 702, it generates torque on the guidewire 30 (which may be a guidewire 30 in a detachably coupled catheter 15), thereby allowing manual control of the distal end of the guidewire 30. This can allow the operator to finely move such a distal end of the guidewire 30 in the treatment site 50 to make better scraping contact with the vessel wall and / or facilitate traversing the patient's tortuous vasculature.

[0207] Although not in Figure 7 , but the T-connector 706 may include a Luer interface (such as a Luer interface (luer) 3104, as described below in Fig.31 ). The luer interface can be configured to removably couple the syringe 60 to the T-connector 706. In examples including such a luer interface, the luer interface can be configured to rotate about a direction perpendicular to the first direction 712. The rotation can include any rotation angle, including a full 360 degree circumferential rotation around the body 702.

[0208] Once the syringe 60 has been removably coupled to the Luer interface, the rotational motion may be limited to prevent excessive rotation of the syringe 60. In the described configuration, the syringe 60 may be configured to control the rotation of the Luer interface. Similar to the above disclosure, the rotation of the Luer interface may generate torque on the guidewire 30, thereby allowing manual control of the distal end of the guidewire 30.

[0209] The Luer may have an O-ring on the proximal side to help prevent fluid leakage during infusion. The O-ring may also be clamped on the guidewire 30 while connected to the catheter sheath 40, so that when the Luer interface rotates, the catheter sheath 40 also rotates, and the O-ring of the Luer interface will attempt to rotate the guidewire 30 at the same time.

[0210] Although not in Figure 7 , but in some examples, the Luer interface is not present in the device body. In such examples, the Luer interface can be a ready-made stopcock or three-way valve that receives the catheter sheath 40. This will allow the user to completely remove the sheath 40 from the device while leaving the guide wire 30 in place. This can facilitate the use of the device, such as a guidewire catheter, when another catheter sheath 40 is in place. The second catheter sheath 40 may not be assembled adjacent to the pre-existing catheter sheath 40 in the vascular system, so by removing the catheter sheath 40 from the device, the guide wire 30 can still be inserted into the treatment site 50.

[0211] Another advantage of being able to remove the sheath 40 is that the sheath 40 can be tracked to the treatment site first. In addition, removing the catheter sheath 40 from the guidewire 30 can allow the sheath 40 to travel over the already placed guidewire. Once the catheter sheath 40 is placed, the guidewire (if present) can be removed, allowing the device to be further advanced into the vascular system.

[0212] Figure 8 A cross-sectional view of controller 20 is shown according to some examples. Figure 8 An example controller with Figure 7 There are many similarities between the example controllers of FIG. 20 , most of which will be reiterated here. The controller 20 may include a proximal body end 806 and a distal body end 808 opposite the proximal body end 806. Although not described herein, the controller 20 may include a proximal body end 806 and a distal body end 808 opposite the proximal body end 806. Figure 8 , but the controller 20 may be removably coupled to the catheter 20 at the body distal end 808 .

[0213] like Figure 8 As shown, the controller 20 may include an at least partially flat bottom portion, thereby allowing the controller 20 to be placed on a desk or other work surface for ease of use of the controller 20. Figure 8 , but as previously shown in Figure 5A , 5B As described in Figures 5 and 5C, the controller 20 can be handheld, with two-handed operation using the controller 20, where one hand will provide support for the controller 20 and the other hand will operate the controller 20. The controller 20 can also be removably coupled to any other work surface not described herein, that is, the controller 20 does not need to be specifically placed on a table or held in the operator's hand in order for the controller 20 to be operable.

[0214] like Figure 8 As can be seen in FIG. 8 , the controller 20 may include a main body 802. Figure 7 The example controller 20 is different, Figure 8 The example controller 20 of the embodiment does not include a saddle slidably coupled to the body 802. In the described example, a T-joint 804 can be disposed within the body 802 of the controller 20. The T-joint 804 can be slidably movable in a first direction 810 and opposite to the first direction 810, wherein the first direction 810 is a direction of movement from the body proximal end 806 to the body distal end 808. In the example of the controller 20 that includes a catheter removably coupled to and / or passing through the body distal end 808, the catheter can be further removably coupled to the T-joint 804.

[0215] Figure 8Also shown is a T-joint 804, which is present at a point closest to the proximal end 806 of the body. At this point, the sheath 40 will be retracted around the guidewire 30, exposing the guidewire 30 to the treatment site 50. In some examples, the catheter can be delivered in this configuration, but it is likely that the guidewire 30 will be delivered to the treatment site 50 while still within the sheath 40 to avoid inadvertently scraping a vascular location that is not the treatment site 50. After the treatment has been performed, the operator can move the T-joint 804 along the first direction 810 to cover the guidewire 30 again, allowing the catheter to be safely removed from the patient's vasculature.

[0216] Figure 8 Also shown is a syringe 60 removably coupled to the T-joint 804. If / when a catheter is present, the syringe 60 can also be in fluid communication with the catheter. In some examples, the catheter includes a fluid lumen that allows fluid from the syringe 60 to pass through the catheter when the syringe 60 is depressed. As previously described, this is useful for procedures such as sclerosants, where it is recommended to use a fluid medication such as a sclerosant before, simultaneously with, or after scraping the vessel wall.

[0217] The syringe 60 is shown extending perpendicular to the first direction 810. This is exemplary only, and it should be understood that the syringe 60 can be placed at any angle to provide the best ergonomics or comfort for the operator. In some examples, the syringe 60 acts as a type of handle for the operator, allowing the T-joint 804 to be easily controlled to slidably move in both the first direction 810 and the direction opposite to the first direction 810.

[0218] Fig. 9A Cross-sectional views of additional example controllers are shown. Fig. 9B Shown from the side view Fig. 9A The controller 20, and Fig. 9C The top view shows Fig. 9A A controller of , wherein the injector 60 is not present. Similar to Figure 7 and Figure 8 The controller 20, Fig. 9A , Fig. 9B and Fig. 9C The controller 20 includes a body 902 having a body proximal end 906 and a body distal end 908 opposite the body proximal end 906. It can be seen that the beginning of the catheter 15 (not labeled but shown) enters the body 902 through the body distal end 908.

[0219] In the example, the T-shaped connector 904 is shown as being at least partially located within the body 902. As previously described, the T-shaped connector 904 can be or include a Luer connector and a Luer interface for removably receiving the syringe 60. The T-shaped connector can be coupled to a saddle, such as Figure 7 of saddle 704. However, Fig. 9A , Fig. 9B and Fig. 9C The saddle in FIG. 9 is mostly obscured by the body 902 because the saddle is at least partially, if not mostly, located within the body 902. However, portions of the saddle extend from the sides of the body 902, and these portions are shown as pull tabs 910. It should be understood that the decision to use the term "one or more pull tabs" is merely a lexicographical choice and may be replaced with any other suitable term, such as "one or more finger pads" or equivalent.

[0220] Similar to Figure 7 and Figure 8 According to the disclosure, the controller 20 may be able to manipulate the sheath 40 around the guidewire 30 . Fig. 9A and 9B The syringe 60 is shown with a T-fitting 904 positioned toward the proximal end 906 of the body. Fig. 9C Although the syringe 60 is not shown, a T-shaped connector 904 is also shown positioned toward the body proximal end 906. In all cases, this may indicate that the sheath 40 is fully retracted around the guidewire 30, thereby exposing the guidewire 30. This may, but does not necessarily, indicate that the catheter 15 is at the treatment site 50 and the guidewire 30 has been exposed for providing treatment.

[0221] Once treatment has been completed, the syringe 60 and the T-connector 904 can be pushed along a first direction 916 extending from the proximal end 906 of the body to the distal end 908 of the body. Figure 7 , it is discussed how the operator manipulates the saddle 704 itself in order to push and pull the syringe 60 and the T-connector 904. Similarly, in Fig. 9A , 9B In 9C, the pull tab 910 may be manipulated in place of or in addition to the syringe 60 and T-shaped connector 904. In the described example, pushing the syringe 60, T-shaped connector 904, and / or pull tab 910 causes the sheath 40 to extend around the guidewire 30, thereby enclosing or capturing the guidewire 30. In the described configuration, the guidewire 30 may be in a less expanded state, thereby allowing for easier or safer removal of the catheter 15 from the patient (or insertion into the patient, if this occurs prior to delivering therapy).

[0222] In contrast to the pushing action, once the catheter 15 has been delivered to the treatment site 50, the operator can then pull the syringe 60, the T-joint 904, and / or the pull tab 910 to retract the sheath 40. This retraction of the sheath 40 exposes the guidewire 30, and in the case where the distal end of the guidewire 30 includes a shaped profile, the guidewire 30 can be expanded into the shaped profile (or further expanded into the shaped profile as the case may be) to contact the vessel wall, thereby allowing scraping to occur during treatment.

[0223] Fig. 9A , 9B 9A and 9C also include a light emitting diode (LED) 912 (labeled in 9A and 9C). LED 912 can be used to convey an array of information to the operator. For example, LED 912 can indicate that the device is receiving power or is turned on. LED 912 can indicate that the sheath 40 is fully retracted around the guide wire 30, thereby indicating that the guide wire 30 is ready to be rotated to provide a scraping treatment.

[0224] Throughout this disclosure, reference is made to segmented mechanical or mechanochemical ablation. In these or other cases, LED 912 may indicate the treatment time to the operator. For example, the operator may wish to provide mechanical agitation to the treatment segment 55 for a set period of time before moving to a subsequent treatment segment 55. In these cases, LED 912 may illuminate to indicate that the treatment time has elapsed and it is time to move to a subsequent treatment segment 55. Or, perhaps, LED 912 is continuously illuminated, and LED 912 is turned off to indicate that the treatment time has elapsed.

[0225] In mechanochemical ablation, it is often desirable to inject a drug, such as a sclerosant, at a specific rate. In these cases, LED 912 may illuminate or turn off, as appropriate, to indicate that mechanical ablation has occurred for the desired amount of time and it is time to begin injecting the drug into treatment segment 55. Likewise, LED 912 may indicate that the injection time has elapsed and it is time to move catheter 15 to a subsequent treatment segment 55.

[0226] Although in Fig. 9A , 9B 9C shows one LED 912, but it should be understood that multiple LEDs 912 may be present in the device and may be used for a number of different purposes. For example, although not explicitly labeled, Figure 8 Two LEDs are shown on the body 802, near the location of the syringe 60 and the T-connector 804. These LEDs 912 may be labeled to prevent operator confusion.

[0227] Additionally or alternatively, the controller 20 may include a display (such as Figure 5A , 5B5C) or some sort of alarm or other noise maker for the purpose of indicating treatment time to the operator. In the case of an alarm or another noise maker, the operation will be similar to that of LED 912 - the alarm may sound to indicate the end of mechanical ablation of a treatment segment 55, the end of injection of medication into a treatment segment 55, the time to move to a subsequent treatment segment 55, and / or the end of the entire treatment. The display may be performed in much the same manner, while also indicating how much time is left in each of these steps.

[0228] Finally, in Fig. 9A , 9B Also seen in 9A and 9C (labeled only in 9A and 9C) is an actuator 914. Actuator 914 can be any device capable of receiving input from an operator, such as a switch, button, lever, touch screen, etc. Actuator 914 can be used for one or more purposes, including but not limited to opening and closing the device and turning a motor within the device on and off. Although in Fig. 9A , Fig. 9B and Fig. 9C One actuator 914 is shown in FIG. 1 , but it should be understood that multiple actuators 914 may be present on the device for different purposes, such as Figure 5A , Figure 5B and Figure 5C Actuators 506a and 506b.

[0229] Fig.10 1002. Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C Any controller 20 shown and described in and other possible exemplary controllers 20 may be operated in conjunction with the disclosure of sterile package 1002. Likewise, it should be understood that 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.25AAny combination of the catheter 15 , guidewire 30 , and sheath 40 shown and described in, as well as other potential example guidewires 30 , may operate in tandem with the disclosure of the sterile package 1002 .

[0230] like Fig.10 As shown, the controller 20 can be mounted in a cavity or recess of the sterile package 1002. A space for the catheter 15 to reside is also provided in the sterile package 1002, but Fig.10 Shown is how the device appears when in use rather than when in storage. A slit 1004 may be provided in the sterile package 1002 through which the catheter 15 may fit. This may allow the controller 20 to be operated from within the sterile package 1002 while the catheter 15 leaves the sterile package 1002 for insertion into a patient.

[0231] Although the reference "slit 1004" is used throughout this disclosure, it should be understood that any other equivalent void in the sterile package 1002, such as a passage or opening, may be used.

[0232] In some examples, the catheter 15 can be removed from the controller 20 to be placed through the slit 1004. In other examples, the slit 1004 can slidably receive the catheter 15 when the catheter 15 is already coupled to the controller 20. In either case, the controller 20 can be operated from within the sterile package 1002, allowing the operator to perform treatment without the need for a sterile drape.

[0233] In examples where the catheter 15 is not removably coupled to the controller 20, the entire ablation system 10 may need to be sterilized between treatments. However, in examples where the catheter 15 is removably coupled to the controller 20, the catheter 15 may be sterilized separately without the need to sterilize the controller 20 between treatments. This may help reduce waste by allowing the controller 20 to be reused.

[0234] In addition, the catheter 15 can be made disposable (which may mean that in the case where the catheter 15 includes a sheath 40 and a guidewire 30, the sheath 40 and / or the guidewire 30 are disposable). This can greatly reduce costs and waste generation because the controller 20 can be reused between treatments and the catheter 15 can be discarded after use. In addition, the operator may not need to sterilize the drape, and the surface of the controller 20 placed in the sterile package 1002 may not need to be completely sterilized (it can simply be wiped) because the controller 20 will not be in direct contact with these surfaces.

[0235] In any examples where the catheter 15 is removably coupled to the controller 20 , the controller 20 may be packaged separately within the sterile package 1002 , thereby allowing the controller 20 to be sold separately from the catheter 15 .

[0236] Additionally, the sterile package 1002 can be "chip-clipped" along the wall for quick and easy access, regardless of whether the catheter 15 is removably coupled to the controller 20. This will allow operators to quickly obtain the controller 20 without having to sift through a store or cartons of devices and catheters to find the device they need.

[0237] Fig.11 A top view of an example ablation system 10 is shown. Fig.11 As shown, the controller 20 may include an expandable foot 1102. The expandable foot 1102 may be meshed or otherwise configured to allow an operator to control how wide the expandable foot 1102 is relative to the base of the controller 20. By extending the expandable foot 1102, additional stability may be provided to the controller 20, thereby preventing the controller 20 from tipping over on its side due to external forces.

[0238] It should be understood that Fig.11 The extendable legs 1102 shown may be used with Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C Any of the various controller 20 examples shown and described in the accompanying drawings, as well as any additional controllers not specifically shown herein, may be used in combination.

[0239] This may prove particularly useful in examples where the motor is located below the T-joint / saddle location, resulting in a shorter length but taller height for the controller 20. This shorter length and taller height footprint may result in the controller 20 having a higher center of gravity, making it more susceptible to tipping over, but the extendable feet 1102 may prevent this from occurring. In such instances where the motor is located below the T-joint / saddle location, gears may be used to create a gear ratio so that the rotation of the catheter 15 and / or guidewire 30 may be controlled to a desired rotational speed.

[0240] Fig.11 Also shown is a torque knob 1104. The torque knob 1104 can allow the operator to provide torque to the catheter 15 and / or the guidewire 30, thereby adjusting the traversing direction of the distal end of the catheter 15 and / or the guidewire 30. This is similar to Figure 7 However, instead of Figure 7In the embodiment shown and described in the drawings, the need to rotate the syringe 60 around the body 702, the torque knob 1104 can provide a simple method of controlling these distal ends of the catheter 15 and / or the guidewire 30 without adjusting the syringe 60 at all. Again, the newly generated torque can allow the operator to perform fine movement of the distal end of the catheter 15 and / or the guidewire 30 in the treatment site 50 to make better scraping contact with the vessel wall, and / or to facilitate traversing the tortuous vascular system of the patient. Such a torque knob 1104 can work in conjunction with the described controller by using a dual-axis motor or an example in which the motor is located below the T-joint / saddle.

[0241] It should be understood that Fig.11 The torque knob 1104 shown can be used with the Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C Any of the various controller 20 examples shown and described in the specification and described herein, as well as any additional controllers not specifically shown herein, may be used in combination.

[0242] Finally, if Fig.11 As shown, the controller 20 may include an arm 1106. In an example where the controller 20 is positioned so that the catheter 15 and / or guidewire 30 folds back on itself prior to insertion into the patient, the arm 1106 may help prevent the catheter 15 and / or guidewire 30 from kinking, which may prove detrimental to any fluid delivery (e.g., delivery of a drug). The arm 1106 may further set a radius at which the catheter 15 is held away from the controller 20. Additionally or alternatively, the arm 1106 may be used as a catheter clamp to hold the catheter 15 in place during treatment. The arm 1106 may further prevent the device from operating in an aggressive radius, which may have a negative impact on the performance of the device. The arm 1106 may also prevent the ablation system 10 from becoming twisted (i.e., the ablation system 10 may twist on itself when the motor is running, and the arm 1106 may prevent this).

[0243] It should be understood that Fig.11 The arm 1106 shown can be used as previously described in Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C Any of the various controller 20 examples shown and described in the specification and described herein, as well as any additional controllers not specifically shown herein, may be used in combination.

[0244] Fig. 12A ,12B 12C show an example side view of the guidewire 30. Specifically, Fig. 12A , 12B 12C show different examples of components for releasing drugs (e.g., sclerosants) in an ablation system 10 featuring a guidewire 30. The guidewire 30 may include a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. The guidewire proximal end 1202 generally points to an area proximal to any feature of the guidewire distal end 1204. Because Fig. 12A , Fig. 12B and Fig. 12C (as shown below and described 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 ) shows only the most distal portion of the guidewire, so it is not possible to show the guidewire proximal end 1202 at the location where it begins near any current controller 20. For this reason, throughout this disclosure, the guidewire proximal end 1202 is understood to be the guidewire 30 that is proximal to the portion of the guidewire 30 that is intended to scrape (or ablate or agitate) the vessel wall.

[0245] like Fig. 12A , Fig. 12B and Fig. 12C As shown, the guidewire 30 may include a sinusoidal shape. The sinusoidal shape allows the guidewire 30 to contact the wall of the blood vessel into which the guidewire 30 has been inserted. In some examples, the guidewire 30 is made of a nickel-titanium alloy (e.g., Nitinol #1 ASTM F2063) or a similar material that can recover to its shape after compression (e.g., the compression that the guidewire 30 may experience when stored in the sheath 40).

[0246] Any of the examples described and shown herein may also be operated within a stent. In such an example, the guidewire 30 will contact both the stent and the tissue. In addition, many of the examples shown and described in the present disclosure include three or four peaks. It should be understood that the number of peaks present in the accompanying drawings and described in the present disclosure is merely exemplary, and any number of peaks in a sinusoidal shaped guidewire may exist as desired, and a greater number of peaks may mean a greater length of the treatment segment 55, or simply a greater number of contact points along such a treatment segment 55.

[0247] Furthermore, any dimensions regarding the pitch or amplitude of the guidewire 30 are also merely exemplary, and it should be understood that guidewires of different sizes may prove useful for vasculature or treatment segments 55 of different sizes. For example, the guidewire 30 may have an amplitude of approximately 12 millimeters. In the described example, because the guidewire 30 is at least partially compressible, the guidewire 30 may operate in vasculature having a diameter that is smaller than the amplitude of the guidewire 30. In such an exemplary guidewire 30 having an amplitude of approximately 12 millimeters, the working range or range of vessel diameters that the guidewire 30 is able to treat would be approximately 4 millimeters to approximately 12 millimeters.

[0248] In the case where the diameter of the treated vessel is smaller than the amplitude of the guidewire 30, the guidewire 30 will be in compression, causing the peak of the sinusoidal shape to stretch, thereby extending the contact with the vessel wall, thereby effectively increasing the length of the treatment segment 55. In the example described, the guidewire 30 can also treat larger diameter vessels, but it will not be in continuous contact with the vessel wall. Therefore, for such applications, a larger amplitude guidewire 30 may be required.

[0249] In surgeries such as sclerotherapy, it may be desirable to damage or penetrate the intima of a blood vessel and only damage the tunica media of the blood vessel. Conventional guide wires in the prior art contact the vessel wall at the distal tip, causing the contact point to be abrupt and sharp. This is accompanied by the possible problem of penetrating the tunica media in addition to the intima, which may cause the guide wire to enter the surrounding adventitia. Solutions to the problems currently include rotating the guide wire in the opposite direction, hoping that the guide wire will untie itself from the blood vessel to a point where the guide wire can be safely removed. Another solution includes pulling (usually very hard) the guide wire to forcefully remove the guide wire from the patient's body. The solution may cause pain or discomfort to the patient, or may even result in complete stripping of the vein.

[0250] For sinusoidal shapes such as Fig. 12A , Fig. 12B and Fig. 12C With the sinusoidal shape of the example in FIG. 3 , the contact point is blunter or less sharp than a conventional guidewire 30. This makes penetration of the media and into the adventitia much less likely and thus increases the safety and efficacy of the sclerotherapy procedure.

[0251] Another problem with current sclerotherapy treatments is the multiple functions that the operator must keep track of simultaneously. For example, in many prior art devices, a treatment may include pulling a guide wire back through the vessel being treated at a rate of approximately 1 to 2 mm / second. At the same time, the operator must inject a medication, such as a sclerosant, from a manually operated syringe at a rate of approximately 0.1 ml / cm to 0.2 ml / cm. The operator must use one eye to watch two separate gauges - the distance the wire is withdrawn and the distance the syringe plunger is depressed. Because the catheter's retraction rate is time-dependent, the operator must also somehow keep track of the elapsed time - typically by mental counting, which is both prone to error and another item that can distract the operator from the procedure. Treatments are typically close to 40 cm long, which means that based on the parameters suggested above, these treatments can take anywhere from 200 to 400 seconds.

[0252] In many prior art devices, the distal end of the guidewire is the only point of contact between the guidewire and the vessel wall. Therefore, there is no "treatment segment" involved in these prior art devices described in this specification. This is the fundamental reason why the procedure requires the operator to withdraw the guidewire at a specific rate while injecting the drug at a separate, different and specific rate. The present disclosure seeks to remedy this deficiency of the prior art by eliminating the need to withdraw the catheter while injecting the drug at the same time.

[0253] By using a sinusoidal guidewire 30 (or other guidewires shaped and configured to contact a certain length of the vessel wall), which treats a certain length of vein at a time, a method for segmented treatment rather than continuous treatment can be constructed. In these methods, the guidewire 30 is provided to the most distal part of the treatment site 50 and then activated for a predetermined amount of time. Utilizing the present invention, the operator only needs to worry about the amount of the drug being injected, because the amount of the drug no longer depends on the distance that the guidewire 30 has been retracted, so the amount of the drug can be changed a lot without causing adverse effects. Once the prescribed amount of drug has been delivered to the treatment segment 55, the operator can withdraw the catheter 15 to the subsequent treatment segment 55 at a specified rate or any rate desired by the operator, without having to inject any more drugs until the catheter 15 has reached the subsequent treatment segment 55.

[0254] like Figure 5A and Figure 5B The display 508 described in the above also can relieve the operator of the extra burden, because they no longer need to mentally count the time. Fig. 9A and 9CThe LED 912 described in can be used for similar purposes. Any such indicator, whether display 508, LED 912, or some other method of providing information to the operator such as via a noise from an alarm, can allow the operator to no longer track the passage of time themselves, thereby allowing them to fully focus on the smaller details of the procedure.

[0255] In some examples, the syringe can even be replaced by an Archimedean screw to deliver a set amount of drug per rotation of the guidewire 30. Additional features can include a torque limiter, which can indicate whether the guidewire 30 is rotating through an unexpected media, such as whether the guidewire 30 has penetrated into the adventitia. A clutch can also be included. If some parameters such as torque exceed a certain threshold, the clutch can automatically stop the guidewire 30 from rotating. If the guidewire 30 has penetrated into the adventitia, this automatic stop of the rotation of the guidewire 30 can help prevent the blood vessel from tangling itself.

[0256] Fig. 12A A guide wire 30 having at least one hole 1206 is shown. Fig. 12A As shown, the guide wire 30 can be a hypotube having a plurality of holes 1206 along the length of its body, and a nozzle-type tip including an additional hole 1206 at the distal end 1204 of the guide wire. The hole 1206 is present to deliver drugs (such as sclerosants) to the treatment site 50 during surgery. Arrows are present at the proximal end 1202 of the guide wire to show the rotation of the guide wire 30 during surgery. The guide wire 30 can be rotated in either direction during surgery, and the rotation allows the sinusoidal-shaped peaks to make complete peripheral contact with the vessel wall, thereby improving the scraping during surgery. In some examples, but not all examples, the guide wire 30 rotates only in a single direction. Also shown is a central axis 1208, around which the guide wire 30 rotates.

[0257] Fig. 12B A guide wire 30 having at least one hole 1206 is shown, similar to Fig. 12A However, unlike Fig. 12A The example is different. Fig. 12B A weighted tip 1210 is included at the guidewire distal end 1204. The arrows show possible directions of rotation about the central axis 1208, but the inclusion of the weighted tip 1210 creates a gyroscopic effect that can help keep the guidewire 30 centered within the vessel, thereby ensuring consistent contact with the vessel wall.

[0258] Fig. 12CA guidewire 30 is shown with a weighted tip 1210, but in the example shown, there is no hole 1206. The sheath 40 is shown and serves as a fluid lumen when the guidewire 30 is exposed. In the example shown, a drug such as a sclerosant can be delivered to the treatment site 50 through the sheath and contact the vessel wall near the rotation of the guidewire 30 along the treatment length.

[0259] Fig.13A , 13B 13C show several possible cross-sectional profiles of the guidewire 30. Specifically, Fig.13A A circular cross-sectional profile 1302 of the guidewire 30 is shown, Fig. 13B A rectangular or flat strip cross-sectional profile 1304 of the guidewire 30 is shown, and Fig. 13C A triangular cross-sectional profile 1306 of the guidewire 30 is shown.

[0260] It should be understood that Fig.13A , Fig. 13B and Fig. 13C The various cross-sectional profiles shown can be compared with those previously described in Fig. 12A , Fig. 12B , Fig. 12C Any of the various guidewire 30 examples shown and described in the drawings can be used in combination, as well as with 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 Any of the various guidewire 30 examples shown and described in the drawings may be used in combination, or in combination with any additional guidewires not specifically shown herein.

[0261] like Fig.13A As shown, the circular cross-sectional profile 1302 is the most traditional shape of the guidewire. Its circular profile may cause damage, but the lack of sharp edges reduces the possibility of penetrating the media and entering the adventitia. If greater scraping is desired, the circular cross-sectional profile 1302 can have an applied surface roughness.

[0262] Fig. 13B The flat bar cross-sectional profile 1304 and Fig. 13C The triangular cross-sectional profile 1306 has a ratio Fig.13AThe circular cross-sectional profile 1302 has sharper edges. These sharp edges can scrape the vessel wall faster than the circular cross-sectional profile 1302, but the chance of penetrating the media is increased, rather than just damaging the media.

[0263] Fig.14 A side view of an example guidewire 30 that terminates at a point that does not fall along the central axis 1208 is shown. A weighted end 1210 is included in the example, and due to the off-axis position of the weighted end 1210, an opposite or at least opposite effect of the gyroscopic effect is achieved. The weighted end 1210 causes the guidewire 30 to rotate more erratically, resulting in more intense peaks of the sinusoidal guidewire 30 and contact (if less frequent) of the weighted end 1210 with the vessel wall. In some examples, the weighted end 1210 is not included, but the guidewire 30 still terminates off-axis from the central axis 1208.

[0264] Fig.15 A side view of a guidewire 30 having a variable thickness is shown. In the example shown, the guidewire proximal end 1202 has a thick diameter 1502, and the guidewire distal end 1204 has a thin diameter 1504. The thick diameter 1502 is larger than the thin diameter 1504. The thick diameter 1502 portion of the guidewire 30 can be more rigid than the thin diameter 1504 portion of the guidewire 30 due to its thickness. This can allow the thick diameter 1502 portion of the guidewire 30 to "kick out" from the vessel wall, resulting in increased contact between the thin diameter 1504 portion of the guidewire 30 and the vessel wall. The thick diameter 1502 portion of the guidewire 30 can also allow for the application of increased surface roughness, which can improve the scraping ability of the guidewire 30. In addition, since the thick diameter 1502 portion of the guidewire 30 has a larger profile size, it can better contact with the vessel wall.

[0265] Although Fig.15 A thick diameter 1502 at the proximal end 1202 of the guidewire and a thin diameter 1504 at the distal end 1204 of the guidewire are shown, but these positions are exemplary only. Based on the needs of the user, any portion of the guidewire 30 can include a thick diameter 1502 or a thin diameter 1504, and thus different effects can be achieved.

[0266] Fig.16 A side view of another exemplary guidewire 30 forming a triangular sinusoidal profile 1602 is shown. In fact, any type of shaped sine wave can be used according to the needs of the user. The triangular sinusoidal profile 1602 produces a sharper contact point with the vessel wall (e.g., Figure 2 ), which can improve scraping of these segments. These sharper points or triangular peaks 1604 may scratch or cut into the intima and / or media, thereby further damaging the vessel wall than simple scraping.

[0267] Fig.17A side view of an example guidewire 30 including a twisted wire 1702 configuration is shown. The surface of the twisted wire 1702 can be rougher than the surface of a single-wire guidewire or wire due to the increased number of ridges around the perimeter. This increased roughness can allow the twisted wire 1702 to make more positive contact with the vessel wall within the treatment site 50. Additionally, the strands of the twisted wire 1702 can be loosened or tightened, allowing the operator to "dial in" or set the radius desired for the treatment. For example, a looser twisted wire 1702 will have a larger radius, and thus the overall guidewire 30 diameter will increase. Conversely, a tighter twisted wire 1702 will have a smaller radius, thereby reducing the diameter of the entire guidewire 30.

[0268] Fig.18 A side view of an example guidewire 30 including a helical hollow strand 1802 configuration is shown. Fig.17 The twisted wire 1702 of the invention, due to the increased number of ridges around the perimeter, the helical hollow strand 1802 can be rougher than a helical hollow strand of a single guidewire or thread. Again, this increased roughness can allow the helical hollow strand 1802 to make more positive contact with the vessel wall within the treatment site 50. The helical nature of the helical hollow strand 1802 makes it a candidate for a type of guidewire 50 that includes a lumen, perhaps for delivering drugs.

[0269] Additionally or alternatively, although not in Fig.18 1802 and can be pulled so that the helical hollow strand 1802 forms a different shaped profile, such as a sinusoidal profile. In addition to allowing the helical hollow strand 1802 to be delivered to the treatment site 50 with a lower profile (or even completely straightened), such a pull cord can allow the peak-to-peak distance or peak amplitude of the helical hollow strand 1802 to be sinusoidal in profile. This may prove useful in situations where the peak size or peak-to-peak distance can be optimized for a particular treatment segment 55.

[0270] Furthermore, the drug delivered through the hollow portion of the helical hollow strand 1802 may not need to be delivered to the distal-most end of the helical hollow strand 1802. Instead, the drug may be delivered as an infiltrate through a separate coil.

[0271] Finally, although in Fig.18 It is also not specifically shown in the figure, but there may be a second spiral hollow strand 1802 wound around the first spiral hollow strand 1802, wherein the coils either continue in the same direction or are opposite to each other. In such an example, an oscillating action can be formed by the spiral hollow strand 1802 without opening the coil.

[0272] Fig.191 shows a side view of an example guidewire 30 including a spring-like structure 1902. In a straightened form, the spring-like structure 1902 can appear as a three-dimensional sinusoid or spiral. However, the spring-like structure 1902 is not limited thereto. Fig.19 As shown, the spring-like structure 1902 itself can form a sinusoidal profile. This benefit is similar to Fig.17 The twisted wire 1702 and Fig.18 Because the spring-like structure 1902 includes additional ridges around the periphery of the guidewire 30, this may increase the roughness of the guidewire 30. Again, this increased roughness may allow the spring-like structure 1902 to make more positive contact with the vessel wall in the treatment segment 55.

[0273] Fig. 20 2002. A side view of an example guidewire 30 is shown including a cage structure 2002. The cage structure 2002 includes a plurality of individual components, such as guidewire strands, that are helically wound around each other, similar to Fig.17 The twisted wire 1702 and Fig.18 The helical hollow strand 1802 of the cage structure 2002. However, in the cage structure 2002, the individual strands may include gaps or spaces between each other. The individual strands of the cage structure 2002 may allow the guide wire 30 to contact the vessel wall in the treatment segment 55 multiple times per rotation, thereby increasing the scraping performance of the guide wire 30. Fig. 20 2002 will be reconsidered as a concept Fig.26C The proximal characteristic structure 2602 and Fig.27B The distal feature structure 2702 in.

[0274] Fig.21 A side view of an example guidewire 30 is shown, which terminates at a point that does not fall along the central axis 1208, similar to Fig.14 . Also similar to Fig.14 , Fig.21 The guidewire 30 of the embodiment can include a weighted tip 1210 and cause an effect opposite to the gyroscopic effect due to the off-axis termination point of the weighted tip 1210. The weighted tip 1210 can cause the guidewire 30 to rotate more erratically, thereby causing the peak of the sinusoidal guidewire 30 and the weighted tip 1210 to make more positive contact with the vessel wall. In some examples, the weighted tip 1210 is not included, but the guidewire 30 still terminates off-axis from the central axis 1208.

[0275] and Fig.14 The instances are different. Fig.21 The guidewire 30 continues the path of the sinusoidal profile of the guidewire 30. Advantages of the described example may include Fig.14 The example of a more unstable distal end path of the guidewire 30. In addition, fewer bends in the guidewire 30 are required to construct Fig.21 , which can reduce manufacturing costs. The weighted tip 1210 is shown as terminating at a point such that the weighted tip 1210 is flush with one of the peaks of the sinusoidal profile of the guidewire 30. This is not strictly necessary, and the termination point of the weighted tip 1210 can be positioned as desired by the user (although a termination point along the central axis 1208 can result in the gyroscopic effect being employed again).

[0276] Fig.22A , 22B 22C show various side views of an exemplary non-uniform amplitude guidewire 30. Specifically, Fig.22A An example guidewire 30 is shown having first and fourth peaks that are greater in magnitude than the second and third peaks. Fig. 22B An example guidewire 30 is shown having three peaks on one side of the central axis 1208 (not shown in the figures). Fig. 22C An example guidewire 30 is shown having first and fourth peaks that are smaller in magnitude than the second and third peaks. Fig.22A , Fig. 22B and Fig. 22C This is exemplary only and not exhaustive - any form of non-uniform amplitude guidewire 30 may be used as desired.

[0277] It should be understood that Fig.22A , Fig. 22B and Fig. 22C Any of the exemplary non-uniform amplitude guidewires 30 shown and described may be used with the guidewires 30 previously described. 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 Any of the various guidewire 30 examples shown and described herein or any additional guidewire combination not specifically shown herein may be used.

[0278] The benefits of this non-uniform amplitude guidewire include drug dispersion and treatment segment scraping effects. Fig.22A The guidewire 30 of FIG. 1 can cause a spray effect of the drug in the middle portion due to the lower amplitude peak in the middle portion. In contrast, Fig. 22CThe example guide wire 30 may result in a spraying effect away from the middle portion due to the higher amplitude peak located there. Fig. 22B The unilateral peak shown in may result in a different scraping process due to damage occurring simultaneously along one side of the vessel rather than dispersed around the periphery.

[0279] Fig.23A An example guidewire 30 is shown having a sinusoidal profile in two dimensions. This is one possible profile shape for a guidewire 30 that includes peaks for scraping the treatment segment 55 rather than just points around the treatment site 50. Fig. 23B Shows Fig.23A A front view of an example guidewire 30. Fig. 23B As shown, a sinusoidal profile guidewire 30 existing in two dimensions will have a sinusoidal cross-sectional profile 2302 that resembles a rectangle. When rotated, the sinusoidal cross-sectional profile 2302 approximates the shape of the wall of the vessel within the treatment segment 55 that will scrape.

[0280] Although the shape of the exemplary guidewire 30 has been shown as various interpretations of a sinusoidal profile, the present disclosure may implement profiles of additional shapes. In addition, the previous guidewire 30 has been shown as lying on a two-dimensional plane. Fig.24A and Fig.25A It will be shown that any of the foregoing disclosures and drawings (i.e., Fig. 12A , Fig. 12B , Fig. 12C , Fig.14 , Fig.15 , Fig.16 , Fig.17 , Fig.18 , Fig.19 , Fig. 20 , Fig.21 , Figure 22 and Fig.23A ) can also exist in a three-dimensional plane, such as a spiral (or spring-like) or a variation in which the peaks alternate rotationally about the central axis 1208.

[0281] Fig.24A One such three-dimensional example guidewire 30 is shown. Fig.24A The guide wire 30 is similar to Fig.19 The spring-like structure of 1902, but in Fig.24A In the embodiment of the present invention, the guide wire 30 does not present an additional sinusoidal profile in two dimensions. Instead, the guide wire 30 is a sinusoidal curve that exists in three dimensions, thereby forming a spiral or spring-like shape. Fig. 24B Shows Fig.24A Front view of an example guidewire. Fig. 24B As shown, the helical guidewire 30 will have a spring-like cross-sectional profile 2402 that is similar to a circle. When rotated, the spring-like cross-sectional profile 2402 approximates a shape that will scrape the blood vessel wall within the treatment segment 55.

[0282] Fig.25A An exemplary guidewire 30 is shown in which a sinusoidal profile is manipulated in three dimensions after each peak occurs. The possibilities for such configurations are nearly endless, so for purposes of discussion, Fig.25A Just one such example configuration is represented.

[0283] exist Fig.25A 12, each time the guidewire reaches a peak along the sinusoidal curve and returns to the central axis 1208 (not shown), the sinusoidal curve shape rotates approximately ninety degrees clockwise. Again, the angles are exemplary only, and any angle may be selected. Additionally, the decision to rotate clockwise when moving from proximal to distal along the guidewire 30 is also exemplary only. Counterclockwise rotation or a combination of clockwise and counterclockwise rotation may also be achieved. Because Fig.25A Four peaks are included, so once the fourth peak has been reached, a complete rotation in three-dimensional space will occur. Once again, the decision to use four peaks in the example described is non-limiting, and any number of peaks along the guidewire may be included. Likewise, a complete rotation in three-dimensional space is not strictly required.

[0284] Fig.25B Shows Fig.25A Front view of an example guidewire. Fig.25A The example guidewire 30 includes four peaks, and because it rotates about ninety degrees after each peak, the three-dimensional cross-sectional profile 2502 appears as a cross or a plus sign. In the example, the three-dimensional cross-sectional profile 2502 approximates the shape of the blood vessel wall scraped within the treatment segment 55 when the guidewire 30 rotates. The shape of the three-dimensional cross-sectional profile 2502 may be affected by the number and degree of rotation of the guidewire 30 after each peak occurs.

[0285] Finally, the location at which the rotation occurs is not strictly necessary. For example, the guidewire 30 can be rotated at each peak in three-dimensional space, rather than rotating at the base of each peak, such as Fig.25A and Fig.25B As shown. Rotation can also occur at any point between the peak and the base of the peak. In addition, any combination of these rotation points can be used - for example, a first rotation occurring at the base after the first peak occurs and a next rotation occurring at the second peak.

[0286] Fig.26A , 26B , 26C, 26D, 26E, 26F, 26G and 26H show side views of exemplary proximal features 2602 for guidewire 30. Fig.26A , Fig.26B , Fig.26C , Fig.26D , Fig.26E , Fig.26F and Figure 26G In some cases, the proximal feature 2602 can at least partially occlude a blood vessel proximal to the treatment area. This occlusion or flow retardation can help prevent blood from entering the treatment area. While blood entering the treatment site 50 will not cause a serious obstacle to the procedure, there is a chance that too much blood will dilute the drug or sclerosant, thereby reducing its efficacy and the effectiveness of the entire treatment. This occlusion or flow retardation can also help stop or slow blood flow, thereby allowing the sclerosant to stay in the treatment site 50 for a longer time, thereby increasing the efficacy of the sclerosant. This occlusion can further help prevent the drug from leaving the treatment site 50 in a proximal direction.

[0287] It should be understood that Fig.26A , Fig.26B , Fig.26C , Fig.26D , Fig.26E , Fig.26F , Figure 26G and Fig.26H Any of the proximal features 2602 shown may be used with 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 Any of the various guidewire 30 examples shown and described in the accompanying drawings, as well as any additional guidewires not specifically shown herein, may be used in combination.

[0288] about Fig.26A , the balloon 2604 can be located proximal to the exposed portion of the guidewire 30 and reside on the sheath 40. After the guidewire 30 is deployed from the sheath 40, the balloon 2604 can be expanded via the inflatable Tuohy needle lumen (which may be the working lumen in the sheath 40) to occlude the blood vessel. In some examples, the balloon 2604 can include a fluid-permeable balloon, and drugs such as sclerosants can be delivered through the micropores of the fluid-permeable balloon.

[0289] Fig.26B Similar to Fig.26A, wherein the biasing balloon 2606 can be located on the sheath 40 proximal to the exposed portion of the guidewire 30. Again, after the guidewire 30 is deployed from the sheath 40, the biasing balloon 2606 can be expanded via the inflatable Tuohy needle lumen (which may be the working lumen in the sheath 40) to occlude the vessel. Similarly, the biasing balloon 2606 can include a fluid-permeable balloon, and drugs such as sclerosants can be delivered through the micropores of the fluid-permeable balloon. However, unlike Fig.26A The balloon 2604 is different. Fig.26B The biasing balloon 2606 can be biased toward one side of the sheath 40. In such an example, the biasing balloon 2606 can unload the guidewire 30 when in the expanded state, thereby making the guidewire 30 more actively contact the blood vessel wall.

[0290] Fig.26C and 26D Hollow and solid variations of the helical occluding element are depicted. Specifically, Fig.26C A cage 2608 is shown that expands to approximately the same diameter as the blood vessel when released from the sheath 40. In the example, the cage 2608 is made of a material that allows the cage 2608 to expand and contract, such as a nickel-titanium alloy. The cage 2608, when rotated, can act as a three-dimensional impeller that will at least partially prevent blood from entering the treatment site 50 and / or drugs from flowing out of the treatment site 50. In some examples, the cage 2608 is made of a material that does not allow compression, and therefore, the cage 2608 is sized to fit within the sheath 40.

[0291] Fig.26D A slotted entity 2610 is shown, which is Fig.26C However, the diameter of the slotted body 2610 can be smaller than the diameter of the cage 2608 because it cannot be compressed as far and must still fit within the sheath 40 when it is not in its released state. The solid nature of the slotted body 2610 prevents any blood from entering the treatment site 50 through the slotted body 2610, as well as any potential outflow of drug from the treatment site 50, and the grooves in the slotted body 2610 perform a pushing action to prevent at least some blood from bypassing the slotted body 2610 and entering the treatment site 50.

[0292] Fig.26EAn impeller 2612 having three blades is shown. The number of blades is not important, and the desired number of blades may be used. The impeller 2612 may be made of a material (e.g., a nickel-titanium alloy) that allows the impeller 2612 to expand and contract. In the example described, the size of the impeller 2612 may be larger than the diameter of the sheath 40. Then, when released from the sheath 40, the impeller 2612 may expand to approximately the same diameter as the blood vessel. In other examples, the impeller 2612 is made of a material that does not expand and contract as much, and therefore, the size of the impeller 2612 will be designed to fit within the sheath 40 when in its retracted state. When the guidewire 30 rotates, the impeller 2612 will also rotate, thereby hindering the blood from advancing to the treatment site 50.

[0293] Fig.26F and Figure 26G A sponge-like entity 2614 is shown as the proximal feature structure 2602. Specifically, Fig.26F In the embodiment of the present invention, the sponge-like entity 2614 resides on the guidewire 30. The sponge-like entity 2614 can be easily compressed within the sheath 40 when in its retracted configuration, and can expand to occlude the blood vessels proximal to the treatment site 50 when released from the sheath 40.

[0294] Similarly, in Figure 26G In the embodiment of the present invention, the sponge-like entity 2614 is used as the proximal feature structure 2602, but in this case, the sponge-like entity 2614 resides on the sheath 40. The sponge-like entity 2614 can be easily compressed within the patient's vasculature and, once delivered, allowed to expand to occlude the blood vessels proximal to the treatment site 50. Fig.26F and Figure 26G In some embodiments, the sponge-like entity 2614 can prevent blood from entering the treatment site 50 during treatment and / or prevent drugs such as sclerosants from leaving the treatment site 50 during treatment.

[0295] Fig.26H A sinusoidal actuator 2616 is shown in the guidewire 30 within the sheath 40, proximate the guidewire distal end 1204. When the sheath 40 is fully retracted around the guidewire 30, the sinusoidal propulsion force 2616 may still be present within the sheath 40. The sinusoidal actuator 2616 is not intended to occlude blood flow, but rather to unload the guidewire 30 to bring the guidewire 30 into more active contact with the vessel wall.

[0296] Fig.27A , Fig.27B , Fig.27C , Fig.27D and Fig.27ESide views of various potential distal features 2702 for the guidewire are shown. In all cases, the distal features 2702 at least partially occlude the vessel distal to the treatment area. This occlusion or flow retardation can help prevent the drug (e.g., a sclerosant) from traveling too far into the vessel, such as into a junction with another more major vessel that is not desired to be treated. This occlusion or flow retardation can also prevent any blood from passing through from the distal side into the treatment site 50, which could potentially dilute the delivered drug.

[0297] It should be understood that Fig.27A , Fig.27B , Fig.27C , Fig.27D and Fig.27E Any of the distal features 2702 shown may be used 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 Any of the various guidewire 30 examples shown and described in the accompanying drawings, as well as any additional guidewires not specifically shown herein, may be used in combination.

[0298] about Fig.27A , the single-blade impeller 2704 can be located distal to the guidewire 30. When the guidewire 30 is released from the sheath 40, the single-blade impeller 2704 can expand to a length approximately the same as the radius of the blood vessel. In these examples, the single-blade impeller 2704 is made of a material that allows such expansion and contraction of the single-blade impeller 2704, such as a nickel-titanium alloy.

[0299] In other embodiments, the single blade impeller 2704 may be sized to fit within the sheath 40 when in its fully expanded configuration, and be made of a more rigid material and not allow as much expansion or contraction. As the guidewire 30 rotates, the single blade impeller 2704 also rotates, thereby hindering the advancement of the drug (e.g., sclerosant) away from the treatment site 50. Because the single blade impeller 2704 cannot be symmetrical about the guidewire 30 (as there cannot be symmetry around a circle with only one component), the single blade impeller 2704 may not be used with the gyroscopic effect. Similar to Fig.14 and Fig.21With an off-axis termination guidewire 30, the single-blade impeller 2704 can move the guidewire 30 eccentrically, thereby creating more positive contact with the vessel wall.

[0300] Fig.27B and Fig.27C Hollow and solid variations of the helical occluding element at the distal end 1204 of the guidewire are depicted. Specifically, 27B shows a cage 2706 that expands to a diameter approximately the same as the blood vessel when released from the sheath 40. In the example, the cage 2706 is made of a material (such as a nickel-titanium alloy) that allows the cage 2706 to expand and contract. The cage 2706 can be used as a three-dimensional impeller when rotating, and the three-dimensional impeller will at least partially prevent drugs (such as hardeners) from leaving the treatment site 50 while also preventing blood from accidentally flowing into the treatment site 50. In some examples, the cage 2706 is made of a material that does not allow compression, and therefore, its size is designed to fit within the sheath 40.

[0301] Fig.27C A slotted entity 2708 is shown, which is Fig.27B The cage 2706 of FIG. 1006 functions in a similar manner. However, the diameter of the slotted body 2708 is smaller than the diameter of the cage 1006 because it cannot be compressed as far and must still fit within the sheath 40 when it is not in its released state. The solid nature of the slotted body 2708 prevents any delivered drug (e.g., a sclerosant) from exiting the treatment site 50 through the slotted body 2708, and the grooves in the slotted body 2708 perform a pushing action to prevent at least some of the drug from bypassing the slotted body 2708 and exiting the treatment site 50. Similar to FIG. Fig.27B The grooved entity 2708 can also prevent blood from accidentally flowing into the treatment site 50 from the distal side.

[0302] Fig.27D An impeller 2710 having three blades is shown. The number of blades is not important, and a desired number of blades may be used. The impeller 2710 may be made of a material, such as a nickel-titanium alloy, that allows the impeller 2710 to expand and contract. In the example described, the size of the impeller 2710 may be larger than the diameter of the sheath 40. Then, when released from the sheath 40, the impeller 2710 may expand to a diameter approximately the same as the blood vessel. In other examples, the impeller 2710 is made of a material that does not expand and contract as much, and therefore, the size of the impeller 2710 will be designed to fit within the sheath 40 when in its retracted state. When the guidewire 30 rotates, the impeller 2710 will also rotate, thereby hindering the advancement of the drug (e.g., a sclerosant) away from the treatment site 50. This hindering effect may also extend to preventing any unintended blood from flowing into the treatment site 50.

[0303] Fig.27EA sponge-like entity 2712 is shown. The sponge-like entity 2712 can be easily compressed within the sheath 40 when in its retracted configuration, and can expand to occlude a vessel distal to the treatment site 50 when released from the sheath 40. Unlike the sponge-like entity 2614 of the proximal feature 2602, the sponge-like entity 2712 of the distal feature 2702 cannot reside on the sheath 40 because once the sheath 40 is retracted around the guidewire 30 to expose the guidewire 30, the sponge-like entity 2712 is no longer distal to the treatment site 50.

[0304] Fig.28A , 28B 28C show side views of an example guidewire 30, including additional features at the distal end of the guidewire 30. Although many of the foregoing figures include a weighted tip 1210 at the distal end of the guidewire 30, the weighted tip 1210 is not required (e.g. Fig. 12A As shown, wherein the end includes a hole 1206). Fig.28A , 28B and 28C provide additional examples of the distal-most end of the guidewire 30 that are not necessarily intended to maintain gyroscopic stability of the guidewire during rotation.

[0305] It should be understood that Fig.28A , Fig.28B and Fig.28C Any additional features at the distal end of the guidewire 30 shown may be used in conjunction with 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 Any of the various guidewire 30 examples shown and described in the drawings, as well as any additional guidewire combinations not specifically shown herein, may be used.

[0306] Fig.28A A hemispherical tip 2802 is shown at the most distal end of the guidewire 30. The hemispherical tip 2802 may be weighted or unweighted. In either case, the hemispherical tip 2802 may unbalance the most distal tip of the guidewire 30 due to its lack of three-dimensional symmetry, thereby adversely affecting gyroscopic stability. This effect may cause the hemispherical tip 2802 to contact the vessel wall, possibly erosively, thereby adding additional scraping points to the treatment segment 55 where the guidewire 30 is located.

[0307] Fig.28B An offset weighted tip 2804 is shown at the distal-most end of the guidewire 30. The offset weighted tip 2804 does not necessarily require a weight, but the weight can increase the effect of the distal-most end on the guidewire 30. Fig.28A The offset weighted tip 2804 may have an adverse effect on gyroscopic stability by causing the guidewire to be unbalanced due to its newly acquired lack of symmetry about the central axis 1208 (not shown in the figure). This effect may cause the offset weighted tip 2804 to contact (possibly erosively contact) the vessel wall by adding additional scraping points to the treatment segment 55 where the guidewire 30 is located.

[0308] Fig.28C A balloon tip 2806 is shown at the distal-most end of the guidewire 30. The balloon tip 2806 may be delivered to the treatment site 50 in an unexpanded (or uninflated) configuration and then inflated to dilate and occlude a vessel distal to the treatment site 50. In such an example, the guidewire 30 may include a lumen, or hypotube, to deliver an inflation fluid to the balloon tip 2806, thereby allowing the balloon tip 2806 to inflate to its expanded configuration.

[0309] Fig.29A An exemplary side view of a guidewire 30 including an auxiliary guidewire 2902 is shown. The auxiliary guidewire 2902 can add complementary geometry along different portions of the guidewire 30, thereby creating a rougher surface and "hook-up" points to facilitate greater scraping of the vessel wall. Although the auxiliary guidewire 2902 is shown as being wrapped around most of the guidewire 30, the auxiliary guidewire 2902 can be wrapped around only a small portion of the guidewire, such as near the peak, in order to reduce material usage (and possibly reduce material costs).

[0310] Although not in Fig.29A 20, but in some examples, the auxiliary guidewire 2902 can be a hypotube extending back to the controller 20, allowing the auxiliary guidewire 2902 to be used as a fluid lumen for delivering drugs (such as sclerosants) to the treatment site 50. In these examples, holes can exist along the length of the auxiliary guidewire 2902, along which length it will be located in the treatment segment 55, or at the most distal end of the auxiliary guidewire 2902, for distal injection of drugs.

[0311] It should be understood that Fig.29A The auxiliary guide wire 2902 shown can be used 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 Any of the various guidewire 30 examples shown and described herein, as well as any additional guidewires not specifically shown herein, may be used in combination.

[0312] Fig.29B A side view of an exemplary guidewire 30 including a supplemental geometry that appears similar to Fig.29A The auxiliary guide wire 2902 is very similar to the auxiliary guide wire 2902. However, Fig.29A Unlike the auxiliary guidewire 2902 of the embodiment, the supplemental geometry is a heating guidewire 2904. The heating guidewire 2904 may be capable of carrying heat to the treatment segment 55, thereby increasing the temperature in the treatment segment 55. By heating the treatment segment 55, any drug injected therein may see improved drug diffusion.

[0313] It should be understood that Fig.29B The heating wire 2904 shown can be used with 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 The various wire 30 examples shown and described herein, as well as any additional wires not specifically shown herein, may be used in combination.

[0314] The heated guidewire 2904 can also be an additional wire made of a shape memory material (such as a nickel titanium alloy), and the hot portion of the "heated guidewire" can be provided by the body of the patient into which the guidewire 30 is inserted. In these cases, an austenite transformation end temperature (A(f) temperature) can be set on the shape memory material so that it returns from its martensite state to its austenite state at these body-provided temperatures. In such an example, the guidewire 30 can be delivered to the treatment segment 55 in a slightly straight state, and the heated guidewire 2904 will begin to heat during said delivery. Once the guidewire 30 is delivered to the treatment segment 55 and exposed from the sheath 40, the heated guidewire 2904 can be allowed to reach its A(f) temperature, thereby returning to its austenite shape and forcing the guidewire 30 into the desired contour to scrape the vessel wall.

[0315] Fig.29C A guidewire 30 including a porous surface geometry 2906 is shown according to some examples. The porous surface geometry 2906 can add surface roughness to the guidewire, such as Fig.13A and Fig.15 The porous surface geometry 2906 may prevent the smooth surface portion of the guidewire 30 from contacting the vessel wall in the treatment segment 55. On the contrary, the porous surface geometry 2906 may cause sharper edges and uneven surfaces to physically contact the vessel wall, thereby scraping the vessel wall more aggressively.

[0316] It should be understood that Fig.29C The porous surface geometry 2906 shown can be similar to that 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 The various guidewire 30 examples shown and described herein, as well as any additional guidewires not specifically shown herein, may be used in combination.

[0317] Fig. 30A , Fig. 30B , Fig. 30C and Fig.30D Various examples of guidewires are shown, including additional geometries. For example, Fig. 30A The additional geometric shape 3002a can be composed of two-dimensional or three-dimensional circular blocks. Fig. 30BThe additional geometric shape 3002b may be at least one spherical object in two or three dimensions. Fig. 30C As shown, the additional geometry 3002c is a spike - again in two or three dimensions. Fig.30D The additional geometric shape 3002d may be a brush or a brush-like object.

[0318] Any of these additional geometries 3002a, 3002b, 3002c, and / or 3002d may be used in combination with one another. These additional geometries 3002a, 3002b, 3002c, and / or 3002d may facilitate scraping of the vessel wall along the treatment segment 55. In addition, although the additional geometries 3002a, 3002b, 3002c, and / or 3002d are only used in combination with one another, the additional geometries 3002a, 3002b, 3002c, and / or 3002d may be used in combination with one another. Fig. 30A , 30B , 30C and 30D are shown at the peaks of the sinusoidal shape of the guidewire 30, but it should be understood that these additional geometric shapes 3002a, 3002b, 3002c and / or 3002d may be included at any location on the guidewire 30, including the entire body of the guidewire 30, as desired by the user.

[0319] It should be understood that Fig. 30A , 30B , 30C and 30D may be combined with any of the additional geometries 3002a, 3002b, 3002c and / or 3002d as previously described. Fig. 12A , 12B , 12C, 14, 15, 16, 17, 18, 19, 20, 21, 22A, 22B, 22C, 23A, 24A and 25A, as well as any additional guidewire combinations not specifically shown herein.

[0320] Fig.31 An exemplary Luer connector 3102 is shown, which includes a Luer interface 3104. The Luer connector 3102 can be a syringe 60 through which it can be removably connected to ( Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C ) T-joints 706, 804 and / or 904 or Figure 7 Saddle 704 (or not shown but Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C those saddles described in .

[0321] Fig.32A top view of an exemplary catheter 15 is shown including a sheath 40 and a guidewire 30. A plurality of marking devices are shown on the body of the sheath 40. Any of these marking devices may partially surround or completely surround the body of the sheath 40.

[0322] Fig.32 Annular ring 3202 is included in the sheath 40, and annular ring 3202 exists around sheath 40. Although shown and described as annular ring 3202, it should be understood that any type of slidable depth marker can be used and perform the same function as annular ring 3202. Annular ring 3202 can be slidably connected to sheath 40, thereby allowing the user to move annular ring 3202 to a desired position along sheath 40. For example, annular ring 3202 can be placed on sheath 40 at a distance from the distal end of sheath 40, so that the distance represents the distance to the deep vein system in the patient's body. This can indicate to the operator that after annular ring 3202 reaches the insertion point of the patient, catheter 15 (if further inserted) can enter the patient's deep vein system or other vascular systems that are not intended for treatment.

[0323] In addition or alternatively, the annular ring 3202 may be sized so that it cannot enter the patient's insertion point. As described in the previous paragraph, this can prevent the catheter 15 from entering the patient's deep venous system. This can also prove useful during surgery, such as segmented mechanical or mechanochemical ablation as described throughout this specification. For example, once the operator reaches the target treatment segment 55 and begins rotating the guidewire 30, perhaps by providing power to the motor, the operator can slide the annular ring 3202 along the sheath 40 until the insertion point, and then release the catheter 15.

[0324] The annular ring 3202 can hold the catheter 15 in place relative to the insertion point, allowing the operator to use their hands freely. In some examples, the rotation of the guidewire 30 attempts to pull the catheter 15 further into the patient due to the forward propulsion from the rotational motion. In such examples, the size of the annular ring 3202 is designed so that when the annular ring 3202 is connected to the sheath 40, the annular ring 3202 maintains its position relative to the sheath 40 due to the friction between the annular ring 3202 and the sheath 40. However, the annular ring 3202 is still configured to slide relative to the sheath 40 under the influence of an external force, such as manual manipulation by the operator, which overcomes any friction between the annular ring 3202 and the sheath 40.

[0325] Because the annular ring 3202 can be sized so that it cannot enter the insertion point in the patient's body, the annular ring 3202 can thus prevent the sheath 40 from further entering the patient's vasculature. In other examples, a catheter clamp can be included for similar purposes.

[0326] exist Fig.32Also visible in the figure are a plurality of distance markings 3204 along the sheath 40. The operator can use the distance markings 3204 to determine how far the catheter 15 is within the patient. This is particularly useful in situations involving the withdrawal of the catheter 15. For example, during segmented mechanical or mechanochemical ablation, the operator can treat the treatment segment 55 and then begin withdrawing the catheter 15 from the patient until it reaches the subsequent treatment segment 55. In this case, if the first treatment segment 55 is reached and aligned with the distance markings 3204, the operator can withdraw the catheter 15 after treating the treatment segment 55 until the subsequent distance markings 3204 have been reached, thereby indicating that the subsequent treatment segment 55 has also been reached.

[0327] To this end, it may be beneficial to include distance markings 3204 that are approximately the same length as the treatment segment 55. As previously disclosed in the present disclosure, the treatment segment 55 can be the same length as the guidewire distal end 1204. Therefore, the distance markings 3204 can also be the same length as the guidewire distal end 1204. However, none of these distance marking lengths are strictly required, and variations in distances can be used depending on the needs of the user.

[0328] at last, Fig.32 Also shown is a warning track 3206 distal to the marker 3204. The warning track 3206 can appear as a series of closely spaced markers, but other markers or indicators can also be used. In practice, the warning track 3206 can indicate to the operator that the end of the feasible treatment length has been reached, meaning that pulling the catheter 15 further from the patient will result in ineffective treatment.

[0329] The length of the warning track 3206, the location of the warning track 3206, and the number of distance markers 3204 and the distance between the distance markers 3204 are customizable, and multiple catheters 15 can be used for specific purposes, such as longer or shorter treatment lengths. Similarly, the length of the guidewire distal end 1204 can be customizable to increase or decrease the length of the treatment segment 55.

[0330] It should be understood that Fig.32 The annular ring 3202, distance marking 3204 and warning track 3206 shown can be used together, separately or in any combination with each other. Fig.32 The annular ring 3202, distance markers 3204, and warning track 3206 shown may be the same as previously described. 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 Any of the various guidewire 30 examples shown and described in the accompanying drawings, as well as any additional guidewires not specifically shown herein, may be used in combination.

[0331] Fig.33 A method for operating the controller 20 (which may be Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and / or Fig. 9C 3304). As seen in the block diagram, power source 3302 can be connected by a guide wire to receive input from actuator 3304. As previously described, power source 3302 can be a contained power source, such as a battery or a guide wire power source. Similarly, actuator 3304 can be a button, a switch, or anything capable of receiving user input to operate controller 20.

[0332] The actuator has wires connected to a limit switch 3306, which in turn has wires connected to a motor 3308 and LED 3310 (separated by a resistor 3312 so that they receive the correct amount of power). The limit switch 3306 allows power to flow to the motor 3308 and LED 3310, or prevents power from flowing to the motor 3308 and LED 3310.

[0333] For example, consider an ablation system 10 that includes a controller 20 having a sheath 40 and a guidewire 30 disposed through a working lumen of the sheath 40. If the controller 20 is capable of moving the sheath so that retracting the sheath 40 exposes the guidewire 30 and extending the sheath 40 surrounds the guidewire 30, it may be desirable to prevent the guidewire from rotating unless the guidewire 30 is fully exposed from the sheath 40.

[0334] In such an example, a limit switch 3306 can be provided to allow power to the motor 3308 and LED 3310 only when the sheath 40 is fully retracted. Similarly, the limit switch 3306 can prevent power from being provided to the motor 3308 and LED 3310 if the sheath 40 is fully extended from its fully retracted state.

[0335] This is just one example of how the limit switch 3306 may be implemented into the circuitry of the controller 20 to enable control over when the motor 3308 receives power, and any implementation of the limit switch 3306 may be implemented as desired by the user. Fig. 9Aand 9C As shown and described in , LED 3310 may be present to communicate to the operator that the motor is on, or that the motor is ready to be on (i.e., in the above example, the sheath 40 is fully retracted). Other purposes of LED 3310, such as use as a timer or indicator of treatment completion during segmented mechanical or mechanochemical ablation, may also be accomplished by the limit switch.

[0336] It should be understood that Fig.33 The overall block diagram shown and other example wire guide configurations of the circuit can be used as previously described in Figure 5A , Figure 5B , Figure 5C , Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C Any of the various controller 20 examples shown and described in the specification and described herein, as well as any additional controllers not specifically shown herein, may be used in combination.

[0337] Fig.34 A flow chart describing an exemplary method of treating venous disease using an ablation system is shown. In some instances, the method includes using a sclerotherapy device (at step 3400). A sclerotherapy device is understood to be any combination of an ablation device 10 and / or controller 20 and catheter 15 (or sheath 40 and guidewire 30). As used throughout, a sclerotherapy device need not be capable of specifically delivering a sclerosant, and any system capable of causing mechanical or mechanochemical ablation of a blood vessel is considered synonymous with such use of a "sclerotherapy device."

[0338] According to some examples, the method includes determining a first treatment site 50 in the vasculature of the patient (at step 3402). As previously discussed, the treatment site 50 (or first treatment site 50) can be along the length of the blood vessel, otherwise described as a treatment segment 55 (or first treatment segment 55 as in the specific example).

[0339] The method may include treating a first treatment site 50 by extending the guidewire 30 into the blood vessel and allowing it to expand (at step 3404). Also as previously described, the distal end of the guidewire 30 used to treat each treatment site 50 may be the length of the treated segment (treatment segment 55), thereby allowing the guidewire 30 to treat (or scrape) each treatment segment 55 at a time.

[0340] In some examples, the method includes repositioning the sheath to a second treatment site 50 (at step 3406). In the examples described above, the second treatment site 50 can also be along the length of the blood vessel, otherwise described as a treatment segment 55 (or second treatment segment 55).

[0341] According to some examples, the method includes treating a second treatment site 50 (at step 3408). As also described in detail above, the distal end of the guidewire 30 used to treat each treatment site 50 can be the length of the treated segment, allowing the guidewire 30 to treat (or scrape) the entire second treatment segment 55 at one time. The use of "first" and "second" is merely exemplary, and there may be more treatment steps or stages. In these examples, any next step may be considered to be performed on a subsequent treatment site 50 or treatment segment 55.

[0342] The method may include imaging the treatment site 50 with ultrasound (at step 3410). This is just one way to position the catheter 15 in the patient while delivering the catheter to the treatment site 50, or at least partially retract the catheter 15 to position the catheter 15 at a subsequent treatment site 50.

[0343] In some examples, the method includes providing a sclerosant to at least one of the first treatment site 50 and the second treatment site 50 through the sheath 40 (at step 3412). The sclerosant can be any drug and can be delivered by a device other than the sheath 40, such as through the lumen of the catheter 15 and / or the lumen of the guidewire 30. When delivered through the sheath 40, the drug can pass through the working lumen within the sheath 40.

[0344] Additionally, according to some examples, when the catheter 15 (sheath 40) is removed from the first treatment site 50 and repositioned to the second treatment site 50, no drug is delivered, thereby allowing the operator to have one less thing to focus on, as they no longer need to inject the drug at a specific rate while withdrawing the catheter 15 at a specific rate. In this way, the method achieves segmented mechanical or mechanochemical ablation. It should be understood that stating segmented mechanical or mechanochemical ablation means segmented mechanical or segmented mechanochemical ablation.

[0345] Fig.35 A flow chart depicting an example method of controlling a catheter is shown. In some examples, the method of controlling a catheter includes using a controller (at step 3500). The controller may be Figure 5A , 5B , 5C, 7, 8, 9A, 9B and 9C, or it may be a similar controller including a sliding portion capable of receiving a syringe. According to some examples, the method of controlling a catheter includes inserting a syringe into a T-shaped connector along a second direction perpendicular to the first direction (at step 3502).

[0346] The first direction is Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C, but it is reiterated that it is the direction of lateral travel of the saddle and the T-joint around the body of the device. In other words, the first direction is the direction of travel between the proximal end of the body and the distal end of the body. In step 3502, the syringe is inserted into the T-joint in a direction perpendicular to the first direction. Because the present invention exists in three-dimensional space, it should be understood that the second direction can be any direction circumferentially around the first direction. In addition, as Figure 7 , Figure 8 , Fig. 9A , Fig. 9B and Fig. 9C As shown, perfectly vertical insertion of the syringe is not required, and other directions and / or angles of insertion of the syringe into the T-fitting may also be used.

[0347] The method of controlling the catheter may include guiding the catheter to the patient's treatment site (at step 3504). In an example comprising a catheter coupled to the distal end of the body, and once the syringe has been inserted into the T-shaped connector, the catheter can be supplied to the treatment site to start the procedure.

[0348] Fig.36 A method flow chart depicting exposure of a guidewire from a catheter according to some examples is shown. In some examples, the method of exposing the guidewire from the catheter includes sliding a T-joint from the distal end of the body toward the proximal body end (in step 3600). In examples including a catheter, the catheter can be coupled to the device body at the distal end of the body. By sliding the saddle and T-joint from the distal end of the body to the proximal end of the body, the catheter is effectively "pulled back" as the saddle and T-joint move.

[0349] According to some examples, the method of exposing the guidewire from the catheter includes retracting a sheath around the guidewire (at step 3602). In examples where the guidewire is included within the catheter body, when the catheter is pulled back in response to movement of the saddle and T-joint, the catheter sheath surrounding the guidewire moves around the guidewire, as shown in step 3600. The guidewire either does not move in response to movement of the saddle and T-joint, or moves at a slower rate than the catheter.

[0350] The method of exposing the guidewire from the catheter may include exposing the distal end of the guidewire (at step 3604). Once the saddle and T-joint have been moved from the distal end of the body all the way to the proximal end of the body, the guidewire can be exposed from the catheter sheath, thereby allowing contact between the guidewire and the wall of the vascular system. This allows the guidewire to be used during surgery while also allowing the guidewire to be delivered to the treatment site without being exposed.

[0351] Fig.37An example method flow chart depicting the capture of a guidewire into a catheter is shown. In some examples, the method of capturing a guidewire with a catheter includes sliding a T-joint from the proximal end of the body to the distal end of the body (at step 3700). In examples that include a catheter, the catheter can be coupled to the device body at the distal end of the body. By sliding the saddle and T-joint from the proximal end of the body to the distal end of the body, the catheter is effectively "pushed forward" as the saddle and T-joint move.

[0352] According to some examples, a method of capturing a guidewire with a catheter includes extending a sheath around the guidewire (at step 3702). In examples where the guidewire is included within the catheter body, when the catheter is pushed forward in response to movement of the saddle and T-joint, the catheter sheath surrounding the guidewire moves around the guidewire, as shown in step 3700. The guidewire either does not move in response to movement of the saddle and T-joint, or moves at a slower rate than the catheter.

[0353] The method of capturing the guidewire with the catheter may include capturing the distal end of the guidewire (at step 3704). Once the saddle and T-joint have been moved from the proximal end of the body to the distal end of the body, the catheter sheath can completely cover the guidewire, thereby effectively capturing or encapsulating the distal end of the guidewire into the catheter sheath. Once the procedure is completed, this can help prevent damage to non-treatment areas.

[0354] Fig.38 A flow chart depicting a method of controlling a distal end of a catheter according to some examples is shown. In some examples, the method of controlling the distal end of the catheter includes rotating a syringe and a Luer interface (at step 3800). By rotating the syringe and the Luer interface, rotational motion can also be applied to the catheter coupled to the device body.

[0355] According to some examples, the method of controlling the distal end of the catheter includes providing torque to the catheter at step 3802. The rotational movement of the syringe and the Luer interface can apply torque to the catheter, and the torque can be in the direction of rotation of the syringe and the Luer interface, or opposite to the direction of rotation of the syringe and the Luer interface.

[0356] The method for controlling the distal end of the catheter may include controlling the direction of travel of the distal end of the catheter (in step 3804). In response to the torque applied, the distal end of the catheter moves. For example, if the torque applied to the catheter is the same as the rotation direction of the syringe and the Luer interface, and the rotation direction is a clockwise direction around the body of the device, the distal end of the catheter can turn toward the left side (wherein the length of the catheter from the proximal catheter end to the distal catheter end is a first direction, and the left side is based on the first direction). On the contrary, if the torque applied to the catheter is opposite to the rotation direction of the syringe and the Luer interface, the distal end of the catheter can turn toward the right side. The use of "left" and "right" is only exemplary, and it should be understood that the device can be configured to apply torque to the catheter in such a way that the distal end of the catheter can be controlled in any direction according to the needs of the operator.

[0357] Fig.39 An example method flow diagram depicting controlling a motor is shown. In some examples, the method of controlling a motor includes pressing a button (at step 3900). The button can be mechanically coupled to the device body and electrically coupled to the motor, thereby allowing control of the motor. According to some examples, the method of controlling a motor includes energizing the motor (at step 3902). In response to actuation of the button, power is supplied to the motor, thereby allowing the motor to rotate.

[0358] The method of controlling the motor may include pressing a button (at step 3904). Once the program is completed, or at any time when it is no longer necessary to rotate the motor, the button may be actuated again. In some examples, the method of controlling the motor includes turning off the motor (at step 3906). Once the button is actuated at a subsequent time, or at any time when the motor is currently powered on, the button will remove access to power from the motor, thereby stopping the motor from rotating. Although in Fig.39 The term "button" is used in the text, but it should be understood that as shown in the previous figures (see Figure 5A , Figure 5B , Figure 5C , Fig. 6A , Figure 6B , Fig. 9A , Fig. 9B and Fig. 9C ) may be used to supply power to or remove power from the motor.

[0359] Fig.40 A flow chart depicting a method of providing fluid through a catheter according to some examples is shown. In some examples, the method of providing fluid through a catheter includes depressing a plunger of a syringe (at step 4000). By depressing the plunger of the syringe, any fluid in the syringe is ejected from an opening in the syringe tip.

[0360] According to some examples, the method of providing fluid through a catheter includes releasing fluid through the catheter (at step 4002). In an example where the catheter is in fluid communication with a syringe, the fluid ejected from the syringe in step 4000 may be injected into the catheter body through the fluid lumen. This allows the fluid to travel the length of the catheter and reach the treatment site.

[0361] Fig.41 A method flow chart depicting segmented mechanical ablation according to some examples is shown. In some examples, the method of segmented mechanical ablation includes inserting a catheter into the vascular system of a patient (at step 4100). The catheter can then be delivered to a treatment site, which is also referred to as a treatment segment due to the treatment length provided without the need to move the catheter. According to some examples, the method of segmented mechanical ablation includes moving the catheter to a first treatment segment (at step 4102). The first treatment segment can be the most distal position in the total treatment length, allowing the operator to move the catheter through the total treatment length by pulling the catheter out of the patient's body instead of pushing the catheter further into the patient's body. However, it should be understood that movement in either direction can be achieved by the method, and the operator can choose how to perform such segmented ablation treatment.

[0362] The method of segmented mechanical ablation may include actuating a motor and rotating at least a portion of the catheter (in step 4104). Mechanical agitation (or scraping or ablation) of the vessel wall may be due to rotating the catheter and physically contacting a portion of the catheter with the intima and media of the vessel wall. This contact may be sufficient to damage these layers, and in some cases, this damage may be sufficient to kill the vessel, thereby completing the treatment of varicose veins at least in the treatment segment. In other examples, the catheter performs a less rotating and more reciprocating motion movement, thereby "scraping" the vessel wall in order to perform this damage. This reciprocating motion can be caused by converting the rotational motion of the motor into a guidewire motion of the catheter, or can be caused by other means if necessary.

[0363] In some examples, the method of segmented mechanical ablation includes scraping the first treatment segment for a predetermined amount of time (at step 4106). The predetermined amount of time depends on the needs of the operator and how long the particular vessel being treated may require. The length of time may also be based on how the procedure is performed. Fig.41 The segmented mechanical ablation in the method shown is still as in Fig.45 In the case of segmented mechanical ablation, the catheter may be left in the treatment segment (without longitudinal movement through the vein) for about five seconds to about thirty seconds. Again, these numbers are exemplary only, and the operator may choose to leave the catheter in the treatment segment for any length of time they desire.

[0364] According to some examples, the method of segmented mechanical ablation includes moving the catheter to a second treatment segment (at step 4108). The second treatment segment can be adjacent or substantially adjacent to the first treatment segment, however, this is not strictly required. By having the second treatment segment close to or adjacent to the first treatment segment, the operator can ensure that the entire vessel is being treated.

[0365] The method of segmented mechanical ablation may include scraping the second treatment segment for a predetermined amount of time (at step 4110). The scraping (or, again, agitation or ablation) may be performed in the same manner as described above in step 4106. The predetermined amount of time may be the same as the predetermined amount of time discussed in step 4106, or it may be a different predetermined amount of time, depending on the operator's needs for the particular segment of the vein being treated.

[0366] Fig.42 A method flow chart depicting the exposure of a guide wire and encapsulation in a sheath according to some examples is shown. In some examples, the method of exposing a guide wire and encapsulation in a sheath includes indicating that a predetermined amount of time has passed (in step 4200). The indication step is not strictly limited to the method of exposing and encapsulating a guide wire in a sheath, and may be present in any other method listed herein, or if the indication step is not needed, it is not included in the present method. The indication may occur by a component (such as an LED, a speaker, or a display) that may be located externally, that may be on a controller. The indication may be audible or visual.

[0367] According to some examples, the method of exposing and enclosing a guidewire in a sheath includes retracting at least a portion of the sheath from the guidewire (in step 4202). The guidewire that can pass through the working lumen of the sheath can be additionally slidably disposed within the sheath. In some examples, this allows the sheath to be retracted around the guidewire.

[0368] The method of exposing and enclosing the guidewire in the sheath may include exposing the distal end of the guidewire at step 4204. Once the sheath is retracted, a portion of the guidewire (the distal end of the guidewire in the example) may be exposed from the sheath, thereby allowing the distal end of the guidewire to contact the vessel wall in a treatment such as segmented mechanical ablation.

[0369] In some instances, the method of exposing and enclosing the guidewire in the sheath includes extending the sheath around the guidewire (at step 4206). By slidably moving the sheath in the opposite direction of step 4202, the operator can extend the sheath around the guidewire all the way to its initial position, or at least partially to its initial position. This may prove useful in instances where the operator desires a different length of the distal end of the guidewire to treat a specific length of blood vessel.

[0370] According to some examples, the method of exposing and encapsulating the guide wire in the sheath includes at least partially encapsulating the guide wire distal end (in step 4208). By extending the sheath, the operator can encapsulate the guide wire distal end again, thereby facilitating the safe removal of the catheter from the patient. Similarly, since the sheath can only partially extend around the guide wire, the guide wire distal end can only be partially surrounded by the sheath. If the sheath is extended all the way back to its initial position, the guide wire can be completely enclosed again.

[0371] Fig.43 A flow chart depicting a method of limiting power input to a motor according to some examples is shown. The method of limiting power input to a motor may include allowing power to flow from a power source to the motor (at step 4300). In examples including a limit switch, the limit switch may be a component that allows or prevents power flow. As will be described in Fig.47 As described in more detail in , the limit switch can be controlled by some other properties of the overall ablation system.

[0372] In some examples, the method of limiting the power input to the motor includes rotating the guide wire (at step 4302). Fig.41 As discussed in , the rotation of the guidewire may be responsible for causing ablation (or agitation or scraping) of the vessel wall. The rotation of the motor may also translate in the longitudinal movement of the guidewire, thereby allowing a scraping effect rather than rotational ablation.

[0373] According to some examples, the method of limiting the power input to the motor includes preventing power from flowing from the power source to the motor (at step 4304). As described in step 4300, this can be achieved by using a limit switch. The method of limiting the power input to the motor may include terminating the rotation of the guide wire (at step 4306). Once power is no longer allowed to flow to the motor, any effect of the motor on the movement of the guide wire may cease.

[0374] Fig.44 A flow chart depicting a method for measuring distance in a segmented treatment according to some examples is shown. In some examples, the method for measuring distance in a segmented treatment includes maintaining a longitudinal position of a catheter relative to a first treatment segment (at step 4400). Fig.41 As described in , the catheter can be held in place longitudinally within the blood vessel for a predetermined amount of time. In some examples, the shape of the distal end of the guidewire allows the entire segment to be treated at once, so there is no need to move the catheter when treating such a segment. This can allow the operator to keep track of one less thing at a time and free up one of the operator's hands to assist with other parts of the procedure.

[0375] According to some examples, a method of metering distance in segmented treatment includes moving the catheter out of the patient by a distance approximately equal to the length from a first distance marker to a second distance marker (at step 4402). These distance markers can be located on the axis of the catheter. When the catheter is withdrawn from the patient's body, subsequent distance markers can become visible, thereby indicating to the operator how far the catheter has been removed from the patient as a whole. In some examples, the distance markers are separated by a distance approximately equal to the length of the treatment segment. In such an example, the operator who pulls the catheter out of the patient's body will be able to identify when the distal end of the catheter has moved from one treatment segment to a subsequent treatment segment. This spacing of the distance markers will additionally make it less likely that the operator will miss a portion of the blood vessel to be treated, because each treatment segment will be treated separately with the minimum spacing (if any) between segments.

[0376] The method of measuring the distance in segmented treatment may include indicating that the end of the feasible treatment length of the catheter has been reached (in step 4404). A warning track or the like on the body of the catheter can indicate additional information to the operator. The warning track can be visually different from the distance mark of the previous segment to allow the operator to quickly distinguish the difference between the information being transmitted. In addition, the warning track will likely reside on the catheter distal to the distance mark. This is because, in some examples, the purpose of the warning track is to indicate that the operator is leaving the treatment area, that is, the operator has reached the end of the feasible treatment length of the catheter. This can indicate to the operator that the treatment of the blood vessel has been completed at least in the instant treatment.

[0377] Fig.45 A flow chart depicting a method of segmented mechanochemical ablation according to some examples is shown. According to some examples, the method of segmented mechanochemical ablation includes injecting a drug at a first treatment segment (at step 4500). Similar to Fig.41 According to the disclosure of the present invention, the injection can occur for a predetermined amount of time. The predetermined amount of time can be the same or different from the amount of time to perform mechanical ablation. In addition, the injection can occur before, after, or during the mechanical ablation portion of the treatment. For example, the operator can insert the catheter into the correct position for treatment and then power the motor to start scraping the vessel wall with the distal end of the guide wire for five seconds. After these five seconds have passed, the operator can begin to press the plunger of the syringe to inject the drug into the treatment site. This can be done over a period of time so that a specific rate of drug infusion is achieved. During the injection, the distal end of the guide wire can continue to rotate and scrape the vessel wall. The injection and mechanical ablation can occur for about five seconds. Once the injection has been completed, the operator can allow the distal end of the guide wire to continue to mechanically ablate the vessel wall for another ten seconds, which can drive the drug further into the damaged endothelium. It should be understood that the times listed here are only exemplary, and different times can be used for different treatments.

[0378] The method of segmented mechanochemical ablation may include terminating the injection of the drug before moving the catheter to the second treatment segment (in step 4502). For segmental mechanochemical ablation, the drug only needs to be injected when the catheter is placed in the treatment segment. This is different from the mechanochemical ablation methods in the prior art, in which the drug must be constantly delivered when the catheter is retracted through the patient's vasculature. Because the injection of the drug is terminated before moving the catheter from the first treatment segment to the second treatment segment, the operator does not need to focus on the injection of the drug while the catheter is moving. This can help eliminate human error when trying to measure two different rates (retraction rate and injection rate) simultaneously.

[0379] In some examples, the method of segmented mechanochemical ablation includes injecting a drug into the second treatment segment (at step 4504). The injection may also be continued for a predetermined amount of time, as described in step 4500. However, the time for injecting the predetermined amount into the second treatment segment need not be the same length of time as the predetermined amount for injecting into the first treatment segment.

[0380] According to some examples, the method of segmented mechanochemical ablation includes removing the catheter from the patient's vascular system (at step 4506). Once the treatment has been completed, the operator can remove the device from the patient. The method of segmented mechanochemical ablation may include terminating the injection of the drug before removing the catheter from the patient's vascular system (at step 4508). After the final treatment segment has been treated, the operator can stop injecting any drug from the syringe through the catheter before removing the catheter from the patient.

[0381] Fig.46 A method flow chart depicting tracking of a catheter sheath separated from a guidewire according to some examples is shown. In some examples, the method of tracking a catheter sheath separated from a guidewire includes removably coupling the sheath to the body of a controller (in step 4600). Removably coupling the sheath to the body of the controller can allow the sheath to be longitudinally manipulated differently from the guidewire. According to some examples, the method of tracking a catheter sheath separated from a guidewire includes removing the sheath from the body (in step 4602). Because the sheath is removably coupled to the body of the controller in the examples, the sheath can be disassembled or removed from the body while leaving the guidewire in place (still being coupled to the body of the controller in some way).

[0382] The method of tracking the catheter sheath separated from the guidewire may include guiding the sheath to the patient's treatment area (in step 4604). By separating the sheath from the body of the controller while leaving the guidewire in place, the sheath can be delivered to the treatment site before the guidewire. In examples where the profile of the guidewire is such that it even gently affects the profile of the sheath when stored internally, it may be desirable to track the sheath to the treatment site without increasing the cross-section of the sheath. Then, once the sheath is in the correct position, the guidewire can be set through the sheath to also reach the treatment site.

[0383] Fig.47 A flow chart depicting an additional method of limiting power input to the motor according to some examples is shown. In some examples, the additional method of limiting power input to the motor includes retracting the sheath around the guidewire (at step 4700). The limiting feature can be implemented by a limit switch, such as Fig.43 The invention relates to a method of treating a guide wire of a patient in a manner as described herein. In such an example, a limit switch can be operably coupled to the sheath so that the limit switch only allows power to flow (from the power source, through the limit switch, to the motor) when the sheath is in a fully retracted position. In other examples, the limit switch allows power to flow from the power source to the motor when the sheath is only partially retracted, thereby allowing a variable treatment length of the exposed guide wire. In either example, because the limit switch prevents the motor from receiving power until the sheath is retracted or at least partially retracted, the motor cannot be operated intentionally or unintentionally when the guide wire is not exposed. This can help to safely deliver the catheter to the treatment site without worrying about the guide wire rotating prematurely.

[0384] According to some examples, an additional method of limiting power flow to the motor includes exposing the distal end of the guidewire (at step 4702). Fig.42 As described in , once the sheath is retracted, a portion of the guidewire (in the example described, the distal end of the guidewire) may be exposed from the sheath, thereby allowing the distal end of the guidewire to contact the vessel wall during treatments such as segmented mechanical ablation.

[0385] Additional methods of limiting the power input to the motor may include allowing the motor to rotate (at step 4704). Once the sheath is retracted or at least partially retracted, the limit switch may allow the motor to receive power and therefore rotate. Fig.41 and Fig.43 As discussed in, the rotation of the guidewire and thus the rotation of the distal end of the guidewire may be the cause of ablation (or agitation or scraping) of the vessel wall. Once again, the rotation of the motor may also be converted in the longitudinal movement of the guidewire, thereby allowing a scraping effect via the distal end of the guidewire, rather than rotational ablation.

[0386] In some examples, an additional method of limiting the power input to the motor includes extending the sheath around the guide wire (in step 4706). By slidably moving the sheath in the opposite direction of step 4700, the operator can extend the sheath backward around the guide wire. Again, the movement can include moving the sheath all the way back to its initial position (i.e., the position the sheath may have been in when the catheter was initially delivered to the treatment site), or only partially extending the sheath around the guide wire. In addition to the already mentioned variable treatment length that this provides, this may also affect a limit switch, thereby preventing the motor from receiving any more power, as will be discussed in step 4710.

[0387] According to some examples, an additional method of limiting the power flow to the motor includes at least partially surrounding the distal end of the guidewire (at step 4708). Fig.42 As discussed in , by extending the sheath, the operator can once again seal the distal end of the guidewire, thereby facilitating safe removal of the catheter from the patient. Similarly, since the sheath can only partially extend around the guidewire, the distal end of the guidewire can only be partially surrounded by the sheath. If the sheath is extended all the way back to its initial position, the guidewire can once again be completely sealed. In addition, as described in step 4706, this sealing of the distal end of the guidewire can also affect the limit switch to prevent power from flowing to the motor.

[0388] Additional methods of limiting the power input to the motor can include preventing the motor from rotating (in step 4710). Once the procedure has been completed and the operator wants to remove the catheter from the patient, the operator may also want to stop the ablation mechanism (whether mechanical or chemical) from occurring to avoid damaging healthy veins. In addition to simply turning off the motor, by binding the position of the sheath to the limit switch, the operator may not accidentally start the motor again during this retraction of the catheter from the patient's body. Again, the limit switch can be adjusted to allow a variable length treatment segment at the distal end of the guidewire by preventing the motor from receiving power only when the sheath is fully extended.

[0389] Fig.48A flow chart depicting a method for stabilizing a controller body according to some examples is shown. In some examples, the method for stabilizing the controller body includes changing the rotation ratio between the motor and the catheter (in step 4800). Although not necessary for a stable controller, in some cases, the controller can have a taller but shorter body when the motor is placed below the T-joint and / or saddle rather than behind it. In such an example, it may be necessary to increase the stability of the device due to its now higher center of gravity. When the motor is placed below the T-joint and / or saddle, because the motor will no longer be aligned with the insertion point of the catheter, a gear ratio may become necessary to convert the rotational motion of the motor into the rotational motion of the catheter. If the user of the device desires an adjustable rotation option for the catheter, these gear ratios can also be used in controllers where the motor is behind the T-joint and / or saddle.

[0390] According to some examples, the method of stabilizing the controller body includes extending the expandable legs (at step 4802). The ablation system may include expandable legs on the bottom of the controller body, which may be as shown in FIG. Fig.11 The extendable legs can lower the center of gravity of the controller when extended. This is particularly useful in example controllers like the controller in the previous paragraph, where the placement of the motors gives the controller an inherently higher center of gravity and the user wants that center of gravity to be lowered.

[0391] The controller body stabilization method may include stabilizing the controller body at step 4804. The controller body gains stability by lowering the center of gravity of the controller by deploying the extendable legs at step 4802. This reduces any chances of an operator accidentally tipping the controller over during surgery.

[0392] Fig.49 A flow chart depicting a method for using a controller with a sterile package according to some examples is shown. In some examples, the method for using a controller with a sterile package includes removing a catheter from the sterile package (at step 4900). In some examples, the controller and the catheter are packaged together in the sterile package. The catheter will need to be at least partially removed from the sterile package in order to be inserted into the patient. In some examples, the catheter is packaged separately from the controller.

[0393] According to some examples, a method of using a controller with a sterile package includes guiding a catheter to a treatment site of a patient (at step 4902). The catheter can be guided to the treatment site of the patient when coupled to the controller, or the catheter can be detachable and the operator can choose to guide the catheter to the treatment site before coupling the catheter to the controller. The present disclosure also enables the operator to couple the catheter to the controller when the catheter is delivered to the treatment site if the operator wishes to do so.

[0394] The method of using a controller with a sterile package may include operating the controller from within the sterile package (at step 4904). A cavity or recess may be present in the sterile package in which the controller resides when packaged. After the catheter is removed from the sterile package (in an example where the catheter and the controller are packaged in the same sterile package), the controller may remain within the sterile package. In this way, the controller may maintain its sterility during use. This may allow an operator to perform treatment without the need for a sterile drape. Additionally, this may reduce the cost of the procedure because, while the catheter will still need to be sterilized or disposed of, the controller does not need to be sterilized after each use as long as its environment remains sterile.

[0395] In some examples, the method of using a controller with a sterile package includes placing a catheter through a slit in the sterile package (at step 4906). The sterile package can include a slit located distal to the controller (the portion of the catheter proximal to the controller that will be inserted in order to be coupled to the controller). The slit can also be a hole or other cavity-type vacancy in the sterile package through which the catheter can be inserted. In this way, the catheter can be coupled to the controller without removing the controller from the sterile package, thereby maintaining the sterility of the controller.

[0396] Fig.50 A method flow chart depicting the removable connection of a catheter to a controller according to some examples is shown. According to some examples, the method of removably connecting a catheter to a controller includes removably connecting the catheter to the controller (in step 5000). As previously described throughout the application, the catheter may be able to be completely removed from the controller, thereby providing a detachable connection between the catheter and the controller. This is understood to be not strictly necessary, and the example ablation system may be provided with a catheter fixedly connected to the controller.

[0397] The method of removably coupling a catheter to a controller may include removing a sheath from the controller (at step 5002). In some examples, the catheter includes a sheath having a working lumen. In other examples, the sheath may be removable from the controller. In such examples, the sheath may be tracked to a treatment site prior to coupling to the controller. In examples including a guidewire passing through the working lumen of the sheath, the sheath may be detached from the controller and tracked to a treatment site separate from the guidewire, such as Fig.46 described.

[0398] In some examples, the method of removably coupling a catheter to a controller includes sterilizing a sheath separately from the controller (at step 5004). According to some examples, the method of removably coupling a catheter to a controller includes treating the sheath (at step 5006). In an exemplary ablation system where the sheath is detachable from the controller, the sheath can be sterilized when not connected to the controller. Fig.49As mentioned, this can help reduce sterilization costs. In addition, the sheath can be completely discarded without having to discard the controller, which means that the controller can be reused more times than the catheter.

[0399] The method of removably coupling the catheter to the controller may include removing the guide wire from the controller (in step 5008). In some exemplary ablation systems, the catheter also includes a guide wire that passes through the working lumen of the sheath. If necessary, the catheter may also include a guide wire without the sheath. In either case, the guide wire may be tracked to the treatment site before being coupled to the controller (or a motor, in an exemplary ablation system including a motor for rotating the guide wire).

[0400] In some examples, the method of removably coupling a catheter to a controller includes sterilizing a guidewire separately from the controller (at step 5010). According to some examples, the method of removably coupling a catheter to a controller includes treating the guidewire (at step 5012). In an example ablation system in which the guidewire is detachable from the controller, the guidewire can be sterilized when not connected to the controller. Also, as shown in FIG. Fig.49 As described in , this can help reduce sterilization costs. In addition, similar to the sheath of step 5006, the guidewire can be completely disposed of without having to dispose of the controller, which means that the controller can be reused more times than the catheter.

[0401] Included in the present disclosure is an ablation system 10, which includes a controller 20. In some examples, the ablation system 10 includes a sheath 40, the sheath 40 having a working lumen, a sheath proximal end, and a sheath distal end. According to some examples, the sheath proximal end is coupled to the controller 20, and the sheath distal end is configured for insertion into a patient's vascular system, the sheath distal end being positioned relative to the sheath proximal end. The ablation system 10 may include a guidewire 30 extending from the controller 20 through the working lumen to the sheath distal end. In some instances, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202, the guidewire distal end 1204 being configured to engage a vessel wall in the treatment segment 55.

[0402] According to some examples, the sheath 40 is retractable to expose the guidewire distal end 1204. The guidewire distal end 1204 can be arranged and configured to define a compressed state when the guidewire distal end 1204 is located within the sheath 40, and to define an uncompressed state when the sheath 40 is retracted from the guidewire distal end 1204. In some examples, the guidewire 30 is configured to be delivered to the treatment section 55 in a compressed state. According to some examples, the sheath 40 is variably retracted to expose the length of the guidewire distal end 1204. The length of the guidewire distal end 1204 can be configured to form a variable treatment length.

[0403] In some examples, the sheath 40 is removably coupled to the controller 20. According to some examples, the sheath 40 is configured to track to the treatment segment 55 while the guidewire 30 remains stationary. The ablation system 10 may also include a motor 610 and / or 3308 configured to provide a rotational output, wherein the guidewire 30 is coupled to the motor 610 and / or 3308.

[0404] In some examples, the sheath 40 includes an open distal end configured to deliver a drug to the treatment segment 55. According to some examples, the sheath 40 also includes a lumen to deliver the drug to the treatment segment 55. The sheath 40 may include an opening at the distal end of the sheath to deliver the drug to the treatment segment 55. In some instances, the drug is a sclerosant.

[0405] According to some examples, the sheath 40 includes a closed distal end and an opening at the distal end of the sheath to deliver a drug to the treatment section 55. The drug may be a sclerosant.

[0406] In some instances, the guidewire distal end 1204 includes a sinusoidal configuration. According to some examples, the guidewire distal end 1204 includes a weighted tip 1210. The weighted tip 1210 can be attached to the distal-most end of the guidewire 30. In some instances, the guidewire distal end 1204 defines a sinusoidal cross-sectional profile.

[0407] According to some examples, the sinusoidal sine includes a non-uniform amplitude. The sheath 40 may include a closed distal end and a hole at the distal end of the sheath to deliver the drug to the treatment section 55. In some examples, the non-uniform amplitude is configured to cause a jet effect of the drug.

[0408] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to provide a rotational output. In some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. According to some examples, the sinusoidal configuration is configured to be able to rotate in response to the rotational output of the motor 610 and / or 3308.

[0409] The guidewire 30 can define a central axis 1208. In some instances, the guidewire distal end 1204 includes a sinusoidal configuration. According to some examples, the guidewire distal end 1204 includes a weighted end 1210. The weighted end 1210 can be centered on the central axis 1208, and the weighted end 1210 is configured to produce a gyroscopic effect. In some examples, the weighted end 1210 is offset from the center and parallel to the central axis 1208. According to some examples, the weighted end 1210 is configured to contact the wall of the blood vessel. The weighted end 1210 can be offset from the center and at a certain angle to the central axis 1208. In some examples, the weighted end 1210 is configured to contact the wall of the blood vessel.

[0410] According to some examples, the guidewire 30 includes a thickness gradient to enable a thicker section of the guidewire distal end 1204 to improve contact with the vessel wall. The guidewire 30 may have a circular cross-sectional profile 1302. In some instances, the guidewire 30 has a flat bar cross-sectional profile 1304. According to some examples, the guidewire 30 has a triangular cross-sectional profile 1306.

[0411] The guidewire 30 may include a twisted wire 1702. In some examples, the twisted wire 1702 defines a radius, and wherein the radius is adjustable. According to some examples, the twisted wire 1702 is configured to allow for high contact forces on the vessel wall. The twisted wire 1702 may define a sinusoidal profile.

[0412] In some examples, the controller 20 includes a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. According to some examples, the motor 610 and / or 3308 is configured to provide a rotational output. The guidewire proximal end 1202 can be rotationally coupled to the motor 610 and / or 3308. In some examples, the twisted wire 1702 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0413] In some examples, the guidewire 30 includes a helical hollow strand 1802 guidewire. According to some examples, the helical hollow strand 1802 is configured to be able to deliver a drug to the treatment segment 55. The drug can be a sclerosant. In some examples, the drug is configured to seep through the coil of the helical hollow strand 1802 guidewire. According to some examples, the helical hollow strand 1802 guidewire defines a sinusoidal profile. The amplitude of the sinusoidal profile can be adjustable. In some examples, the ablation system 10 also includes a pull rope connected to the distal end of the helical hollow strand 1802 guidewire, the pull rope being configured to adjust the amplitude of the sinusoidal profile.

[0414] According to some examples, the helical hollow strand 1802 guidewire defines a first helical hollow strand 1802 guidewire, and the guidewire 30 further includes a second helical hollow strand 1802 guidewire. The second helical hollow strand 1802 guidewire can at least partially surround the first helical hollow strand 1802 guidewire. In some examples, the first helical hollow strand 1802 guidewire and the second helical hollow strand 1802 guidewire generate an oscillating motion.

[0415] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to provide a rotational output. In some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. According to some examples, the spiral hollow strand 1802 is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0416] The helical hollow strand 1802 guidewire can be configured to lay flat when inside the sheath 40. In some examples, the helical hollow strand 1802 is configured to expand when the sheath 40 is retracted.

[0417] According to some examples, the guidewire distal end 1204 includes a spring-like configuration. The guidewire distal end 1204 may define a spring-like transverse profile 2402. In some examples, the spring-like configuration defines a sinusoidal profile.

[0418] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to provide a rotational output. In some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. According to some examples, the spring-like structure is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0419] The guidewire distal end 1204 may include a three-dimensional cross-sectional profile. In some examples, the three-dimensional cross-sectional profile is a two-dimensional sinusoidal configuration, and the sinusoidal configuration defines a period. According to some examples, each period of the sinusoidal configuration rotates in the third dimension.

[0420] The sinusoidal configuration can further define a time period that is part of a cycle. In some examples, each time period of the sinusoidal configuration turns in the third dimension. According to some examples, each time period is half of a cycle.

[0421] The guide wire distal end 1204 can 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 provide power to the motor 610 and / or 3308. According to some examples, the motor 610 and / or 3308 is configured to provide a rotation output. The guide wire proximal end 1202 can be rotationally 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 rotation output of the motor 610 and / or 3308.

[0422] According to some examples, guidewire distal end 1204 includes a triangular sinusoidal profile 1602. Triangular sinusoidal profile 1602 may include a triangular peak 1604. In some examples, triangular peak 1604 is configured to contact a wall of a blood vessel.

[0423] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to provide a rotational output. In some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. According to some examples, the triangular sinusoidal profile 1602 is configured to be able to rotate in response to the rotational output of the motor 610 and / or 3308.

[0424] The guide wire distal end 1204 may include a basket shape. In some examples, the basket 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 provide power to the motor 610 and / or 3308. The motor 610 and / or 3308 may be configured to provide a rotational output. In some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. According to some examples, the basket shape is configured to rotate in response to the rotational output of the motor 610 and / or 3308.

[0425] The guide wire 30 can be made of a material that can be shaped. In some examples, the guide wire 30 is made of a nickel-titanium alloy.

[0426] According to some examples, the guidewire 30 includes a lumen from the guidewire proximal end 1202 to the guidewire distal end 1204. The guidewire 30 may also include a hole 1206 at the distal end of the guidewire 30. In some examples, the lumen is configured to deliver a drug to the treatment segment 55 through the hole 1206. According to some examples, the drug is a sclerosant. The guidewire 30 may include a hole at the guidewire distal end 1204. In some examples, the lumen is configured to deliver a drug to the treatment segment 55 through the hole.

[0427] According to some examples, the ablation system 10 further includes a proximal feature 2602 proximal to the guidewire distal end 1204. The proximal feature 2602 can 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 sclerosant.

[0428] The proximal feature structure 2602 can 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 a biased balloon 2606. The biased balloon 2606 can be biased toward one side of the sheath 40. In some examples, the biased balloon 2606 is configured to unload the guidewire 30 when the biased balloon 2606 is in an expanded state, so that the guidewire 30 more actively contacts the vessel wall. According to some examples, the sheath 40 provides an inflation fluid to the balloon 2604, and the inflation fluid is configured to inflate the balloon 2604.

[0429] The proximal feature 2602 can be a cage 2608 on the guidewire 30. In some examples, the proximal feature 2602 is a slotted entity 2610 on the guidewire 30. According to some examples, the proximal feature 2602 is an impeller 2612 on the guidewire 30. The proximal feature 2602 can be a sponge-like entity 2614 that at least partially surrounds the guidewire 30. In some examples, the proximal feature 2602 is a sponge-like entity 2614 that at least partially surrounds the sheath 40.

[0430] According to some examples, the proximal feature 2602 is a sinusoidal actuator 2616 in the guidewire 30. The sinusoidal actuator 2616 can be at least partially contained within the sheath 40 when the sheath 40 is retracted. In some examples, the sinusoidal actuator 2616 is configured to unload the guidewire 30, thereby causing the guidewire 30 to more actively contact the vessel wall.

[0431] According to some examples, the ablation system 10 further includes a distal feature structure 2702 located proximal to the distal portion of the guidewire distal end 1204. The distal feature structure 2702 can be configured to prevent blood from entering the treatment segment 55. In some examples, the distal feature structure 2702 is configured to prevent drugs from leaving the treatment segment 55.

[0432] According to some examples, the distal feature 2702 is a single blade impeller 2704 on the guidewire 30. The distal feature 2702 can be a cage 2706 on the guidewire 30. In some examples, the distal feature 2702 is a slotted solid 2708 on the guidewire 30. According to some examples, the distal feature 2702 is an impeller 2710 on the guidewire 30. The distal feature 2702 can be a sponge-like solid 2712 that at least partially surrounds the guidewire 30.

[0433] In some examples, the distal-most tip of the guidewire 30 is a hemispherical tip 2802. According to some examples, the hemispherical tip 2802 is weighted. The hemispherical tip 2802 can be configured to contact the wall of a blood vessel.

[0434] In some examples, the most distal end of the guidewire 30 is an offset weighted tip 2804. According to some examples, the offset weighted tip 2804 is weighted. The offset weighted tip 2804 can be configured to contact the wall of the vessel.

[0435] In some examples, the guidewire 30 includes a lumen. According to some examples, the distal end of the guidewire 30 is a balloon tip 2806. The lumen can be configured to provide an inflation fluid to the balloon tip 2806, the inflation fluid being configured to expand the balloon tip 2806. In some examples, the balloon tip 2806 is configured to occlude a blood vessel when in an expanded state.

[0436] According to some examples, the ablation system 10 further includes an auxiliary guidewire 2902 wrapped around at least a portion of the guidewire distal end 1204. The auxiliary guidewire 2902 can be a heating guidewire 2904. In some examples, the heating guidewire 2904 is configured to force the guidewire 30 into a predetermined shape in response to temperature. According to some examples, the predetermined shape is a sinusoidal profile. The temperature can be human body temperature.

[0437] In some examples, the auxiliary guidewire 2902 is a hypotube. According to some examples, the hypotube is configured to deliver a drug to the treatment segment 55. The drug may be a sclerosant.

[0438] In some examples, at least a portion of the guidewire distal end 1204 includes a porous surface geometry 2906. According to some examples, the porous surface geometry 2906 is configured to make erosive contact with the wall of a blood vessel.

[0439] At least a portion of the guidewire distal end 1204 may include additional geometries 3002a, 3002b, 3002c, and / or 3002d. In some examples, the additional geometries 3002a include rounded nubs. According to some examples, the additional geometries 3002b include balls. The additional geometries 3002c may include spikes. In some examples, the additional geometries 3002d include brushes. According to some examples, the additional geometries 3002a, 3002b, 3002c, and / or 3002d are configured to make active contact with the wall of the blood vessel. The guidewire 30 may include a sinusoidal profile. In some examples, the sinusoidal profile defines a peak. According to some examples, the additional geometries 3002a, 3002b, 3002c, and / or 3002d are located on the peak.

[0440] The ablation system 10 may also include an annular ring 3202 that at least partially surrounds the sheath 40. In some examples, the annular ring 3202 is slidably coupled to the sheath 40. According to some examples, the size of the annular ring 3202 is set so that it cannot enter the insertion point in the patient's body. The annular ring 3202 can be configured to keep the sheath 40 and the guide wire 30 in place during treatment. In some examples, the annular ring 3202 is configured to indicate the distance from the deep venous system in the patient's body.

[0441] According to some examples, the ablation system 10 also includes at least one distance mark 3204 on the sheath 40. The at least one distance mark 3204 can be configured to show the distance of the sheath 40 removed from the patient. In some examples, the at least one distance mark 3204 is configured to notify the user that the subsequent treatment segment 55 has been reached. According to some examples, the space between the at least one distance mark 3204 and the subsequent at least one distance mark 3204 is approximately the same as the length of the guidewire distal end 1204. The guidewire distal end 1204 can define the treatment segment 55. In some instances, the at least one distance mark 3204 at least partially surrounds the sheath 40.

[0442] According to some examples, the ablation system 10 also includes a warning track 3206 on the sheath 40. The warning track 3206 can be configured to notify the user that the end of the feasible treatment length has been reached. In some examples, the warning track 3206 at least partially surrounds the sheath 40.

[0443] The present disclosure also includes an ablation system 10 including a controller 20. In some examples, the ablation system 10 includes a sheath 40, which includes a working lumen, a sheath proximal end, and a sheath distal end. According to some examples, the sheath proximal end is connected to the controller 20, and the sheath distal end is configured for insertion into the patient's vascular system, and the sheath distal end is positioned relative to the sheath proximal end. The ablation system 10 may include a guidewire 30 extending from the controller 20 through the working lumen to the sheath distal end. In some instances, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202, and the guidewire distal end 1204 is configured to engage the vessel wall in the treatment segment 55.

[0444] According to some examples, the controller 20 includes a motor 610 and / or 3308 and a power supply 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. The controller 20 may also 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 rotation output. According to some examples, the guide wire proximal end 1202 is rotationally coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 can rotate the guide wire distal end 1204 at a speed between about 1000 revs / min (RPM) and about 4000RPM. In some examples, the controller 20 includes a torque limiter and a clutch to stop the rotation of the guide wire 30 when the torque limit is exceeded.

[0445] According to some examples, the controller 20 is a handle. The handle may include a slot 602, and the proximal end of the sheath includes an inflatable Tuohy needle 604 coupled to the slot 602. In some examples, the inflatable Tuohy needle 604 is retracted into the slot 602 to retract the sheath 40 and expose the guidewire distal end 1204. According to some examples, a flow path is established from the handle into the sheath 40 for injecting a sclerosant at the treatment segment 55.

[0446] 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 time remaining in the treatment.

[0447] Also included in the present disclosure is an ablation system 10 that includes a body 702, 802, and / or 902 defining a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908 opposite the body proximal end 708, 806, and / or 906. The ablation system 10 may include a saddle 704 slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916 extending from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. In some examples, the ablation system 10 includes a T-joint 706, 804, and / or 904 that is slidably connected to the body 702, 802, and / or 902 and is at least partially surrounded by a central portion of the saddle 704, whereby the T-joint 706, 804, and / or 904 moves along a first direction 712, 810, and / or 916 in response to movement of the saddle 704.

[0448] According to some examples, ablation system 10 further includes an injector 60 configured to be coupled to T-junction 706, 804, and / or 904. A component selected from the group consisting of injector 60, saddle 704, and combinations thereof can be configured to control movement of T-junction 706, 804, and / or 904. In some examples, injector 60 is configured to be inserted into T-junction 706, 804, and / or 904 along a second direction that is angled to first direction 712, 810, and / or 916. According to some examples, the angle is vertical.

[0449] The ablation system 10 may further include an injector 60 configured to be coupled to the T-joint 706, 804, and / or 904. In some examples, a component selected from the group consisting of the injector 60, the saddle 704, and a combination thereof is configured to control the movement of the T-joint 706, 804, and / or 904. According to some examples, the ablation system 10 further includes a sheath 40, the sheath 40 including a sheath proximal end, a sheath distal end opposite the sheath proximal end, and a working lumen therebetween. The sheath proximal end may be configured to be coupled to the body distal end 710, 808, and / or 908. In some examples, the working lumen is in fluid communication with the injector 60.

[0450] According to some examples, the sheath 40 is configured to receive the guidewire 30, which includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. Sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 can retract the sheath 40 around the guidewire 30, thereby exposing the guidewire distal end 1204. In some examples, sliding the T-shaped connector 706, 804, and / or 904 from the body proximal end 708, 806, and / or 906 toward the body distal end 710, 808, and / or 908 extends the sheath 40 around the guidewire 30, thereby at least partially surrounding the guidewire distal end 1204.

[0451] According to some examples, the sheath 40 is configured to receive a hypotube, the hypotube comprising a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. Sliding the T-joint 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 can retract the sheath 40 around the hypotube, thereby exposing the hypotube distal end. In some examples, sliding the T-joint 706, 804, and / or 904 from the body proximal end 708, 806, and / or 906 toward the body distal end 710, 808, and / or 908 causes the sheath 40 to extend around the hypotube, at least partially surrounding the hypotube distal end.

[0452] According to some examples, the sheath 40 is configured to receive a catheter shaft, and the catheter shaft includes a catheter shaft proximal end and a catheter shaft distal end relative to the catheter shaft proximal end. Sliding the T-joint 706, 804 and / or 904 from the body distal end 710, 808 and / or 908 toward the body proximal end 708, 806 and / or 906 can retract the sheath 40 around the catheter shaft, thereby exposing the catheter shaft distal end. In some instances, sliding the T-joint 706, 804 and / or 904 from the body proximal end 708, 806 and / or 906 toward the body distal end 710, 808 and / or 908 extends the sheath 40 around the catheter shaft, thereby at least partially surrounding the catheter shaft distal end.

[0453] According to some examples, the T-joint 706, 804, and / or 904 includes a Luer connector 3102. The ablation system 10 may also include a syringe 60 configured to be coupled to the T-joint 706, 804, and / or 904. In some examples, a component selected from the group consisting of the syringe 60, the saddle 704, and a combination thereof is configured to control movement of the T-joint 706, 804, and / or 904. According to some examples, the Luer connector 3102 includes a Luer interface 3104 configured to removably couple the syringe 60 to the T-joint 706, 804, and / or 904. The Luer interface 3104 may be configured to rotate approximately 180 degrees around the first direction 712, 810, and / or 916. In some examples, the syringe 60 is configured to control rotation of the Luer interface 3104.

[0454] According to some examples, the ablation system 10 also includes a catheter 15 having a catheter proximal end and a catheter distal end opposite the catheter proximal end. The catheter proximal end can be configured to be coupled to the body distal 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 interface 3104 is configured to provide torque on the catheter 15. The torque can be configured to control the direction of travel of the catheter distal end.

[0455] In some examples, the ablation system 10 further includes a sheath 40, the sheath 40 including a sheath proximal end and a sheath distal end opposite the sheath proximal end. According to some examples, the sheath proximal end is configured to be removably coupled to a Luer connector 3102. The sheath 40 can be in fluid communication with the syringe 60. In some examples, the Luer interface 3104 is configured to provide torque on the sheath 40. According to some examples, the torque is configured to control the direction of travel of the sheath distal end.

[0456] The sheath 40 may further include a working lumen. In some examples, the ablation system 10 further includes a guidewire 30 extending from the body 702, 802, and / or 902 through the working lumen to the distal end of the sheath, the guidewire 30 having a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. According to some examples, the guidewire distal end 1204 is configured to engage the wall of the blood vessel in the treatment segment 55.

[0457] Ablation system 10 can also include a torque knob 1104 rotatably coupled to body 702, 802, and / or 902. In some examples, torque knob 1104 is located on body proximal end 708, 806, and / or 906.

[0458] According to some examples, the ablation system 10 further includes an injector 60 configured to be coupled to the T-joint 706, 804, and / or 904. A component selected from the group consisting of the injector 60, the saddle 704, and a combination thereof can be configured to control the movement of the T-joint 706, 804, and / or 904. In some examples, the ablation system 10 further includes a catheter 15 having a catheter proximal end and a catheter distal end opposite to the catheter proximal end. According to some examples, the catheter proximal end is configured to be coupled to the body distal end 710, 808, and / or 908. The catheter 15 can be in fluid communication with the injector 60.

[0459] In some examples, torque knob 1104 is configured to provide torque on catheter 15. According to some examples, the torque is configured to control the direction of travel of the distal end of the catheter.

[0460] The ablation system 10 may also include a guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. In some examples, the guidewire proximal end 1202 is configured to be coupled to the body distal end 710, 808, and / or 908. According to some examples, the torque knob 1104 is configured to provide torque on the guidewire 30. The torque may be configured to control the direction of travel of the guidewire distal end 1204.

[0461] In some examples, the ablation system 10 also includes a motor 610 and / or 3308 at least partially enclosed within the body 702, 802, and / or 902. According to some examples, the motor 610 and / or 3308 is at least partially enclosed within the proximal end 708, 806, and / or 906 of the body. The ablation system 10 can also include an actuator 506a, 506b, 608, 914, and / or 3304, which is coupled to the body 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308, and the actuator 506a, 506b, 608, 914, and / or 3304 is configured to energize and de-energize the motor 610 and / or 3308.

[0462] In some examples, the ablation system 10 further includes a guidewire 30, which includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. According to some examples, the guidewire proximal end 1202 is configured to be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to achieve rotation of the guidewire 30.

[0463] In some examples, the ablation system 10 further includes a hypotube comprising a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. According to some examples, the hypotube proximal end is configured to be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to achieve rotation of the hypotube.

[0464] In some examples, the ablation system 10 further includes a catheter shaft comprising a catheter shaft proximal end and a catheter shaft distal end opposite the catheter shaft proximal end. According to some examples, the catheter shaft proximal end is configured to be coupled to the motor 610 and / or 3308. The motor 610 and / or 3308 can be configured to achieve rotation of the catheter shaft.

[0465] In some examples, ablation system 10 further includes a limit switch 3306 electrically coupled to motor 610 and / or 3308. According to some examples, limit switch 3306 is configured to prevent motor 610 and / or 3308 from rotating when saddle 704 is positioned at a position other than body proximal end 708, 806, and / or 906. Limit switch 3306 may be configured to allow motor 610 and / or 3308 to rotate when saddle 704 is positioned at body proximal end 708, 806, and / or 906.

[0466] In some examples, ablation system 10 further includes LED 912 and / or 3310 electrically coupled to motor 610 and / or 3308. According to some examples, LED 912 and / or 3310 is configured to be powered off when saddle 704 is positioned at a location other than body proximal end 708, 806, and / or 906. LED 912 and / or 3310 can be configured to be powered on when saddle 704 is positioned at body proximal end 708, 806, and / or 906.

[0467] In some examples, the saddle 704 is at least partially within the body 702, 802, and / or 902. According to some examples, the saddle 704 includes a pull tab configured to facilitate movement of the saddle 704. The T-joint 706, 804, and / or 904 can be fixedly coupled to the saddle 704.

[0468] In some examples, the ablation system 10 further includes a display 508 configured to indicate information. According to some examples, the display 508 is configured to show a timer. The timer can be configured to count down the time remaining in the treatment. In some examples, the ablation system 10 further includes a catheter 15 coupled to the body distal end 710, 808, and / or 908. According to some examples, the timer is configured to count down until the treatment in the treatment segment 55 is completed and the catheter 15 will be moved to the subsequent treatment segment 55.

[0469] The ablation system 10 may further include an injector 60 configured to be coupled to the T-junction 706, 804, and / or 904. In some examples, a component selected from the group consisting of the injector 60, the saddle 704, and combinations thereof is configured to control movement of the T-junction 706, 804, and / or 904. According to some examples, the timer is configured to count down a time until an operator should start injecting medication from the injector 60. The timer may be configured to count down a time until an operator should stop injecting medication from the injector 60.

[0470] In some examples, the ablation system 10 further includes an alarm configured to emit a noise when the treatment is finished. According to some examples, the ablation system 10 further includes a catheter 15 coupled to the body distal end 710, 808, and / or 908. The ablation system 10 may also include an alarm configured to emit a noise when the treatment in the treatment segment 55 is completed and the operator is about to move the catheter 15 to a subsequent treatment segment 55.

[0471] In some examples, the ablation system 10 further includes a syringe 60 configured to be coupled to the T-junction 706, 804, and / or 904. According to some examples, a component selected from the group consisting of the syringe 60, the saddle 704, and a combination thereof is configured to control movement of the T-junction 706, 804, and / or 904. The ablation system 10 may further include an alarm configured to emit a noise when the operator should start injecting the drug from the syringe 60. In some examples, the alarm is configured to emit a noise when the operator should stop injecting the drug from the syringe 60.

[0472] According to some examples, the ablation system 10 further includes an LED 912 and / or 3310, which is configured to turn on at the end of treatment. The ablation system 10 may also include an LED 912 and / or 3310, which is configured to turn off at the end of treatment. In some examples, the ablation system 10 further includes a catheter 15 coupled to the distal end 710, 808 and / or 908 of the body, and an LED 912 and / or 3310, which is configured to turn on when the treatment in the treatment segment 55 is completed and the operator is about to move the catheter 15 to a subsequent treatment segment 55. According to some examples, the ablation system 10 also includes a catheter 15 connected to the distal end 710, 808 and / or 908 of the body, and an LED 912 and / or 3310, which is configured to turn off when treatment in the treatment segment 55 is completed and the operator wants to move the catheter 15 to a subsequent treatment segment 55.

[0473] The ablation system 10 may further include an injector 60 configured to be coupled to the T-joint 706, 804, and / or 904. In some examples, a component selected from the group consisting of the injector 60, the saddle 704, and a combination thereof is configured to control movement of the T-joint 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 the operator should start injecting the drug from the injector 60. The LED 912 and / or 3310 may be configured to turn off when the operator should stop injecting the drug from the injector 60.

[0474] In some examples, ablation system 10 further includes a syringe 60 configured to be coupled to T-junction 706, 804, and / or 904. According to some examples, a component selected from the group consisting of syringe 60, saddle 704, and combinations thereof is configured to control movement of T-junction 706, 804, and / or 904. Ablation system 10 may further include LED 912 and / or 3310 configured to be turned off when an operator should start injecting a drug from syringe 60. In some examples, LED 912 and / or 3310 is configured to be turned on when an operator should stop injecting a drug from syringe 60.

[0475] According to some examples, ablation system 10 also includes motor 610 and / or 3308 located near the bottom of body 702, 802, and / or 902. Ablation system 10 may also include a gear coupled to motor 610 and / or 3308. In some examples, the gear is configured to control the output rotational speed of motor 610 and / or 3308.

[0476] According to some examples, ablation system 10 also includes expandable legs 1102 on the base of body 702, 802, and / or 902. Expandable legs 1102 can be configured to promote stability of body 702, 802, and / or 902.

[0477] In some examples, the ablation system 10 further includes a catheter 15, which includes a catheter proximal end and a catheter distal end opposite to the catheter proximal end. According to some examples, the catheter proximal end is coupled to the body distal end 710, 808 and / or 908. The ablation system 10 may also include an arm 1106 coupled to one side of the body 702, 802 and / or 902.

[0478] In some examples, the arm 1106 is configured to maintain the distance between the catheter 15 and the body 702, 802, and / or 902 when the distal end of the catheter is advanced in a direction opposite to the first direction 712, 810, and / or 916. According to some examples, the distance between the catheter 15 and the body 702, 802, and / or 902 is a radius. The arm 1106 can be configured to maintain the catheter 15 in place during treatment.

[0479] In some examples, the ablation system 10 further includes a catheter 15, which includes a catheter proximal end and a catheter distal end opposite the catheter proximal end. According to some examples, the catheter proximal end is coupled to the body distal end 710, 808 and / or 908. The ablation system 10 may also include a catheter clip configured to hold the catheter 15 in place during treatment.

[0480] In some examples, the ablation system 10 also includes a sheath 40, which includes a working lumen, a sheath proximal end, and a sheath distal end. According to some examples, the sheath proximal end is connected to the body distal end 710, 808, and / or 908, and the sheath distal end is configured to be inserted into the patient's vascular system, and the sheath distal end is positioned relative to the sheath proximal end. The ablation system 10 may further include a guidewire 30 extending from the body distal end 710, 808, and / or 908 through the working lumen to the sheath distal end, the guidewire 30 having a guidewire proximal end 1202 and a guidewire distal end 1204 opposite to the guidewire proximal end 1202. In some examples, the guidewire distal end 1204 is configured to engage the wall of the blood vessel in the treatment segment 55.

[0481] According to some examples, the sheath 40 is removably coupled to the body distal end 710, 808, and / or 908. The sheath 40 can be configured to track to the treatment segment 55 while the guidewire 30 remains stationary.

[0482] In some examples, the ablation system 10 further comprises a sterile package 1002. According to some examples, the body 702, 802 and / or 902, the saddle 704, the T-joint 706, 804 and / or 904, the sheath 40 and the guidewire 30 are configured to be assembled in the cavity of the sterile package 1002. The sheath 40 and the guidewire 30 can be removably connected to the body distal end 710, 808 and / or 908. In some examples, the sheath 40 and the guidewire 30 are configured to be sterilized separately from the body 702, 802 and / or 902. According to some examples, the sheath 40 and the guidewire 30 are configured to be disposable. The ablation system 10 can be configured to be operated when in the sterile package 1002.

[0483] In some examples, the sterile package 1002 includes a slit 1004. According to some examples, the slit 1004 is configured to slidably receive the sheath 40. The body 702, 802, and / or 902, the saddle 704, and the T-joint 706, 804, and / or 904 can be configured to be positioned within a cavity of the sterile package 1002 during operation. In some examples, the sheath 40 and the guidewire 30 are configured to be slidably coupled to the slit 1004 during surgery. According to some examples, the body 702, 802, and / or 902, the saddle 704, and the T-joint 706, 804, and / or 904 are configured to be reusable.

[0484] Ablation system 10 may also include sterile package 1002, wherein body 702, 802, and / or 902, saddle 704, and T-junction 706, 804, and / or 904 are configured to fit within a lumen of sterile package 1002. In some examples, ablation system 10 is configured to be operated while in sterile package 1002.

[0485] The present disclosure also includes a method, the method including inserting the syringe 60 into the T-joint 706, 804, and / or 904 of the saddle 704 of the body 702, 802, and / or 902. In some examples, the body 702, 802, and / or 902 has a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908. According to some examples, the saddle 704 is slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. The first direction 712, 810, and / or 916 can extend from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. In some examples, the T-joint 706, 804, and / or 904 moves along the first direction 712, 810, and / or 916 in response to the movement of the saddle 704. According to some examples, the syringe 60 is inserted into the T-joint 706, 804, and / or 904 along a second direction perpendicular to the first direction 712, 810, and / or 916. The method may include guiding the catheter 15 to the treatment site 50 of the patient.

[0486] In some examples, the catheter 15 includes a sheath 40 configured to receive a guidewire 30, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. According to some examples, the method further includes sliding a T-joint 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the saddle 704. The method may also include retracting the sheath 40 around the guidewire 30 in response to sliding the T-joint 706, 804, and / or 904. In some examples, the method further includes exposing the guidewire distal end 1204 in response to retracting the sheath 40.

[0487] According to some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the syringe 60. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the pull tab.

[0488] According to some examples, the catheter 15 includes a sheath 40 configured to receive a guidewire 30, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. The method may also include sliding a T-joint 706, 804, and / or 904 from a body proximal end 708, 806, and / or 906 toward a body distal end 710, 808, and / or 908 via a saddle 704. In some examples, the method further includes extending the sheath 40 around the guidewire 30 in response to sliding the T-joint 706, 804, and / or 904. According to some examples, the method further includes at least partially enclosing the guidewire distal end 1204 in response to extending the sheath 40.

[0489] The method may further include sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the syringe 60. In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the pull tab.

[0490] The catheter 15 may include a sheath 40 configured to receive a hypotube, the hypotube including a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. In some examples, the method further includes sliding a T-joint 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via a saddle 704. According to some examples, the method further includes retracting the sheath 40 around the hypotube in response to sliding the T-joint 706, 804, and / or 904. The method may also include exposing the hypotube distal end in response to retracting the sheath 40.

[0491] In some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the syringe 60. According to some examples, the saddle 704 includes a pull tab. The method may also include sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the pull tab.

[0492] In some examples, the catheter 15 includes a sheath 40 configured to receive a hypotube, the hypotube including a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. According to some examples, the method also includes sliding a T-joint 706, 804, and / or 904 from a body proximal end 708, 806, and / or 906 toward a body distal end 710, 808, and / or 908 via a saddle 704. The method may also include extending the sheath 40 around the hypotube in response to sliding the T-joint 706, 804, and / or 904. In some examples, the method also includes at least partially closing the hypotube distal end in response to extending the sheath 40.

[0493] According to some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the syringe 60. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the pull tab.

[0494] According to some examples, the catheter 15 includes a sheath 40, which is configured to receive a catheter shaft, and the catheter shaft includes a catheter shaft proximal end and a catheter shaft distal end opposite to the catheter shaft proximal end. The method can also include sliding a T-joint 706, 804, and / or 904 from a body distal end 710, 808, and / or 908 toward a body proximal end 708, 806, and / or 906 via a saddle 704. In some instances, the method also includes retracting the sheath 40 around the catheter shaft in response to sliding the T-joint 706, 804, and / or 904. According to some examples, the method also includes exposing the catheter shaft distal end in response to retracting the sheath 40.

[0495] The method may further include sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the syringe 60. In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 toward the body proximal end 708, 806, and / or 906 via the pull tab.

[0496] The catheter 15 may include a sheath 40 configured to receive a catheter shaft including a catheter shaft proximal end and a catheter shaft distal end opposite the catheter shaft proximal end. In some examples, the method includes sliding a T-joint 706, 804, and / or 904 from a body proximal end 708, 806, and / or 906 toward a body distal end 710, 808, and / or 908 via a saddle 704. According to some examples, the method also includes extending the sheath 40 around the catheter shaft in response to sliding the T-joint 706, 804, and / or 904. The method may also include at least partially enclosing the catheter shaft distal end in response to extending the sheath 40.

[0497] In some examples, the method further includes sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the syringe 60. According to some examples, the saddle 704 includes a pull tab. The method may also include sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body toward the distal end 710, 808, and / or 908 of the body via the pull tab.

[0498] In some examples, the T-junction 706, 804, and / or 904 further comprises a luer interface 3104 configured to receive the syringe 60. According to some examples, the method further comprises inserting the syringe 60 into the luer interface 3104. The luer interface 3104 can be configured to rotate about 180 degrees around the first direction 712, 810, and / or 916. In some examples, the method further comprises rotating the syringe 60 and the luer interface 3104. According to some examples, the method further comprises providing torque to the catheter 15 in response to rotating the syringe 60 and the luer interface 3104. The method can also comprise controlling the direction of travel of the distal end of the catheter shaft in response to providing torque to the catheter 15.

[0499] In some examples, the luer interface 3104 includes a connection configured to removably couple the sheath 40 to the body 702, 802, and / or 902. According to some examples, the method also includes removably coupling the sheath 40 to the body 702, 802, and / or 902. The method may further include removing the sheath 40 from the body 702, 802, and / or 902. In some examples, the method also includes guiding the sheath 40 to the treatment site 50 of the patient.

[0500] According to some examples, the motor 610 and / or 3308 is at least partially enclosed within the body 702, 802, and / or 902. The catheter 15 can at least partially surround the guidewire 30, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. In some examples, the guidewire proximal end 1202 is configured to be coupled to the motor 610 and / or 3308. According to some examples, the method further includes rotating the guidewire 30 via the motor 610 and / or 3308.

[0501] The actuator 506a, 506b, 608, 914, and / or 3304 can be coupled to the body 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308. In some examples, the method also includes interacting with the actuator 506a, 506b, 608, 914, and / or 3304. According to some examples, the method also includes energizing the motor 610 and / or 3308 in response to the interaction with the actuator 506a, 506b, 608, 914, and / or 3304. The method may also include de-energizing the motor 610 and / or 3308 in response to the interaction with the actuator 506a, 506b, 608, 914, and / or 3304.

[0502] In some examples, the motor 610 and / or 3308 is at least partially enclosed within the body 702, 802, and / or 902. According to some examples, the catheter 15 at least partially surrounds a hypotube, the hypotube comprising a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. The hypotube proximal end can be configured to be coupled to the motor 610 and / or 3308. In some examples, the method also includes rotating the hypotube via the motor 610 and / or 3308.

[0503] According to some examples, the actuator 506a, 506b, 608, 914, and / or 3304 is coupled to the body 702, 802, and / or 902 and is electronically coupled to the motor 610 and / or 3308. The method may also include interacting with the actuator 506a, 506b, 608, 914, and / or 3304. In some examples, the method also includes energizing the motor 610 and / or 3308 in response to the interaction with the actuator 506a, 506b, 608, 914, and / or 3304. According to some examples, the method also includes de-energizing the motor 610 and / or 3308 in response to the interaction with the actuator 506a, 506b, 608, 914, and / or 3304.

[0504] The motor 610 and / or 3308 can be at least partially enclosed within the body 702, 802, and / or 902. In some examples, the catheter 15 at least partially surrounds a catheter shaft, the catheter shaft comprising a catheter shaft proximal end and a catheter shaft distal end opposite the catheter shaft proximal end. According to some examples, the catheter shaft proximal end is configured to be coupled to the motor 610 and / or 3308. The method can also include rotating the catheter shaft via the motor 610 and / or 3308.

[0505] In some examples, the actuator 506a, 506b, 608, 914, and / or 3304 is coupled to the body 702, 802, and / or 902 and electronically coupled to the motor 610 and / or 3308. According to some examples, the method also 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 the interaction with the actuator 506a, 506b, 608, 914, and / or 3304. In some examples, the method also includes de-energizing the motor 610 and / or 3308 in response to the interaction with the actuator 506a, 506b, 608, 914, and / or 3304.

[0506] According to some examples, the syringe 60 includes a syringe body and a plunger. The method may also include depressing the plunger of the syringe 60. In some examples, the method also includes releasing the fluid through the catheter 15 in response to depressing the plunger.

[0507] The present disclosure also includes a method, the method including guiding a guidewire 30 to a treatment site 50 of a patient. In some instances, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. According to some examples, the guidewire 30 is coupled to a motor 610 and / or 3308, and the motor 610 and / or 3308 is at least partially surrounded by the body 702, 802, and / or 902. The method may include powering the motor 610 and / or 3308. According to some examples, the method includes rotating the guidewire 30 in response to powering the motor 610 and / or 3308.

[0508] The method may also include extending the guidewire 30 through the sheath 40 coupled to the body 702, 802, and / or 902. In some examples, the method includes removably coupling the sheath 40 to the body 702, 802, and / or 902. According to some examples, the method also includes guiding the sheath 40 to the treatment site 50 of the patient while the sheath 40 is separated from the body 702, 802, and / or 902.

[0509] The method may also include retracting the sheath 40 around the guidewire 30. In some examples, the method further includes exposing the guidewire distal end 1204 in response to retracting the sheath 40. According to some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. The method may further include allowing the motor 610 and / or 3308 to rotate in response to retracting the sheath 40 around the guidewire 30.

[0510] In some examples, the body 702, 802, and / or 902 includes a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908. According to some examples, the saddle 704 is slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. The first direction 712, 810, and / or 916 can extend from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. In some examples, the method further includes sliding the saddle 704 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906. According to some examples, in response to sliding the saddle 704 from the body distal end 710 , 808 , and / or 908 to the body proximal end 708 , 806 , and / or 906 , the sheath 40 is retracted around the guidewire 30 .

[0511] The saddle 704 can include a T-joint 706, 804, and / or 904. In some examples, the method further includes sliding the T-joint 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906. According to some examples, the T-joint 706, 804, and / or 904 includes a Luer interface 3104. The method can further include inserting the syringe 60 into the Luer interface 3104. In some examples, the method further includes sliding the syringe 60 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906.

[0512] According to some examples, the syringe 60 includes a syringe body and a plunger. The method may also include depressing the plunger of the syringe 60. In some examples, the method also includes releasing the fluid through the sheath 40 in response to depressing the plunger. According to some examples, the guidewire 30 includes an inner cavity. The method may also include releasing the fluid through the guidewire 30 in response to depressing the plunger.

[0513] In some examples, the saddle 704 includes a pull tab. According to some examples, the method further includes sliding the pull tab from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906. The method may also include partially retracting the sheath 40 around the guidewire 30. In some examples, the method further includes partially exposing the guidewire distal end 1204 in response to partially retracting the sheath 40 around the guidewire 30.

[0514] According to some examples, the method further includes extending the sheath 40 around the guidewire 30. The method can further include at least partially enclosing the guidewire distal end 1204 in response to extending the sheath 40. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes preventing the motor 610 and / or 3308 from rotating in response to extending the sheath 40 around the guidewire 30.

[0515] The body 702, 802, and / or 902 may include a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908. In some examples, the saddle 704 is slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. According to some examples, the first direction 712, 810, and / or 916 extends from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. The method may further include sliding the saddle 704 from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. In some examples, in response to sliding the saddle 704 from the body proximal end 708 , 806 , and / or 906 to the body distal end 710 , 808 , and / or 908 , the sheath 40 is extended around the guidewire 30 .

[0516] According to some examples, the saddle 704 includes a T-shaped connector 706, 804, and / or 904. The method further includes sliding the T-shaped connector 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body to the distal end 710, 808, and / or 908 of the body. In some examples, the T-shaped connector 706, 804, and / or 904 includes a Luer interface 3104. According to some examples, the method also includes inserting the syringe 60 into the Luer interface 3104. The method may also include sliding the syringe 60 from the proximal end 708, 806, and / or 906 of the body to the distal end 710, 808, and / or 908 of the body.

[0517] In some examples, the syringe 60 includes a syringe body and a plunger. According to some examples, the method further includes depressing the plunger of the syringe 60. The method may also include releasing the fluid through the sheath 40 in response to depressing the plunger. In some examples, the guidewire 30 includes an inner cavity. According to some examples, the method further includes releasing the fluid through the guidewire 30 in response to depressing the plunger.

[0518] The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. According to some examples, the method further includes partially extending the sheath 40 around the guidewire 30. The method may further include at least partially surrounding the guidewire distal end 1204 in response to partially extending the sheath 40 around the guidewire 30.

[0519] In some examples, the body 702, 802, and / or 902 includes a torque knob 1104. According to some examples, the method further includes providing torque to the guidewire 30. The method may also include controlling the direction of travel of the guidewire distal end 1204 in response to the guidewire 30 providing torque.

[0520] In some examples, the motor 610 and / or 3308 is located near the bottom of the body 702, 802, and / or 902. According to some examples, the method further includes changing a rotation ratio between the motor 610 and / or 3308 and the guidewire 30 via gears.

[0521] The body 702, 802, and / or 902 may include an extendable leg 1102 on the bottom of the body 702, 802, and / or 902. In some examples, the method further includes extending the extendable leg 1102. According to some examples, the method further includes stabilizing the body 702, 802, and / or 902 in response to extending the extendable leg 1102.

[0522] The present disclosure also includes a method comprising guiding a hypotube to a treatment site 50 of a patient, the hypotube comprising a hypotube proximal end and a hypotube distal end opposite the hypotube proximal end. In some examples, the hypotube is coupled to a motor 610 and / or 3308, and the motor 610 and / or 3308 is at least partially surrounded by the body 702, 802, and / or 902. According to some examples, the method includes powering the motor 610 and / or 3308. The method may include rotating the hypotube in response to powering the motor 610 and / or 3308.

[0523] In some examples, the method further includes extending the hypotube through a catheter 15 coupled to the body 702, 802, and / or 902. According to some examples, the method further includes removably coupling the catheter 15 to the body 702, 802, and / or 902. The method may further include guiding the catheter 15 to the treatment site 50 of the patient while the catheter 15 is detached from the body 702, 802, and / or 902.

[0524] In some examples, the method further includes retracting the catheter 15 around the hypotube. According to some examples, the method further includes exposing the hypotube distal end in response to retracting the catheter 15. The limit switch 3306 can be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes allowing the motor 610 and / or 3308 to rotate in response to retracting the catheter 15 around the hypotube.

[0525] According to some examples, the body 702, 802, and / or 902 includes a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908. The saddle 704 can be slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. In some examples, the first direction 712, 810, and / or 916 extends from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. According to some examples, the method further includes sliding the saddle 704 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906. Retracting the catheter 15 about the hypotube may occur in response to the saddle 704 sliding from the body distal end 710 , 808 , and / or 908 to the body proximal end 708 , 806 , and / or 906 .

[0526] In some examples, the saddle 704 includes a T-joint 706, 804, and / or 904. According to some examples, the method further includes sliding the T-joint 706, 804, and / or 904 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906. The T-joint 706, 804, and / or 904 can include a Luer interface 3104. In some examples, the method further includes inserting the syringe 60 into the Luer interface 3104. According to some examples, the method includes sliding the syringe 60 from the body distal end 710, 808, and / or 908 to the body proximal end 708, 806, and / or 906.

[0527] The syringe 60 may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe 60. According to some examples, the method further includes releasing the fluid through the lumen in the hypotube in response to depressing the plunger. The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the distal end 710, 808, and / or 908 of the body to the proximal end 708, 806, and / or 906 of the body.

[0528] According to some examples, the method includes partially retracting the catheter 15 around the hypotube. The method may include partially exposing the hypotube distal end in response to partially retracting the catheter 15 around the hypotube.

[0529] In some examples, the method further includes extending the catheter 15 around the hypotube. According to some examples, the method further includes at least partially closing the hypotube distal end in response to extending the catheter 15. The limit switch 3306 can be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes preventing the motor 610 and / or 3308 from rotating in response to extending the catheter 15 around the hypotube.

[0530] According to some examples, the body 702, 802, and / or 902 includes a body proximal end 708, 806, and / or 906 and a body distal end 710, 808, and / or 908. The saddle 704 can be slidably coupled to the body 702, 802, and / or 902, whereby the saddle 704 moves along a first direction 712, 810, and / or 916. In some examples, the first direction 712, 810, and / or 916 extends from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. According to some examples, the method further includes sliding the saddle 704 from the body proximal end 708, 806, and / or 906 to the body distal end 710, 808, and / or 908. Extending the catheter 15 around the hypotube may occur in response to sliding the saddle 704 from the body proximal end 708 , 806 , and / or 906 to the body distal end 710 , 808 , and / or 908 .

[0531] In some examples, the saddle 704 includes a T-joint 706, 804, and / or 904. According to some examples, the method further includes sliding the T-joint 706, 804, and / or 904 from the proximal end 708, 806, and / or 906 of the body to the distal end 710, 808, and / or 908 of the body. The T-joint 706, 804, and / or 904 can include a Luer interface 3104. In some examples, the method further includes inserting the syringe 60 into the Luer interface 3104. According to some examples, the method further includes sliding the syringe 60 from the proximal end 708, 806, and / or 906 of the body to the distal end 710, 808, and / or 908 of the body.

[0532] The syringe 60 may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe 60. According to some examples, the method further includes releasing the fluid through the lumen in the hypotube in response to depressing the plunger.

[0533] The saddle 704 may include a pull tab. In some examples, the method further includes sliding the pull tab from the proximal end 708, 806, and / or 906 of the body to the distal end 710, 808, and / or 908 of the body. According to some examples, the method further includes extending the catheter 15 partially around the hypotube. The method may also include at least partially closing the distal end of the hypotube in response to extending the catheter 15 partially around the hypotube.

[0534] In some examples, the body 702, 802, and / or 902 includes a torque knob 1104. According to some examples, the method further includes providing torque to the hypotube. The method may also include controlling the direction of travel of the distal end of the hypotube in response to providing torque to the hypotube.

[0535] In some examples, the motor 610 and / or 3308 is located near the bottom of the body 702, 802, and / or 902. According to some examples, the method also includes changing the rotation ratio between the motor 610 and / or 3308 and the hypotube via gears. The body 702, 802, and / or 902 may include an extendable leg 1102 on the bottom of the body 702, 802, and / or 902. In some examples, the method also includes extending the extendable leg 1102. According to some examples, the method also includes stabilizing the body 702, 802, and / or 902 in response to extending the extendable leg 1102.

[0536] The present disclosure also includes a method that includes removing the catheter 15 from the sterile package 1002. In some examples, the method includes guiding the catheter 15 to the treatment site 50 of the patient. According to some examples, the method includes operating the controller 20 from within the sterile package 1002. The catheter 15 can be coupled to the controller 20.

[0537] In some examples, the method further includes removably coupling the catheter 15 to the controller 20. According to some examples, the sterile package 1002 includes a slit 1004. The method can further include placing the catheter 15 through the slit 1004 in the sterile package 1002.

[0538] In some examples, the method further includes removing the catheter 15 from the treatment site 50 of the patient. According to some examples, the catheter 15 includes a sheath 40 and a guidewire 30. The method may also include positioning the sheath 40. In some examples, the method further includes disposing the guidewire 30.

[0539] According to some examples, the catheter 15 includes a sheath 40 and a guidewire 30. The method may further include separating the sheath 40 from the controller 20. In some examples, the method may further include sterilizing the sheath 40 separately from the controller 20. According to some examples, the method may further include separating the guidewire 30 from the controller 20. The method may further include sterilizing the guidewire 30 separately from the controller 20.

[0540] The present disclosure also includes an ablation system 10, which includes a controller 20. In some examples, the ablation system 10 includes a sheath 40, the sheath 40 includes a sheath proximal opening, a sheath opening distal end, and a working lumen extending from the sheath proximal opening to the sheath opening distal end. According to some examples, the sheath proximal opening is connected to the controller 20, and the sheath opening distal end is configured for insertion into the patient's vascular system, and the sheath opening distal end is positioned relative to the sheath proximal opening. The ablation system 10 may include a guide wire 30, which extends from the controller 20 through the sheath proximal opening and reaches the sheath opening distal end through the working lumen. In some examples, the guide wire 30 has a guide wire proximal end 1202 and a guide wire distal end 1204 opposite to the guide wire proximal end 1202, and the guide wire distal end 1204 is configured to mechanically process the vascular wall of the treatment segment 55, whereby the length of the guide wire distal end 1204 defines the length of the treatment segment 55. Mechanical treatment should be construed as equivalent to any term defining the type of disruption, including but not limited to scraping, ablating, breaking, agitating, modifying, and the like.

[0541] According to some examples, the working lumen is configured to slidably receive the guidewire 30 and allow fluid to pass around the guidewire 30 through the chemically treated treatment segment 55. Chemical treatment should be interpreted as equivalent to any term that defines treatment via chemicals, such as ablation, sealing, erosion, etc. When the ablation system 10 receives a first input, the guidewire distal end 1204 can mechanically treat the vessel wall. In some examples, when the ablation system 10 receives a second input, the ablation system 10 delivers the fluid to the treatment segment 55. According to some examples, when the ablation system 10 receives a third input, the ablation system 10 delivers the fluid to a subsequent treatment segment 55.

[0542] The sheath 40 can be retractable to expose the guidewire distal end 1204. In some examples, the controller 20 includes a motor 610 and / or 3308, a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power source 606 and / or 3302. According to some examples, when the sheath 40 is fully retracted, the limit switch 3306 allows power to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308. The sheath 40 can be variably retracted to expose at least a portion of the length of the guidewire distal end 1204. In some instances, the portion of the length of the guidewire distal end 1204 is configured to form a variable treatment length.

[0543] According to some examples, the sheath 40 can be extended to enclose at least a portion of the guidewire distal end 1204. The controller 20 can include a motor 610 and / or 3308, a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308, and a limit switch 3306 electrically coupled to the motor 610 and / or 3308 and the power source 606 and / or 3302. In some examples, the limit switch 3306 prevents power from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308 when the sheath 40 is at least partially extended.

[0544] According to some examples, the ablation system 10 further includes at least one distance marker 3204 located on the sheath 40 between the proximal opening of the sheath and the distal end of the sheath opening. 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 distal end of the sheath opening. According to some examples, the warning track 3206 is configured to indicate that the end point of the feasible treatment length has been reached.

[0545] The ablation system 10 can also include a slidable depth marker (i.e., an annular ring 3202) at least partially surrounding the sheath 40. In some examples, the slidable depth marker is slidably coupled to the sheath 40. According to some examples, the size and configuration of the slidable depth marker are such that it cannot enter the insertion point in the patient's body. The slidable depth marker can be positioned and configured to maintain the position of the sheath 40 and the guidewire 30 during treatment. In some examples, the slidable depth marker is positioned and configured along the sheath 40 to indicate the distance to the deep venous system in the patient's body.

[0546] According to some examples, the controller 20 includes an actuator 506a, 506b, 608, 914, and / or 3304 configured to receive a first input. The controller 20 may include a motor 610 and / or 3308 and a power source 606 and / or 3302 configured to provide power to the motor 610 and / or 3308. In some examples, the guidewire proximal 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 guidewire 30. The guidewire distal end 1204 may be configured to rotate in response to the motor 610 and / or 3308 rotating the guidewire 30. In some examples, the ablation system 10 includes a syringe 60 fluidly coupled to the working lumen. According to some examples, the syringe 60 is configured to receive a second input and a third input.

[0547] The present disclosure also includes a method including inserting a catheter 15 into a vascular system of a patient. In some examples, the method includes moving the catheter 15 into 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 into a second treatment segment 55. In some instances, the method includes treating the second treatment segment 55 via the catheter 15.

[0548] According to some examples, the catheter 15 includes a sheath 40 having a working lumen and a guidewire 30 extending through the working lumen, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. The method may further include scraping the first treatment segment 55 via the guidewire distal end 1204. In some instances, the method further includes moving the guidewire 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 via the guidewire distal end 1204.

[0549] The guidewire 30 can be electrically coupled to the motor 610 and / or 3308. In some examples, the method further includes rotating the guidewire 30 via the motor 610 and / or 3308. According to some examples, the method further includes scraping the first treatment segment 55 via rotating the guidewire 30. The method may also include scraping the second treatment segment 55 by rotating the guidewire 30.

[0550] In some examples, the method further includes retracting the sheath 40 around the guidewire 30. According to some examples, the method further includes exposing the guidewire distal end 1204 in response to retracting the sheath 40 around the guidewire 30.

[0551] The guidewire 30 can be electrically coupled to the motor 610 and / or 3308. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes allowing the motor 610 and / or 3308 to receive power via the limit switch 3306 in response to the sheath 40 being fully retracted. The method may also include providing a rotational output to the guidewire 30 via the motor 610 and / or 3308. In some examples, the method further includes rotating the guidewire 30 via the rotational output. According to some examples, the method further includes scraping the first treatment segment 55 via rotating the guidewire 30. The method may also include scraping the second treatment segment 55 by rotating the guidewire 30.

[0552] In some examples, the guidewire 30 is electrically coupled to the motor 610 and / or 3308. According to some examples, the 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 may also include indicating that the motor 610 and / or 3308 is receiving power by powering the LED.

[0553] According to some examples, the method further includes extending the sheath 40 around the guidewire 30. The method may further include at least partially surrounding the guidewire distal end 1204 in response to retracting the sheath 40 around the guidewire 30.

[0554] In some examples, the guidewire 30 is electrically coupled to the motor 610 and / or 3308. According to some examples, the 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 in response to the sheath 40 being at least partially extended. In some examples, the method also includes preventing the motor 610 and / or 3308 from providing a rotational output. According to some examples, the method also includes preventing the guidewire 30 from rotating in response to preventing the motor 610 and / or 3308 from providing a rotational output.

[0555] The LED 912 and / or 3310 can be electrically coupled to the motor 610 and / or 3308. In some examples, the method further 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.

[0556] The syringe 60 can be fluidly coupled to the catheter 15. In some instances, the method further includes injecting the drug at the first treatment segment 55 via the syringe 60. According to some examples, the method includes injecting the drug at the second treatment segment 55 via the syringe 60. The method can further include preventing the injection of the drug when the catheter 15 is repositioned to the second treatment segment 55.

[0557] In some examples, the sheath 40 includes a first distance mark 3204 and a second distance mark 3204. According to some examples, the method further includes pulling the catheter 15 out of the patient from the first distance mark 3204 to the second distance mark 3204. The method may also include repositioning the guidewire distal end 1204 by pulling the catheter 15 out of the patient. In some instances, the distance from the first distance mark 3204 to the second distance mark 3204 is approximately equal to the treatment length of the guidewire distal end 1204. According to some examples, the method further includes repositioning the guidewire distal end 1204 to the treatment length.

[0558] The catheter 15 may include a warning track 3206. In some examples, the method further includes indicating, via the warning track 3206, that the end of the feasible treatment length of the catheter 15 has been reached. According to some examples, the catheter 15 includes an annular ring 3202 at least partially surrounding the catheter 15. The method may also include indicating, via the annular ring 3202, a distance to a deep venous system in the patient's body.

[0559] 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 (such as saline, or a drug such as a sclerosant) at the first treatment segment 55 via a syringe 60. In some instances, the method includes repositioning the catheter 15 to the second treatment segment 55. According to some examples, the method includes injecting a fluid at the second treatment segment 55 via a syringe 60.

[0560] The method may further include preventing the injection of fluid when 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 guidewire 30 extending through the working lumen, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202. According to some examples, the method further includes scraping the first treatment segment 55 via the guidewire distal end 1204. The method may further include repositioning the guidewire 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 via the guidewire distal end 1204.

[0561] According to some examples, the guidewire 30 is electrically coupled to the motor 610 and / or 3308. The method may further include rotating the guidewire 30 by the motor 610 and / or 3308. In some instances, the method further includes scraping the first treatment segment 55 via rotating the guidewire 30. According to some examples, the method further includes scraping the second treatment segment 55 by rotating the guidewire 30.

[0562] The method may also include retracting the sheath 40 around the guidewire 30. In some examples, the method also includes exposing the guidewire distal end 1204 in response to retracting the sheath 40 around the guidewire 30.

[0563] According to some examples, the guidewire 30 is electrically coupled to the motor 610 and / or 3308. The limit switch 3306 can be electronically coupled to the motor 610 and / or 3308. In some examples, the method further includes allowing the motor 610 and / or 3308 to receive power via the limit switch 3306 in response to the sheath 40 being fully retracted. According to some examples, the method further includes providing a rotational output to the guidewire 30 via the motor 610 and / or 3308. The method may also include rotating the guidewire 30 via the rotational output. In some instances, the method further includes scraping the first treatment segment 55 via rotating the guidewire 30. According to some examples, the method further includes scraping the second treatment segment 55 by rotating the guidewire 30.

[0564] The guidewire 30 can be electrically coupled to the motor 610 and / or 3308. In some examples, the LED 912 and / or 3310 is electrically coupled to the motor 610 and / or 3308. According to some examples, the method further includes powering the LED. The method can also include indicating that the motor 610 and / or 3308 is receiving power by powering the LED.

[0565] In some examples, the method further includes extending the sheath 40 around the guidewire 30. According to some examples, the method further includes at least partially surrounding the guidewire distal end 1204 in response to retracting the sheath 40 around the guidewire 30.

[0566] The guidewire 30 can be electrically coupled to the motor 610 and / or 3308. In some examples, the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes preventing the motor 610 and / or 3308 from receiving power via the limit switch 3306 in response to the sheath 40 being at least partially extended. The method can further include preventing the motor 610 and / or 3308 from providing a rotational output. In some examples, the method further includes preventing the guidewire 30 from rotating in response to preventing the motor 610 and / or 3308 from providing a rotational output.

[0567] According to some examples, LED 912 and / or 3310 is electrically coupled to motor 610 and / or 3308. The method may also include preventing LED 912 and / or 3310 from receiving power. In some examples, the method also includes indicating that motor 610 and / or 3308 is not receiving power by preventing LED 912 and / or 3310 from receiving power.

[0568] According to some examples, sheath 40 includes a first distance marker 3204 and a second distance marker 3204. The method may further include pulling catheter 15 out of the patient from first distance marker 3204 to second distance marker 3204. In some examples, the method further includes repositioning guidewire distal end 1204 by pulling catheter 15 out of the patient.

[0569] According to some examples, the distance from the first distance marker 3204 to the second distance marker 3204 is approximately equal to the treatment length of the guidewire distal end 1204. The method may further include repositioning the guidewire distal end 1204 to the treatment length.

[0570] In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method further includes indicating via the warning track 3206 that the end of the feasible treatment length of the catheter 15 has been reached.

[0571] The catheter 15 may include an annular ring 3202 at least partially surrounding the catheter 15. In some examples, the method also includes indicating, via the annular ring 3202, a distance to a deep venous system in the patient's body.

[0572] The present disclosure also includes a method including inserting a catheter 15 into a vascular system of a patient. 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 amount of time in response to rotating at least a portion of the catheter 15. In some instances, the method includes moving the catheter 15 to a second treatment segment 55. According to some instances, the method includes scraping the second treatment segment 55 for a predetermined amount of time in response to rotating at least a portion of the catheter 15.

[0573] The method may also include indicating that a predetermined amount of time has elapsed via a component selected from the group consisting of LED 912 and / or 3310, a speaker, a display 508, and combinations thereof. In some examples, the component is electrically coupled to a power source 606 and / or 3302 that provides power to motor 610 and / or 3308.

[0574] According to some examples, the catheter 15 includes a sheath 40 and a guidewire 30, the sheath 40 includes a working lumen, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite to the guidewire proximal end 1202, and the guidewire 30 extends through the working lumen. The method may also include retracting at least a portion of the sheath 40 from the guidewire 30. In some instances, the method further includes exposing the guidewire distal end 1204 in response to retracting the portion of the sheath 40 from the guidewire 30. According to some examples, the method also includes extending the sheath 40 around the guidewire 30. The method may further include at least partially surrounding the guidewire distal end 1204 in response to extending the sheath 40 around the guidewire 30.

[0575] In some examples, the guidewire 30 is operably coupled to the motor 610 and / or 3308, and the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the method further includes allowing power to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 in response to the sheath 40 being in the fully retracted state. The method may also include rotating the guidewire 30 in response to allowing power to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308. In some examples, the method further includes preventing power from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 in response to the sheath 40 being in the non-fully retracted state. According to some examples, the method further includes terminating rotation of the guidewire 30 in response to preventing power from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308.

[0576] The catheter 15 may include a sheath 40 having a working lumen and a guidewire 30, the sheath 40 including a first distance marker 3204 and a second distance marker 3204, the guidewire 30 including a guidewire proximal end 1202 and a guidewire distal end 1204 opposite the guidewire proximal end 1202, and the guidewire 30 extending through the working lumen. In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method also includes maintaining a longitudinal position of the catheter 15 relative to the first treatment segment 55, wherein the longitudinal position is defined by the distal end of the catheter 15 relative to the first treatment segment 55. The method may also include moving the catheter 15 out of the patient by a distance approximately equal to the length from the first distance marker 3204 to the second distance marker 3204, wherein the length is approximately equal to the treatment length of the guidewire distal end 1204. In some examples, the method also includes indicating via the warning track 3206 that the end of the feasible treatment length of the catheter 15 has been reached.

[0577] According to some examples, the catheter 15 includes a sheath 40 and a guidewire 30, the sheath 40 includes a working lumen, the sheath 40 includes a first distance mark 3204 and a second distance mark 3204, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite to the guidewire proximal end 1202, and the guidewire 30 extends through the working lumen. The method may also include moving the catheter 15 out of the patient by a distance approximately equal to the length from the first distance mark 3204 to the second distance mark 3204, wherein the length is approximately equal to the treatment length of the guidewire distal end 1204.

[0578] In some examples, the catheter 15 includes a warning track 3206. According to some examples, the method further includes indicating via the warning track 3206 that the end of the feasible treatment length of the catheter 15 has been reached.

[0579] The syringe 60 can be fluidly coupled to the catheter 15. In some examples, the method further includes injecting the fluid at the first treatment segment 55 via the syringe 60. According to some examples, the method further includes terminating the injection of the fluid before moving the catheter 15 to the second treatment segment 55. The method may further include injecting the fluid at the second treatment segment 55 via the syringe 60. In some examples, the method further includes removing the catheter 15 from the patient's vascular system. According to some examples, the method further includes terminating the injection of the fluid before removing the catheter 15 from the patient's vascular system.

[0580] The catheter 15 may include a sheath 40 and a guidewire 30, the sheath 40 includes a working lumen, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite to the guidewire proximal end 1202, and the guidewire 30 extends through the working lumen. In some examples, the guidewire 30 is operably coupled to the motor 610 and / or 3308, and the limit switch 3306 is electronically coupled to the motor 610 and / or 3308. According to some examples, the catheter 15 includes a sheath 40 and a guidewire 30, the sheath 40 includes a working lumen, the sheath 40 includes a first distance mark 3204 and a second distance mark 3204, the guidewire 30 includes a guidewire proximal end 1202 and a guidewire distal end 1204 opposite to the guidewire proximal end 1202, and the guidewire 30 extends through the working lumen.

[0581] The catheter 15 may include a warning track 3206. In some instances, the method further includes maintaining a longitudinal position of the catheter 15 relative to the first treatment segment 55, wherein the longitudinal position is 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 guidewire 30. The method may further include exposing the guidewire distal end 1204 in response to retracting the portion of the sheath 40 from the guidewire 30. In some examples, the method further includes allowing power to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 in response to the sheath 40 being in a fully retracted state.

[0582] According to some examples, the method further includes actuating the 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 also include rotating the guidewire 30 in response to allowing power to flow from the power source 606 and / or 3302 to the motor 610 and / or 3308. In some instances, the method further includes moving the catheter 15 out of the patient by a distance approximately equal to the length from the first distance marker 3204 to the second distance marker 3204, wherein the length is approximately equal to the treatment length of the guidewire distal end 1204.

[0583] In some examples, the method further includes extending the sheath 40 around the guidewire 30. According to some examples, the method further includes at least partially surrounding the guidewire distal end 1204 in response to extending the sheath 40 around the guidewire 30. The method may further include preventing power from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308 via the limit switch 3306 in response to the sheath 40 being in a non-fully retracted state. In some examples, the method further includes terminating the rotation of the guidewire 30 in response to preventing power from flowing from the power source 606 and / or 3302 to the motor 610 and / or 3308. According to some examples, the method further includes indicating that the end of the feasible treatment length of the catheter 15 has been reached via the warning track 3206.

[0584] None of the steps described herein are necessary or indispensable. Any step may be adjusted or modified. Other or additional steps may be used. Any part of any step, process, structure and / or device disclosed or shown in an embodiment, flow chart or example in this specification may be combined or used or used in place of any other part of any step, process, structure and / or device disclosed or shown in different embodiments, flow charts or examples. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

[0585] The section titles and subtitles provided herein are non-limiting. The section titles and subtitles do not represent or limit the full scope of the embodiments described in the sections to which the titles and subtitles belong. For example, a section entitled "Topic 1" may include embodiments that are not related to Topic 1, and embodiments described in other sections may be applied to and combined with the embodiments described in the "Topic 1" section.

[0586] To increase clarity of various features, other features are not labeled in each figure.

[0587] The various features and processes described above can be used independently of each other, or can be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, in some embodiments, certain methods, events, states or processing blocks may be omitted. The methods, steps and processes described herein are also not limited to any particular order, and the blocks, steps or states associated therewith may be performed in other appropriate orders. For example, the tasks or events described may be performed in an order different from the order specifically disclosed. Multiple steps may be combined in a single block or state. Example tasks or events may be performed in serial, parallel or in some other manner. Tasks or events may be added to the disclosed example embodiments or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently from those described. For example, compared to the disclosed example embodiments, elements may be added, removed or rearranged from the disclosed example embodiments.

[0588] In particular, any of the various catheter components and features included in the ablation system 10 described herein and shown in the figures may be used independently of one another, or may be combined in various ways in any of the examples disclosed herein.

[0589] In addition, some of the components listed herein use the same numbers from figure to figure, including but not limited to catheter 15, controller 20, guide wire 30, sheath 40, syringe 60, guide wire proximal end 1202, guide wire distal end 1204, counterweight end 1210, proximal feature structure 2602 and distal feature structure 2702. It should be understood that these components use the same reference numerals only for ease of reference and ease of understanding by the reader. Although these components can use the same numbers, there can be differences in these components, as shown in the various figures in which they appear and as described in the specification of this article.

[0590] Unless expressly stated otherwise, or otherwise understood in the context of use, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, is generally intended to convey that certain embodiments include and other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language is generally not intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for determining, with or without author input or prompting, whether such features, elements, and / or steps are included or will be performed in any particular embodiment. The terms "comprising," "including," "having," and the like are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, and the like. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense) such that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Unless expressly stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" is understood in context as generally used to convey that an item, term, etc. can be X, Y, or Z. Thus, such linking language is not generally intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z each be present.

[0591] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Therefore, A, B, and / or C can be replaced with A, B, and C written in one sentence and A, B, or C written 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.

[0592] Although certain example embodiments have been described, these embodiments are presented only as examples and are not intended to limit the scope of the invention disclosed herein. Therefore, nothing in the foregoing description implies that any particular feature, characteristic, step, module, or block is necessary or indispensable. 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 invention disclosed herein.

Claims

1. A system comprising: - Controller; - a sheath comprising a sheath proximal opening, a sheath distal opening, and a working lumen extending from the sheath proximal opening to the sheath distal opening, wherein the sheath proximal opening is connected to a controller, the sheath distal opening is configured to be inserted into a vascular system of a patient, the sheath distal opening being opposite to the sheath proximal opening; as well as - a guidewire extending from the controller through the proximal opening of the sheath, the working lumen to the distal opening of the sheath, the guidewire having a proximal end and a distal end opposite the proximal end, the distal end of the guidewire being configured to mechanically treat a vessel wall of the treatment segment, wherein the length of the distal end of the guidewire defines the length of the treatment segment, wherein the working lumen is configured to slidably receive a guide wire and allow fluid to pass around the guide wire to deliver chemotherapy to the treatment segment, When the system receives a first input, the distal end of the guidewire mechanically processes the blood vessel wall; when the system receives a second input, the system delivers fluid to the treatment segment; when the system receives a third input, the system delivers fluid to a subsequent treatment segment.

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

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

4. The system of claim 2, wherein the sheath is variably retractable to expose at least a portion of the distal length of the guidewire, and Wherein the portion of the distal length of the guidewire 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 end of the guidewire.

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

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

8. The system of claim 7, wherein 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 on the sheath between the at least one distance marker and the distal opening of the sheath.

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

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

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

13. The system of claim 11, wherein the slidable depth marker is sized and configured to not enter the patient's insertion point.

14. The system of claim 13, wherein the slidable depth markers are positioned and configured to maintain the position of the sheath and guidewire during treatment.

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

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

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

18. The system of claim 17, wherein the proximal end of the guidewire is operably connected to a motor, and the motor is configured to rotate the guidewire.

19. The system of claim 18, wherein the distal end of the guidewire is configured to rotate in response to rotation of the guidewire by the motor.

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

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