Segmental vascular ablation

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

CROSS-REFERENCE TO RELATED APPLICATIONS

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

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

The entire contents of the following application are incorporated by reference herein: U.S. Provisional Patent Application No. 63/476,156; filed Dec. 19, 2022; and entitled CATHETER WIRE CONTROLLER.

INTRODUCTION

Technical Field

The present disclosure relates to systems and methods for the treatment of varicose veins.

BACKGROUND

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

During the procedure, a specialized catheter is inserted into the varicose vein through a small incision. The catheter has a rotating tip that mechanically agitates (or abrades, or ablates) the vein's inner lining, causing endothelial damage. Simultaneously, a drug, such as sclerosant, which acts as a chemical solution that irritates and closes the vein, is delivered through the catheter. This combination of mechanical agitation (or abrasion, or ablation) and chemical irritation induces the closure of the varicose vein, causing it to shrink and eventually be absorbed by the body.

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 typically performed as an outpatient procedure, and patients can often resume normal activities shortly after the treatment.

SUMMARY

Included in the present disclosure is an ablation system (e.g., see the ablation system10as shown inFIG.1), including a controller (e.g., see the controller20as shown inFIG.1). In some examples, the system includes a sheath (e.g., see the sheath40as shown inFIG.2) including an open proximal sheath end, an open distal sheath end, and a working lumen extending from the open proximal sheath end to the open distal sheath end. According to some examples, the open proximal sheath end is coupled to the controller and the open distal sheath end is configured for insertion into a vascular system of a patient, the open distal sheath end located opposite the open proximal sheath end.

The ablation system may include a wire (e.g., see the wire30as shown inFIG.2) extending from the controller through the open proximal sheath end through the working lumen to the open distal sheath end. In some examples, the wire has a proximal wire end (e.g., see the proximal wire end1202as shown inFIG.12) and a distal wire end (e.g., see the distal wire end1204as shown inFIG.12) opposite the proximal wire end, the distal wire end configured to mechanically treat a vessel wall of a treatment segment (e.g., see the treatment segment55as shown inFIG.2), whereby a length of the distal wire end defines a length of the treatment segment.

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

Also included in the present disclosure is a method, including inserting a catheter (e.g., see the catheter15as shown inFIG.1) into a vascular system of a patient. In some examples, the method includes moving the catheter to a first treatment segment (e.g., see the treatment segment55as shown inFIG.2). According to some examples, the method includes actuating a motor (e.g., see the motor610as shown inFIG.6A) and rotating at least a portion of the catheter in response to actuating the motor.

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

COMPONENT INDEX

DETAILED DESCRIPTION

The present disclosure describes systems and techniques for treating vascular disorders such as varicose veins. Some existing prior art systems include the use of highly complicated interventional devices (e.g., ablation catheters), which involve significant user training to enable correct and effective use due to the devices' requirements for the user to multitask while performing complicated dexterous techniques.

For instance, certain sclerotherapeutic catheters require the 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 simultaneously operating a second, distinct manual control to longitudinally translate (e.g., distally advance and/or proximally withdraw) the catheter to disperse the chemical agent throughout the target vessel. In some such examples, the secondary control merely consists of the clinician manually pushing and/or pulling the catheter through the patient's vasculature. Such systems are not widely regarded to be user-friendly or patient-friendly.

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

In other words, many traditional sclerotherapy treatments and devices require the clinician to manually infuse a “steady” flow of sclerosant, manipulate a separate control (e.g., squeeze a trigger) to actuate an abrasive element to mechanically disturb the vessel wall, and also simultaneously manually withdraw the catheter at a consistent rate. The required cognitive load and skill of the user to simultaneously accomplish all of these steps is high, leading to a greater likelihood of errors due to mismatching the amount of mechanical ablation performed and the amount of sclerosant delivered to the target treatment site with an inconsistent withdrawal rate of the catheter. This not only creates a perception of a difficult-to-use device but also may lead to inferior or incomplete venous ablation, e.g. if an insufficient amount of sclerosant is delivered, or if an insufficient amount of mechanical abrasion is performed with a withdrawal speed that is too fast.

Additionally, the present disclosure describes systems and methods for controlling a catheter, perhaps a catheter including a wire. These controls include the unveiling of a wire from a lumen within a catheter and exposing said wire to treat a treatment site, as well as directional control of a catheter tip. Some existing solutions include the use of steerable catheter tips and electronic-based delivery/wire unveiling systems. The present disclosure permits manual control of wire unveiling, as well as distal catheter tip directional control.

FIG.1illustrates a diagrammatic view of an ablation system10as it may appear while a procedure is occurring on a patient's leg. A sheath40and a wire30are introduced to treatment site50via direct access to the vein being treated. Here, the wire30is shown as released from the sheath40prior to or during the procedure. The operator initiates the procedure from the controller20.

FIG.2illustrates a side view of a wire30within a vessel, according to some examples.FIG.3illustrates a cross-sectional view of an example vessel, to better show the intima, media, and adventitia. As can be seen inFIG.2, the wire30may extend through a working lumen of a sheath40. This figure shows the wire30penetrating and/or disturbing the intima and making physical contact with the media at a treatment site50. The intima in the locations affected by the rotating wire is thereby destroyed.

Because the length of the wire30exposed to the treatment site50is capable of making contact with a length of the vessel, rather than just a perimeter of the vessel, the treatment site50will often be called the treatment segment55throughout this disclosure. This ability to treat a treatment segment55rather than just a perimeter of the treatment site50enables to use of segmental mechanical or mechanochemical ablation. As an operator would now be able to treat a treatment segment55all at once, the need to withdraw a catheter15while at the same time injecting a drug into the treatment site50is rendered unnecessary. Thus, the operator may now focus on injecting the drug at a proper rate in isolation, and once the drug is injected, then moving the catheter15during periods of time during which the drug is not being administered. This may cut the difficulty of such a procedure exponentially, as the operator would no longer need to divide their attention between controlling multiple rates of administrating treatment (i.e., injection rate and catheter15withdrawal rate), but rather, just one rate of treatment administration at a time. Stated differently, this permits the procedure to be separated into the actions of injecting and withdrawing, while never requiring that both of these actions need to be performed at the same time. Additionally, throughout this disclosure, the term “drug” or “sclerosant” is used. It is understood that any fluid may be delivered in combination with any portion of this disclosure where such a fluid may be delivered.

FIGS.4A and4Billustrate side views of an example of an ablation system10. In some examples, the ablation system10includes a controller20, which is shown and described in greater detail inFIGS.5A,5B,5C,7,8,9A,9B, and9Cin various embodiments. The ablation system may also include a catheter15, and in some examples, the catheter15includes a sheath40and a wire30extending through said sheath40.

For the purposes of this disclosure, in some instances, the terms “catheter” and “sheath” are used interchangeably, and it is understood that the catheter may be more than just a sheath, such as examples including a wire. It is additionally understood that recitations of catheter could also include ablation systems without a sheath or a wire.

The sheath40may extend from the controller20. In some examples, the wire30extends through a working lumen in the sheath40. The wire30may be stored within the sheath40while the catheter15traverses a patient's vasculature until it reaches a treatment site50, at which point the sheath40may be pulled back, or retracted, in order to unveil the wire30. Various examples of the wire30are illustrated and discussed in greater detail inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A. Also shown inFIG.4Ais a syringe60in fluid communication with the controller20at a distal end of the controller20. The syringe60may provide a drug, such as sclerosant, through the catheter15, the sheath40, and/or the wire30.

FIG.5Aillustrates a perspective view of an example of a controller20, andFIGS.5B and5Cillustrate a side view and a top view, respectively, of the controller20ofFIG.5A. As can be seen inFIGS.5A,5B, and5C, the controller20may include a proximal controller end502and a distal controller end504opposite the proximal controller end502. The controller20may also include at least one actuator, as seen in actuator506aand actuator506b. As illustrated, multiple actuators may be implemented in or on a single controller20.

InFIGS.5A,5B, and5C, actuator506ais present at the base (proximal controller end502) of the controller20. Another actuator506bis shown at the top of the controller20near the distal controller end504. These actuators may operate as a sort of “and” gate, where both actuators must be activated (i.e., switched to an “on” position) in order for the controller20to turn on. This is useful as a safety precaution during transport of the controller20so that the controller20does not inadvertently turn on.

In some examples, either actuator506aor actuator506bmay act as a power activation actuator, providing power to any internal circuitry, such as a motor. In such examples, the other actuator (i.e., actuator506bif actuator506ais the power activation actuator) may be a rotation activation actuator, thus telling the motor, in this example, to begin rotating. However, if desired, and as will be described and discussed in further detail inFIGS.9A,9B, and9C, the use of a single actuator would also work. The actuator may be any type of actuator, such as a button, a switch, a touch screen on a user interface, etc.

Also shown inFIGS.5A and5Bis a display508. The display508may provide information to the operator of the controller20, such as the amount of time that has passed during a procedure, or the amount of time remaining in cases where the controller20is programmable to operate for a set duration.

Specifically, in light of mechanochemical ablation (or just mechanical ablation in instances where no drug is delivered), the display508may facilitate a segmental ablation technique. For example, once a catheter15has been inserted and located at a correct treatment site50, once an operator has used an actuator to turn on a device, the display may count down the time until the treatment site has been abraded enough such that a drug should be delivered. Additionally, or alternatively, the display508may also countdown a time during which the drug should continue to be delivered, at the end of which the operator discontinues the injection of the drug.

In examples where the treatment site50includes a treatment segment55, the display508may inform an operator of when the treatment segment55is done being treated, which would tell the operator is time to move the catheter15to the next, or a subsequent, treatment segment55.

FIG.6Aillustrates a diagrammatic side view showing the wire30enclosed in the sheath40.FIG.6Billustrates the diagrammatic side view ofFIG.6A, but with the wire30exposed from the sheath40. As seen in bothFIGS.6A and6B, the controller20may include a slot602in the distal controller end504. At a proximal end of the sheath40, an inflation tuohy604may be present. The wire30is delivered to a treatment site50while enclosed in the sheath40(in some examples). In other examples, the sheath40is detachable from the controller20and capable of being delivered to the treatment site50prior to the wire30being delivered to said treatment site50.

Once the wire30reaches the treatment site50, the wire30may be exposed from the sheath40. In this regard, the sheath40may be retracted from the wire30, whereby the sheath moves away from the treatment site50while leaving the wire30in place in the treatment site50. The operator may perform this pull-back, or retractive, motion on the sheath40manually (as well be illustrated and discussed inFIGS.7,8,9A,9B, and9C) and then rotates the sheath40in order to lock the inflation tuohy604in the slot602. This locking of the inflation tuohy604in the slot602may prevent the sheath40from moving axially during a procedure.

As can also be seen inFIGS.6A and6B, the controller20may include a motor610, such as an electric motor, which may be activated by an actuator608. A power supply606is also included within the controller20(though the power supply606could be external to the controller20, if desired). This power supply606permits the actuator608to connect power to the motor610, thus effectuating rotation of the motor610, and in turn effectuating rotation of the wire30.

Throughout the present specification, the motor610may be described as coupling to, and effectuating rotation upon, the wire30and/or the catheter15. These are used interchangeably through this specification, as either component may be what is coupled to the motor610and thereby rotates. Additionally, there may be intervening components between the motor610and the wire30and/or the catheter15. For example, the wire30and/or the catheter15may couple, detachably or fixedly, to one or more hypotubes. In turn, these hypotubes may couple, again, either detachably or fixedly, to the motor610.

It is understood that the diagrammatic side views of the controller20as shown inFIGS.6A and6Bmay be used in combination with any of the various controller20examples as shown and described previously inFIGS.5A,5B,5C, as well as any of the various controller20as will be shown and described inFIGS.7,8,9A,9B, and9C.

FIG.7illustrates a profile view of a controller20, according to some examples. The controller20may include a proximal body end708and a distal body end710opposite the proximal body end708. While not shown inFIG.7, the controller20may removably couple to a catheter15at the distal body end710.

As seen inFIG.7, the controller20may include a flat, or at least partially flat, bottom portion, permitting the controller20to be placed on a tabletop or other working surface in order to facilitate the operation of said controller20. While not shown inFIG.7, but as seen and described in previousFIGS.5A,5B, and5C, the controller20may be hand-held. This may make it such that the controller20is operated in a two-handed manner, wherein one hand would provide support for the controller20, and the other hand would operate the controller20. The controller20may also be removably coupled to any working surface not specifically described herein, i.e., the controller20does not need to be placed on a table or held in an operator's hand in order for the controller20to be operational.

As can also be seen inFIG.7, the controller may include a body702and a saddle704slidably coupled to the body702. The saddle704is capable of slidably moving in a first direction712, as well as opposite this first direction712. As shown inFIG.7, the first direction712is considered the direction moving from the proximal body end708to the distal body end710. A T-fitting706may be disposed within the body106of the controller20and at least partially surrounded by a center portion of the saddle704. The T-fitting may be capable of slidably moving in the first direction712, as well as opposite this first direction712in response to movements of the saddle704. In examples of the controller20including a catheter15removably coupled to/through the distal body end710, the catheter15may further be removably coupled to the T-fitting706.

Such a catheter15may include a wire30for the purposes of abrading a vessel wall at a treatment site50, as detailed inFIG.2. In some procedures, it is desirable to keep the wire30contained within the catheter body, or a sheath40, until said wire30has been delivered to the treatment site50in order to prevent premature abrasion of vessel walls, or stated another way, abrasion of vessel walls not intended for treatment. Once the catheter15reaches the desired treatment sire, the saddle705may move along the first direction712to expose or enclose the wire30.

In other examples, the catheter15track or move to a treatment site50whereby the catheter exposes the wire30. This may permit greater flexibility in designs where the wire30includes a shape that is larger than the sheath40opening. In some examples, once the wire30is enclosed by the sheath40, the sheath40responds by expanding slightly in order to accept the wire30within its confines. This may limit the flexibility of the sheath40, and therefore, exposing the wire30while tracking the catheter15to the desired treatment site50may permit greater flexibility in order to traverse a tortuous vasculature of a patient.

Throughout the specification, the catheter15is disclosed as including a wire30. However, it is understood that the present specification is not limited to the use of a wire30. The present specification also enables the use of a hypotube, a catheter shaft, or combinations thereof, and in combination with a wire30.

As illustrated in the example controller20ofFIG.7, the saddle704is present at the distal body end710. At this location, the wire30remains within a lumen of the sheath40. As an operator moves the saddle704opposite the first direction712toward the proximal body end708, the sheath40may be pulled back about the wire30, exposing the wire30. At this point, the wire30may be used to abrade the vessel wall.

The body702may include an actuator (such as actuator506aor506b, as described and discussed inFIGS.5A,5B, and5C, actuator608, as described and discussed inFIGS.6A and6B, and/or actuator914as will be discussed in further detail inFIGS.9A,9B, and9C). In some examples, this actuator506a,506b,608, and/or914controls circuitry and/or a motor (such as the motor610as described and discussed inFIGS.6A and6B, and/or the motor3308as will be discussed in further detail inFIG.33) within the body702. This actuator506a,506b,608, and/or914may control the rotation of the wire30, facilitating abrasion of the vessel wall. When this abrasion is completed, the operator may move the saddle704in the first direction712, to push the sheath40forward again, thereby enclosing (or capturing, resheathing, etc.) the wire30within the sheath40once again, permitting safe removal of the catheter15from the vasculature of the patient.

FIG.7also shows a syringe60removably coupled to the T-fitting706through the saddle704. This syringe60may be in fluid communication with the catheter15in examples where the catheter15is present. In some examples, the catheter15includes a fluid lumen (such as a working lumen through the sheath40), permitting fluid from the syringe60to pass through the catheter15when the syringe60is depressed. This may be useful in procedures such as sclerotherapy, where a fluid drug, such as sclerosant, is recommended for delivery to a treatment site50either before, in tandem with, or after abrasion of the vessel wall.

The syringe60is depicted as extending perpendicular to the first direction712. This is as an example only, and it is understood that the syringe60may be placed at any angle so as to provide the best ergonomics and/or comfort to the operator. In some examples, the syringe60acts as a type of handle for the operator, permitting easy control of the saddle704and the T-fitting706in moving in both the first direction712and opposite the first direction712.

The saddle704and the T-fitting706may slide due to manual control of the syringe60, but the T-fitting706may also be operated by direct control of the saddle704, such as through an operator pushing on the saddle704with one of their hands while operating the depression of the syringe60with their other hand. As will be explored inFIGS.9A,9B, and9C, the saddle704may further include pull tabs (such as the pull tabs910ofFIGS.9A,9B, and9C) to facilitate manual movement of the saddle704. In these examples, the syringe60would move along with the T-fitting706but would not be the cause of such a movement.

Additionally, while not explicitly shown inFIG.7, in some examples, the syringe60may not be removably coupled to the T-fitting706. In such examples, an extrusion tube/infusion tube may connect the syringe60to a removably coupled catheter15. This would permit the syringe60to not be coupled to the T-fitting706and, therefore, not be coupled to the controller20. Instead, the syringe60would be coupled to flexible tubing, permitting greater freedom of movement of the syringe60separate from the controller20when desirable.

Also illustrated inFIG.7is a slot in the saddle704perpendicular to the first direction712and extending at least partially about the saddle704. This slot may permit the syringe60to perform rotational movement about the body702. In some examples, when an operator rotates the syringe60about the body702, it creates a torque on a wire30, perhaps a wire30in a removably coupled catheter15, permitting manual control of a distal end of the wire30. This may permit the operator to make fine movements of such a distal end of the wire30in the treatment site50in order to make better abrasive contact with the vessel walls and/or facilitate traversal of the tortuous vasculature of the patient.

While not illustrated inFIG.7, the T-fitting706may include a luer (such as the luer3104as seen and described below inFIG.31). This luer may be configured to detachably couple the syringe60to the T-fitting706. In examples including such a luer, the luer may be configured to rotate about a direction perpendicular to the first direction712. This rotation may include any angle of rotation, including full 360-degree circumferential rotation about the body702.

Once a syringe60has been detachably coupled to the luer, this rotational movement would likely be limited in order to prevent over-rotation of the syringe60. In this configuration, the syringe60may be configured to control the rotation of the luer. Similar to the above disclosure, the rotation of the luer may create torque on a wire30, thereby permitting manual control of a distal end of the wire30.

The luer may have an O-ring on a proximal side, facilitating the prevention of fluid leakage during the infusion This O-ring may also grip onto the wire30while simultaneously being attached to the catheter sheath40so that when the luer is rotating, the catheter sheath40also rotates, and the O-ring of the luer will attempt to rotate the wire30at the same time.

While not shown inFIG.7, in some examples, the luer is not present within the device body. In such examples, the luer could be an off-the-shelf stopcock or three-way valve that accepts the catheter sheath40. This would permit a user to fully remove the sheath40from the device while leaving the wire30in place. This may facilitate the use of the device in situations where another catheter sheath40is in situ—such as a guidewire catheter. A second catheter sheath40may not fit within the vasculature next to a preexisting catheter sheath40, so by removing the catheter sheath40from the present device, the wire30could still be inserted into the treatment site50.

Another advantage of being able to remove the sheath40is that the sheath40may be tracked to the treatment site first. Also, removing the catheter sheath40from the wire30may permit the sheath40to be tracked over an already placed guidewire. Once the catheter sheath40has been placed, the guidewire, if present, may be removed, permitting the device to be advanced further into the vasculature.

FIG.8illustrates a profile view of a controller20, according to some examples. The example controller ofFIG.8shares many similarities with the example controller ofFIG.7, much of which will be reiterated here. The controller20may include a proximal body end806and a distal body end808opposite the proximal body end806. While not shown inFIG.8, the controller20may removably couple to a catheter20at the distal body end808.

As seen inFIG.8, the controller20may include an at least partially flat bottom portion, permitting the controller20to be placed on a tabletop, or another working surface, in order to facilitate the use of said controller20. While not shown inFIG.8, but as described previously inFIGS.5A,5B, and5C, the controller20may be hand-held, making use of the controller20a two-handed operation wherein one hand would provide support for the controller20, and the other hand would operate the controller20. The controller20may also be removably coupled to any other working surface not described herein, i.e., the controller20does not need to specifically be placed on a tabletop or held in an operator's hands in order for the controller20to be operational.

As can be seen inFIG.8, the controller20may include a body802. Dissimilar to the example controller20ofFIG.7, the example controller20ofFIG.8does not include a saddle slidably coupled to the body802. In this example, a T-fitting804may be disposed within the body802of the controller20. The T-fitting804may be capable of slidably moving in a first direction810, as well as opposite the first direction810, wherein the first direction810is the direction of movement from the proximal body end806to the distal body end808. In examples of the controller20, including a catheter removably coupled to and/or through the distal body end808, the catheter may further be removably coupled to the T-fitting804.

Also illustrated inFIG.8is the T-fitting804present at a point nearest the proximal body end806. At this location, the sheath40would be retracted about the wire30, exposing the wire30to a treatment site50. In some examples, the catheter may be delivered in this configuration, but it is likely that the wire30would be delivered to the treatment site50while still within the sheath40to avoid unintentional abrasion of vessel locations that are not the treatment site50. After a treatment has been performed, the operator may move the T-fitting804along the first direction810in order to sheath the wire30once again, permitting the safe removal of the catheter from the vasculature of the patient.

FIG.8also shows a syringe60removably coupled to the T-fitting804. The syringe60may also be in fluid communication with the catheter, if/when a catheter is present. In some examples, the catheter includes a fluid lumen, permitting fluid from the syringe60to pass through the catheter when the syringe60is depressed. As described previously, this is useful for procedures such as sclerotherapy, where a fluid drug, such as sclerosant, is recommended to be used either before, in tandem with, or after abrasion of the vessel wall.

The syringe60is shown as extending perpendicular to the first direction810. This is by example only, and it is understood that the syringe60may be placed at any angle so as to provide the best ergonomics or comfort to the operator. In some examples, the syringe60acts as a type of handle for the operator, permitting easy control of the T-fitting804in slidably moving in both the first direction810and opposite the first direction810.

FIG.9Aillustrates a profile view of an additional example controller.FIG.9Bshows the controller20ofFIG.9Afrom a side view, andFIG.9Cshows the controller of9A from a top view, without a syringe60present. Similar to the controllers20ofFIGS.7and8, the controller20ofFIGS.9A,9B, and9Cincludes a body902having a proximal body end906and a distal body end908opposite the proximal body end906. The beginning portion of a catheter15, not labeled but shown, can be seen entering the body902through the distal body end908.

A T-fitting904is illustrated, in this example, located at least partially within the body902. The T-fitting904, as described previously, may be or include a luer hub and luer for detachably receiving a syringe60. This T-fitting may be coupled to a saddle, such as the saddle704ofFIG.7. The saddle inFIGS.9A,9B, and9C, however, is mostly obscured by the body902, as this saddle is located at least partially, if not mostly, within the body902. Portions of the saddle stick out from the sides of the body902, however, and these are shown as pull tab(s)910. It is understood that the decision to use the term “pull tab(s)” is solely a lexicographical choice, and any other fitting term, such as “finger pad(s)” or equivalent may be substituted.

Similar to the disclosure ofFIGS.7and8, the controller20may be capable of maneuvering a sheath40about a wire30.FIGS.9A and9Billustrate the syringe60and the T-fitting904located toward the proximal body end906.FIG.9C, while not illustrating a syringe60, also shows the T-fitting904located toward the proximal body end906. In all instances, this may indicate that the sheath40is fully retracted about the wire30, exposing the wire30. This is likely, but not necessarily, indicative that the catheter15is located at a treatment site50and the wire30has been exposed in order to provide a treatment.

Once a treatment has been completed, the syringe60, and the T-fitting904, may be pushed along the first direction916, which runs from the proximal body end906to the distal body end908. InFIG.7, it was discussed how the saddle704itself could be manipulated by the operator in order to push and pull the syringe60and T-fitting904. Similarly, inFIGS.9A,9B, and9C, the pull tab(s)910may be manipulated, either instead of, or in addition to, the syringe60and the T-fitting904. In this example, pushing the syringe60, T-fitting904, and/or pull tab(s)910causes the sheath40to extend about the wire30, thereby enclosing or capturing the wire30. In this configuration, the wire30may be in a less expanded state, allowing for easier, or safer, removal of the catheter15from the patient (or insertion into the patient, if this is occurring prior to the treatment being delivered).

In opposition to this pushing motion, once a catheter15has been delivered to a treatment site50, the operator may then pull the syringe60, the T-fitting904, and/or the pull tab(s)910in order to retract the sheath40. This retraction of the sheath40exposes the wire30, and in instances when a distal end of the wire30includes a shaped profile, the wire30may expand into this shaped profile (or further expand into this shaped profile as the case may be) in order to make contact with the vessel walls, allowing for abrasion to occur during a treatment.

Also included inFIGS.9A,9B, and9C, (labeled in9A and9C) is a light emitting diode (LED)912. The LED912may be used to convey an array of information to an operator. For example, the LED912may indicate that the device is receiving power or turned on. The LED912may indicate that the sheath40is fully retracted about the wire30, indicating that the wire30is ready to be rotated in order to provide an abrasive treatment.

Throughout this disclosure, reference is made to segmental mechanical or mechanochemical ablation. The LED912may indicate treatment times to an operator in these or other instances. For example, perhaps the operator desires to provide a mechanical agitation of a treatment segment55for a set period of time prior to moving to a subsequent treatment segment55. In these cases, the LED912may light up to indicate that the treatment time has passed, and it is time to move to the subsequent treatment segment55. Or, perhaps, the LED912is constantly lit up, and the LED912turns off to indicate that this treatment time has passed.

In mechanochemical ablation, it is often desired to inject a drug, such as sclerosant at a specific rate. In these cases, the LED912may indicate, through lighting up or turning off, as the case may be, that the mechanical ablation has occurred for a desired amount of time, and it is time to begin injecting the drug into the treatment segment55. Likewise, the LED912may indicate that the injection time has passed, and it is time to move the catheter15to a subsequent treatment segment55.

While one LED912is shown inFIGS.9A,9B, and9C, it is understood that multiple LEDs912may be present in the device, and could serve multiple different purposes. For example, while not explicitly labeled,FIG.8illustrates two LEDs on the body802proximal to the location of the syringe60and the T-fitting804. These LEDs912may be labeled in order to prevent confusion for an operator.

Additionally, or alternatively, the controller20may include a display (such as the display508ofFIGS.5A,5B, and5C) or some kind of alarm, or other noise maker, for the purposes of indicating treatment times to an operator. In the case of an alarm or another noise maker, the operation would be similar to that of the LED912— the alarm may sound to indicate the end of a mechanical ablation of a treatment segment55, the end of an injection of a drug into the treatment segment55, the time to move to a subsequent treatment segment55, and/or the end of an overall treatment. The display may perform in much the same way while also indicating how much time is remaining in each of these steps.

Finally, also seen inFIGS.9A,9B, and9C(only labeled in9A and9C) is an actuator914. The actuator914may be any device capable of receiving input from an operator, such as a switch, a button, a lever, a touch screen, etc. The actuator914may serve one or multiple purposes, including but not limited to turning on and off the device and turning on and off a motor within the device. While one actuator914is shown inFIGS.9A,9B, and9C, it is understood that multiple actuators914may be present on the device for different purposes, such as the actuators506aand506bofFIGS.5A,5B, and5C.

FIG.10illustrates a top view of a device contained within a sterile pack1002. It is understood that any controller20, as shown and described inFIGS.5A,5B,5C,7,8,9A,9B, and9C, as well as other potential example controllers20, may be operational in tandem with the disclosure of the sterile pack1002. Likewise, it is understood that any combination of catheter15, wire30, and sheath40, as shown and described inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, as well as other potential example wires30, may be operational in tandem with the disclosure of the sterile pack1002.

As seen inFIG.10, a controller20may fit within a cavity, or recess, of the sterile pack1002. Spaces are provided within the sterile pack1002for the catheter15to reside as well, butFIG.10is illustrating how the device may appear when in use rather than when in storage. A slit1004may be provided in the sterile pack1002, through which the catheter15may fit. This may permit the controller20to be operated from within the sterile pack1002while the catheter15exits the sterile pack1002for insertion into the body of a patient.

While the component “slit1004” is used throughout this disclosure, it is understood that any other equivalent vacancy in the sterile pack1002, such as a channel or an opening may be used.

In some examples, the catheter15may be removable from the controller20to be placed through this slit1004. In other examples, the slit1004slidably receives the catheter15while the catheter15is already coupled to the controller20. In either case, the controller20may be operated from within the sterile pack1002, permitting operators to perform a treatment while not necessitating a sterile drape.

In examples where the catheter15is not detachably coupled to the controller20, the entire ablation system10may need to be sterilized in between treatments. However, in examples where the catheter15is detachably coupled to the controller20, the catheter15may be sterilized separately without needing to sterilize the controller20in between treatments. By permitting the controller20to be reused, this may help to cut down on waste.

Additionally, the catheter15may be made to be disposable (this could mean the sheath40and/or the wire30are disposable in cases where the catheter15includes a sheath40and a wire30). This may greatly cut down on costs and waste generation, as the controller20may be reused between treatments, and the catheter15may be thrown away after use. Additionally, the operator may not need to sterile drape, and the surface on which the controller20in the sterile pack1002is placed may not need to be fully sterilized (it could be simply wiped down), as the controller20would not make direct contact with these surfaces.

In any example where the catheter15is detachably coupled to the controller20, the controller20may be packaged by itself within the sterile pack1002, permitting the controller20to be sold separately from the catheter15.

Additionally, whether or not the catheter15is detachably coupled to the controller20, the sterile pack1002may be “chip-clipped” along a wall for quick and easy access. This would permit operators to gain quick access to the controller20without the need to sift through storage or cardboard boxes of devices and catheters in order to find the device that they need.

FIG.11illustrates a top view of an example ablation system10. As seen inFIG.11, the controller20may include an expandable foot1102. This expandable foot1102may be webbed or otherwise constructed in order to permit an operator to control how wide the expandable foot1102is with regard to the base of the controller20. Through expanding the expandable foot1102, the controller20may be provided additional stability, preventing the controller20from tipping on its side due to an external force.

It is understood that the expandable foot1102as shown inFIG.11may be used in combination with any of the various controller20examples as shown and described previously inFIGS.5A,5B,5C,7,8,9A,9B, and9Cas well as any additional controller not specifically illustrated herein.

This may prove particularly useful in examples where the motor is located under the T-fitting/saddle location, causing the controller20to be shorter in length but taller in height. This shorter length and taller height footprint may cause the controller20to have a higher center of gravity, making it more prone to tipping over, but the expandable foot1102may prevent this from happening. In such cases where the motor is located under the T-fitting/saddle location, gears could be used to create a gear ratio such that the rotation of the catheter15and/or wire30is controllable to be a desired rotation speed.

Also shown inFIG.11is a torque knob1104. The torque knob1104may permit an operator to provide torque to the catheter15and/or the wire30, thereby adjusting the direction of traverse of a distal end of the catheter15and/or the wire30. This is similar to the slot in the saddle704ofFIG.7. However, instead of needing to rotate the syringe60about the body702as shown and described inFIG.7, the torque knob1104may provide an easy method of controlling these distal ends of the catheter15and/or the wire30without adjusting the syringe60at all. Again, this newly created torque may permit the operator to make fine movements of the distal end of the catheter15and/or wire30in the treatment site50in order to make better abrasive contact with the vessel walls, and/or facilitate traversal of the torturous vasculature of the patient. Such a torque knob1104may work in conjunction with the controller as described through the use of a dual-shafted motor, or the example where the motor is beneath the T-fitting/saddle.

It is understood that the torque knob1104as shown inFIG.11may be used in combination with any of the various controller20examples as shown and described previously inFIGS.5A,5B,5C,7,8,9A,9B, and9C, as well as any additional controller not specifically illustrated herein.

Finally, as shown inFIG.11, the controller20may include an arm1106. In examples where the controller20is positioned such that the catheter15and/or the wire30turns back upon itself prior to being inserted into a patient, the arm1106may facilitate the prevention of the catheter15and/or the wire30acquiring a kink, which may prove detrimental to any fluid delivery, such as that of a drug. The arm1106may further set a radius that the catheter15is kept away from the controller20. Additionally, or alternatively, the arm1106may act as a catheter clamp, keeping the catheter15in place during a treatment. The arm1106may further prevent the device from being run while in an aggressive radius, which may have negative effects on the performance of the device. The arm1106may also prevent the ablation system10from becoming twisted (i.e., while the motor is running, the ablation system10may twist on itself, and the arm1106may prevent this).

It is understood that the arm1106as shown inFIG.11may be used in combination with any of the various controller20examples as shown and described previously inFIGS.5B,5C,7,8,9A,9B, and9C, as well as any additional controller not specifically illustrated herein.

FIGS.12A,12B, and12Cillustrate example side views of a wire30. Specifically,FIGS.12A,12B, and12Cillustrate different examples of components for releasing a drug, such as sclerosant, in an ablation system10featuring a wire30. The wire30may include a proximal wire end1202, and a distal wire end1204opposite the proximal wire end1202. The proximal wire end1202points generally to an area proximal any feature of the distal wire end1204. BecauseFIGS.12A,12B, and12C(as well asFIGS.14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25Aas shown and described below) only show a distalmost portion of the wire, it is not possible to show the proximal wire end1202at the location where it begins near any present controller20. For this reason, throughout this disclosure, the proximal wire end1202is understood to refer to the wire30proximal to the portion of the wire intended to abrade (or ablate, or agitate) the vessel walls.

As shown inFIGS.12A,12B, and12C, the wire30may include a sinusoidal shape. This sinusoidal shape permits the wire30to make contact with the walls of a vessel into which the wire30has been inserted. In some examples, the wire30is made from Nitinol (such as Nitinol #1 ASTM F2063) or a similar material that may return to its shape after compression, such as the compression the wire30may experience when stored within the sheath40.

Any of the examples described and shown herein are also operational within a stent. In such examples, the wire30would make contact with both the stent and the tissue. Additionally, many of the examples shown and described in the present disclosure include either three or four peaks. It is understood that the number of peaks present in the figures and described in the disclosure is for example only, and any number of peaks in a sinusoidally shaped wire may be present as desired, and a greater number of peaks could mean a greater treatment segment55length, or simply a greater number of contact points along such a treatment segment55.

Additionally, any dimensions regarding the spacing or amplitude of the wire30are also by example only, and it is understood that different size wires may prove useful for different-sized vasculature or treatment segments55. For example, the wire30may have an amplitude of approximately 12 millimeters. In this example, because the wire30is at least partially compressible, the wire30is operable in vasculature that has a smaller diameter than the amplitude of the wire30. In such an example wire30having an amplitude of approximately 12 millimeters, the working range, or range of vessel diameters, the wire30may be capable of treating would be from about 4 millimeters to about 12 millimeters.

In instances where the diameter of the vessel being treated is smaller than the amplitude of the wire30, the wire30will be under compression, causing the peaks of the sinusoidal shape to stretch out, lengthening the contact made with the vessel walls and, in turn, effectively increasing the length of the treatment segment55. The wire30could treat larger diameter vessels as well in this example, but it would be unable to make continuous contact with the vessel walls. Thus, a larger amplitude wire30may be desired for such an application.

In a procedure such as sclerotherapy, it may be desirable to either damage or penetrate the intima of a vessel, and to only damage the media of the vessel. Traditional wires in the prior art make contact with the vessel wall at the distal tip, resulting in this point of contact being abrupt and sharp. This comes with the possible issue of penetrating the media in addition to the intima, which may cause the wire to enter the surrounding adventitia. The solutions to this problem currently include rotating the wire in the reverse direction with the hope that the wire will untangle itself from the vessel to the point where the wire may be safely removed. Another solution includes pulling, often quite hard, on the wire to forcefully remove the wire from the patient. This solution may cause pain or discomfort for the patient, or could even result in stripping the vein entirely.

With a sinusoidal shape, such as that of the examples inFIGS.12A,12B, and12C, the point of contact is much blunter, or more obtuse, than traditional wires30. This makes the likelihood of penetrating the media and entering the adventitia much less likely, and thus increases the safety and efficacy of sclerotherapy procedures.

An additional issue with current sclerotherapy treatments is the multitude of functions the operator must keep track of simultaneously. For example, in many prior art devices, a treatment may include pulling the wire back through the vessel that is being treated at a rate of about 1 to 2 millimeters per second. At the same time, the operator must be injecting a drug, such as sclerosant, from a manually operated syringe at a rate of about 0.1 to 0.2 milliliters per centimeter. Already, the operator must have one eye on two separate gauges of measurement—the distance wire is being withdrawn, and the distance a plunger of the syringe has been depressed. Because the retraction rate of the catheter is time-dependent, the operator must also keep track of the time passing in some way—often by counting mentally, which is both prone to error, as well as another item that may distract the operator from the procedure. Treatments are often close to 40 centimeters long, which means that these treatments can take anywhere from 200 to 400 seconds based on the parameters suggested above.

In many prior art devices, the distal tip of the wire is the only point of contact between the wire and the vessel wall. Thus there is no “treatment segment” involved in these prior art devices as described in the current specification. This is the root cause for procedures to necessitate an operator to withdraw the wire at a specific rate while a drug is injected at a separate, distinct, 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.

Through the use of a sinusoidal-shaped wire30(or other wire shaped and configured to contact a length of a vessel wall), which treats a length of the vein at once, methods may be constructed for segmental treatment, rather than continuous treatment. In these methods, the wire30is provided to the distal-most portion of the treatment site50and then activated for a predetermined amount of time. With the present invention, the operator only needs to worry about the quantity of the drug being injected, which, because it is no longer dependent on the distance the wire30has been retracted, can be much more variable without causing adverse effects. Once a prescribed amount of the drug has been delivered to the treatment segment55, the operator may then withdraw the catheter15to a subsequent treatment segment55, either at a specified rate or at any rate the operator desires, while not having to inject any more of the drug until the catheter15has reached this subsequent treatment segment55.

The display508as described inFIGS.5A and5Bcan also take an additional burden off of the operator as they would no longer need to mentally count the time. Similarly, the LED912as described inFIGS.9A and9Cmay serve a similar purpose. Any such indicator, be it the display508, the LED912, or some other method of providing information to an operator, such as via noise from an alarm, can permit the operator to no longer keep track of the passage of time themselves, allowing them to give their full attention to smaller details of the procedure.

In some examples, the syringe may even be replaced by an Archimedes screw to deliver a set amount of drug per rotation of the wire30. Additional features may include a torque limiter, which may indicate if the wire30is rotating through an unintended medium, such as if the wire30has penetrated into the adventitia. A clutch may also be included. Should some parameter such as the torque pass a certain threshold, the clutch may automatically stop the wire30from rotating. If the wire30has penetrated into the adventitia, this automatic stoppage of the rotation of the wire30may help to prevent the vessel from tangling upon itself.

FIG.12Aillustrates a wire30having at least one aperture1206. As shown inFIG.12A, the wire30may be a hypotube having multiple apertures1206along the length of its body, as well as a nozzle-type tip at the distal wire end1204which includes an additional aperture1206. The apertures1206are present to deliver a drug, such as sclerosant, to a treatment site50during a procedure. An arrow is present at the proximal wire end1202to show the rotation of the wire30during a procedure. The wire30may rotate in either direction during a procedure, and this rotation permits the peaks of the sinusoidal shape to make full peripheral contact with the vessel walls, improving abrasion during the procedure. In some examples, but not all examples, the wire30only rotates in a single direction. Also shown is a central axis1208, about which the wire30rotates.

FIG.12Billustrates a wire30having at least one aperture1206, similar to those shown inFIG.12A. However, dissimilar to the example ofFIG.12A,FIG.12Bincludes a weighted tip1210at the distal wire end1204. An arrow shows a possible direction of rotation about a central axis1208, but the inclusion of a weighted tip1210creates a gyroscopic effect, which can facilitate keeping the wire30centered within the vessel, ensuring consistent contact with the walls of the vessel.

FIG.12Cillustrates a wire30with a weighted tip1210, but no apertures1206are present in this example. The sheath40is shown and acts as a fluid lumen while the wire30is exposed. In this example, a drug, such as sclerosant, may be delivered to the treatment site50through the sheath, and contact the vessel walls proximal to the rotation of the wire30along the length of treatment.

FIGS.13A,13B, and13Cillustrate a few possible cross-sectional profiles of a wire30. Specifically,FIG.13Aillustrates a circular cross-sectional profile1302of a wire30,FIG.13Billustrates a rectangular, or flat bar cross-sectional profile1304of a wire30, andFIG.13Cillustrates a triangular cross-sectional profile1306of a wire30.

It is understood that the various cross-sectional profiles as shown inFIGS.13A,13B, and13C may be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B.12C, as well as in combination with any of the various wire30examples as will be shown and described inFIGS.14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, or any additional wire not specifically illustrated herein.

A circular cross-sectional profile1302, as shown inFIG.13A, is the most traditional shape for a wire. Its rounded profile may cause damage, but the lack of sharp edges reduces the likelihood of penetration through the media and into the adventitia. If greater abrasion is desired, the circular cross-sectional profile1302may have an applied surface roughness.

The flat bar cross-sectional profile1304ofFIG.13Band triangular cross-sectional profile1306ofFIG.13Chave sharper edges than the circular cross-sectional profile1302ofFIG.13A. These sharp edges may abrade vessel walls more quickly than the circular cross-sectional profile1302can, but with an increased chance of penetrating the media, rather than just damaging it.

FIG.14illustrates a side view of an example wire30that terminates at a point that does not fall along the central axis1208. A weighted tip1210is included in this example, and, because of the off-axis location of the weighted tip1210, the opposite of, or at least an opposing effect to, a gyroscopic effect is achieved. The weighted tip1210causes the wire30to rotate more erratically, causing the peaks of the sinusoidal shaped wire30, as well as the weighted tip1210, to make harsher, if less frequent, contact with the vessel walls. In some examples, no weighted tip1210is included, but the wire30still terminates off-axis from the central axis1208.

FIG.15illustrates a side view of a wire30having a variable thickness. In the example shown, the proximal wire end1202has a thick diameter1502, and the distal wire end1204has a thin diameter1504. The thick diameter1502is greater than the thin diameter1504. The thick diameter1502portion of the wire30, because of its thickness, may be more rigid than the thin diameter1504portion of the wire30. This can allow the thick diameter1502portion of the wire30to “kick” off of the vessel walls, causing the thin diameter1504portion of the wire30to make increased contact with the vessel walls. The thick diameter1502portion of the wire may also permit increased surface roughness to be applied, which can improve the abrasion abilities of the wire30. Additionally, because of the greater profile size of a thick diameter1502portion of the wire30, better contact with the vessel walls can be made.

WhileFIG.15shows the thick diameter1502at the proximal wire end1202and the thin diameter1504at the distal wire end1204, these positions are exemplary only. Any portion of the wire30may include a thick diameter1502or a thin diameter1504based on the needs of the user, and thus different effects may be achieved.

FIG.16illustrates a side view of an additional example wire30forming a triangular sinusoidal profile1602. In fact, any type of shaped sine wave may be used as desired by the user. A triangular sinusoidal profile1602creates sharper points of contact with the vessel walls (as seen inFIG.2), which may improve the abrasion against these sections. These sharper points, or triangular peaks1604, may scratch or cut into the intima and/or media, thus further damaging the vessel wall than simple abrasion might.

FIG.17illustrates a side view of an example wire30, including a stranded cable1702construction. The surface of the stranded cable1702may be rougher than that of a monofilament wire or cable because of the increased number of ridges about the perimeter. This increased roughness may permit the stranded cable1702to make more aggressive contact with the walls of a vessel within a treatment site50. Additionally, the strands of the stranded cable1702may be loosened or tightened, permitting the operator to “dial in” or set the radius desired for a treatment. For example, a looser stranded cable1702would have a greater radius, and thus the overall wire30diameter would increase. Contra, a tighter stranded cable1702would have a smaller radius, thus decreasing the diameter of the overall wire30.

FIG.18illustrates a side view of an example wire30, including a helical hollow strand1802construction. Similar to the stranded cable1702ofFIG.17, the helical hollow strand1802may be rougher than that of a monofilament wire or cable because of the increased number of ridges about the perimeter. Once again, this increased roughness may permit the helical hollow strand1802to make more aggressive contact with the walls of a vessel within a treatment site50. The helical nature of the helical hollow strand1802makes it a candidate for a type of wire50that includes a lumen, perhaps for delivering a drug.

Additionally, or alternatively, while not shown inFIG.18, a pull string could be threaded through the hollow portion of the helical hollow strand1802and pulled such that the helical hollow strand1802forms a differently shaped profile, such as a sinusoidal-shaped profile. In addition to allowing the helical hollow strand1802to be delivered to a treatment site50in a lower profile (maybe even completely straightened out), such a pull string may allow the peak-to-peak distance or peak amplitude of a sinusoidal profile helical hollow strand1802. This may prove useful in situations where the peak size or peak-to-peak distance can be optimized for a specific treatment segment55.

In addition, a drug delivered through the hollow portion of the helical hollow strand1802may not need to be delivered to the distalmost end of the helical hollow strand1802. Instead, the drug may be delivered as a weeping agent through the individual coils.

Finally, while also not specifically illustrated inFIG.18, there could be a second helical hollow strand1802wrapped around the first helical hollow strand1802— with the coils either perpetuating in the same direction or contrasting with one another. In such an example, an oscillating motion may be formed by the helical hollow strands1802without necessitating the opening of the coils.

FIG.19illustrates a side view of an example wire30including a spring-like construction1902. In a straightened form, the spring-like construction1902may appear as a three-dimensional sinusoid, or helix. However, the spring-like construction1902is not limited to this, as is shown inFIG.19, and said spring-like construction1902may itself form a sinusoidally shaped profile. The benefits of this are similar to those discussed in the stranded cable1702ofFIG.17and the helical hollow strand1802ofFIG.18in that the spring-like construction1902includes further ridges about the wire30perimeter, which may increase the roughness of the wire30. Once again, this increased roughness may permit the spring-like construction1902to make more aggressive contact with the wall of the vessel in the treatment segment55.

FIG.20illustrates a side view of an example wire30, including a cage-like construction2002. The cage-like construction2002includes multiple individual components, such as strands of wire, helically winding about one another, similar to the stranded cable1702ofFIG.17and the helical hollow strand1802ofFIG.18. However, in the cage-like construction2002, the individual strands may include gaps, or spaces, between one another. The individual strands of the cage-like construction2002may permit the wire30to make contact with the wall of a vessel in a treatment segment55multiple times per rotation, thus increasing the abrasive properties of the wire30. While not shown inFIG.20, the cage-like construction could also be modified in the shape of its profile, such as a sinusoidally shaped profile, if desired. The cage-like construction2002will be revisited as a concept as both a proximal feature2602inFIG.26Cas well as a distal feature2702inFIG.27B.

FIG.21illustrates a side view of an example wire30that terminates at a point that does not fall along the central axis1208, similar to that ofFIG.14. Also similar toFIG.14, the wire30ofFIG.21may include a weighted tip1210, and because of the off-axis termination point of this weighted tip1210, an opposing effect to a gyroscopic effect is caused. The weighted tip1210may cause the wire30to rotate more erratically, causing the peaks of the sinusoidal-shaped wire30, as well as the weighted tip1210, to make more aggressive contact with the vessel walls. In some examples, no weighted tip1210is included, but the wire30still terminates off-axis from the central axis1208.

Dissimilar to the example ofFIG.14, the wire30ofFIG.21continues the path of the sinusoidal profile of the wire30. Advantages in this example may include a less erratic path of the distalmost tip of the wire30than the example ofFIG.14. Additionally, fewer bends in the wire30are required to construct the example inFIG.21, which may cut down on manufacturing costs. The weighted tip1210is shown to terminate at a point such that it is even with one of the peaks of the sinusoidal profile of the wire30. This is not strictly necessary, and the termination point of the weighted tip1210may be positioned as desired by the user (though a termination point along the central axis1208may cause the gyroscopic effect to be employed again).

FIGS.22A,22B, and22Cillustrate various side views of example non-uniform amplitude wires30. Specifically,FIG.22Ashows an example wire30having a first peak and a fourth peak that are greater in amplitude than the second peak and the third peak.FIG.22Billustrates an example wire30having three peaks on one side of the central axis1208(not shown in this figure).FIG.22Cshows an example wire30having a first peak and a fourth peak that are smaller in amplitude than the second peak and the third peak.FIGS.22A,22B, and22Care examples only and non-exhaustive—any formation of non-uniform amplitude wire30as desired may be used.

It is understood that any of the example non-uniform amplitude wires30as shown and described inFIGS.22A,22B, and22Cmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12G,141,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, or any additional wire not specifically illustrated herein.

The benefits of such non-uniform amplitude wires include drug dispersion effects and treatment segment abrasion effects. For example, the wire30ofFIG.22Amay cause a spraying effect of a drug in the middle section due to the lower amplitude peaks there. Contrastingly, the example wire30ofFIG.22Cmay cause the spraying effect to be away from the middle section, due to the higher amplitude peaks located there. Additionally, the one-sided peaks as displayed inFIG.22Bmay cause a different course of abrasion due to the damage occurring along one side of the vessel all at once, rather than being dispersed about the perimeter.

FIG.23Aillustrates an example wire30having a sinusoidal profile in two dimensions. This is one possible profile shape for a wire30that includes peaks for abrading a treatment segment55rather than just a point about a treatment site50.FIG.23Billustrates a front view of the example wire30ofFIG.23A. As seen inFIG.23B, a sinusoidal profile wire30existing in two dimensions will have a sinusoidal crossing profile2302that resembles a rectangle. When rotated, the sinusoidal crossing profile2302is approximately the shape that would be abrading the walls of the vessel within the treatment segment55.

While the shape of example wires30has been shown to be various interpretations of a sinusoidal profile, additional shaped profiles may be realized by the present disclosure. Additionally, the preceding wires30have been shown as lying on a two-dimensional plane. AsFIGS.24A and25Awill show, any of the preceding disclosure and figures (i.e.,FIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22, and23A) may also exist in a three-dimensional plane, such as a helix (or spring-shape) or variations where the peaks alternate rotationally about the central axis1208.

FIG.24Aillustrates one such three-dimensional example wire30. The wire30ofFIG.24Ais similar to the spring-like construction1902ofFIG.19, but inFIG.24Athe wire30does not present an additional sinusoidally-shaped profile in two dimensions. Rather, the wire30is a sinusoid existing in three dimensions, thus forming a helical or spring-like shape.FIG.24Billustrates a front view of the example wire ofFIG.24A. As seen inFIG.24B, a helical-shaped wire30will have a spring-like crossing profile2402that resembles a circle. When rotated, the spring-like crossing profile2402is approximately the shape that would be abrading the walls of the vessel within the treatment segment55.

FIG.25Aillustrates an example wire30where a sinusoidal profile is maneuvered in three-dimensional space after each peak occurs. The possibilities of such a configuration are neigh endless, soFIG.25Arepresents just one such example configuration for the purposes of discussion.

InFIG.25A, every time the wire hits a peak along a sinusoid and returns to the central axis1208(not shown), the sinusoid shape rotates clockwise by approximately ninety degrees. Once again, this angle is by example only, and any angle could be selected. Additionally, the decision to rotate clockwise when moving proximal to distal along the wire30is also by example only. Counter-clockwise or combinations of clockwise and counter-clockwise rotation may also be implemented. BecauseFIG.25Aincludes four peaks, once the fourth peak has been reached, a full rotation in three-dimensional space will have occurred. Once again, the decision to use four peaks in this example is non-limiting, and any number of peaks along the wire may be included. Likewise, a full rotation in three-dimensional space is also not strictly required.

FIG.25Billustrates a front view of the example wire ofFIG.25A. Because four peaks were included in the example wire30ofFIG.25A, and because the rotation was approximately ninety degrees after every peak, the three-dimensional crossing profile2502appears as a cross, or plus sign. In this example, the three-dimensional crossing profile2502is approximately the shape that would be abrading the walls of the vessel within the treatment segment55when the wire30is rotated. This three-dimensional crossing profile2502may be influenced in shape by the number of rotations, and the degree of rotation, of the wire30after each peak occurs.

Finally, the location at which the rotation occurs is not strictly necessary either. For example, the wire30may be rotated in three-dimensional space at each peak instead of at the base of each peak, as shown inFIGS.25A and25B. The rotation may also occur at any point between the peak and the base of the peak. Additionally, any combinations of these rotation points may be used—for example, the first rotation happening at the base after the first peak occurs and the next rotation happening at the second peak.

FIGS.26A,26B,26C,26D,26E,26F,26G, and26Hillustrate side views of example proximal features2602for the wire30. In the cases ofFIGS.26A,26B,26C,26D,26E,26F, and26G, the proximal features2602may be capable of at least partially occluding the vessel proximal to the area of treatment. This occlusion, or flow arrest, may help to prevent blood from entering the area of treatment. While blood entering the treatment site50is not debilitating to the procedure, there is a chance that too much blood will dilute the drug, or sclerosant, thus lowering its efficacy and the effectiveness of the treatment as a whole. This occlusion, or flow arrest, may also help to stop or slow the blood flow, allowing the sclerosant to dwell in the treatment site50longer, increasing the efficacy of the sclerosant. This occlusion may further help to prevent the drug from leaving the treatment site50in the proximal direction.

It is understood that any of the proximal features2602as shown inFIGS.26A,26B,26C,26D,26E,26F,26G, and26Hmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B.12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

With respect toFIG.26A, a balloon2604may be proximal to the exposed portion of the wire30and reside upon the sheath40. After the wire30is deployed from the sheath40, the balloon2604may be inflated via an inflation lumen, perhaps a working lumen in the sheath40, to occlude the vessel. In some examples, the balloon2604may include a weeping balloon, and a drug, such as sclerosant, may be delivered through the micropores of the weeping balloon.

FIG.26Bis similar toFIG.26A, in that an offset balloon2606may reside upon the sheath40proximal to the exposed portion of the wire30. Again, after the wire30is deployed from the sheath40, the offset balloon2606may be inflated via an inflation lumen, perhaps a working lumen in the sheath40, to occlude the vessel. Also similarly, the offset balloon2606may include a weeping balloon, and a drug, such as sclerosant, may be delivered through the micropores of the weeping balloon. However, dissimilar to the balloon2604ofFIG.26A, the offset balloon2606ofFIG.26Bmay be biased toward one side of the sheath40. In such examples, the offset balloon2606may offload the wire30while in an inflated state, thereby causing the wire30to make more aggressive contact with the wall of the vessel.

FIGS.26C and26Ddepict hollow and solid variations of a spiral-type occlusion element. Specifically,FIG.26Cillustrates a cage2608, which, when released from the sheath40, expands to approximately the same diameter as the vessel. In this example, the cage2608is made from a material, such as Nitinol, which permits expansion and contraction of the cage2608. The cage2608, when rotating, may act as a three-dimensional impeller, which will at least partially impede the progress of blood into the treatment site50and/or the outflow of a drug from said treatment site50. In some examples, the cage2608is made from a material that does not permit compression, and as such, it is sized to fit within the sheath40.

FIG.26Dillustrates a grooved solid2610, which acts in a similar manner to the cage ofFIG.26C. The grooved solid2610, however, may be smaller in diameter than the cage2608, as it cannot compress as far and must still fit within the sheath40when it is not in its released state. The solid nature of the grooved solid2610prevents any blood from entering the treatment site50through the grooved solid2610, as well as any potential outflow of a drug from said treatment site50, and the grooves in the grooved solid2610perform an impelling action to prevent at least some blood from going around the grooved solid2610and into the treatment site50.

FIG.26Eshows an impeller2612having three blades. The number of blades is not important, and as many blades as desired may be used. The impeller2612may be made from a material, such as Nitinol, which permits expansion and contraction of the impeller2612. In this example, the impeller2612may be sized larger than the sheath40diameter. The impeller2612may then expand to approximately the same diameter as the vessel when released from the sheath40. In other examples, the impeller2612is made from a material that does not expand and contract very much, and as such, the impeller2612would be sized to fit within the sheath40when in its retracted state. When the wire30rotates, the impeller2612would also rotate, thus impeding the progress of blood to the treatment site50.

FIGS.26F and26Gshow a sponge-like solid2614as the proximal feature2602. Specifically, inFIG.26F, the sponge-like solid2614resides on the wire30. The sponge-like solid2614may easily compress within the sheath40when in its retracted configuration and can expand to occlude the vessel proximal to the treatment site50when released from the sheath40.

Similarly, inFIG.26G, the sponge-like solid2614acts as the proximal feature2602, but in this case, the sponge-like solid2614resides on the sheath40. The sponge-like solid2614may easily compress within the vasculature of the patient, and once delivered be permitted to expand in order to occlude the vessel proximal to the treatment site50. In bothFIGS.26F and26G, the sponge-like solid2614may prevent blood from entering the treatment site50during treatment, and/or prevent a drug, such as sclerosant, from leaving the treatment site50during treatment.

FIG.26Hillustrates a sinusoidal urge2616in the wire30proximal to the distal wire end1204within the sheath40. This sinusoidal urge2616may still exist within the sheath40when the sheath40is fully retracted about the wire30. The sinusoidal urge2616is not intended to occlude blood flow, but rather, may offload the wire30in order to cause the wire30to make more aggressive contact with the wall of the vessel.

FIGS.27A,27B,27C,27D, and27Eillustrate side views of various potential distal features2702for a wire. In all cases, the distal features2702at least partially occlude the vessel distal to the area of treatment. This occlusion, or flow arrest, may help to prevent a drug, such as sclerosant, from traveling too far into a vessel, such as into a junction with another, more major vessel that it is not desirable to treat. This occlusion, or flow arrest, may also prevent any blood from traversing into the treatment site50from the distal side, which could potentially dilute the drug being delivered.

It is understood that any of the distal features2702as shown inFIGS.27A,27B,27C,27D, and27Emay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

With respect toFIG.27A, a single blade impeller2704may be distal to the wire30. As the wire30is released from the sheath40, the single blade impeller2704may expand to be approximately the same length as the radius of the vessel. In these examples, the single blade impeller2704is made from a material, such as Nitinol, that allows this expansion and contraction of the single blade impeller2704.

In other examples, the single blade impeller2704may be sized to fit within the sheath40while in its fully expanded configuration, and made of a material that is more rigid, and does not permit as much expansion or contraction. When the wire30rotates, the single blade impeller2704rotates as well, impeding the progress of a drug, such as sclerosant, out of the treatment site50. Because the single blade impeller2704cannot be symmetrical about the wire30(as you cannot have symmetry around a circle with only one component), the single blade impeller2704may not be able to be used with a gyroscopic effect. Similar to the off-axis terminating wire30ofFIGS.14and21, the single blade impeller2704may cause the wire30to move eccentrically, creating more aggressive contact with the vessel walls.

FIGS.27B and27Cdepict hollow and solid variations of a spiral-type occlusion element at the distal wire end1204. Specifically,27B illustrates a cage2706which, when released from the sheath40, expands to approximately the same diameter as the vessel. In this example, the cage2706is made from a material, such as Nitinol, which permits expansion and contraction of the cage2706. The cage2706, when rotating, may act as a three-dimensional impeller, which will at least partially impede the progress of a drug, such as sclerosant, out of the treatment site50while also preventing unintended inflow of blood into said treatment site50. In some examples, the cage2706is made from a material that does not permit compression, and as such, it is sized to fit within the sheath40.

FIG.27Cillustrates a grooved solid2708, which acts in a similar manner to the cage2706ofFIG.27B. The grooved solid2708, however, is smaller in diameter than the cage1006, as it cannot compress as far, and must still fit within the sheath40when it is not in its released state. The solid nature of the grooved solid2708prevents any of a delivered drug, such as sclerosant, from exiting the treatment site50through the grooved solid2708, and the grooves in the grooved solid2708perform an impelling action to prevent at least some of the drug from going around the grooved solid2708and out of the treatment site50. Similar toFIG.27B, the grooved solid2708may also prevent any unintended inflow of blood into the treatment site50from the distal side.

FIG.27Dshows an impeller2710having three blades. The number of blades is not important, and as many blades as desired may be used. The impeller2710may be made from a material, such as Nitinol, which permits expansion and contraction of the impeller2710. In this example, the impeller2710may be sized larger than the sheath40diameter. The impeller2710may then expand to approximately the same diameter as the vessel when released from the sheath40. In other examples, the impeller2710is made from a material that does not expand and contract very much, and as such, the impeller2710would be sized to fit within the sheath40when in its retracted state. When the wire30rotates, the impeller2710would also rotate, thus impeding the progress of a drug, such as sclerosant, out of treatment site50. This impeding effect may also extend to preventing any unintended inflow of blood into the treatment site50.

FIG.27Eshows a sponge-like solid2712. The sponge-like solid2712may easily compress within the sheath40when in its retracted configuration and can expand to occlude the vessel distal to the treatment site50when released from the sheath40. Dissimilar to the proximal feature2602sponge-like solid2614, the distal feature2702sponge-like solid2712cannot reside upon the sheath40, as once the sheath40is retracted about the wire30in order to expose the wire30, the sponge-like solid2712could no longer be at the distal end of the treatment site50.

FIGS.28A,28B, and28Cillustrate side views of example wires30, including additional features at a distalmost tip of the wire30. While many of the preceding figures included a weighted tip1210at the distalmost tip of the wire30, the weighted tip1210is not necessary (such as seen inFIG.12A, where the tip included an aperture1206).FIGS.28A,28B, and28Cprovide additional examples of distalmost tips of the wire30that are not necessarily intended to keep the wire gyroscopically stable during rotation.

It is understood that any of the additional features at a distalmost tip of the wire30as shown inFIGS.28A,28B, and28Cmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A.22B,22C.23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

FIG.28Aillustrates a hemispherical tip2802at the distalmost tip of the wire30. This hemispherical tip2802may be weighted or unweighted. In either case, the hemispherical tip2802, because of its lack of three-dimensional symmetry, may unbalance the distalmost tip of the wire30, causing an opposing effect to gyroscopic stability. This effect may cause the hemispherical tip2802to make contact, perhaps aggressive contact, with the vessel wall, adding an additional point of abrasion to the treatment segment55in which the wire30is located.

FIG.28Billustrates an offset weighted tip2804at the distalmost tip of the wire30. The offset weighted tip2804need not necessarily be weighted, but weight may increase the effect this distalmost tip has on the wire30. Similar to the hemispherical tip2802ofFIG.28A, this offset weighted tip2804may cause an opposing effect to gyroscopic stability through unbalancing the wire because of its newly acquired lack of symmetry about the central axis1208(not shown in this figure). This effect may cause the offset weighted tip2804to make contact (again, perhaps aggressive contact) with the vessel wall by adding an additional point of abrasion to the treatment segment55in which the wire30is located.

FIG.28Cillustrates a balloon tip2806at the distalmost tip of the wire30. This balloon tip2806may be delivered to a treatment site50in an unexpanded (or uninflated) configuration and then inflated in order to expand and occlude the vessel distal of the treatment site50. In such examples, it is likely that the wire30includes a lumen, or is a hypotube, in order to deliver an inflation fluid to the balloon tip2806in order to permit the balloon tip2806to inflate to its expanded configuration.

FIG.29Aillustrates an example side view of a wire30, including a supplementary wire2902. The supplementary wire2902may add supplemental geometry along different portions of the wire30, creating a rougher surface and “snag” points to facilitate greater abrasion of the vessel wall. While the supplementary wire2902is shown wrapped around the majority of the wire30, the supplementary wire2902may be wrapped around only small portions of the wire, such as near the peaks, in order to cut down on material use (and perhaps the cost of materials).

While not specifically shown inFIG.29A, in some examples, the supplementary wire2902may be a hypotube that extends back to the controller20, permitting the supplementary wire2902to be used as a fluid lumen for delivery of a drug, such as a sclerosant, to the treatment site50. In these examples, apertures may exist along the length of the supplementary wire2902along where it would be located in a treatment segment55, or at a distal-most end of the supplementary wire2902for a distal injection of the drug.

It is understood that the supplementary wire2902as shown inFIG.29Amay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,2L22A,22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

FIG.29Billustrates a side view of an example wire30including supplemental geometry that appears quite similar to the supplementary wire2902ofFIG.29A. Dissimilar to the supplementary wire2902ofFIG.29A, however, this supplemental geometry is a heated wire2904. The heated wire2904may be capable of carrying heat to the treatment segment55, thereby increasing the temperature in said treatment segment55. Through heating up this treatment segment55, any drug injected therein may see improved drug diffusion.

It is understood that the heated wire2904as shown inFIG.29Bmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

The heated wire2904may also be an additional wire made of a shape memory material, such as Nitinol, and the heat portion of “heated wire” may be provided by the body of the patient the wire30is inserted into. In these cases, the austenite transformation finish temperature (A(f) temperature) may be set on the shape memory material such that it returns to its austenite state from its martensite state under these bodily provided temperatures. In such examples, the wire30may be delivered to a treatment segment55in a somewhat straight state, and the heated wire2904will begin heating up during this delivery. Once the wire30has been delivered to the treatment segment55and exposed from the sheath40, the heated wire2904may be permitted to reach its A(f) temperature, thus returning to its austenite shape and forcing the wire30into the desired profile for abrading the vessel wall.

FIG.29Cillustrates a wire30, including a porous surface geometry2906, according to some examples. This porous surface geometry2906may add a surface roughness to the wire, as alluded to inFIGS.13A and15. The porous surface geometry2906may prevent smooth surface portions of the wire30from contacting the vessel walls in a treatment segment55. Instead, the porous surface geometry2906may cause sharper edges and uneven surfaces to physically contact the vessel walls, thus more aggressively abrading the vessel walls.

It is understood that the porous surface geometry2906as shown inFIG.29Cmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A.22B,22C,23A.24A, and25A, as well as any additional wire not specifically illustrated herein.

FIGS.30A,30B,30C, and30Dillustrate various examples of wires, including additional geometry. For example, the additional geometry3002aofFIG.30Amay consist of rounded nubs, either in two or three dimensions. The additional geometry3002bofFIG.30Bmay be at least one ball-shaped object, either in two or three dimensions. In some examples, the additional geometry3002c, as seen inFIG.30C, is a spike—again, either in two or three dimensions. The additional geometry3002dofFIG.30Dmay be a brush, or brush-like object.

Any of these additional geometries3002a,3002b,3002c, and/or3002dmay be used in conjunction with one another. These additional geometries3002a,3002b,3002c, and/or3002dmay facilitate abrasion of the vessel wall along a treatment segment55. Additionally, while the additional geometries3002a,3002b,3002c, and/or3002dare shown only at the peaks of the sinusoidal shape of wire30presented inFIGS.30A,30B,30C, and30D, it is understood that these additional geometries3002a,3002b,3002c, and/or3002dmay be included at any location of the wire30, including the entire body of the wire30, as desired by the user.

It is understood that any of the additional geometries3002a,3002b,3002c, and/or3002das shown inFIGS.30A,30B,30C, and30Dmay be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,16,17,18,19,20,21,22A.22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

FIG.31illustrates an example luer hub3102, including a luer3104. This luer hub3102may be the mechanism by which the syringe60is detachably coupled to the T-fitting706,804, and/or904(ofFIGS.7,8,9A,9B, and9C) or the saddle704ofFIG.7(or those saddles not shown but described inFIGS.8,9A,9B, and9C).

FIG.32illustrates a top view of an example catheter15, including a sheath40and a wire30. Multiple marking devices are shown on the body of the sheath40. Any of these marking devices may partially surround or fully surround the body of the sheath40.

Included inFIG.32is a donut3202, which exists about the sheath40. While shown and described as a donut3202, it is understood that any type of slidable depth marker may be used and perform the same functions as the donut3202. The donut3202may be slidably coupled to the sheath40, permitting a user to move the donut3202to a desired location along the sheath40. For example, the donut3202may be placed on the sheath40at a distance from the distal end of the sheath40such that the distance represents the distance to a deep venous system in the patient. This could indicate to an operator that once the donut3202has reached the insertion point of the patient, the catheter15, if inserted any further, may enter the patient's deep venous system or other vasculature not intended for treatment.

Additionally, or alternatively, the donut3202may be sized such that it cannot enter the insertion point of the patient. As described in the previous paragraph, this may prevent the catheter15from accessing the deep venous system of the patient. This may also prove utilitarian during a procedure, such as segmental mechanical or mechanochemical ablation as described throughout the present specification. For example, once an operator has reached a target treatment segment55and started rotating the wire30, perhaps through providing power to a motor, the operator may be able to slide the donut3202along the sheath40up to the insertion point and then release the catheter15.

The donut3202may hold the catheter15in place relative to the insertion point, allowing the operator free use of both of their hands. In some examples, a rotation of the wire30attempts to draw the catheter15further into the body of the patient due to forward propulsion from the spinning motion. In such examples, the donut3202is sized such that when the donut3202is coupled to the sheath40, the donut3202holds its position with respect to the sheath40due to frictional forces between the donut3202and the sheath40. However, the donut3202is still configured to slide with respect to the sheath40under the influence of outside forces, such as manual manipulation by an operator that overcomes any frictional forces between the donut3202and the sheath40.

Because the donut3202may be sized such that it cannot enter the insertion point in the body of a patient, the donut3202may thereby prevent the sheath40from further entering the vasculature of the patient. In other examples, a catheter clamp may be included to serve a similar purpose.

Also seen inFIG.32are a plurality of distance markings3204along the sheath40. The distance markings3204may be used by an operator to determine how far the catheter15is within the patient. This is particularly useful in cases involving the withdrawal of the catheter15. For example, during segmental mechanical or mechanochemical ablation, an operator may treat a treatment segment55and then begin withdrawing the catheter15from the patient until it reaches a subsequent treatment segment55. In this scenario, if the first treatment segment55is reached and aligned with a distance marking3204, the operator may then, after treating the treatment segment55, withdraw the catheter15until a subsequent distance marking3204has been reached, indicating that a subsequent treatment segment55has been reached as well.

For this reason, it may be beneficial to include distance markings3204that are approximately the same length as the treatment segment55. As disclosed previously in this disclosure, the treatment segment55may be the same length as the distal wire end1204. Thus, the distance markings3204may also be the same length as the distal wire end1204. However, neither of these distance marking lengths is strictly necessary, and variations in the distance may be used as desired by the user.

Finally,FIG.32also shows a warning track3206distal of the distance markings3204. This warning track3206may appear as a series of closely spaced markings, but other markings or indicators may be used as well. In practice, the warning track3206may indicate to an operator that the end of a workable treatment length has been reached, meaning that pulling the catheter15any further from the patient would result in ineffective treatment.

The length of the warning track3206, position of the warning track3206, as well as the number of distance markings3204and distance between distance markings3204is customizable, and multiple catheters15may be utilized for specific purposes—such as longer or shorter lengths of treatment. Likewise, the length of the distal wire end1204may be customizable in order to increase or decrease the length of the treatment segment55.

It is understood that the donut3202, the distance markings3204, and the warning track3206as shown inFIG.32may be used together, separately, or in any combination with one another. It is additionally understood that the donut3202, the distance markings3204, and the warning track3206as shown inFIG.32may be used in combination with any of the various wire30examples as shown and described previously inFIGS.12A,12B,12C,14,15,16,17,18,19,20,21,22A,22B,22C,23A,24A, and25A, as well as any additional wire not specifically illustrated herein.

FIG.33illustrates an example block diagram for operating a controller20, perhaps any of the controllers20as shown and described inFIGS.5A,5B,5C,7,8,9A,9B, and/or9C. As seen in this block diagram, a power supply3302may be wired to receive an input from an actuator3304. As described previously, the power supply3302may be a contained power supply, such as a battery or wired power. Similarly, the actuator3304may be a button, a switch, or anything capable of receiving a user input to operate the controller20.

The actuator is wired to a limit switch3306, which in turn is wired to a motor3308and an LED3310(separated by a resistor3312in order to receive the correct amount of power). The limit switch3306either permits power to flow to the motor3308and the LED3310or prevents power from flowing to the motor3308and the LED3310.

For example, considering an ablation system10, including a controller20with a sheath40and a wire30disposed through a working lumen of the sheath40. If the controller20is capable of moving the sheath, such that retracting the sheath40exposes the wire30, and extending the sheath40encloses the wire30, it may be desired to prevent the wire from turning unless the wire30is fully exposed from the sheath40.

In such an example, the limit switch3306may be provided to only permit power to the motor3308and the LED3310when the sheath40is fully retracted. Similarly, if the sheath40is extended at all from its fully retracted state, the limit switch3306may prevent power from being provided to the motor3308and the LED3310.

This is only one example of how a limit switch3306may be implemented into the circuitry of a controller20in order to effectuate control over when the motor3308receives power, and any implementation of the limit switch3306may be implemented as desired by the user. Also, as shown and described inFIGS.9A and9C, the LED3310may be present in order to communicate to the operator that the motor is on, or that the motor is ready to be turned on (i.e., in the example above, that the sheath40is fully retracted). Other purposes of the LED3310, such as for use as a timer or indicator of treatment completion during segmental mechanical or mechanochemical ablation may be realized as well through this limit switch.

It is understood that the entirety of the block diagram as shown inFIG.33, as well as other example wiring configurations for a circuit, may be used in combination with any of the various controller20examples as shown and described previously inFIGS.5A,5B,5C,7,8,9A,9B, and9C, as well as any additional controller not specifically illustrated herein.

FIG.34illustrates a flowchart depicting an example method of treating a venous disease with an ablation system. In some examples, the method includes using a sclerotherapy device (at step3400). The sclerotherapy device is understood to be any ablation device10and/or combination of controller20and catheter15(or sheath40and wire30). As used throughout, a sclerotherapy device need not be capable of specifically delivering sclerosant, and any system which is capable of causing mechanical or mechanochemical ablation of a vessel is considered synonymous with this use of “sclerotherapy device.”

According to some examples, the method includes determining a first treatment site50in the vasculature of the patient (at step3402). As discussed previously, the treatment site50(or first treatment site50) may be a length along a vessel, otherwise described as a treatment segment55(or first treatment segment55as in this specific example).

The method may include treating the first treatment site50by extending the wire30into the blood vessel and allowing it to expand (at step3404). As also described previously, the distal end of the wire30for treating each treatment site50may be the length of the segment being treated (the treatment segment55), thus permitting the wire30to treat (or abrade) each treatment segment55at once.

In some examples, the method includes repositioning the sheath to a second treatment site50(at step3406). In examples as described above, the second treatment site50may likewise be a length along a vessel, otherwise described as a treatment segment55(or second treatment segment55).

According to some examples, the method includes treating the second treatment site50(at step3408). As also detailed above, the distal end of the wire30for treating each treatment site50may be the length of the segment being treated, thus permitting the wire30to treat (or abrade) the entirety of the second treatment segment55at once. The use of “first” and “second” is for example only, and more steps or stages of treatment may be present. In these examples, any next step could be considered to be performed on a subsequent treatment site50or treatment segment55.

The method may include imaging the treatment50with ultrasound (at step3410). This is but one method of locating the catheter15within the patient while delivering the catheter to a treatment site50, or retracting the catheter15at least partially to locate the catheter15at a subsequent treatment site50.

In some examples, the method includes providing sclerosant through a sheath40to at least one of the first treatment site50and the second treatment site50(at step3412). The sclerosant could be any drug, and could be delivered through means other than the sheath40, such as through a lumen of the catheter15and/or a lumen of the wire30. When delivered through the sheath40, the drug may pass through a working lumen within the sheath40.

Additionally, according to some examples, the drug is not delivered while the catheter15(sheath40) is removed from the first treatment site50and relocated to the second treatment site50, permitting the operator to worry about one less thing in that they no longer need to inject the drug at a specific rate while simultaneously withdrawing the catheter15at a specific rate. In this way, the method achieves segmental mechanical or mechanochemical ablation. It should be appreciated that stating segmental mechanical or mechanochemical ablation means segmental mechanical or segmental mechanochemical ablation.

FIG.35illustrates a flow chart depicting an example method of controlling a catheter. In some examples, the method of controlling a catheter includes using a controller (at step3500). This controller may be the controller illustrated inFIGS.5A,5B,5C,7,8,9A,9B, and9C, 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-fitting along a second direction perpendicular to a first direction (at step3502).

The first direction is expressed inFIGS.7,8,9A,9B, and9Cas first direction712, first direction810, and first direction916, respectively, but to reiterate, it is the direction of lateral travel of the saddle and T-fitting about the device body. Expressed another way, the first direction is the direction of travel between the proximal body end and the distal body end. In step3502, the syringe is inserted into a T-fitting along a direction perpendicular to the first direction. Because the invention exists in three-dimensional space, it is understood that this second direction could be any direction circumferentially about the first direction. Additionally, as expressed inFIGS.7,8,9A,9B, and9C, perfectly perpendicular insertion of the syringe is not necessary, and other directions and/or angles of insertion of the syringe into the T-fitting may also be used.

The method of controlling a catheter may include directing the catheter to a treatment site of a patient (at step3504). In examples including a catheter coupled to the distal body end, and once the syringe has been inserted into the T-fitting, the catheter may be supplied to the treatment site for a procedure to begin.

FIG.36illustrates a flow chart depicting a method of exposing a wire from a catheter, according to some examples. In some examples, the method of exposing a wire from a catheter includes sliding a T-fitting from a distal body end toward a proximal body end (at step3600). In examples including a catheter, the catheter may be coupled to the device body at the distal body end. By sliding the saddle and the T-fitting from the distal body end to the proximal body end, the catheter is effectively “pulled back” along with the movement of the saddle and the T-fitting.

According to some examples, the method of exposing a wire from a catheter includes retracting a sheath about the wire (at step3602). In examples including a wire within the catheter body, when the catheter is pulled back in response to the movement of the saddle and the T-fitting, as expressed in step3600, the catheter sheath surrounding the wire moves about the wire. The wire either does not move in response to the movement of the saddle and the T-fitting, or moves at a rate that is lower than that of the catheter.

The method of exposing a wire from a catheter may include exposing a distal wire end (at step3604). Once the saddle and the T-fitting have moved all the way from the distal body end to the proximal body end, the wire may be exposed from the catheter sheath, permitting contact between the wire and the walls of the vasculature. This permits the wire to be used during a procedure, while also allowing the wire to be delivered to the treatment site while not exposed.

FIG.37illustrates a flow chart depicting an example method of capturing a wire into a catheter. In some examples, the method of capturing a wire with a catheter includes sliding a T-fitting from a proximal body end to a distal body end (at step3700). In examples including a catheter, the catheter may be coupled to the device body at the distal body end. By sliding the saddle and the T-fitting from the proximal body end to the distal body end, the catheter is effectively “pushed forward” along with the movement of the saddle and the T-fitting.

According to some examples, the method of capturing a wire with a catheter includes extending a sheath about the wire (at step3702). In examples including a wire within the catheter body, when the catheter is pushed forward in response to the movement of the saddle and the T-fitting, as expressed in step3700, the catheter sheath surrounding the wire moves about the wire. The wire either does not move in response to the movement of the saddle and the T-fitting, or moves at a rate that is lower than that of the catheter.

The method of capturing a wire with a catheter may include capturing a distal wire end (at step3704). Once the saddle and the T-fitting have moved all the way from the proximal body end to the distal body end, the catheter sheath may completely cover the wire, effectively capturing, or enclosing, the distal wire end into the catheter sheath. Once a procedure is completed, this may facilitate the prevention of damage to non-treatment areas.

FIG.38illustrates a flow chart depicting a method of controlling a distal catheter end, according to some examples. In some examples, the method of controlling a distal catheter end includes rotating a syringe and a luer (at step3800). By rotating the syringe and luer, a rotational movement may also be applied to a catheter coupled to the device body.

According to some examples, the method of controlling a distal catheter end includes providing torque to a catheter (at step3802). The rotational movement of the syringe and luer may apply a torque to the catheter, and this torque may either be in the direction of rotation of the syringe and luer, or opposite the direction of rotation of the syringe and luer.

The method of controlling a distal catheter end may include controlling a direction of travel of the distal catheter end (at step3804). In response to the applied torque, the distal catheter end moves. For example, if the torque applied to the catheter is in the same direction of rotation as the syringe and luer, and this direction of rotation is clockwise about the body of the device, the distal catheter end may be steered toward the left (wherein the length of the catheter from the proximal catheter end to the distal catheter end is a first direction, the left being based upon this first direction). Contra, if the torque applied to the catheter is opposite the direction of rotation of the syringe and the luer, the distal catheter end may be steered toward the right. The use of “left” and “right” is for example only, and it is understood that the device may be set up to apply torque to the catheter in such a way as to control the distal catheter end in any direction as desired by the operator.

FIG.39illustrates a flow chart depicting an example method of controlling a motor. In some examples, the method of controlling a motor includes pressing a button (at step3900). The button may 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 powering on the motor (at step3902). In response to actuation of the button, power is supplied to the motor, thereby allowing the motor to rotate.

The method of controlling a motor may include pressing the button (at step3904). Once a procedure is completed, or at any time it is desired to no longer have the motor rotate, the button may be actuated again. In some examples, the method of controlling a motor includes powering off the motor (at step3906). Once the button is actuated a subsequent time, or any time that the motor is currently powered on, the button will remove access to the power from the motor, thus stopping the motor from rotating. While the use of “button” is used inFIG.39, it is understood that any toggleable mechanism, or “actuator” as described and shown in the previous figures (seeFIGS.5A,5B,5C,6A,6B,9A,9B, and9C), such as a switch, can be used to supply or remove power from the motor.

FIG.40illustrates a flow chart depicting a method of providing a fluid through a catheter, according to some examples. In some examples, the method of providing a fluid through a catheter includes depressing a plunger of a syringe (at step4000). Through depressing the plunger of the syringe, any fluid within the syringe is ejected from the opening in the tip of the syringe.

According to some examples, the method of providing a fluid through a catheter includes releasing a fluid through the catheter (at step4002). In examples where a catheter is in fluid communication with the syringe, the fluid ejected from the syringe in step4000is injected into the catheter body, perhaps through a fluid lumen. This allows the fluid to travel the length of the catheter, and to a treatment site.

FIG.41illustrates a flow chart depicting a method of segmental mechanical ablation, according to some examples. In some examples, the method of segmental mechanical ablation includes inserting a catheter into a vascular system of a patient (at step4100). The catheter may then be delivered to a treatment site, also referred to as a treatment segment due to the length of treatment provided without necessitating movement of the catheter. According to some examples, the method of segmental mechanical ablation includes moving the catheter to a first treatment segment (at step4102). The first treatment segment may be the distal most location in an overall treatment length, permitting an operator to move the catheter through the overall treatment length by pulling the catheter out from the patient, rather than pushing the catheter further into the patient. However, it is understood that either direction of movement is enabled by this method, and the operator can choose how to perform such a segmental ablation treatment.

The method of segmental mechanical ablation may include actuating a motor and rotating at least a portion of the catheter (at step4104). The mechanical agitation (or abrasion, or ablation) of the vessel wall may be due to rotating the catheter and having portions of the catheter physically contact the intima and media of the vessel wall. This contact may be enough to damage these layers, and in some instances, this damage may be enough to kill the vessel, thus completing treatment of a varicose vein at least in this treatment segment. In other examples, the catheter makes a motion that is less rotational and more reciprocating, thereby “scratching” the vessel walls in order to perform this damage. This reciprocating motion may either be caused through conversion of rotational motion of the motor into linear motion of the catheter, or by other means if desired.

In some examples, the method of segmental mechanical ablation includes abrading the first treatment segment for a predetermined amount of time (at step4106). The predetermined amount of time is dependent on the needs of the operator, and what length of time may be necessitated by the specific vessel being treated. The length of time may also change based on whether the procedure is segmental mechanical ablation, as described in the method ofFIG.41, or segmental mechanochemical ablation, as will be discussed inFIG.45. In the case of segmental mechanical ablation, the catheter may be left within the treatment segment (unmoving longitudinally through the vein) for about five to about thirty seconds. Again, these numbers are by example only, and an operator could choose to leave the catheter within the treatment segment for whatever length of time they so desire.

According to some examples, the method of segmental mechanical ablation includes moving the catheter to a second treatment segment (at step4108). This second treatment segment may be adjacent, or approximately adjacent, to the first treatment segment, however, this is not strictly necessary. By having the second treatment segment near or adjacent to the first treatment segment, an operator can be sure that the entirety of the vessel is being treated.

The method of segmental mechanical ablation may include abrading the second treatment segment for the predetermined amount of time (at step4110). This abrasion (or, again, agitation or ablation) may be performed in the same manner as described above in step4106. The predetermined amount of time may be same as the predetermined amount of time as discussed in step4106, or it may be a different predetermined amount of time, depending on the needs of the operator for a specific segment of a vein being treated.

FIG.42illustrates a flow chart depicting a method of exposing and enclosing a wire in a sheath, according to some examples. In some examples, the method of exposing and enclosing a wire in a sheath includes indicating that the predetermined amount of time has passed (at step4200). This indication step is not strictly limited to methods of exposing and enclosing a wire in a sheath, and may be present in any of the other methods listed herein, or not included in the present method if this indication step is not desired. This indication may occur through a component, likely located extracorporeally, perhaps on the controller, such as an LED, a speaker, or a display. The indication may be audible or visual.

According to some examples, the method of exposing and enclosing a wire in a sheath includes retracting at least a portion of the sheath from the wire (at step4202). The wire, which may be passed through a working lumen of the sheath, may additionally be slidably disposed within the sheath. In some examples, this permits the sheath to be retracted about the wire.

The method of exposing and enclosing a wire in a sheath may include exposing the distal wire end (at step4204). Once the sheath is retracted, a portion of the wire, in this example the distal wire end, may be exposed from the sheath, permitting the distal wire end to make contact with the walls of a vessel in treatments such as segmental mechanical ablation.

In some examples, the method of exposing and enclosing a wire in a sheath includes extending the sheath about the wire (at step4206). By slidably moving the sheath opposite the direction of step4202, an operator may extend the sheath back about the wire, all the way to its initial position, or at least partially. This may prove useful in examples where the operator desires a different length of the distal wire end to treat a specific length of vessel.

According to some examples, the method of exposing and enclosing a wire in a sheath includes at least partially enclosing the distal wire end (at step4208). Through extending the sheath, the operator may enclose the distal wire end once again, facilitating safe removal of the catheter from the patient. Again, as the sheath may only be partially extended about the wire, the distal wire end may be only partially enclosed by the sheath. If the sheath is extended all the way back to its initial position, the wire may be entirely enclosed once again.

FIG.43illustrates a flow chart depicting a method of limiting power flow to a motor, according to some examples. The method of limiting power flow to a motor may include allowing electricity to flow from a power supply to a motor (at step4300). In examples including a limit switch, the limit switch may be the component by which the electricity is either allowed to or prevented from flowing. As will be described in more detail inFIG.47, the limit switch may be controlled by some other property of the ablation system as a whole.

In some examples, the method of limiting power flow to a motor includes rotating the wire (at step4302). As explored inFIG.41, the rotation of the wire may be what causes the ablation (or agitation, or abrasion) of the vessel wall. The rotation of the motor may also be translated in the longitudinal movement of the wire, permitting a scratching effect rather than rotational ablation.

According to some examples, the method of limiting power flow to a motor includes preventing electricity to flow from the power supply to the motor (at step4304). As described in step4300, this may be accomplished through the use of a limit switch. The method of limiting power flow to a motor may include terminating a rotation of the wire (at step4306). Once electricity is no longer permitted to flow to the motor, any effects the motor has on the movement of the wire may stop.

FIG.44illustrates a flow chart depicting a method of gauging distances in a segmental treatment, according to some examples. In some examples, the method of gauging distances in a segmental treatment includes maintaining a longitudinal position of the catheter with respect to the first treatment segment (at step4400). As described inFIG.41, the catheter may be kept in place longitudinally within a vessel for a predetermined amount of time. In some examples, a shape of the distal wire end permits the entirety of a segment to be treated at once, thus the catheter does not need to be moved while such a segment is being treated. This may permit an operator to keep track of one less thing at a time, and free up one of the operator's hands to assist with other portions of the procedure.

According to some examples, the method of gauging distances in a segmental treatment includes moving the catheter out of the patient a distance approximately equal to a length from the first distance marking to the second distance marking (at step4402). These distance marking may be located on a shaft of the catheter. As the catheter is withdrawn from the body of the patient, subsequent distance markings may become visible, indicating to an operator how far the catheter as a whole has been removed from the patient. In some examples, the distance markings are separated by a distance approximately equal to the length of the treatment segment. In such examples, an operator pulling the catheter out from the body of the patient would be able to identify when the distal end of the catheter has been moved from one treatment segment to a subsequent treatment segment. This spacing of the distance markings would additionally make it unlikely that the operator would miss a portion of the vessel to be treated, as every treatment segment would be individually treated with minimal spacing, if any, between segments.

The method of gauging distances in a segmental treatment may include indicating that an end of a workable treatment length of the catheter has been reached (at step4404). A warning track, or similar, on the body of the catheter may indicate additional information to an operator. The warning track may be visually distinct from the distance markings of the prior paragraph in order to permit an operator to quickly discern the difference between the information being conveyed. Additionally, the warning track would likely reside on the catheter distal the distance markings. This is because, in some examples, the purpose of the warning track is to indicate that the operator is leaving the treatment area, i.e., the operator has reached the end of the catheter's workable treatment length. This may indicate to the operator that the treatment of the vessel, at least in this instant treatment, has been completed.

FIG.45illustrates a flow chart depicting a method of segmental mechanochemical ablation, according to some examples. According to some examples, the method of segmental mechanochemical ablation includes injecting a drug at the first treatment segment (at step4500). Similar to the disclosure ofFIG.41, this injection may occur for a predetermined amount of time. The predetermined amount of time may be the same as the amount of time mechanical ablation is performed, or different. Additionally, the injection may occur before, after, or during the mechanical ablation portion of treatment. For example, an operator may insert the catheter to the correct location for treatment, and then power the motor to begin abrading the vessel wall with a distal wire end for five seconds. After these five seconds have passed, the operator may begin depressing a plunger of the syringe to inject the drug into the treatment site. This may be performed over a period of time such that a specific rate of drug infusion is accomplished. During this injection, the distal wire end may continue to rotate and abrade the vessel wall. This injection and mechanical ablation may occur for approximately five seconds. Once the injection has been completed, the operator may permit the distal wire end to continue mechanically ablating the vessel wall for another ten seconds, which may drive the drug further into the damaged endothelium. It is understood that the times listed here are by example only, and different times may be used for different treatments.

The method of segmental mechanochemical ablation may include terminating an injection of the drug prior to moving the catheter to the second treatment segment (at step4502). For segmental mechanochemical ablation, the drug only needs to be injected while the catheter is placed within a treatment segment. This is dissimilar to mechanochemical ablation methods in the prior art, in which the drug must be constantly delivered while the catheter is retracted through the vasculature of the patient. Because the injection of the drug is terminated prior to moving the catheter from the first treatment segment to the second treatment segment, the operator does not need to focus their attention on the injection of the drug at the same time as the movement of the catheter. This may facilitate the elimination of human error when trying to measure two different rates—a rate of retraction and a rate of injection—at the same time.

In some examples, the method of segmental mechanochemical ablation includes injecting the drug at the second treatment segment (at step4504). This injection may also be for a predetermined amount of time, as described in step4500. However, the predetermined amount of time for the injection into the second treatment segment need not be the same length of time as the predetermined amount of time for the injection into the first treatment segment.

According to some examples, the method of segmental mechanochemical ablation includes removing the catheter from the vascular system of the patient (at step4506). Once a treatment has been completed, the operator may remove the device from the patient. The method of segmental mechanochemical ablation may include terminating the injection of the drug prior to removing the catheter from the vascular system of the patient (at step4508). After a final treatment segment has been treated, the operator may discontinue injecting any drug from the syringe through the catheter prior to removing the catheter from the patient.

FIG.46illustrates a flow chart depicting a method of tracking a catheter sheath separate from a wire, according to some examples. In some examples, the method of tracking a catheter sheath separate from a wire includes removably coupling a sheath to a body of a controller (at step4600). Removably coupling the sheath to the body of the controller may permit the sheath to be manipulated longitudinally distinct from the wire. According to some examples, the method of tracking a catheter sheath separate from a wire includes removing the sheath from the body (at step4602). Because the sheath is detachably coupled to the body of the controller in this example, the sheath may be detached, or removed, from the body while leaving a wire in place (still coupled in some way to the body of the controller).

The method of tracking a catheter sheath separate from a wire may include directing the sheath to a treatment area of a patient (at step4604). By detaching the sheath from the body of the controller while leaving the wire in place, the sheath can be delivered to a treatment site in advance of the wire. In examples where the profile of the wire is such that it affects the profile of the sheath while stored inside, even mildly, it may be desired to track the sheath to the treatment site without this addition to its crossing profile. Then, once the sheath is located at the correct position, the wire may be disposed through the sheath to also reach the treatment site.

FIG.47illustrates a flow chart depicting an additional method of limiting power flow to a motor, according to some examples. In some examples, the additional method of limiting power flow to a motor includes retracting a sheath about a wire (at step4700). This limiting feature may be performed by a limit switch, such as described in the method ofFIG.43. In such examples, the limit switch may be operatively coupled to the sheath, such that the limit switch only allows power to flow through (from the power supply, through the limit switch, to the motor) when the sheath is in a fully retracted position. In other examples, the limit switch permits power to flow from the power supply to the motor when the sheath is only partially retracted, thereby allowing for variable treatment lengths of the exposed 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 operate, either intentionally or unintentionally, when the wire is not exposed. This may facilitate safe delivery of the catheter to the treatment site without the concern of the wire rotating prematurely.

According to some examples, the additional method of limiting power flow to a motor includes exposing a distal wire end (at step4702). As described previously inFIG.42, once the sheath is retracted, a portion of the wire, in this example the distal wire end, may be exposed from the sheath, permitting the distal wire end to make contact with the walls of a vessel in treatments such as segmental mechanical ablation.

The additional method of limiting power flow to a motor may include allowing a motor to rotate (at step4704). Once the sheath is retracted, or at least partially retracted, the limit switch may allow the motor to receive power, and thus rotate. As discussed inFIGS.41and43above, the rotation of the wire, and thus the rotation of the distal wire end, may be what causes the ablation (or agitation, or abrasion) of the vessel wall. Once again, the rotation of the motor may also be translated in the longitudinal movement of the wire, permitting a scratching effect via the distal wire end, rather than rotational ablation.

In some examples, the additional method of limiting power flow to a motor includes extending the sheath about the wire (at step4706). By slidably moving the sheath opposite the direction of step4700, an operator may extend the sheath back about the wire. Again, this movement may include the sheath moving 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 about the wire. Aside from the already mentioned variable treatment length this provides, this may also impact the limit switch, thus preventing the motor from receiving any more power, as will be discussed in step4710.

According to some examples, the additional method of limiting power flow to a motor includes at least partially enclosing the distal wire end (at step4708). As discussed inFIG.42above, through extending the sheath, the operator may enclose the distal wire end once again, facilitating safe removal of the catheter from the patient. Again, as the sheath may only be partially extended about the wire, the distal wire end may be only partially enclosed by the sheath. If the sheath is extended all the way back to its initial position, the wire may be entirely enclosed once again. Additionally, as mentioned in step4706, this enclosing of the distal wire end may also influence a limit switch to prevent power from flowing to the motor.

The additional method of limiting power flow to a motor may include preventing the motor from rotating (at step4710). Once a 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, be it mechanical or chemical, from occurring so as not to damage healthy veins. Beyond simply turning the motor off, by tying the position of the sheath to a limit switch, the operator may not accidentally start the motor again during this retraction of the catheter from the patient's body. Once again, the limit switch may be adjusted to permit variable length treatment segments of the distal wire end by only preventing the motor from receiving power when the sheath is fully extended.

FIG.48illustrates a flow chart depicting a method of stabilizing a controller body, according to some examples. In some examples, the method of stabilizing a controller body includes changing a ratio of rotation between a motor and a catheter (at step4800). While not necessary for stabilizing a controller, in some instances, where the motor is placed beneath the T-fitting and/or saddle instead of behind, the controller may have a taller, but shorter in length body. In such examples, it may be necessary to increase the devices stability due to its now higher center of gravity. In placing the motor under the T-fitting and/or saddle, because the motor would no longer be in line with the insertion point of the catheter, a gear ratio may become necessary to convert the rotational movement of the motor to a rotational movement of the catheter. These gear ratios may also be used in controllers where the motor is behind the T-fitting and/or saddle, should a user of the device desire adjustable rotation options for the catheter.

According to some examples, the method of stabilizing a controller body includes expanding an expandable foot (at step4802). An expandable foot on the bottom of the body of the controller, perhaps webbed as shown inFIG.11, may be included in the ablation system. This expandable foot, when expanded, may lower the controller's center of gravity. This is particularly useful in example controllers like the one in the preceding paragraph where the placement of the motor gives the controller an inherent higher center of gravity, and the user wants this center of gravity to be lowered.

The method of stabilizing a controller body may include stabilizing a body of a controller (at step4804). By lowering the controller's center of gravity by expanding the expandable foot in step4802, the controller body gains stability. This lowers any chance of an operator accidentally tipping the controller over during a procedure.

FIG.49illustrates a flow chart depicting a method of using a controller with a sterile pack, according to some examples. In some examples, the method of using a controller with a sterile pack includes removing a catheter from a sterile pack (at step4900). In some examples, the controller and the catheter come packaged together in the sterile pack. The catheter would need to be removed, at least partially, from the sterile pack in order to be inserted into the body of a patient. In some examples, the catheter is packaged separately from the controller.

According to some examples, the method of using a controller with a sterile pack includes directing the catheter to a treatment site of a patient (at step4902). The catheter may be directed to the treatment site of the patient while coupled to the controller, or the catheter may be detachable, and an operator may choose to direct the catheter to the treatment site prior to coupling the catheter to the controller. The current disclosure also enables an operator to couple the catheter to the controller while the catheter is being delivered to the treatment site, should an operator wish to do so.

The method of using a controller with a sterile pack may include operating a controller from within the sterile pack (at step4904). A cavity, or recess, may exist in the sterile pack in which the controller resides while packaged. After removing the catheter from the sterile pack (in examples where the catheter and the controller are packaged in the same sterile pack), the controller may be kept inside the sterile pack. In this way, the controller may maintain its sterility during use. This may permit an operator to perform a treatment without necessitating a sterile drape. Additionally, this may cut down on the costs of procedures, because, while the catheter will still need to be either sterilized or disposed of, the controller need not be sterilized after every use as long as its environment is kept sterile.

In some examples, the method of using a controller with a sterile pack includes placing the catheter through a slit in the sterile pack (at step4906). The sterile pack may include a slit distal the controller (near the portion of the controller where the catheter would be inserted in order to couple to the controller). This slit could also be an aperture, or other cavity-type vacancy in the sterile pack through which the catheter could be inserted. In this way, the catheter may be coupled to the controller without necessitating the removal of the controller from the sterile pack, thereby maintaining the controller's sterility.

FIG.50illustrates a flow chart depicting a method of detachably coupling a catheter to a controller, according to some examples. According to some examples, the method of detachably coupling a catheter to a controller includes detachably coupling a catheter to a controller (at step5000). As previously described throughout the application, the catheter may be capable of being removed from the controller entirely, thereby providing a detachable coupling between the catheter and the controller. This is understood to not be strictly necessary, and example ablation systems may be provided with the catheter fixedly coupled to the controller.

The method of detachably coupling a catheter to a controller may include detaching a sheath from the controller (at step5002). In some examples, the catheter includes a sheath having a working lumen. In further examples, the sheath may be detachable from the controller. In such examples, the sheath may be tracked to a treatment site prior to being coupled to the controller. In examples where a wire is included through the working lumen of the sheath, the sheath may be detached from the controller and tracked to a treatment site separate from the wire, as described inFIG.46.

In some examples, the method of detachably coupling a catheter to a controller includes sterilizing the sheath separately from the controller (at step5004). According to some examples, the method of detachably coupling a catheter to a controller includes disposing of the sheath (at step5006). In example ablation systems where the sheath is detachable from the controller, the sheath may be sterilized while not connected to said controller. As described inFIG.49, this could help to cut down on sterilization costs. Additionally, the sheath may be disposed of entirely without having to dispose of the controller, meaning the controller could be reused a greater number of times than the catheter.

The method of detachably coupling a catheter to a controller may include detaching a wire from the controller (at step5008). In some example ablation systems, the catheter further includes a wire which is passed through the working lumen of a sheath. The catheter may also include a wire without a sheath, if desired. In either case, the wire may be tracked to a treatment site prior to being coupled to the controller (or motor, in example ablation systems including a motor for rotating the wire).

In some examples, the method of detachably coupling a catheter to a controller includes sterilizing the wire separately from the controller (at step5010). According to some examples, the method of detachably coupling a catheter to a controller includes disposing of the wire (at step5012). In example ablation systems where the wire is detachable from the controller, the wire may be sterilized while not connected to said controller. As also described inFIG.49, this could help to cut down on sterilization costs. Additionally, like the sheath of step5006, the wire may be disposed of entirely without having to dispose of the controller, meaning the controller could be reusable a greater number of times than the catheter.

Included in the present disclosure is an ablation system10, including a controller20. In some examples, the ablation system10includes a sheath40having a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the controller20and the distal sheath end is configured for insertion into a vascular system of a patient, the distal sheath end located opposite the proximal sheath end. The ablation system10may include a wire30extending from the controller20through the working lumen to the distal sheath end. In some examples, the wire30includes a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the distal wire end1204configured to engage a wall of a vessel in a treatment segment55.

According to some examples, the sheath40is retractable to expose the distal wire end1204. The distal wire end1204may be arranged and configured to define a compressed state when the distal wire end1204is located within the sheath40and an uncompressed state when the sheath40is retracted from the distal wire end1204. In some examples, the wire30is configured to be delivered to the treatment segment55in the compressed state. According to some examples, the sheath40is variably retractable to expose a length of the distal wire end1204. The length of the distal wire end1204may be configured to form a variable treatment length.

In some examples, the sheath40is detachably coupled to the controller20. According to some examples, the sheath40is configured to track to the treatment segment55while the wire30remains stationary. The ablation system10may further include a motor610and/or3308configured to provide rotational output, wherein the wire30is coupled to the motor610and/or3308.

In some examples, the sheath40includes an open distal end configured to deliver a drug to the treatment segment55. According to some examples, the sheath40further includes a lumen to deliver the drug to the treatment segment55. The sheath40may include an opening at the distal sheath end to deliver the drug to the treatment segment55. In some examples, the drug is sclerosant.

According to some examples, the sheath40includes a closed distal end and an opening at the distal sheath end to deliver a drug to the treatment segment55. The drug may be sclerosant.

In some examples, the distal wire end1204includes a sinusoidal configuration. According to some examples, the distal wire end1204includes a weighted tip1210. The weighted tip1210may be attached to a most distal end of the wire30. In some examples, the distal wire end1204defines a sinusoidal crossing-profile.

According to some examples, the sinusoidal configuration includes a non-uniform amplitude. The sheath40may include a closed distal end and a hole at the distal sheath end to deliver a drug to the treatment segment55. In some examples, the non-uniform amplitude is configured to cause a spraying effect of the drug.

According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The motor610and/or3308may be configured to provide rotational output. In some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. According to some examples, the sinusoidal configuration is configured to rotate in response to the rotational output of the motor610and/or3308.

The wire30may define a central axis1208. In some examples, the distal wire end1204includes a sinusoidal configuration. According to some examples, the distal wire end1204includes a weighted tip1210. The weighted tip1210may be centered on the central axis1208, the weighted tip1210configured to create a gyroscopic effect. In some examples, the weighted tip1210is off-center and lies parallel to the central axis1208. According to some examples, the weighted tip1210is configured to make contact with the wall of the vessel. The weighted tip1210may be off-center and lie at an angle to the central axis1208. In some examples, the weighted tip1210is configured to make contact with the wall of the vessel.

According to some examples, the wire30includes a thickness gradient to enable thicker sections of the distal wire end1204to have improved contact with the wall of the vessel. The wire30may have a circular cross-sectional profile1302. In some examples, the wire30has a flat bar cross-sectional profile1304. According to some examples, the wire30has a triangular cross-sectional profile1306.

The wire30may include a stranded cable1702. In some examples, the stranded cable1702defines a radius, and wherein the radius is adjustable. According to some examples, the stranded cable1702is configured to permit a high contact force on the wall of the vessel. The stranded cable1702may define a sinusoidal profile.

In some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. According to some examples, the motor610and/or3308is configured to provide rotational output. The proximal wire end1202may be rotationally coupled to the motor610and/or3308. In some examples, the stranded cable1702is configured to rotate in response to the rotational output of the motor610and/or3308.

In some examples, the wire30includes a helical hollow strand1802wire. According to some examples, the helical hollow strand1802wire is configured to deliver a drug to the treatment segment55. The drug may be sclerosant. In some examples, the drug is configured to weep through a coil of the helical hollow strand1802wire. According to some examples, the helical hollow strand1802wire defines a sinusoidal profile. The amplitude of the sinusoidal profile may be adjustable. In some examples, the ablation system10further includes a pull string coupled to a distal end of the helical hollow strand1802wire, the pull string configured to adjust the amplitude of the sinusoidal profile.

According to some examples, the helical hollow strand1802wire defines a first helical hollow strand1802wire, the wire30further including a second helical hollow strand1802wire. The second helical hollow strand1802wire may at least partially surround the first helical hollow strand1802wire. In some examples, the first helical hollow strand1802wire and the second helical hollow strand1802wire create an oscillating motion.

According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The motor610and/or3308may be configured to provide rotational output. In some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. According to some examples, the helical hollow strand1802wire is configured to rotate in response to the rotational output of the motor610and/or3308.

The helical hollow strand1802wire may be configured to lie flat while inside the sheath40. In some examples, the helical hollow strand1802wire is configured to expand when the sheath40is retracted.

According to some examples, the distal wire end1204includes a spring-like configuration. The distal wire end1204may define a spring-like crossing profile2402. In some examples, the spring-like configuration defines a sinusoidal profile.

According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The motor610and/or3308may be configured to provide rotational output. In some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. According to some examples, the spring-like configuration is configured to rotate in response to the rotational output of the motor610and/or3308.

The distal wire end1204may include a three-dimensional cross-sectional profile. In some examples, the three-dimensional cross-sectional profile is a sinusoidal configuration in two dimensions, the sinusoidal configuration defining a period. According to some examples, each period the sinusoidal configuration turns in a third dimension.

The sinusoidal configuration may further define a time segment that is a portion of a period. In some examples, each time segment the sinusoidal configuration turns in a third dimension. According to some examples, each time segment is half the period.

The distal wire end1204may define a three-dimensional crossing-profile. In some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. According to some examples, the motor610and/or3308is configured to provide rotational output. The proximal wire end1202may be rotationally coupled to the motor610and/or3308. In some examples, the three-dimensional cross-sectional profile is configured to rotate in response to the rotational output of the motor610and/or3308.

According to some examples, the distal wire end1204includes a triangular sinusoidal profile1602. The triangular sinusoidal profile1602may include a triangular peak1604. In some examples, the triangular peak1604is configured to make contact with the wall of the vessel.

According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The motor610and/or3308may be configured to provide rotational output. In some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. According to some examples, the triangular sinusoidal profile1602is configured to rotate in response to the rotational output of the motor610and/or3308.

The distal wire end1204may include a basket-like shape. In some examples, the basket-like shape is configured to expand. According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The motor610and/or3308may be configured to provide rotational output. In some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. According to some examples, the basket-like shape is configured to rotate in response to the rotational output of the motor610and/or3308.

The wire30may be made from a material that is capable of being shape-set. In some examples, the wire30is made from Nitinol.

According to some examples, the wire30includes a lumen from the proximal wire end1202to the distal wire end1204. The wire30may further include an aperture1206at a most distal end of the wire30. In some examples, the lumen is configured to deliver a drug to the treatment segment55through the aperture1206. According to some examples, the drug is sclerosant. The wire30may include a hole at the distal wire end1204. In some examples, the lumen is configured to deliver a drug to the treatment segment55through the hole.

According to some examples, the ablation system10further includes a proximal feature2602proximal the distal wire end1204. The proximal feature2602may be configured to prevent blood from entering the treatment segment55. In some examples, the proximal feature2602is configured to prevent a drug from leaving the treatment segment55. According to some examples, the drug is sclerosant.

The proximal feature2602may be a balloon2604on the sheath40. In some examples, the balloon2604at least partially surrounds the sheath40. According to some examples, the balloon2604is an offset balloon2606. The offset balloon2606may be biased toward a side of the sheath40. In some examples, the offset balloon2606is configured to offload the wire30when the offset balloon2606is in an inflated state, thereby causing the wire30to contact the wall of the vessel more aggressively. According to some examples, the sheath40provides an inflation fluid to the balloon2604, the inflation fluid configured to expand the balloon2604.

The proximal feature2602may be a cage2608on the wire30. In some examples, the proximal feature2602is a grooved solid2610on the wire30. According to some examples, the proximal feature2602is an impeller2612on the wire30. The proximal feature2602may be a sponge-like solid2614at least partially surrounding the wire30. In some examples, the proximal feature2602is a sponge-like solid2614at least partially surrounding the sheath40.

According to some examples, the proximal feature2602is a sinusoidal urge2616in the wire30. The sinusoidal urge2616may be at least partially contained within the sheath40when the sheath40is retracted. In some examples, the sinusoidal urge2616is configured to offload the wire30, thereby causing the wire30to contact the wall of the vessel more aggressively.

According to some examples, the ablation system10further includes a distal feature2702proximal on a distal portion of the distal wire end1204. The distal feature2702may be configured to prevent blood from entering the treatment segment55. In some examples, the distal feature2702is configured to prevent a drug from leaving the treatment segment55.

According to some examples, the distal feature2702is single blade impeller2704on the wire30. The distal feature2702may be a cage2706on the wire30. In some examples, the distal feature2702is a grooved solid2708on the wire30. According to some examples, the distal feature2702is an impeller2710on the wire30. The distal feature2702may be a sponge-like solid2712at least partially surrounding the wire30.

In some examples, a distal most tip of the wire30is a hemispherical tip2802. According to some examples, the hemispherical tip2802is weighted. The hemispherical tip2802may be configured to make contact with the wall of the vessel.

In some examples, a distal most tip of the wire30is an offset weighted tip2804. According to some examples, the offset weighted tip2804is weighted. The offset weighted tip2804may be configured to make contact with the wall of the vessel.

In some examples, the wire30includes a lumen. According to some examples, a distal most tip of the wire30is a balloon tip2806. The lumen may be configured to provide an inflation fluid to the balloon tip2806, the inflation fluid configured to expand the balloon tip2806. In some examples, the balloon tip2806is configured to occlude the vessel when in an expanded state.

According to some examples, the ablation system10further includes a supplementary wire2902wrapped around at least a part of the distal wire end1204. The supplementary wire2902may be a heated wire2904. In some examples, the heated wire2904is configured to coerce the wire30into a predetermined shape in response to a temperature. According to some examples, the predetermined shape is a sinusoidal profile. The temperature may be a human body temperature.

In some examples, the supplementary wire2902is a hypotube. According to some examples, the hypotube is configured to deliver a drug to a treatment segment55. The drug may be sclerosant.

In some examples, at least a portion of the distal wire end1204includes a porous surface geometry2906. According to some examples, the porous surface geometry2906is configured to make aggressive contact with the wall of the vessel.

At least a portion of the distal wire end1204may include an additional geometry3002a,3002b,3002c, and/or3002d. In some examples, the additional geometry3002aincludes a rounded nub. According to some examples, the additional geometry3002bincludes a ball. The additional geometry3002cmay include a spike. In some examples, the additional geometry3002dincludes a brush. According to some examples, the additional geometry3002a,3002b,3002c, and/or3002dis configured to make aggressive contact with the wall of the vessel. The wire30may include a sinusoidal profile. In some examples, the sinusoidal profile defines a peak. According to some examples, the additional geometry3002a,3002b,3002c, and/or3002dis located on the peak.

The ablation system10may further include a donut3202at least partially surrounding the sheath40. In some examples, the donut3202is slidably coupled to the sheath40. According to some examples, the donut3202is sized such that it cannot enter an insertion point in the patient. The donut3202may be configured to keep the sheath40and the wire30in place during a treatment. In some examples, the donut3202is configured to indicate a distance to a deep venous system in the patient.

According to some examples, the ablation system10further includes at least one distance marking3204on the sheath40. The at least one distance marking3204may be configured to show a distance the sheath40is removed from the patient. In some examples, the at least one distance marking3204is configured to inform a user that a subsequent treatment segment55has been reached. According to some examples, a space between the at least one distance marking3204and a subsequent at least one distance marking3204is about the same as a length of the distal wire end1204. The distal wire end1204may define a treatment segment55. In some examples, the at least one distance marking3204at least partially surrounds the sheath40.

According to some examples, the ablation system10further includes a warning track3206on the sheath40. The warning track3206may be configured to inform a user that an end of a workable treatment length has been reached. In some examples, the warning track3206at least partially surrounds the sheath40.

Also included in the present disclosure is an ablation system10including a controller20. In some examples, the ablation system10includes a sheath40including a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the controller20and the distal sheath end is configured for insertion into a vascular system of a patient, the distal sheath end located opposite the proximal sheath end. The ablation system10may include a wire30extending from the controller20through the working lumen to the distal sheath end. In some examples, the wire30includes a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the distal wire end1204configured to engage a wall of a vessel in a treatment segment55.

According to some examples, the controller20includes a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. The controller20may further include an actuator506a,506b,608,914, and/or3304to activate the motor610and/or3308. In some examples, the motor610and/or3308is configured to provide rotational output. According to some examples, the proximal wire end1202is rotationally coupled to the motor610and/or3308. The motor610and/or3308may rotate the distal wire end1204at between about 1000 revolutions per minute (RPM) and about 4000 RPM. In some examples, the controller20includes a torque limiter and a clutch to stop a rotation of the wire30if a torque limit is exceeded.

According to some examples, the controller20is a handle. The handle may include a slot602and the proximal sheath end includes a inflation tuohy604that couples to the slot602. In some examples, retraction of the inflation tuohy604into the slot602retracts the sheath40and exposes the distal wire end1204. According to some examples, a flow path from the handle into the sheath40is established for injection of sclerosant at the treatment segment55.

The controller20may include a display508. In some examples, the display508is configured to show a timer. According to some examples, the timer is configured to countdown a time remaining in a treatment.

Also included in the present disclosure is an ablation system10, including a body702,802, and or902defining a proximal body end708,806, and/or906and a distal body end710,808, and/or908opposite the proximal body end708,806, and/or906. The ablation system10may include a saddle704slidably coupled to the body702,802, and or902whereby the saddle704moves along a first direction712,810, and or916extending from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. In some examples, the ablation system10includes a T-fitting706,804, and/or904slidably coupled to the body702,802, and or902and at least partially surrounded by a center portion of the saddle704, whereby the T-fitting706,804, and/or904moves along the first direction712,810, and or916in response to a movement of the saddle704.

According to some examples, the ablation system10further includes a syringe60configured to couple to the T-fitting706,804, and/or904. A component selected from the group consisting of the syringe60, the saddle704, and combinations thereof may be configured to control a movement of the T-fitting706,804, and/or904. In some examples, the syringe60is configured to insert into the T-fitting706,804, and/or904along a second direction that is at an angle to the first direction712,810, and or916. According to some examples, the angle is perpendicular.

The ablation system10may further include a syringe60configured to couple to the T-fitting706,804, and/or904. In some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. According to some examples, the ablation system10further includes a sheath40including a proximal sheath end, a distal sheath end opposite the proximal sheath end, and a working lumen therebetween. The proximal sheath end may be configured to couple to the distal body end710,808, and/or908. In some examples, the working lumen is in fluid communication with the syringe60.

According to some examples, the sheath40is configured to receive a wire30, the wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. Sliding the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906may retract the sheath40about the wire30, exposing the distal wire end1204. In some examples, sliding the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908extends the sheath40about the wire30, at least partially enclosing the distal wire end1204.

According to some examples, the sheath40is configured to receive a hypotube, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. Sliding the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906may retract the sheath40about the hypotube, exposing the distal hypotube end. In some examples, sliding the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908extends the sheath40about the hypotube, at least partially enclosing the distal hypotube end.

According to some examples, the sheath40is configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. Sliding the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906may retract the sheath40about the catheter shaft, exposing the distal catheter shaft end. In some examples, sliding the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908extends the sheath40about the catheter shaft, at least partially enclosing the distal catheter shaft end.

According to some examples, the T-fitting706,804, and/or904includes a luer hub3102. The ablation system10may further include a syringe60configured to couple to the T-fitting706,804, and/or904. In some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. According to some examples, the luer hub3102includes a luer3104, the luer3104configured to detachably couple the syringe60to the T-fitting706,804, and/or904. The luer3104may be configured to rotate approximately 180 degrees about the first direction712,810, and or916. In some examples, the syringe60is configured to control a rotation of the luer3104.

According to some examples, the ablation system10further includes a catheter15having a proximal catheter end and a distal catheter end opposite the proximal catheter end. The proximal catheter end may be configured to couple to the distal body end710,808, and/or908. In some examples, the catheter15is in fluid communication with the syringe60. According to some examples, the luer3104is configured to provide a torque on the catheter15. The torque may be configured to control a direction of travel of the distal catheter end.

In some examples, the ablation system10further includes a sheath40including a proximal sheath end and a distal sheath end opposite the proximal sheath end. According to some examples, the proximal sheath end is configured to removably couple to the luer hub3102. The sheath40may be in fluid communication with the syringe60. In some examples, the luer3104is configured to provide a torque on the sheath40. According to some examples, the torque is configured to control a direction of travel of the distal sheath end.

The sheath40may further include a working lumen. In some examples, the ablation system10further includes a wire30extending from the body702,802, and or902through the working lumen to the distal sheath end, the wire30having a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. According to some examples, the distal wire end1204is configured to engage a wall of a vessel in a treatment segment55.

The ablation system10may further include a torque knob1104rotatably coupled to the body702,802, and or902. In some examples, the torque knob1104is located on the proximal body end708,806, and/or906.

According to some examples, the ablation system10further includes a syringe60configured to couple to the T-fitting706,804, and/or904. A component selected from the group consisting of the syringe60, the saddle704, and combinations thereof may be configured to control a movement of the T-fitting706,804, and/or904. In some examples, the ablation system10further includes a catheter15having a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is configured to couple to the distal body end710,808, and/or908. The catheter15may be in fluid communication with the syringe60.

In some examples, the torque knob1104is configured to provide a torque on the catheter15. According to some examples, the torque is configured to control a direction of travel of the distal catheter end.

The ablation system10may further include a wire30, including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. In some examples, the proximal wire end1202is configured to couple to the distal body end710,808, and/or908. According to some examples, the torque knob1104is configured to provide a torque on the wire30. The torque may be configured to control a direction of travel of the distal wire end1204.

In some examples, the ablation system10further includes a motor610and/or3308at least partially enclosed within the body702,802, and or902. According to some examples, the motor610and/or3308is at least partially enclosed within the proximal body end708,806, and/or906. The ablation system10may further include an actuator506a,506b,608,914, and/or3304coupled to the body702,802, and or902and electronically coupled to the motor610and/or3308, the actuator506a,506b,608,914, and/or3304configured to power the motor610and/or3308on and off.

In some examples, the ablation system10further includes a wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. According to some examples, the proximal wire end1202is configured to couple to the motor610and/or3308. The motor610and/or3308may be configured to effectuate rotation to the wire30.

In some examples, the ablation system10further includes a hypotube, including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. According to some examples, the proximal hypotube end is configured to couple to the motor610and/or3308. The motor610and/or3308may be configured to effectuate rotation to the hypotube.

In some examples, the ablation system10further includes a catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. According to some examples, the proximal catheter shaft end configured to couple to the motor610and/or3308. The motor610and/or3308may be configured to effectuate rotation to the catheter shaft.

In some examples, the ablation system10further includes limit switch3306electronically coupled to the motor610and/or3308. According to some examples, the limit switch3306is configured to prevent the motor610and/or3308from rotating when the saddle704is positioned at a location other than the proximal body end708,806, and/or906. The limit switch3306may be configured to permit the motor610and/or3308to rotate when the saddle704is positioned at the proximal body end708,806, and/or906.

In some examples, the ablation system10further includes an LED912and/or3310electronically coupled to the motor610and/or3308. According to some examples, the LED912and/or3310is configured to power off when the saddle704is positioned at a location other than the proximal body end708,806, and/or906. The LED912and/or3310may be configured to power on when the saddle704is positioned at the proximal body end708,806, and/or906.

In some examples, the saddle704is at least partially inside of the body702,802, and or902. According to some examples, the saddle704includes a pull tab configured to facilitate movement of the saddle704. The T-fitting706,804, and/or904may be fixedly coupled to the saddle704.

In some examples, the ablation system10further includes a display508configured to indicate information. According to some examples, the display508is configured to show a timer. The timer may be configured to countdown a time remaining in a treatment. In some examples, the ablation system10further includes a catheter15coupled to the distal body end710,808, and/or908. According to some examples, the timer is configured to countdown a time until a treatment in a treatment segment55is completed and the catheter15is to be moved to a subsequent treatment segment55.

The ablation system10may further include a syringe60configured to couple to the T-fitting706,804, and/or904. In some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. According to some examples, the timer is configured to countdown a time until an operator should begin injecting a drug from the syringe60. The timer may be configured to countdown a time until the operator should discontinue injecting the drug from the syringe60.

In some examples, the ablation system10further includes an alarm configured to sound a noise at an end of a treatment. According to some examples, the ablation system10further includes a catheter15coupled to the distal body end710,808, and/or908. The ablation system10may further include an alarm configured to sound a noise when a treatment in a treatment segment55is completed and an operator is to move the catheter15to a subsequent treatment segment55.

In some examples, the ablation system10further includes a syringe60configured to couple to the T-fitting706,804, and/or904. According to some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. The ablation system10may further include an alarm configured to sound a noise when an operator should begin injecting a drug from the syringe60. In some examples, the alarm is configured to sound the noise when the operator should discontinue injecting the drug from the syringe60.

According to some examples, the ablation system10further includes an LED912and/or3310configured to turn on at an end of a treatment. The ablation system10may further include an LED912and/or3310configured to turn off at an end of a treatment. In some examples, the ablation system10further includes a catheter15coupled to the distal body end710,808, and/or908, and an LED912and/or3310configured to turn on when a treatment in a treatment segment55is completed and an operator is to move the catheter15to a subsequent treatment segment55. According to some examples, the ablation system10further includes a catheter15coupled to the distal body end710,808, and/or908, and an LED912and/or3310configured to turn off when a treatment in a treatment segment55is completed and an operator is to move the catheter15to a subsequent treatment segment55.

The ablation system10may further include a syringe60configured to couple to the T-fitting706,804, and/or904. In some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. According to some examples, the ablation system10further includes an LED912and/or3310configured to turn on when an operator should begin injecting a drug from the syringe60. The LED912and/or3310may be configured to turn off when the operator should discontinue injecting the drug from the syringe60.

In some examples, the ablation system10further includes a syringe60configured to couple to the T-fitting706,804, and/or904. According to some examples, a component selected from the group consisting of the syringe60, the saddle704, and combinations thereof is configured to control a movement of the T-fitting706,804, and/or904. The ablation system10may further include an LED912and/or3310configured to turn off when an operator should begin injecting a drug from the syringe60. In some examples, the LED912and/or3310is configured to turn on when the operator should discontinue injecting the drug from the syringe60.

According to some examples, the ablation system10further includes a motor610and/or3308located near a bottom of the body702,802, and or902. The ablation system10may further include a gear coupled to the motor610and/or3308. In some examples, the gear is configured to control an output rotation speed of the motor610and/or3308.

According to some examples, the ablation system10further includes an expandable foot1102on a base of the body702,802, and or902. The expandable foot1102may be configured to facilitate stability of the body702,802, and or902.

In some examples, the ablation system10further includes a catheter15, including a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is coupled to the distal body end710,808, and/or908. The ablation system10may further include an arm1106coupled to a side of the body702,802, and or902.

In some examples, when the distal catheter end travels in a direction opposite the first direction712,810, and or916, the arm1106is configured to maintain a distance between the catheter15and the body702,802, and or902. According to some examples, the distance between the catheter15and the body702,802, and or902is a radius. The arm1106may be configured to keep the catheter15in place during a treatment.

In some examples, the ablation system10further includes a catheter15, including a proximal catheter end and a distal catheter end opposite the proximal catheter end. According to some examples, the proximal catheter end is coupled to the distal body end710,808, and/or908. The ablation system10may further include a catheter clamp configured to keep the catheter15in place during a treatment.

In some examples, the ablation system10further includes a sheath40, including a working lumen, a proximal sheath end, and a distal sheath end. According to some examples, the proximal sheath end is coupled to the distal body end710,808, and/or908, and the distal sheath end is configured for insertion into a vascular system of a patient, the distal sheath end located opposite the proximal sheath end. The ablation system10may further include a wire30extending from the distal body end710,808, and/or908through the working lumen to the distal sheath end, the wire30having a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. In some examples, the distal wire end1204is configured to engage a wall of a vessel in a treatment segment55.

According to some examples, the sheath40is detachably coupled to the distal body end710,808, and/or908. The sheath40may be configured to track to the treatment segment55while the wire30remains stationary.

In some examples, the ablation system10further includes a sterile pack1002. According to some examples, the body702,802, and or902, the saddle704, the T-fitting706,804, and/or904, the sheath40, and the wire30are configured to fit within a cavity of the sterile pack1002. The sheath40and the wire30may be detachably coupled to the distal body end710,808, and/or908. In some examples, the sheath40and the wire30are configured to be sterilized separate from the body702,802, and or902. According to some examples, the sheath and the wire30are configured to be disposable. The ablation system10may be configured to be operated while in the sterile pack1002.

In some examples, the sterile pack1002includes a slit1004. According to some examples, the slit1004is configured to slidably receive the sheath40. The body702,802, and or902, the saddle704, and the T-fitting706,804, and/or904may be configured to sit within the cavity of the sterile pack1002during an operation. In some examples, the sheath40and the wire30are configured to slidably couple to the slit1004during an operation. According to some examples, the body702,802, and or902, the saddle704, and the T-fitting706,804, and/or904are configured to be reusable.

The ablation system10may further include a sterile pack1002, wherein the body702,802, and or902, the saddle704, and the T-fitting706,804, and/or904are configured to fit within a cavity of the sterile pack1002. In some examples, the ablation system10is configured to be operated while in the sterile pack1002.

Also included in the present disclosure is a method, including inserting a syringe60into a T-fitting706,804, and/or904of a saddle704of a body702,802, and or902. In some examples, the body702,802, and or902has a proximal body end708,806, and/or906and a distal body end710,808, and/or908. According to some examples, the saddle704is slidably coupled to the body702,802, and or902, whereby the saddle704moves along a first direction712,810, and or916. The first direction712,810, and or916may extend from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. In some examples, the T-fitting706,804, and/or904moves along the first direction712,810, and or916in response to movement of the saddle704. According to some examples, the syringe60is inserted into the T-fitting706,804, and/or904along a second direction that is perpendicular to the first direction712,810, and or916. The method may include directing a catheter15to a treatment site50of a patient.

In some examples, the catheter15includes a sheath40configured to receive a wire30, the wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. According to some examples, the method further includes sliding, via the saddle704, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. The method may further include retracting the sheath40about the wire30in response to sliding the T-fitting706,804, and/or904. In some examples, the method further includes exposing the distal wire end1204in response to retracting the sheath40.

According to some examples, the method further includes sliding, via the syringe60, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. The saddle704may include a pull tab. In some examples, the method further includes sliding, via the pull tab, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906.

According to some examples, the catheter15includes a sheath40configured to receive a wire30, the wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. The method may further include sliding, via the saddle704, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. In some examples, the method further includes extending the sheath40about the wire30in response to sliding the T-fitting706,804, and/or904. According to some examples, the method further includes at least partially enclosing the distal wire end1204in response to extending the sheath40.

The method may further include sliding, via the syringe60, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. In some examples, the saddle704includes a pull tab. According to some examples, the method further includes sliding, via the pull tab, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908.

The catheter15may include a sheath40configured to receive a hypotube, the hypotube including a proximal hypotube end a distal hypotube end opposite the proximal hypotube end. In some examples, the method further includes sliding, via the saddle704, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. According to some examples, the method further includes retracting the sheath40about the hypotube in response to sliding the T-fitting706,804, and/or904. The method may further include exposing the distal hypotube end in response to retracting the sheath40.

In some examples, the method further includes sliding, via the syringe60, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. According to some examples, the saddle704includes a pull tab. The method may further include sliding, via the pull tab, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906.

In some examples, the catheter15includes a sheath40configured to receive a hypotube, the hypotube including a proximal hypotube end a distal hypotube end oppo site the proximal hypotube end. According to some examples, the method further includes sliding, via the saddle704, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. The method may further include extending the sheath40about the hypotube in response to sliding the T-fitting706,804, and/or904. In some examples, the method further includes at least partially enclosing the distal hypotube end in response to extending the sheath40.

According to some examples, the method further includes sliding, via the syringe60, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. The saddle704may include a pull tab. In some examples, the method further includes sliding, via the pull tab, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908.

According to some examples, the catheter15includes a sheath40configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. The method may further include sliding, via the saddle704, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. In some examples, the method further includes retracting the sheath40about the catheter shaft in response to sliding the T-fitting706,804, and/or904. According to some examples, the method further includes exposing the distal catheter shaft end in response to retracting the sheath40.

The method may further include sliding, via the syringe60, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906. In some examples, the saddle704includes a pull tab. According to some examples, the method further includes sliding, via the pull tab, the T-fitting706,804, and/or904from the distal body end710,808, and/or908toward the proximal body end708,806, and/or906.

The catheter15may include a sheath40configured to receive a catheter shaft, the catheter shaft including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. In some examples, the method includes sliding, via the saddle704, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. According to some examples, the method further includes extending the sheath40about the catheter shaft in response to sliding the T-fitting706,804, and/or904. The method may further include at least partially enclosing the distal catheter shaft end in response to extending the sheath40.

In some examples, the method further includes sliding, via the syringe60, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908. According to some examples, the saddle704includes a pull tab. The method may further include sliding, via the pull tab, the T-fitting706,804, and/or904from the proximal body end708,806, and/or906toward the distal body end710,808, and/or908.

In some examples, the T-fitting706,804, and/or904further includes a luer3104configured to receive the syringe60. According to some examples, the method further includes inserting the syringe60into the luer3104. The luer3104may be configured to rotate approximately 180 degrees about the first direction712,810, and or916. In some examples, the method further includes rotating the syringe60and the luer3104. According to some examples, the method further includes providing torque to the catheter15in response to rotating the syringe60and the luer3104. The method may further include controlling a direction of travel of the distal catheter shaft end in response to providing torque to the catheter15.

In some examples, the luer3104includes a connection configured to removably couple a sheath40to the body702,802, and or902. According to some examples, the method further includes removably coupling the sheath40the body702,802, and or902. The method may further include removing the sheath40from the body702,802, and or902. In some examples, the method further includes directing the sheath40to the treatment site50of the patient.

According to some examples, a motor610and/or3308is at least partially enclosed within the body702,802, and or902. The catheter15may at least partially surround a wire30, including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. In some examples, the proximal wire end1202is configured to couple to the motor610and/or3308. According to some examples, the method further includes rotating, via the motor610and/or3308, the wire30.

An actuator506a,506b,608,914, and/or3304may be coupled to the body702,802, and or902and electronically coupled to the motor610and/or3308. In some examples, the method further includes interacting with the actuator506a,506b,608,914, and/or3304. According to some examples, the method further includes powering on the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304. The method may further include powering off the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304.

In some examples, a motor610and/or3308is at least partially enclosed within the body702,802, and or902. According to some examples, the catheter15at least partially surrounds a hypotube, including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. The proximal hypotube end may be configured to couple to the motor610and/or3308. In some examples, the method further includes rotating, via the motor610and/or3308, the hypotube.

According to some examples, an actuator506a,506b,608,914, and/or3304is coupled to the body702,802, and or902and electronically coupled to the motor610and/or3308. The method may further include interacting with the actuator506a,506b,608,914, and/or3304. In some examples, the method further includes powering on the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304. According to some examples, the method further includes powering off the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304.

A motor610and/or3308may be at least partially enclosed within the body702,802, and or902. In some examples, the catheter15at least partially surrounds a catheter shaft, including a proximal catheter shaft end and a distal catheter shaft end opposite the proximal catheter shaft end. According to some examples, the proximal catheter shaft end is configured to couple to the motor610and/or3308. The method may further include rotating, via the motor610and/or3308, the catheter shaft.

In some examples, an actuator506a,506b,608,914, and/or3304is coupled to the body702,802, and or902and electronically coupled to the motor610and/or3308. According to some examples, the method further includes interacting with the actuator506a,506b,608,914, and/or3304. The method may further include powering on the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304. In some examples, the method further includes powering off the motor610and/or3308in response to interacting with the actuator506a,506b,608,914, and/or3304.

According to some examples, the syringe60includes a syringe body and a plunger. The method may further include depressing the plunger of the syringe60. In some examples, the method further includes releasing a fluid through the catheter15in response to depressing the plunger.

Also included in the present disclosure is a method, including directing a wire30to a treatment site50of a patient. In some examples, the wire30includes a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. According to some examples, the wire30is coupled to a motor610and/or3308that is at least partially enclosed by a body702,802, and or902. The method may include powering the motor610and/or3308. According to some examples, the method includes rotating the wire30in response to powering the motor610and/or3308.

The method may further include extending the wire30through a sheath40coupled to the body702,802, and or902. In some examples, the method includes detachably coupling the sheath40to the body702,802, and or902. According to some examples, the method further includes directing the sheath40to the treatment site50of the patient while the sheath40is detached from the body702,802, and or902.

The method may further include retracting the sheath40about the wire30. In some examples, the method further includes exposing the distal wire end1204in response to retracting the sheath40. According to some examples, a limit switch3306is electronically coupled to the motor610and/or3308. The method may further include allowing the motor610and/or3308to rotate in response to retracting the sheath40about the wire30.

In some examples, the body702,802, and or902includes a proximal body end708,806, and/or906and a distal body end710,808, and/or908. According to some examples, a saddle704is slidably coupled to the body702,802, and or902whereby the saddle704moves along a first direction712,810, and or916. The first direction712,810, and or916may extend from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. In some examples, the method further includes sliding the saddle704from the distal body end710,808, and/or908to the proximal body end708,806, and/or906. According to some examples, retracting the sheath40about the wire30occurs in response to sliding the saddle704from the distal body end710,808, and/or908to the proximal body end708,806, and/or906.

The saddle704may include a T-fitting706,804, and/or904. In some examples, the method further includes sliding the T-fitting706,804, and/or904from the distal body end710,808, and/or908to the proximal body end708,806, and/or906. According to some examples, the T-fitting706,804, and/or904includes a luer3104. The method may further include inserting a syringe60into the luer3104. In some examples, the method further includes sliding the syringe60from the distal body end710,808, and/or908to the proximal body end708,806, and/or906.

According to some examples, the syringe60includes a syringe body and a plunger. The method may further include depressing the plunger of the syringe60. In some examples, the method further includes releasing a fluid through the sheath40in response to depressing the plunger. According to some examples, the wire30includes a lumen. The method may further include releasing a fluid through the wire30in response to depressing the plunger.

In some examples, the saddle704includes a pull tab. According to some examples, the method further includes sliding the pull tab from the distal body end710,808, and/or908to the proximal body end708,806, and/or906. The method may further include partially retracting the sheath40about the wire30. In some examples, the method further includes partially exposing the distal wire end1204in response to partially retracting the sheath40about the wire30.

According to some examples, the method further includes extending the sheath40about the wire30. The method may further include at least partially enclosing the distal wire end1204in response to extending the sheath40. In some examples, a limit switch3306is electronically coupled to the motor610and/or3308. According to some examples, the method further includes preventing the motor610and/or3308from rotating in response to extending the sheath40about the wire30.

The body702,802, and or902may include a proximal body end708,806, and/or906and a distal body end710,808, and/or908. In some examples, a saddle704is slidably coupled to the body702,802, and or902whereby the saddle704moves along a first direction712,810, and or916. According to some examples, the first direction712,810, and or916extends from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. The method may further include sliding the saddle704from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. In some examples, extending the sheath40about the wire30occurs in response to sliding the saddle704from the proximal body end708,806, and/or906to the distal body end710,808, and/or908.

According to some examples, the saddle704includes a T-fitting706,804, and/or904. The method further includes sliding the T-fitting706,804, and/or904from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. In some examples, the T-fitting706,804, and/or904includes a luer3104. According to some examples, the method further includes inserting a syringe60into the luer3104. The method may further include sliding the syringe60from the proximal body end708,806, and/or906to the distal body end710,808, and/or908.

In some examples, the syringe60includes a syringe body and a plunger. According to some examples, the method further includes depressing the plunger of the syringe60. The method may further include releasing a fluid through the sheath40in response to depressing the plunger. In some examples, the wire30includes a lumen. According to some examples, the method further includes releasing a fluid through the wire30in response to depressing the plunger.

The saddle704may include a pull tab. In some examples, the method further includes sliding the pull tab from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. According to some examples, the method further includes partially extending the sheath40about the wire30. The method may further include at least partially enclosing the distal wire end1204in response to partially extending the sheath40about the wire30.

In some examples, the body702,802, and or902includes a torque knob1104. According to some examples, the method further includes providing torque to the wire30. The method may further include controlling a direction of travel of the distal wire end1204in response to providing torque to the wire30.

In some examples, the motor610and/or3308is located near a bottom of the body702,802, and or902. According to some examples, the method further includes changing a ratio of rotation between the motor610and/or3308and the wire30via a gear.

The body702,802, and or902may include an expandable foot1102on a bottom of the body702,802, and or902. In some examples, the method further includes expanding the expandable foot1102. According to some examples, the method further includes stabilizing the body702,802, and or902in response to expanding the expandable foot1102.

Also included in the present disclosure is a method, including directing a hypotube to a treatment site50of a patient, the hypotube including a proximal hypotube end and a distal hypotube end opposite the proximal hypotube end. In some examples, the hypotube is coupled to a motor610and/or3308that is at least partially enclosed by a body702,802, and or902. According to some examples, the method includes powering the motor610and/or3308. The method may include rotating the hypotube in response to powering the motor610and/or3308.

In some examples, the method further includes extending the hypotube through a catheter15coupled to the body702,802, and or902. According to some examples, the method further includes detachably coupling the catheter15to the body702,802, and or902. The method may further include directing the catheter15to the treatment site50of the patient while the catheter15is detached from the body702,802, and or902.

In some examples, the method further includes retracting the catheter15about the hypotube. According to some examples, the method further includes exposing the distal hypotube end in response to retracting the catheter15. A limit switch3306may be electronically coupled to the motor610and/or3308. In some examples, the method further includes allowing the motor610and/or3308to rotate in response to retracting the catheter15about the hypotube.

According to some examples, the body702,802, and or902includes a proximal body end708,806, and/or906and a distal body end710,808, and/or908. A saddle704may be slidably coupled to the body702,802, and or902whereby the saddle704moves along a first direction712,810, and or916. In some examples, the first direction712,810, and or916extends from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. According to some examples, the method further includes sliding the saddle704from the distal body end710,808, and/or908to the proximal body end708,806, and/or906. Retracting the catheter15about the hypotube may occur in response to sliding the saddle704from the distal body end710,808, and/or908to the proximal body end708,806, and/or906.

In some examples, the saddle704includes a T-fitting706,804, and/or904. According to some examples, the method further includes sliding the T-fitting706,804, and/or904from the distal body end710,808, and/or908to the proximal body end708,806, and/or906. The T-fitting706,804, and/or904may include a luer3104. In some examples, the method further includes inserting a syringe60into the luer3104. According to some examples, the method includes sliding the syringe60from the distal body end710,808, and/or908to the proximal body end708,806, and/or906.

The syringe60may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe60. According to some examples, the method further includes releasing a fluid through a lumen in the hypotube in response to depressing the plunger. The saddle704may include a pull tab. In some examples, the method further includes sliding the pull tab from the distal body end710,808, and/or908to the proximal body end708,806, and/or906.

According to some examples, the method includes partially retracting the catheter15about the hypotube. The method may include partially exposing the distal hypotube end in response to partially retracting the catheter15about the hypotube.

In some examples, the method further includes extending the catheter15about the hypotube. According to some examples, the method further includes at least partially enclosing the distal hypotube end in response to extending the catheter15. A limit switch3306may be electronically coupled to the motor610and/or3308. In some examples, the method further includes preventing the motor610and/or3308from rotating in response to extending the catheter15about the hypotube.

According to some examples, the body702,802, and or902includes a proximal body end708,806, and/or906and a distal body end710,808, and/or908. A saddle704may be slidably coupled to the body702,802, and or902whereby the saddle704moves along a first direction712,810, and or916. In some examples, the first direction712,810, and or916extends from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. According to some examples, the method further includes sliding the saddle704from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. Extending the catheter15about the hypotube may occur in response to sliding the saddle704from the proximal body end708,806, and/or906to the distal body end710,808, and/or908.

In some examples, the saddle704includes a T-fitting706,804, and/or904. According to some examples, the method further includes sliding the T-fitting706,804, and/or904from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. The T-fitting706,804, and/or904may include a luer3104. In some examples, the method further includes inserting a syringe60into the luer3104. According to some examples, the method further includes sliding the syringe60from the proximal body end708,806, and/or906to the distal body end710,808, and/or908.

The syringe60may include a syringe body and a plunger. In some examples, the method further includes depressing the plunger of the syringe60. According to some examples, the method further includes releasing a fluid through a lumen in the hypotube in response to depressing the plunger.

The saddle704may include a pull tab. In some examples, the method further includes sliding the pull tab from the proximal body end708,806, and/or906to the distal body end710,808, and/or908. According to some examples, the method further includes partially extending the catheter15about the hypotube. The method may further include at least partially enclosing the distal hypotube end in response to partially extending the catheter15about the hypotube.

In some examples, the body702,802, and or902includes a torque knob1104. According to some examples, the method further includes providing torque to the hypotube. The method may further include controlling a direction of travel of the distal hypotube end in response to providing torque to the hypotube.

In some examples, the motor610and/or3308is located near a bottom of the body702,802, and or902. According to some examples, the method further includes changing a ratio of rotation between the motor610and/or3308and the hypotube via a gear. The body702,802, and or902may include an expandable foot1102on a bottom of the body702,802, and or902. In some examples, the method further includes expanding the expandable foot1102. According to some examples, the method further includes stabilizing the body702,802, and or902in response to expanding the expandable foot1102.

Also included in the present disclosure is a method, including removing a catheter15from a sterile pack1002. In some examples, the method includes directing the catheter15to a treatment site50of a patient. According to some examples, the method includes operating a controller20from within the sterile pack1002. The catheter15may be coupled to the controller20.

In some examples, the method further includes detachably coupling the catheter15to the controller20. According to some examples, the sterile pack1002includes a slit1004. The method may further include placing the catheter15through the slit1004in the sterile pack1002.

In some examples, the method further includes removing the catheter15from the treatment site50of the patient. According to some examples, the catheter15includes a sheath40and a wire30. The method may further include disposing of the sheath40. In some examples, the method further includes disposing of the wire30.

According to some examples, the catheter15includes a sheath40and a wire30. The method may further include detaching the sheath40from the controller20. In some examples, the method further includes sterilizing the sheath40separately from the controller20. According to some examples, the method further includes detaching the wire30from the controller20. The method may further include sterilizing the wire30separately from the controller20.

Also included in the present disclosure is an ablation system10, including a controller20. In some examples, the ablation system10includes a sheath40including an open proximal sheath end, an open distal sheath end, and a working lumen extending from the open proximal sheath end to the open distal sheath end. According to some examples, the open proximal sheath end is coupled to the controller20and the open distal sheath end is configured for insertion into a vascular system of a patient, the open distal sheath end located opposite the open proximal sheath end. The ablation system10may include a wire30extending from the controller20through the open proximal sheath end through the working lumen to the open distal sheath end. In some examples, the wire30has a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the distal wire end1204configured to mechanically treat a vessel wall of a treatment segment55, whereby a length of the distal wire end1204defines a length of the treatment segment55. Mechanically treating should be interpreted as equivalent to any term defining a type of disruption, including but not limited to abrading, ablating, disrupting, agitating, modifying, etc.

According to some examples, the working lumen is configured to slidably receive the wire30and allow for a passage of a fluid about the wire30therethrough to chemically treat the treatment segment55. Chemically treating should be interpreted as equivalent to any term defining a treatment via chemicals, such as ablating, closing, denuding, etc. When the ablation system10receives a first input the distal wire end1204may mechanically treat the vessel wall. In some examples, when the ablation system10receives a second input, the ablation system10delivers the fluid into the treatment segment55. According to some examples, when the ablation system10receives a third input, the ablation system10delivers the fluid into a subsequent treatment segment55.

The sheath40may be retractable to expose the distal wire end1204. In some examples, the controller20includes a motor610and/or3308, a power supply606and/or3302configured to provide power to the motor610and/or3308, and a limit switch3306electrically coupled to the motor610and/or3308and the power supply606and/or3302. According to some examples, the limit switch3306allows electricity to flow from the power supply606and/or3302to the motor610and/or3308when the sheath40is fully retracted. The sheath40may be variably retractable to expose at least a portion of the length of the distal wire end1204. In some examples, the portion of the length of the distal wire end1204is configured to form a variable treatment length.

According to some examples, the sheath40is extendable to enclose at least a portion of the distal wire end1204. The controller20may include a motor610and/or3308, a power supply606and/or3302configured to provide power to the motor610and/or3308, and a limit switch3306electrically coupled to the motor610and/or3308and the power supply606and/or3302. In some examples, the limit switch3306prevents electricity from flowing from the power supply606and/or3302to the motor610and/or3308when the sheath40is at least partially extended.

According to some examples, the ablation system10further includes at least one distance marking3204located on the sheath40between the open proximal sheath end and the open distal sheath end. The at least one distance marking3204may be arranged and configured according to the length of the treatment segment55. In some examples, the ablation system10further includes a warning track3206located on the sheath40between the at least one distance marking3204and the open distal sheath end. According to some examples, the warning track3206is configured to indicate that an end of a workable treatment length has been reached.

The ablation system10may further include a slidable depth marker (i.e., the donut3202) at least partially surrounding the sheath40. In some examples, the slidable depth marker is slidably coupled to the sheath40. According to some examples, the slidable depth marker is sized and configured such that it cannot enter an insertion point in the patient. The slidable depth marker may be positioned and configured to maintain a position of the sheath40and the wire30during a treatment. In some examples, the slidable depth marker is positioned and configured along the sheath40to indicate a distance to a deep venous system in the patient.

According to some examples, the controller20includes an actuator506a,506b,608,914, and/or3304configured to receive the first input. The controller20may include a motor610and/or3308and a power supply606and/or3302configured to provide power to the motor610and/or3308. In some examples, the proximal wire end1202is operatively coupled to the motor610and/or3308. According to some examples, the motor610and/or3308is configured to rotate the wire30. The distal wire end1204may be configured to rotate in response to the motor610and/or3308rotating the wire30. In some examples, the ablation system10includes a syringe60fluidly coupled to the working lumen. According to some examples, the syringe is configured to receive the second input and the third input.

Also included in the present disclosure is a method, including inserting a catheter15into a vascular system of a patient. In some examples, the method includes moving the catheter15to a first treatment segment55. According to some examples, the method includes treating, via the catheter15, the first treatment segment55. The method may include moving the catheter15to a second treatment segment55. In some examples, the method includes treating, via the catheter15, the second treatment segment55.

According to some examples, the catheter15includes a sheath40having a working lumen and a wire30extending through the working lumen, the wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. The method may further include abrading, via the distal wire end1204, the first treatment segment55. In some examples, the method further includes moving the wire30to the second treatment segment55in response to moving the catheter15to the second treatment segment55. According to some examples, the method further includes abrading, via the distal wire end1204, the second treatment segment55.

The wire30may be electrically coupled to a motor610and/or3308. In some examples, the method further includes rotating, via the motor610and/or3308, the wire30. According to some examples, the method further includes abrading, via rotating the wire30, the first treatment segment55. The method may further include abrading, via rotating the wire30, the second treatment segment55.

In some examples, the method further includes retracting the sheath40about the wire30. According to some examples, the method further includes exposing the distal wire end1204in response to retracting the sheath40about the wire30.

The wire30may be electrically coupled to a motor610and/or3308. In some examples, a limit switch3306is electronically coupled to the motor610and/or3308. According to some examples, the method further includes permitting, via the limit switch3306, the motor610and/or3308to receive power in response to the sheath40being fully retracted. The method may further include providing, via the motor610and/or3308, rotational output to the wire30. In some examples, the method further includes rotating, via the rotational output, the wire30. According to some examples, the method further includes abrading, via rotating the wire30, the first treatment segment55. The method may further include abrading, via rotating the wire30, the second treatment segment55.

In some examples, the wire30is electrically coupled to a motor610and/or3308. According to some examples, an LED912and/or3310is electrically coupled to the motor610and/or3308. The method may further include powering the LED. In some examples, the method further includes indicating, via powering the LED, that the motor610and/or3308is receiving power.

According to some examples, the method further includes extending the sheath40about the wire30. The method may further include at least partially enclosing the distal wire end1204in response to retracting the sheath40about the wire30.

In some examples, the wire30is electrically coupled to a motor610and/or3308. According to some examples, a limit switch3306is electronically coupled to the motor610and/or3308. The method may further include preventing, via the limit switch3306, the motor610and/or3308from receiving power in response to the sheath40being at least partially extended. In some examples, the method further includes preventing the motor610and/or3308from providing rotational output. According to some examples, the method further includes preventing a rotation of the wire30in response to preventing the motor610and/or3308from providing rotational output.

An LED912and/or3310may be electrically coupled to the motor610and/or3308. In some examples, the method further includes preventing the LED912and/or3310from receiving power. According to some examples, the method further includes indicating, via preventing the LED912and/or3310from receiving power, that the motor610and/or3308is not receiving power.

A syringe60may be fluidly coupled to the catheter15. In some examples, the method further includes injecting a drug, via the syringe60, at the first treatment segment55. According to some examples, the method includes injecting a drug, via the syringe60, at the second treatment segment55. The method may further include preventing an injection of a drug while repositioning the catheter15to the second treatment segment55.

In some examples, the sheath40includes a first distance marking3204and a second distance marking3204. According to some examples, the method further includes pulling the catheter15out of the patient from the first distance marking3204to the second distance marking3204. The method may further include repositioning, via pulling the catheter15out of the patient, the distal wire end1204. In some examples, a distance from the first distance marking3204to the second distance marking3204is approximately equal to a treatment length of the distal wire end1204. According to some examples, the method further includes repositioning the distal wire end1204by the treatment length.

The catheter15may include a warning track3206. In some examples, the method further includes indicating, via the warning track3206, that an end of a workable treatment length of the catheter15has been reached. According to some examples, the catheter15includes a donut3202at least partially surrounding the catheter15. The method may further include indicating, via the donut3202, a distance to a deep venous system in the patient.

Also included in the present disclosure is a method, including determining a first treatment segment55and a second treatment segment55in a vascular system of a patient. In some examples, the method includes inserting a catheter15into the vascular system of the patient. According to some examples, the method includes positioning the catheter15at the first treatment segment55. The method may include injecting, via a syringe60, a fluid (such as saline, or a drug such as sclerosant) at the first treatment segment55. In some examples, the method includes repositioning the catheter15to the second treatment segment55. According to some examples, the method includes injecting, via the syringe60, the fluid at the second treatment segment55.

The method may further include preventing an injection of a fluid while repositioning of the catheter15to the second treatment segment55. In some examples, the catheter15includes a sheath40having a working lumen and a wire30extending through the working lumen, the wire30including a proximal wire end1202and a distal wire end1204opposite the proximal wire end1202. According to some examples, the method further includes abrading, via the distal wire end1204, the first treatment segment55. The method may further include repositioning the wire30to the second treatment segment55in response to repositioning the catheter15to the second treatment segment55. In some examples, the method further includes abrading, via the distal wire end1204, the second treatment segment55.

According to some examples, the wire30is electrically coupled to a motor610and/or3308. The method may further include rotating, via the motor610and/or3308, the wire30. In some examples, the method further includes abrading, via rotating the wire30, the first treatment segment55. According to some examples, the method further includes abrading, via rotating the wire30, the second treatment segment55.

The method may further include retracting the sheath40about the wire30. In some examples, the method further includes exposing the distal wire end1204in response to retracting the sheath40about the wire30.

According to some examples, the wire30is electrically coupled to a motor610and/or3308. A limit switch3306may be electronically coupled to the motor610and/or3308. In some examples, the method further includes permitting, via the limit switch3306, the motor610and/or3308to receive power in response to the sheath40being fully retracted. According to some examples, the method further includes providing, via the motor610and/or3308, rotational output to the wire30. The method may further include rotating, via the rotational output, the wire30. In some examples, the method further includes abrading, via rotating the wire30, the first treatment segment55. According to some examples, the method further includes abrading, via rotating the wire30, the second treatment segment55.

The wire30may be electrically coupled to a motor610and/or3308. In some examples, an LED912and/or3310is electrically coupled to the motor610and/or3308. According to some examples, the method further includes powering the LED. The method may further include indicating, via powering the LED, that the motor610and/or3308is receiving power.

In some examples, the method further includes extending the sheath40about the wire30. According to some examples, the method further includes at least partially enclosing the distal wire end1204in response to retracting the sheath40about the wire30.

The wire30may be electrically coupled to a motor610and/or3308. In some examples, a limit switch3306is electronically coupled to the motor610and/or3308. According to some examples, the method further includes preventing, via the limit switch3306, the motor610and/or3308from receiving power in response to the sheath40being at least partially extended. The method may further include preventing the motor610and/or3308from providing rotational output. In some examples, the method further includes preventing a rotation of the wire30in response to preventing the motor610and/or3308from providing rotational output.

According to some examples, an LED912and/or3310is electrically coupled to the motor610and/or3308. The method may further include preventing the LED912and/or3310from receiving power. In some examples, the method further includes indicating, via preventing the LED912and/or3310from receiving power, that the motor610and/or3308is not receiving power.

According to some examples, the sheath40includes a first distance marking3204and a second distance marking3204. The method may further include pulling the catheter15out of the patient from the first distance marking3204to the second distance marking3204. In some examples, the method further includes repositioning, via pulling the catheter15out of the patient, the distal wire end1204.

According to some examples, a distance from the first distance marking3204to the second distance marking3204is approximately equal to a treatment length of the distal wire end1204. The method may further include repositioning the distal wire end1204by the treatment length.

In some examples, the catheter15includes a warning track3206. According to some examples, the method further includes indicating, via the warning track3206, that an end of a workable treatment length of the catheter15has been reached.

The catheter15may include a donut3202at least partially surrounding the catheter15. In some examples, the method further includes indicating, via the donut3202, a distance to a deep venous system in the patient.

Also included in the present disclosure is a method, including inserting a catheter15into a vascular system of a patient. In some examples, the method includes moving the catheter15to a first treatment segment55. According to some examples, the method includes actuating a motor610and/or3308and rotating at least a portion of the catheter15in response to actuating the motor610and/or3308. The method may include abrading the first treatment segment55for a predetermined amount of time in response to rotating at least the portion of the catheter15. In some examples, the method includes moving the catheter15to a second treatment segment55. According to some examples, the method includes abrading the second treatment segment55for the predetermined amount of time in response to rotating at least the portion of the catheter15.

The method may further include indicating, via a component selected from the group consisting of an LED912and/or3310, a speaker, a display508, and combinations thereof, that the predetermined amount of time has elapsed. In some examples, the component is electrically coupled to a power supply606and/or3302that provides electricity to the motor610and/or3308.

According to some examples, the catheter15includes a sheath40including a working lumen and a wire30including proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the wire30extending through the working lumen. The method may further include retracting at least a portion of the sheath40from the wire30. In some examples, the method further includes exposing the distal wire end1204in response to retracting the portion of the sheath40from the wire30. According to some examples, the method further includes extending the sheath40about the wire30. The method may further include at least partially enclosing the distal wire end1204in response to extending the sheath40about the wire30.

In some examples, the wire30is operatively coupled to a motor610and/or3308, and a limit switch3306is electronically coupled to the motor610and/or3308. According to some examples, the method further includes allowing electricity to flow from a power supply606and/or3302to the motor610and/or3308, via the limit switch3306, in response to the sheath40being in a fully retracted state. The method may further include rotating the wire30in response to allowing electricity to flow from the power supply606and/or3302to the motor610and/or3308. In some examples, the method further includes preventing electricity to flow from the power supply606and/or3302to the motor610and/or3308, via the limit switch3306, in response to the sheath40being in a non-fully retracted state. According to some examples, the method further includes terminating a rotation of the wire30in response to preventing electricity to flow from the power supply606and/or3302to the motor610and/or3308.

The catheter15may include a sheath40having a working lumen, the sheath40including a first distance marking3204and a second distance marking3204, and a wire30including proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the wire30extending through the working lumen. In some examples, the catheter15includes a warning track3206. According to some examples, the method further includes maintaining a longitudinal position of the catheter15with respect to the first treatment segment55, wherein the longitudinal position is defined by a distal end of the catheter15with respect to the first treatment segment55. The method may further include moving the catheter15out of the patient a distance approximately equal to a length from the first distance marking3204to the second distance marking3204, wherein the length is approximately equal to a treatment length of the distal wire end1204. In some examples, the method further includes indicating, via the warning track3206, that an end of a workable treatment length of the catheter15has been reached.

According to some examples, the catheter15includes a sheath40including a working lumen, the sheath40including a first distance marking3204and a second distance marking3204, and a wire30including proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the wire30extending through the working lumen. The method may further include moving the catheter15out of the patient a distance approximately equal to a length from the first distance marking3204to the second distance marking3204, wherein the length is approximately equal to a treatment length of the distal wire end1204.

In some examples, the catheter15includes a warning track3206. According to some examples, the method further includes indicating, via the warning track3206, that an end of a workable treatment length of the catheter15has been reached.

A syringe60may be fluidly coupled to the catheter15. In some examples, the method further includes injecting a fluid, via the syringe60, at the first treatment segment55. According to some examples, the method further includes terminating an injection of the fluid prior to moving the catheter15to the second treatment segment55. The method may further include injecting the fluid, via the syringe60, at the second treatment segment55. In some examples, the method further includes removing the catheter15from the vascular system of the patient. According to some examples, the method further includes terminating the injection of the fluid prior to removing the catheter15from the vascular system of the patient.

The catheter15may include a sheath40including a working lumen and a wire30including proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the wire30extending through the working lumen. In some examples, the wire30is operatively coupled to a motor610and/or3308, and a limit switch3306is electronically coupled to the motor610and/or3308. According to some examples, the catheter15includes a sheath40including a working lumen, the sheath40including a first distance marking3204and a second distance marking3204, and a wire30including proximal wire end1202and a distal wire end1204opposite the proximal wire end1202, the wire30extending through the working lumen.

The catheter15may include a warning track3206. In some examples, the method further includes maintaining a longitudinal position of the catheter15with respect to the first treatment segment55, wherein the longitudinal position is defined by a distal end of the catheter15with respect to the first treatment segment55. According to some examples, the method further includes retracting at least a portion of the sheath40from the wire30. The method may further include exposing the distal wire end1204in response to retracting the portion of the sheath40from the wire30. In some examples, the method further includes allowing electricity to flow from a power supply606and/or3302to the motor610and/or3308, via the limit switch3306, in response to the sheath40being in a fully retracted state.

According to some examples, the method further includes actuating a motor610and/or3308and rotating at least a portion of the catheter15in response to actuating the motor610and/or3308. The method may further include rotating the wire30in response to allowing electricity to flow from the power supply606and/or3302to the motor610and/or3308. In some examples, the method further includes moving the catheter15out of the patient a distance approximately equal to a length from the first distance marking3204to the second distance marking3204, wherein the length is approximately equal to a treatment length of the distal wire end1204.

In some examples, the method further includes extending the sheath40about the wire30. According to some examples, the method further includes at least partially enclosing the distal wire end1204in response to extending the sheath40about the wire30. The method may further include preventing electricity to flow from the power supply606and/or3302to the motor610and/or3308, via the limit switch3306, in response to the sheath40being in a non-fully retracted state. In some examples, the method further includes terminating a rotation of the wire30in response to preventing electricity to flow from the power supply606and/or3302to the motor610and/or3308. According to some examples, the method further includes indicating, via the warning track3206, that an end of a workable treatment length of the catheter15has been reached.

None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic 1” may include embodiments that do not pertain to Topic 1, and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.

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

The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, parallel, or some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

Specifically, any of the various catheter components and features included in the ablation system10described herein and illustrated in the figures may be used independently of one another or may be combined in various ways in any of the examples disclosed herein.

Furthermore, some of the components listed herein use the same number from figure to figure, including but not limited to catheter15, controller20, wire30, sheath40, syringe60, proximal wire end1202, distal wire end1204, weighted tip1210, proximal feature2602, and distal feature2702. It should be appreciated these components use the same numbers solely for ease of reference and to facilitate comprehension for the reader. While these components may use the same numbers, differences may be present in these components as illustrated in the various figures in which they appear and as described in the specification herein.

The term “and/or” means that “and” applies to some embodiments and “or” applies to some embodiments. Thus, A, B, and/or C can be 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 can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term “and/or” is used to avoid unnecessary redundancy.