Device for dissecting a body cavity

Abstract

The device (1, 30, 40, 50, 60) for ablating veins includes a vein ablation head (3) operably attached to an elongated catheter member (2) and configured for transluminal delivery and deployment within a vein. The vein ablation head includes a helical coil (4) that is self-adjustable from a non-coiled delivery configuration suitable for transluminal delivery within the catheter member to a coiled deployed configuration having a diameter larger than the vein to be ablated, which circumferentially engages the vein lumen upon deployment. The helical coil has an abrasive surface configured to circumferentially ablate the vein lumen when the coil is moved axially along the body lumen in the coiled configuration. The helical coil may be a single helical coil element.

Description

[Technical Field]

[0001] The present invention relates to a device for ablating a body lumen, particularly a superficial vein. Methods for ablating a body lumen, particularly a superficial vein, and for treating varicose veins are also contemplated. [Background technology]

[0002] Varicose veins are dilated, tortuous veins with structural changes in the vessel wall, malfunctioning venous valves, reflux, and blood pooling. They form a subspecies of chronic venous disease (CVD). Patients experience symptoms ranging from heaviness, pain, and swelling to skin irritation, discoloration, and, in severe cases, ulceration. The cause of varicose veins is unknown, but genetic factors that weaken vein wall components and valves play a key role in their development.

[0003] Varicose veins most commonly occur in the superficial venous network of the lower extremities, but certain conditions can also affect the pelvic and esophageal veins. Superficial veins drain blood from the skin and subcutaneous tissues into the deep venous network, ultimately returning it to the heart. The main superficial vein is the great saphenous vein (GSV), which runs along the inside of the leg from the ankle to the groin. The small saphenous vein (SSV) runs along the back of the calf from the ankle to the knee. The GSV and SSV drain into the deep femoral veins at the junctions of the groin and posterior knee, respectively.

[0004] Veins contain valves that prevent backflow of blood by increasing the efficiency of leg muscle pumps. The valves are bicuspid, formed by folds of endothelium supported by connective tissue and smooth muscle. GSVs contain 10–20 valves, while SSVs typically contain 6–12 valves. Valve dysfunction results in backflow of blood in the opposite direction to the normal flow, which can be confirmed using Doppler ultrasound.

[0005] Veins have thin walls, in contrast to the thick, elastic walls of arteries. Veins are more flexible, allowing their lumen to change shape from a collapsed, low-pressure state to an expanded, distended one when venous pressure increases. The wall thickness of saphenous veins typically ranges from 200 to 700 micrometers (pm). Like arteries, the wall contains three main layers: the intima, media, and adventitia. However, unlike arteries, the layers differ in thickness and composition, resulting in a more flexible, less muscular vessel. The intimal layer contains a single layer of squamous epithelial cells known as the endothelium and several thin elastic fibers, collagen, and smooth muscle cells. Importantly, there is an acellular layer of polymers known as the glycocalyx, which coats the endothelial layer and protects it from shear forces. The glycocalyx is typically a uniformly distributed structure 0.5 to 3 pm thick, exceeding the thickness of the endothelial cells (0.2 pm). The medial layer consists of collagen, elastic fibers, and three layers of smooth muscle cells. The externa or adventitia is the thickest layer and contains dense collagen, sensory nerves and elastic fibers.

[0006] Blood clots, or thrombosis, can occur in both the deep and superficial venous networks. Superficial venous thrombi are usually self-contained due to low throughput and rarely propagate to the deep venous network. They are not dangerous to the patient and do not require treatment unless inflammation, known as thrombophlebitis, occurs. Thrombosis of the deep veins of the lower extremities, known as deep vein thrombosis (DVT), is clinically relevant because it can cause venous outflow obstruction, elevate venous pressure, and lead to edema in the lower extremities. Additionally, clots can travel (embolize) to the lungs, resulting in a potentially fatal condition known as pulmonary embolism (PE).

[0007] Varicose veins are the most common peripheral vascular disorder, affecting up to 40% of the adult population.[1] Risk factors include age, family history, obesity, occupations involving prolonged standing, and a sedentary lifestyle.

[0008] Treatment options range from conservative compression stockings to surgical procedures. Approximately 600,000 to 700,000 varicose vein treatment procedures are performed annually in the United States. In the United States, varicose vein treatment is transitioning from open surgery (including removal of the entire GSV) to minimally invasive thermal intravenous catheter-based techniques (including radiofrequency or laser energy). In some countries, including Germany and the United Kingdom, the majority of treatments are still performed by open vein stripping.

[0009] Generally, catheter-guided, minimally invasive, heat-based treatments are used today to treat superficial venous reflux. A significant limitation of the use of thermal energy is the need for multiple preparatory injections of large amounts of local anesthetic (tumescence) mixed with saline to distance the veins and protect the surrounding tissue from thermal damage. This is time-consuming for the physician and painful for the patient due to the multiple needle stick injections required into the leg. The space required between the skin and the vein for the tumescence injections also limits treatment when the veins are located near critical nerves (as in the case of below-the-knee vein treatment), close to the skin, or near ulcers in patients with advanced CVD (CEAP classifications 5 and 6).

[0010] Despite the use of tumescent anesthesia, thermal injury to surrounding nerves and skin can still occur. The rate of nerve injury leading to persistent paresthesia has been reported to be 0%–9%, ​​although the rate has been higher in studies of below-the-knee GSV or SSV ablation.

[0011] Thromboembolic events are the most serious complication of superficial venous reflux treatment. Real-world studies have reported rates of DVT and PE of 3% to 4% and 0.2% to 0.3%, respectively. [2] All currently used treatments have inherent limitations that may increase the risk of DVT and / or PE. It is important that new treatments for varicose veins aim to further reduce the risk of thromboembolic complications.

[0012] An inherent problem with current thermal treatments is the risk of endothermal heat-induced thrombosis (EHIT), which can lead to DVT and PE. This is thought to be due to forward conduction of thermal energy from the tip of the thermal ablation device into the deep venous system. Modern laser-tipped fibers deliver energy radially, reducing the risk of forward conduction. However, these techniques cannot prevent the diffusion of vapor bubbles to adjacent non-target locations, which is a possible mechanism of action for thermal ablation in addition to light absorption by tissue [3].

[0013] Newer non-thermal non-tumescent (NTNT) techniques for treating CVD have emerged over the past decade. These less painful NTNT techniques are more suitable for the clinic setting where approximately 90% of procedures are currently performed in the United States. Current NTNT techniques include chemical foam sclerotherapy, mechanochemical ablation (MOCA), and cyanoacrylate adhesive (CAG) embolization.

[0014] Chemical sclerotherapy (injection of chemical cleaning agents that destroy the endothelial cell membrane and result in venous occlusion through sclerosing) has been used for many years, but its effectiveness is significantly reduced in large veins due to dilution by blood components and inactivation of the sclerosing agent. Foaming the sclerosing agent with gas to form a microbubble emulsion is a new method that expels blood and allows the chemical to prolong contact with the endothelium. Despite this enhancement, its effectiveness remains significantly lower than that of thermal techniques due to incomplete coverage of the endothelium by the chemical sclerosing agent, as seen in previous histological studies. [4] Furthermore, the risk of DVT may increase because the foam propagates to the deep system, damaging the endothelium and causing DVT. High-concentration sclerosing agent-foam mixtures may be more effective but also increase the risk of DVT and systemic complications. Systemic complications of chemical sclerosing agents include transient ischemic attacks (TIA) and strokes due to the influx of the sclerosing agent compound into the arterial circulation through a small hole in the cardiac septum (patent foramen ovale). The teratogenicity of chemical sclerosing agents is also unknown, and their use in pregnant women is contraindicated.

[0015] MOCA is performed using a combination of chemical sclerosing agents and mechanical action from within the venous lumen to improve agent distribution and stimulate venous spasm, reducing venous diameter. Histological studies have shown limited mechanical effects on endothelial cell integrity [5]. Mid-term follow-up studies have demonstrated clinical efficacy, although at a level inferior to current thermal techniques. The distal end of current MOCA devices, which induces mechanical effects, can become caught or trapped in the venous wall or valve. This results in patient discomfort, bruising, and even inadvertent vein avulsion, as previously reported [6].

[0016] Glue embolization is performed by injecting a cyanoacrylate or similar compound, which causes an inflammatory response and venous occlusion. Limitations include the permanent placement of a foreign body within the venous lumen, the risk of subsequent allergic reactions, and the risk of emboli migrating into the deep venous system, which can lead to DVT or PE.

[0017] Venous leg ulcers represent a significant annual healthcare burden in the United States, accounting for $14 billion [7] and are currently managed primarily with compression bandaging. New data from the EVRA study [8] published in April 2018 provide Level I evidence supporting early endovenous treatment of varicose veins to increase the rate of ulcer healing in patients with CEAP Class VI disease (C6). Thermal methods are less suitable for patients with venous ulcers. The need for multiple injections of tumescent anesthesia lengthens the procedure in older patient populations, and the reduced skin integrity adjacent to the ulcer increases the risk of infection and hematoma formation. Additionally, when treating below-knee veins, where the treatment goal is often to prevent venous reflux near the ulcer bed, there is also an increased risk of paresthesia due to nerve injury [9].

[0018] Devices for treating blood vessels, including varicose veins, are described in the following documents: WO 2017 / 194698, U.S. Patent Application Publication No. 2016 / 030719, U.S. Patent Application Publication No. 2016 / 030068, U.S. Patent Application Publication No. 2016 / 030023, WO 2016 / 102930, U.S. Patent Application Publication No. 2011 / 046543, U.S. Patent Application Publication No. 2016 / 242790, JP 2016-034485, WO 2004 / 112569, U.S. Patent Application Publication No. 2017 / 056048, GB 2519057, and U.S. Patent No. 5,011,489.

[0019] U.S. Patent No. 6,402,745 discloses a spring electrode having a helical configuration that functions to electrically disrupt the lumen of a blood vessel. The electrode is housed within a catheter, and the distal end of the electrode passes through the end of the catheter and helically contacts the lumen of the blood vessel. This device only partially ablates the lumen of the blood vessel due to the contact area between the electrode and the lumen of the blood vessel.

[0020] WO 2014 / 140325 describes an implantable embolic bristle device capable of ablating blood vessels in the treatment of various indications, including varicose veins and hemorrhoids. The device includes a core wire having a plurality of bristles extending radially outward from the core wire, the bristles configured to engage the lumen of the blood vessel and ablate the blood vessel by brushing against the vessel lumen.

[0021] Large implantable devices are likely to cause patient discomfort in superficial veins, especially in the groin and knee. The use of bristles to abrade veins results in incomplete abrasion of the vein lumen. Multiple pointed and / or elongated components significantly increase the risk of snagging and perforation in the thin, flexible vein wall. [Prior art documents] [Patent documents]

[0022] [Patent Document 1] International Publication No. 2017 / 194698 [Patent Document 2] US Patent Application Publication No. 2016 / 030719 [Patent Document 3] US Patent Application Publication No. 2016 / 030068 [Patent Document 4] US Patent Application Publication No. 2016 / 030023 [Patent Document 5] International Publication No. 2016 / 102930 [Patent Document 6] US Patent Application Publication No. 2011 / 046543 [Patent Document 7] US Patent Application Publication No. 2016 / 242790 [Patent Document 8] Japanese Patent Application Laid-Open No. 2016-034485 [Patent Document 9] International Publication No. 2004 / 112569 [Patent Document 10] US Patent Application Publication No. 2017 / 056048 [Patent Document 11] GB Patent Application Publication No. 2519057 [Patent Document 12] U.S. Patent No. 5,011,489 [Patent Document 13] U.S. Patent No. 6,402,745 Summary of the Invention [Problem to be solved by the invention]

[0023] SUMMARY OF THE INVENTION An object of the present invention is to overcome at least one of the above problems. [Means for solving the problem]

[0024] The present invention addresses the need for a device for treating superficial venous reflux, providing best-in-class efficacy comparable to thermal options while avoiding the problems associated with prior art thermal therapy, chemotherapy, and adhesive implant treatment techniques. These objectives are achieved by providing a vein ablation device that includes a coil configured for transluminal delivery to the vein being treated during a procedure (non-implant), and deployment in which the coil circumferentially (ideally completely circumferentially) engages the vein lumen. The coil is an oversized coil (i.e., has a diameter larger than the vein being treated upon deployment) and has a roughened lumen-engaging surface such that upon deployment, the roughened surface presses against the vein lumen, and axial movement of the coil along the vein in the deployed configuration causes the abrasive surface to shear the vein lumen. This results in mechanical ablation of the vein along its length, typically resulting in disruption of the endothelial and medial layers of the vein, ideally ultimately leading to venous occlusion through the formation of a thrombus that undergoes fibrotic transformation without the presence of an intima within the vessel. Ideally, the endothelium is completely disrupted circumferentially. Leaving a small area intact can prevent clot formation and allow blood to continue flowing, leading to treatment failure, recanalization, and / or premature recurrence. Therefore, the device of the present invention includes a helical coil that is oversized relative to the diameter of the vein being treated to ensure circumferential engagement between the helical coil tuberosity and the venous lumen. Furthermore, the coil is self-adjusting (due to its resilient, deformable configuration) to allow continuous circumferential engagement while maintaining a radially outward force along veins or vessel segments with varying diameters and tortuous curves (Figure 59).

[0025] According to a first aspect of the present invention, there is provided an apparatus for ablating a body lumen, the apparatus comprising: a body lumen ablation head operably attached to an elongate catheter member, the body lumen ablation head configured for transluminal delivery and deployment within a body lumen, the body lumen ablation head including a coil adjustable from a non-coiled delivery configuration suitable for transluminal delivery within the catheter member, and a coiled deployed configuration circumferentially engaging the body lumen and having a diameter equal to or greater than the body lumen to be ablated, whereby the coil has an abrasive surface configured to ablate the body lumen when the helical coil is translated axially, with or without rotation, along the body lumen in the coiled configuration.

[0026] According to a second aspect of the present invention, there is provided a method of ablating a body lumen using an apparatus including a body lumen ablation head operably attached to an elongate catheter member and configured for transluminal delivery and deployment within a body lumen, the method comprising: Transluminally delivering a body lumen ablation head to a body lumen to be treated; and deploying the body lumen ablation head within the body lumen to be treated, the body lumen ablation head having an abrasive surface that circumferentially contacts the lumen of the body lumen upon deployment; moving a body lumen ablation head along the portion of the body lumen to be treated, the abrasive surface of the abrasive surface circumferentially contacting the body lumen, whereby the abrasive surface ablates the body lumen; recapturing the ablation head within the catheter member; and removing the device from the body lumen.

[0027] In one embodiment, the coil is a helical coil.

[0028] In one embodiment, the coil is "oversized" relative to the diameter of the body lumen being treated.

[0029] In one embodiment, the diameter of the coil (or the maximum diameter, in the case of a helical coil whose diameter varies along its length) is generally at least about 5% larger than the diameter of the body lumen to be treated (or, in the case of a body lumen whose diameter varies, at least about 5% larger than the diameter at the widest point of the body lumen), e.g., at least 10%, 15%, 20%, 25%, or 30% larger than the diameter of the body lumen to be treated, typically 5-30% larger. It is important that the coil be oversized along at least one turn of the coil, typically 1-2 turns.

[0030] In one embodiment, the device is configured to ablate the lumen of a vein.

[0031] In one embodiment, the coil is made of a shape memory material and is configured to assume a coiled configuration when deployed.

[0032] The helical coil is generally sufficiently resilient and deformable so that it can self-adjust to maintain a circumferential radial force against body lumen walls of varying diameters as it moves along the body lumen. In one embodiment, the helical coil is configured to reflexively self-adjust its diameter during axial movement along the treatment zone in response to varying vein diameters and varying axial forces while maintaining an outward radial force against the vein.

[0033] In its deployed state, the helical coil is oversized relative to the widest portion of the body lumen (i.e., the portion of the body lumen being treated), thereby exerting a radial force around the entire circumference of the body lumen along the length of the body lumen being treated, including its widest point.

[0034] A helical coil is typically sufficiently resilient and deformable to allow the coil to traverse tortuous bends within a body lumen while maintaining a radial force against the lumen along the bends.

[0035] The helical coil is typically sufficiently flexible and deformable to allow the coil to pass through a narrowing or blockage in a body lumen, such as a valve in a vein.

[0036] In one embodiment, the device includes an elongated control arm for a body lumen ablation head disposed within the catheter member.

[0037] Typically, the control arm is connected to the proximal end of the coil.

[0038] The control arm may be a hypotube, for example, a hypotube formed from stainless steel, a polymer, or another material.

[0039] In one embodiment, the coil has a single coil element.

[0040] In one embodiment, a single coil element has 1 to 5 turns, 1 to 4 turns, 1 to 3 turns, preferably 1 to 2 turns, and ideally about 1.5 to 1.7 turns in the deployed configuration.

[0041] In one embodiment, the diameter of the helical coil varies along its length.

[0042] In one embodiment, the diameter of the helical coil increases towards one end (ie, conical).

[0043] The increase in diameter may be from proximal to distal or from distal to proximal.

[0044] As used herein, the term "proximal" as applied to a helical coil means the end of the device closest to the point of introduction, and the term "distal" should be interpreted accordingly.

[0045] In one embodiment, the diameter of the helical coil increases towards the midpoint along the coil and then decreases.

[0046] In one embodiment, the coil distal end terminates at a point located along or adjacent to the longitudinal axis of the helical coil.

[0047] In one embodiment, the helical coil has a proximal portion of a first diameter, an intermediate portion of a reduced diameter relative to the proximal portion, and a distal portion of an increased diameter relative to the intermediate portion.

[0048] In one embodiment, the helical coil has proximal and distal helical coil portions and an intermediate connecting (transition) portion that is typically not helical and may be straight or curved.

[0049] In one embodiment, one of the proximal or distal helical coil portion is a right-handed helix and the other of the proximal or distal helical coil portion is a left-handed helix.

[0050] In one embodiment, the proximal helical coil portion is a right-handed helix and the distal helical coil portion is a left-handed helix.

[0051] In one embodiment, the distal helical coil portion is a right-handed helix and the proximal helical coil portion is a left-handed helix.

[0052] In one embodiment, the coil comprises a plurality of coil elements, for example 2, 3, 4, 5 or more coil elements, typically each coil element being helical.

[0053] The helical coils may be arranged in a double, triple or quadruple coil configuration.

[0054] Typically, the coil elements are coaxial.

[0055] Typically, each coil element has the same diameter when deployed.

[0056] Typically, each coil element has the same pitch when deployed. When in the deployed configuration, the multiple coil elements together provide circumferential engagement with the lumen of the body lumen. Thus, each coil element may be configured to engage only a portion of the circumference of the lumen in the deployed configuration, e.g., 90°-270°, 90°-180°, or 180°-270° of circumferential engagement with the body lumen.

[0057] The coil elements may be connected to the same control arm.

[0058] In one embodiment, the coil has two helical coil elements, for example a double helix.

[0059] Typically, each of the two helical coil elements has at least 0.5 turns when deployed, typically 0.5 to 1.0 turns, or 0.5 to 0.7 turns.

[0060] In one embodiment, the coil has three helical coil elements, for example a triple helix.

[0061] Typically, each of the three helical coil elements has at least 0.3 turns when deployed, typically 0.3 to 1.0 turns, or about 0.3 to 0.5 turns when deployed.

[0062] In one embodiment, the coil has four helical coil elements.

[0063] Typically, each of the four helical coil elements has at least 0.25 turns when deployed, and typically has about 0.25 to about 0.75 turns when deployed.

[0064] In one embodiment, multiple coil elements are connected together at their distal ends.

[0065] In one embodiment, the multiple coil elements are not connected at their distal ends.

[0066] In one embodiment, the coil or each coil element is helical and configured to have a pitch of about 0.5 to 1.5 times the coil diameter in the deployed coiled configuration.

[0067] In one embodiment, the coil or each coil element is helical and configured to have a pitch approximately equal to its diameter in the coiled configuration when deployed.

[0068] In one embodiment, one of the helical coil elements is axially spaced from another of the coil elements. Generally, in this embodiment, the control arms (typically the distal ends of the control arms) are bifurcated to provide distal control arms, each connected to one of the helical coils. However, the device may also include separate control arms for independent control of the two helical coils.

[0069] In embodiments of vein ablation heads having axially spaced helical coils, the control arms of the distal helical coil typically pass axially through the proximal helical coil (through one, more than one, or all of the coils that make up the proximal helical coil).

[0070] In one embodiment, the proximal helical coil has a maximum diameter that is larger (eg, 1.5 to 4 times larger) than the maximum diameter of the distal helical coil.

[0071] In another embodiment, the proximal helical coil has a maximum diameter that is smaller (eg, 1.5 to 4 times smaller) than the maximum diameter of the distal helical coil.

[0072] In one embodiment, the pitch of the proximal and distal coil elements is different.

[0073] In one embodiment, the thinner coil has a larger pitch.

[0074] In one embodiment, the distal helical coil and / or the proximal helical coil are conical.

[0075] In one embodiment, the distal and proximal helical coils are conical in shape.

[0076] Typically, the diameter of the helical coil increases in the proximal direction (ie, towards the entry point of the device).

[0077] In one embodiment, the or each coil is configured to have a diameter in the coiled configuration when deployed that is at least equal to or greater than the diameter of the vein to be treated.

[0078] In one embodiment, the or each helical coil is conical (ie, the diameter of the coil increases or decreases as it approaches the entry point, ie, proximal, of the device).

[0079] Typically, the diameter of the helical coil increases in the proximal direction.

[0080] In one embodiment, the coil has a profile selected from circular, elliptical, curved, convex, concave, T-shaped, inverted T-shaped, or any other shape.

[0081] In one embodiment, the coil has a flat inner surface and an outer surface that is curved, concave, convex, or shaped like an inverted T. Helical coils with these profiles are shown in Figures 34-41.

[0082] In one embodiment, the roughened surface of the coil or each coil element is formed by treating the surface of the coil, typically the outer surface of the coil facing the body lumen (and / or the side surface of the coil) to introduce surface roughness.

[0083] In one embodiment, the inner surface of the coil is not roughened and is ideally smooth, which facilitates retraction of the coil into the catheter member where the smooth surface of the coil contacts the mouth of the catheter.

[0084] In one embodiment, the surface roughness is created by mechanical abrasion, electrical abrasion, chemical abrasion, or abrasion by other means.

[0085] In one embodiment, the outer surface of the coil includes indentations configured to provide a roughened surface.

[0086] In one embodiment, the indentations are configured to provide teeth on the surface, hi one embodiment, the indentations are transverse indentations.

[0087] In one embodiment, the transverse indentations extend completely across the outer surface of the coil.

[0088] In one embodiment, the transverse indentations are located on each side of the outer surface (ie, if the outer surface of the coil is concave).

[0089] In one embodiment, the indentations are longitudinal and extend completely or at least partially along the length of the helical coil. The longitudinal indentations may be straight, curved, wavy, zigzag, diamond-shaped, or any configuration.

[0090] In one embodiment, the helical coil has an inverted T-profile with teeth coming from the legs of the inverted T-shape.

[0091] In one embodiment, the teeth have a profile selected from a triangle, a polygon, a diamond, or any other profile configured to scrape the endothelial layer of a body lumen.

[0092] In one embodiment, the coil includes transverse teeth.

[0093] In one embodiment, the coil has flat inner and outer surfaces and lateral teeth.

[0094] In one embodiment, the coil is formed from a flat wire having a diamond-textured and roughened outer surface and a smooth inner surface.

[0095] In one embodiment, the coil has grooves or holes that act as reservoirs for the therapeutic agent.

[0096] In one embodiment, the coil or each coil element includes a core wire, and the abrasive surface is formed by a second wire helically wound around the core wire to form a second coil.

[0097] In one embodiment, the second wire has a polygonal cross section.

[0098] In one embodiment, the second coil has a pitch of 1 to 5 mm.

[0099] In one embodiment, the pitch of the second coil is greater at its proximal end.

[0100] In one embodiment, the pitch of the second coil is smaller at its proximal end.

[0101] In one embodiment, the second coil is typically coupled to the core wire at multiple locations.

[0102] In one embodiment, the surface of the second wire is treated to introduce surface roughness.

[0103] In one embodiment, the helical coil has a proximal portion that is generally coaxial with the longitudinal axis of the helical coil.

[0104] In one embodiment, the helical coil has a distal portion that is generally coaxial with the longitudinal axis of the helical coil.

[0105] In one embodiment, a control arm for the body lumen ablation head is disposed within the catheter member. Typically, the control arm is connected to the proximal end of the coil. The control arm may be a hypotube, such as a hypotube formed from stainless steel, a polymer, or another material.

[0106] In one embodiment, the control arm is configured for axial movement to deploy the body lumen ablation head at a target location within the body and to retract the body lumen ablation head within the catheter member after treatment.

[0107] In one embodiment, the control arm is configured for rotational movement to rotate the body lumen ablation head within the body lumen.

[0108] In one embodiment, the device includes a distal control arm connected to the coil distal end and a proximal control arm connected to the coil proximal end, whereby relative axial movement of the distal and proximal arms affects coiling and uncoiling of the coil.

[0109] In one embodiment, the distal end of the coil includes an atraumatic head, such as a flexible material or a spherical ball.

[0110] In one embodiment, the device includes a handle operably connected to the proximal end of the catheter member and configured to control deployment and retraction of the coil. In one embodiment, the handle includes a control element configured for axial adjustment of one or more control arms, with or without rotation. In one embodiment, the handle includes a control element configured for rotational adjustment of one or more control arms.

[0111] In one embodiment, the device is configured to adjust between: a delivery configuration in which the helical coil is housed within a catheter member in an uncoiled configuration; a first body lumen ablation configuration in which, in use, the coil is deployed at a first axial position within the body lumen to be treated and compresses against the circumference of the body lumen; a second endocavation configuration in which the coil is deployed, in use, within the body lumen to be treated proximal to the first axial location and compresses against the circumference of the body lumen; and A retracted configuration in which the coil is housed within the catheter member.

[0112] The method of the present invention can be used for venous diseases, particularly superficial venous reflux, preferably varicose veins. The vein to be treated is generally a saphenous vein, typically the great saphenous vein (GSV) or the small saphenous vein (SSV). In one embodiment of the method of the present invention, the body lumen ablation head is moved proximally along the portion of the body lumen to be treated toward the access portion.

[0113] In one embodiment, the method includes treating a portion of a body lumen having a length of at least 2, 4, 6, 8, 10, 12, 14, 16, 18, or 20 cm.

[0114] In one embodiment, the method of the present invention is for completely occluding a body lumen, such as a vein or artery.

[0115] In one embodiment, the devices and methods of the present invention are for partially occluding a body lumen, such as a vein or artery. Accordingly, the devices and methods of the present invention can be used to treat conditions or indications characterized by dysregulated or undesirable blood volume or flow through a portion of the vascular system by partially occluding the portion of the vascular system using the devices of the present invention.

[0116] In other cases, the method of the present invention thickens the vein wall by inducing significant wall thickening, such as circumferential intimal hypertrophy. This effect "arterializes" the vein, making it more resilient to the effects of higher blood pressure and shear forces. This thickening effect should be self-limiting when the vein is continuously exposed to high shear forces and occurs in response to a single mechanical stimulus, as opposed to intimal thickening, which occurs uncontrollably when used as a conduit for the arterial system. Thus, the device and method of the present invention can be used to prepare a vein prior to grafting into the arterial circulation.

[0117] The body lumen may be, for example, the vascular system, such as arteries and veins.

[0118] In one embodiment, the method of the present invention is a method of treating varicose veins by ablating a portion of the superior rectal artery.

[0119] In one embodiment, the method of the present invention is a method of treating hemorrhoids by ablating a portion of a vein.

[0120] In one embodiment, the method of the present invention is a method of thrombus removal by ablating a portion of a vein or artery occluded by a thrombus.

[0121] In one embodiment, the method of the present invention is a preparatory process for priming a target area of ​​a body lumen (ie, a portion of the vasculature) prior to the placement of a medical device such as a valve or stent.

[0122] In one embodiment, the method of the present invention is a preparatory step to prime the target area of ​​the artery prior to grafting to reduce the risk of type 1 endoleak.

[0123] In one embodiment, the body lumen being ablated is an artery supplying a tumor, such as a solid tumor.

[0124] In one embodiment, the body lumen is the portal vein, which provides nutrients from the intestine to the liver. In one embodiment, the subject being treated has a liver disease, such as cancer, and the method is typically performed prior to liver resection.

[0125] In one embodiment, the body lumen to be treated is a blood vessel that forms part of an arteriovenous malformation.

[0126] In one embodiment, the body cavity being treated is a testicular vein. Accordingly, methods of treating a varicocele are also described.

[0127] In one embodiment, the body lumen being treated is a blood vessel supplying a uterine fibroid (ie, a uterine artery).

[0128] In one embodiment, the body lumen being treated is a portion of the gastrointestinal tract, such as the duodenum, jejunum, or ileum.

[0129] In one embodiment, the body lumen to be treated is the prostatic artery.

[0130] In one embodiment, the body lumen to be treated is a pelvic vein.

[0131] In one embodiment, the method of the present invention is used to treat a patent foramen ovale (PFO) by ablating the interface of the arterial septal flap involved in the PFO.

[0132] In one embodiment, the method of the present invention is used to treat patent ductus arteriosus by disrupting the mucosal layer of the ileocecal valve and ileum.

[0133] In one embodiment, the method of the present invention is used to treat small intestinal bacterial overgrowth by ablating the ductus arteriosus.

[0134] In one embodiment, the methods of the present invention are used to treat Barrett's esophagus by mechanically ablating or ablating cells (abnormal cells) in the lower esophagus.

[0135] In one embodiment of the method of the present invention, the method includes the step of delivering a liquid sclerosing agent to a body lumen distal to a catheter member.

[0136] In one embodiment of the method of the present invention, the method includes the step of delivering thermal energy to a body lumen by conduction through a lumen-engaging surface of a device.

[0137] In one embodiment of the method of the present invention, the method includes using an intravenous ultrasound (IVUS) probe attached to or incorporated into the ablation head element to determine the vascular response to the treatment.

[0138] In one embodiment of the method of the present invention, a therapeutic agent is coated on the exterior surface or embedded in grooves or pores of the device and delivered to the interior surface of the body lumen.

[0139] In one embodiment of the method of the present invention, the method uses a body lumen ablation device of the present invention.

[0140] In another aspect, the present invention provides a method of treating a blood vessel (or any body lumen) in a subject, the method comprising: advancing an apparatus distally to a treatment zone within a blood vessel, the apparatus including an elongate catheter having a lumen and a distal end, and a radially expandable treatment element disposed within the lumen and configured to move axially relative to the catheter; deploying a radially expandable treatment element projecting from the distal end of the catheter to extend radially and press circumferentially against the lumen at the distal end of the treatment zone; withdrawing the deployed radially expandable treatment element proximally along the treatment zone while circumferentially pressing against the vessel lumen to mechanically and circumferentially ablate the treatment zone of the vessel; retrieving the radially expandable therapeutic element into the lumen of the catheter; and withdrawing the device from the treated vessel.

[0141] In one embodiment, the blood vessel is a varicose vein, wherein the method is typically a method of treating a varicose vein by ablating the venous lumen to cause occlusion of the varicose vein.

[0142] In one embodiment, the step of mechanically circumferentially ablating a treatment zone of the blood vessel includes affecting circumferential exposure of the subendothelial surface of the blood vessel along the treatment zone.

[0143] In one embodiment, the radially expandable treatment element is self-adjustable from an undeployed delivery configuration suitable for transluminal delivery within a catheter and a radially deployed expanded configuration having a diameter greater than the blood vessel at the treatment zone.

[0144] In one embodiment, the radially expandable treatment element is elastically deformable, and during axial movement along the treatment zone, the radially expandable treatment element reflexively self-adjusts its diameter in response to varying vessel diameters and varying axial forces while maintaining an outward radial force on the vessel.

[0145] In one embodiment, the outer surface of the radially expandable treatment element that faces the vessel lumen has a roughened surface.

[0146] In one embodiment, the outer surface of the radially expandable treatment element that faces the vessel lumen has a roughened surface, the roughened surface including a macro-abrasive surface and a micro-abrasive surface.

[0147] In one embodiment, the blood vessel is a superficial vein, such as the great saphenous vein, the small saphenous vein, a perforator vein, or a tributary vein.

[0148] In one embodiment, the superficial blood vessel is a vein selected from the great saphenous vein and the small saphenous vein.

[0149] In one embodiment, the method is a method of treating superficial venous reflux in a subject, wherein the blood vessel is a superficial vein.

[0150] In one embodiment, the method is a method of treating varicose veins in a subject, wherein the veins being treated are varicose veins.

[0151] In one embodiment, the method results in occlusion of the treated blood vessel.

[0152] In one embodiment, the method narrows but does not occlude a blood vessel.

[0153] In one embodiment, the step of retracting the deployed radially expandable therapeutic element proximally along the treatment zone causes mechanical stretching, resulting in activation of intramural smooth muscle in the vessel wall, resulting in vasospasm along the treatment zone and, optionally, prevention of nitric oxide secretion from endothelial cells and subsequent prolongation of the vasospasm.

[0154] In one embodiment, the radially expandable therapeutic element is a coil.

[0155] In one embodiment, the radially expandable therapeutic element is a helical coil.

[0156] In one embodiment, the method is performed using an imaging modality such as ultrasound guidance.

[0157] In one embodiment, the method includes recapturing the treatment element within the catheter member, returning the treatment element to an undeployed state, allowing for repositioning and repeated deployment.

[0158] In one embodiment, the method includes deploying a temporary lumen occlusion element to stop blood flow in the high flow vessel during at least one step.

[0159] In another aspect, the present invention provides a method of treating superficial venous reflux in a superficial vein of a subject, comprising mechanically circumferentially ablating a treatment zone of the superficial vein.

[0160] In one embodiment, the treatment area of ​​the superficial vein that is circumferentially ablated has a length of 5 to 25 cm.

[0161] In one embodiment, the step of mechanically circumferentially ablating the treatment zone of the superficial vein includes affecting circumferential exposure of the subendothelial surface of the vessel along the treatment zone.

[0162] In one embodiment, the step of mechanically circumferentially ablating a treatment zone of a vein includes deploying a vein ablation device at a portion distal to the target segment of the superficial vein and circumferentially pressing the device against the venous lumen, and retracting the deployed vein ablation device proximally along the treatment zone while keeping the device circumferentially pressed against the venous lumen.

[0163] In one embodiment, the step of mechanically circumferentially ablating a treatment zone of the blood vessel includes affecting circumferential exposure of the subendothelial surface of the blood vessel along the treatment zone.

[0164] In one embodiment, the vein ablation device is self-adjustable from an undeployed delivery configuration suitable for transluminal delivery within a catheter and a radially deployed expanded configuration having a diameter larger than the blood vessel in the treatment zone.

[0165] In one embodiment, the vein ablation device is elastically deformable, and the radially expandable treatment element reflexively self-adjusts its diameter during axial movement along the treatment zone in response to varying vessel diameters and varying axial forces while maintaining an outward radial force on the vessel.

[0166] In one embodiment, the outer surface of the vein ablation device that faces the vessel lumen has a roughened surface.

[0167] In one embodiment, the exterior surface of the vein ablation device that faces the vessel lumen has a roughened surface, the roughened surface including a macro-abrasive surface and a micro-abrasive surface.

[0168] In one embodiment, the radially expandable therapeutic element is a coil, preferably a resiliently deformable coil.

[0169] In one embodiment, the radially expandable treatment element is a resiliently deformable helical coil.

[0170] In one embodiment, the method is performed under ultrasound guidance.

[0171] In one embodiment, the axial movement of the radially expandable therapeutic element (or helical coil) is controlled automatically or semi-automatically, independent of the operator.

[0172] In one embodiment, the device is configured to collect data for operator feedback or further interpretation by human, statistical, big data, or machine learning analysis. Accordingly, the device may incorporate one or more sensors configured to detect in vivo data, such as temperature, pressure, or electrical impedance of tissue or blood. The device may be configured to transmit the in vivo data wirelessly or along wires disposed within the catheter member. The device may be configured to transmit the data to a remote processor.

[0173] Other aspects and preferred embodiments of the present invention are defined and described in the other accompanying claims. [Brief explanation of the drawings]

[0174] [Figure 1] Diagram of the human vasculature in an axial plane showing the composition of a typical vein wall, including the inner layer (intima) of a vein with its associated endothelial and glycocalyx covering, the adjacent middle layer (tunica media), and the outer layer (tunica adventitia). Also included is the typical thickness (in micrometers) of an adult vein wall. [Figure 2] Histological axial cross-section of a goat vein 28 days after mechanical intravenous treatment in our animal study. The image highlights the importance of circumferential coverage in terms of endothelial cell destruction. This image was taken from a partially treated vein in our animal study. The upper right corner shows a thrombus attached to the vein wall, with inflammatory cells migrating from the outer layer into the thrombus, in the early stages of fibrotic transformation. The lower left corner shows intact endothelium. The thrombus fails to adhere or recanalizes due to the intact endothelium. Blood may flow within the channel, resulting in overall treatment failure in this area. [Figure 3] Histological axial cross-section of a goat vein 28 days after mechanical intravenous treatment in our animal study. Circumferential endothelial detachment and shearing occurred due to frictional forces between the superficial and deep layers. The lumen was filled with an adherent thrombus undergoing fibrotic changes, invaded by inflammatory cells, including collagen-forming fibroblasts. [Figure 4] 1 illustrates an apparatus for ablating a body lumen according to a first embodiment of the present invention. [Figure 5] FIG. 2 is a side view of the device of FIG. 1. [Figure 6] FIG. 2 is a perspective view of the device of FIG. 1. [Figure 7] FIG. 2 is a front view of the distal end of the device of FIG. 1. [Figure 8] 5 is a detailed view of a portion of the helical coil of the device of FIG. 4 showing the sawtooth surface formed by the second wire helically wound around the core wire. [Figure 9] FIG. 5 is a detailed view of the helical coil distal end of the device of FIG. 4, showing the larger pitch and spherical end hub of the second wire. [Figure 10] FIG. 5 is a detailed view of the proximal end of the helical coil of the device of FIG. 4, showing the helical coil attached to a steel hypotube mounted within a catheter member. [Figure 11] FIG. 5 is a detailed view of the proximal end of the helical coil of the device of FIG. 4, showing a second wire with a shorter pitch as it approaches the proximal end of the coil to aid in recapture. [Figure 12] 1 is a perspective view of a helical coil forming part of a device according to an alternative embodiment of the present invention, wherein the lumen-engaging surface of the second wire incorporates a series of helical indentations. [Figure 13] 5 is a side view of the device of FIG. 4 in a vein with the helical coil in a deployed configuration, showing how the overcoil is forced into circumferential engagement with the body lumen and how the radial force exerted by the overcoil deforms the vein. [Figure 14] FIG. 14 is a view similar to FIG. 13 showing how a smaller diameter coil is used for a smaller diameter vein. [Figure 15] FIG. 1 is a perspective view of the deployed device in an external view of a vein, illustrating how the radial force exerted by the deployed coils deforms the vein. [Figure 16] FIG. 10 is a detailed view of the helical coil polished surface engaging the venous lumen. [Figure 17]Figure 1 illustrates the procedure of endovenous mechanical ablation of a lower extremity vein to cause occlusion and prevent reflux in the treatment of superficial venous disease. The undeployed device within the outer catheter is shown near the saphenofemoral junction following ultrasound-guided navigation. [Figure 18] During treatment, the radially expandable coil is shown to induce vasospasm at the treatment site. [Figure 19] FIG. 10 illustrates recapture of the radially expandable element prior to catheter withdrawal. [Figure 20] 1 is a perspective view of an apparatus for ablating a body lumen in accordance with a further embodiment of the present invention; [Figure 21] FIG. 21 is an end view of the device of FIG. 20. [Figure 22] FIG. 21 is a side view of the device of FIG. 20 in a partially deployed configuration. [Figure 23] FIG. 21 is a side view of the device of FIG. 20 in a fully deployed configuration. [Figure 24] FIG. 21 is another side view of the device of FIG. 20 in a fully deployed configuration. [Figure 25] FIG. 10 illustrates an apparatus for ablating a body lumen, according to a further embodiment of the present invention, wherein the coil is comprised of two coaxial helical coil elements. [Figure 26] FIG. 26 is an end view of the device of FIG. 25. [Figure 27] FIG. 26 is a side view of the device of FIG. 25. [Figure 28] FIG. 10 illustrates an apparatus for ablating a body lumen, according to a further embodiment of the present invention, wherein the coil is made up of four coaxial helical coil elements. [Figure 29] FIG. 29 is an end view of the device of FIG. 28. [Figure 30] FIG. 29 is a side view of the device of FIG. 28. [Figure 31] FIG. 10 shows a device for ablating a body lumen according to a further embodiment of the present invention, wherein the coil is made up of four coaxial helical coil elements joined at their distal ends. [Figure 32] FIG. 32 is an end view of the device of FIG. 31. [Figure 33] FIG. 32 is a side view of the device of FIG. 31. [Figure 34A] 1 is a perspective view of a portion of a helical coil according to the present invention; [Figure 34B] FIG. 2 is a side view of a portion of a helical coil according to the present invention. [Figure 35A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 35B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 36A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 36B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 37A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 37B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 38A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 38B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 39A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 39B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 40A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 40B] FIG. 10 is a side view of a portion of a further helical coil according to the present invention. [Figure 41A] FIG. 10 is a perspective view of a portion of a further helical coil according to the present invention. [Figure 41B] FIG. 10 is an end view of a portion of a further helical coil according to the present invention. [Figure 42A] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 42B] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 43A] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 43B] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 44A] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 44B] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 45A] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 45B] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 46A] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 46B] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 47A] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 47B] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 48A] FIG. 10 is a side view of a further embodiment of a helical coil forming part of an apparatus according to the present invention. [Figure 48B] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 48C] 10 is a perspective view of a further embodiment of a helical coil forming part of a device according to the invention; FIG. [Figure 49A] FIG. 1 is a side view of a vein ablation head forming part of a device according to the present invention, having two axially spaced helical coils. [Figure 49B] 1 is a perspective view of a vein ablation head forming part of a device according to the invention, having two axially spaced helical coils. FIG. [Figure 50A] FIG. 10 is a side view of a vein ablation head forming part of a further apparatus according to the present invention, having two axially spaced helical coils. [Figure 50B] FIG. 10 is a perspective view of a vein ablation head forming part of a further device according to the invention, having two axially spaced helical coils. [Figure 51A] FIG. 10 is a perspective view of a vein ablation head forming part of a further device according to the invention, having two axially spaced helical coils. [Figure 52] (A) A diagram showing a small artery supplying a tumor. (B) An exploded view of a portion of an artery showing a device of the present invention being used to ablate a portion of the artery's lumen and occlude the artery by forming a thrombus. [Figure 53] (A) A diagram of a portal vein vessel. (B) An exploded view of a portion of a vessel showing a device of the present invention being used to ablate a portion of the arterial lumen and occlude the artery by forming a thrombus. [Figure 54] 1 shows a natural arteriovenous shunt segment of a blood vessel that joins a malformation, and a device according to the invention used to ablate the shunt segment in order to occlude the malformation shunt by thrombus formation. [Figure 55] 1 shows the left spermatic vein and varicocele surrounding the left testicle, and a device according to the invention used to ablate a portion of the left spermatic vein to cause occlusion of the vein by thrombus formation. FIG. [Figure 56A] 1A-1C illustrate how the helical coil forming part of the device of the present invention can self-adapt to changing vessel diameters and constrictions or stenoses within the vessel as it is pulled through the vessel: (A) A deployed helical coil in circumferential contact with the vessel lumen approaching the stenosis. [Figure 56B] 1A-1C illustrate how a helical coil forming part of a device of the present invention can self-adapt to changing vessel diameters and constrictions or stenoses within a vessel as it is pulled through the vessel. (A) The helical coil passing through the stenosis and maintaining circumferential contact with the vessel lumen just proximal to the stenosis. [Figure 56C] 1A-1C illustrate how a helical coil forming part of a device of the present invention can self-adapt to changing vessel diameters and constrictions or stenoses within a vessel as it is pulled through the vessel. (C) The helical coil moves proximal to the stenosis and self-adjusts to maintain circumferential contact with the vessel lumen. [Figure 57A] 1A-1C illustrate how a helical coil forming part of a device of the present invention can pass through a valve in a vein as it is pulled through a portion of the vein: (A) The deployed helical coil in circumferential contact with the lumen of the vein distal to the valve. [Figure 57B] 1A-1C illustrate how a helical coil forming part of a device of the present invention can pass through a valve in a vein as it is pulled through a portion of the vein: (A) The helical coil passing through the valve without getting caught; [Figure 57C] (C) The helical coil forming part of the device of the present invention can pass through a valve in a vein as it is pulled through a portion of the vein. (D) The helical coil moves proximal to the stenosis and self-adjusts to maintain circumferential contact with the lumen of the blood vessel. [Figure 58A] 1A-1C illustrate how the helical coil forming part of the device of the present invention can self-adjust to the diameter of the coil to pass through increasingly narrower sections of a vessel and maintain circumferential engagement with the vessel lumen: (A) A deployed helical coil in circumferential contact with a wider section of the vessel. [Figure 58B] 1A-1C illustrate how the helical coil forming part of the device of the present invention can self-adjust to the diameter of the coil to pass through increasingly narrower vessel segments and maintain circumferential engagement with the vessel lumen: (A) The deployed helical coil in circumferential contact with the narrowed portion of the vessel; [Figure 59A] 1A-1C illustrate how the helical coil forming part of the device of the present invention can self-adapt to different vessel diameters and traverse tortuous vessels: (A) A deployed helical coil in circumferential contact with the vessel lumen at a vessel stenosis. [Figure 59B]1A and 1B show how the helical coil forming part of the device of the present invention can self-adapt to different vessel diameters and traverse tortuous vessels: (A) A helical coil passing through a sharp turn in a vessel while maintaining circumferential contact with the vessel lumen. [Figure 59C] 1A-1C illustrate how the helical coil forming part of the device of the present invention can self-adapt to different vessel diameters and traverse tortuous vessels. (C) A helical coil passing through sharp turns in a larger diameter vessel while maintaining circumferential contact with the vessel lumen. [Figure 60A] 1A-1C illustrate how a helical coil forming part of a device of the present invention can self-adjust its diameter to maintain circumferential engagement with the lumen of a vessel as the vessel dynamically contracts or tapers to a narrower width due to vasospasm. (A) A helical coil deployed in circumferential contact with a vessel segment of length I and diameter D prior to vasospasm; cross section AA is an axial view of the helical wire in contact with the vessel wall under hoop force HF created by pressure from restraining force P. [Figure 60B] 1A-1C show how a helical coil forming part of a device of the invention can self-adjust its diameter to maintain circumferential engagement with the lumen of a vessel as the vessel dynamically contracts or tapers to a narrower width due to vasospasm. (B) A deployed helical coil in circumferential contact over an extended length L within a vessel constricted to diameter d during vasospasm. [Figure 61A] Figure 1 shows the evolution of the static force on the deployed coil as it comes under an axial force FA. (A) Before movement at the start of withdrawal in a vessel of diameter D, with a contact force FC on the outside of the coil and a vessel restraining force P. [Figure 61B] Figure 1 shows the change in static force on a deployed coil as it comes under an axial force FA. (A) Stretched to a length L in a narrowed vessel of diameter d. [Figure 61C](C) Change in static force on the deployed coil as it comes under axial force FA. (D) A significantly narrowed vessel of diameter e with the coil extended to S. There is a loss of vessel wall contact over the proximal portion of the coil to reduce static friction and allow atraumatic passage of the coil. [Figure 62A] 1A-1C illustrate how the device of the present invention can be used to treat vasculature with abnormally high blood volume or high blood flow, partially occluding the vessel and normalizing blood volume or flow: (A) shows the device of the present invention deployed within the artery and pulled proximally, and the pulmonary artery prior to treatment. [Figure 62B] 62A-62C illustrate how the device of the present invention can be used to treat vasculature with abnormally high blood volume or high blood flow, partially occluding the vessel and normalizing blood volume or flow. (B) shows the chronic changes in the pulmonary artery of FIG. 62A after treatment with the device of the present invention, with intimal thickening that partially occludes (stenoses) the artery to provide reduced blood volume and flow through the artery. [Figure 63] FIG. 1 is a perspective view of an embodiment of a typical blood vessel having a smooth inner surface with a diamond pattern and a flat wire with a roughened outer surface. [Figure 64] A perspective view of the device in a blood vessel. Close-up views of embodiments of the external texturing are shown below: (A) Macro-polished grooved surface perpendicular to the vein wall in the withdrawal direction; (B) Macro-polished surface parallel to the vein wall in the withdrawal direction; (C) Diamond configuration of the macro-polished surface. [Figure 65] FIG. 1 shows the tip of an intravenous cannula modified to accommodate a miniaturized helical coil in an undeployed state. [Figure 66] FIG. 66 illustrates the use of the modified cannula shown in FIG. 65 to access a target vein and deploy a helical coil following retraction of the outer sheath. [Figure 67] FIG. 66 illustrates access to superficial tributary veins of the lower extremities using the cannula device of FIG. 65. [Figure 68]Illustrates a method for deploying a miniaturized coil in a tributary vein: (A) Intravenous access is achieved with a guidewire and a sheath is inserted over the guidewire; (B) The sheath is advanced into the vein and the guidewire is removed; (C) The sheath is retracted, exposing the enclosed helical abrasive coil element; (D) The sheath and coil are retracted together to treat the venous segment. [Figure 69] FIG. 69 shows the sheath used in FIG. 68, holding an undeployed helical coil around its inner periphery to accommodate the passage of a guidewire. [Figure 70] 10A-10C illustrate a method of using a peel-away introducer sheath to deploy a helical coil within a target vein. [Figure 71] FIG. 1 illustrates the use of a spiral ablation coil to treat pelvic venous reflux in the left ovarian vein. [Figure 72] Venous remodeling in arteriovenous fistula formation. (A) Normal vein; (B) Intimal hyperplasia with self-limited thickening of the intimal layer; (C) Vein graft failure due to excessive intimal hyperplasia causing luminal occlusion. [Figure 73] FIG. 1 illustrates the use of a helical coil with a roughened inner surface and a smooth outer surface to remove thrombus buildup within a blood vessel. [Figure 74] FIG. 10 illustrates the use of a helical coil with a partially textured outer surface that allows for selective treatment of the vessel wall with or without rotational force in addition to axial retraction. [Figure 75] FIG. 1 illustrates the use of a helical coil during an endoscopic procedure to resurface the mucosal layer of the duodenum in the treatment of diabetes. DETAILED DESCRIPTION OF THE INVENTION

[0175] All publications, patents, patent applications, and other references mentioned herein are incorporated by reference for all purposes, and the contents of each are cited in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0176] Definitions and General Preferences As used herein, unless specifically stated otherwise, the following terms are intended to have the following meanings in addition to the broader (or narrower) meaning that they may enjoy in the art:

[0177] Unless the context requires otherwise, the singular references herein should be construed to include the plural and vice versa. The terms "a" or "an" used in reference to an entity should be construed to refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0178] As used herein, the term "comprises" or variations thereof, such as "comprise" or "comprising," should be interpreted to indicate the inclusion of any enumerated integer (e.g., feature, element, property, attribute, method / process step, or limitation) or group of integers (e.g., feature, element, property, attribute, method / process step, or limitation), but not the exclusion of any other integer or group of integers. Thus, as used herein, the term "comprising" is inclusive or open-ended and does not exclude additional, unenumerated integers or method / process steps.

[0179] As used herein, the term "disease" is used to define any abnormal condition in which physiological function is impaired and is accompanied by specific symptoms. The term is used broadly to encompass any disorder, illness, disorder, pathology, disease, condition, or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or whether an actual etiological basis for the disease has been established). Thus, it also encompasses conditions resulting from infection, trauma, injury, surgery, radiological ablation, poisoning, and malnutrition.

[0180] As used herein, the term "treatment" or "treating" refers to an intervention (e.g., administration of an agent to a subject) that cures, ameliorates, or alleviates the symptoms of a disease or eliminates (or reduces the effects of) its cause (e.g., reducing the accumulation of pathological levels of lysosomal enzymes). In this context, the term is used synonymously with the term "therapy."

[0181] Furthermore, the terms "treatment" or "treating" refer to an intervention (e.g., administration of an agent to a subject) that prevents or delays the onset or progression of a disease, or reduces (or eradicates) its incidence in a treated population. In this context, the term "treatment" is used synonymously with the term "prevention."

[0182] As used herein, an effective amount or therapeutically effective amount of a drug defines an amount that can be administered to a subject sufficient to provide the desired effect, e.g., treatment or prevention as indicated by permanent or temporary improvement in the subject's condition, without undue toxicity, irritation, allergic reaction, or other problems or complications, commensurate with a reasonable benefit / risk ratio. The amount will vary from subject to subject depending on the age and general condition of the individual, the method of administration, and other factors. Therefore, it is not possible to specify an exact effective amount, but one of ordinary skill in the art will be able to determine an appropriate "effective" amount in any individual case using routine experimentation and general background knowledge. In this context, therapeutic results include eradication or alleviation of symptoms, reduction in pain or discomfort, prolonged survival, improved mobility, and other markers of clinical improvement. A therapeutic result need not be a complete cure.

[0183] In the context of the above-mentioned treatments and effective amounts, the term "subject" (which should be interpreted as including "individual," "animal," "patient," or "mammal" where the context allows) defines any subject for which treatment is indicated, particularly a mammalian subject. Mammalian subjects include, but are not limited to, humans, livestock animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, goats, and cows; primates such as monkeys, monkeys, orangutans, and chimpanzees; canines such as dogs and wolves; felines such as cats, lions, and tigers; equines such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters, and guinea pigs. In a preferred embodiment, the subject is a human.

[0184] As used herein, the term "ablation" should be understood to mean the mechanical removal or irreversible functional disruption of the superficial layer of the luminal surface of a body lumen along a portion of the lumen. When the body lumen is a blood vessel or vein, the superficial layer of the lumen is generally a single layer of squamous epithelial cells known as the vascular endothelium and its associated connective tissue, extending down to but not deeper than the superficial cell layer of the tunica media. The endothelium is necessary for the survival of the body lumen because it provides a selective barrier and antithrombogenic surface; removal of the endothelium exposes prothrombotic factors that interact with normal blood components, causing clotting and occlusion of the body lumen, and releasing natural vasoconstrictors into the lumen. When the body lumen is a vein, the term refers to the removal of one or more layers of the intimal layer and the superficial medial layer. The devices and methods of the present invention ablate a longitudinal portion of the body lumen, e.g., 1-60 cm, and ablate the body lumen circumferentially. That is, when a body lumen is ablated along the cross section to be treated, the entire circumference (or partial or nearly the entire circumference) is ablated.

[0185] As used herein, the term "body lumen" refers to a cavity within the body, and may be an elongated cavity such as a blood vessel (i.e., an artery, a vein, a lymphatic vessel, a urethra, a ureter, a paranasal sinus, an ear canal, a nasal cavity, a bronchi, a fallopian tube, or a vas deferens), or an annular space of the heart, such as the left atrial appendage, the left ventricular outflow tract, the aortic valve, the mitral valve, the mitral valve continuation, the tricuspid valve, the pulmonary valve, or a cardiac valve, or a venous valve or valve opening. Preferably, the body lumen is the vascular system (i.e., a vein, an artery, or an arteriovenous system). The vein may be selected from the saphenous vein (SSV, GSV, AASV), the pelvic vein, the varicocele, or the portal vein. The artery may be selected from the aorta, the superior rectal artery, a portion of an artery intended for stenting for complete or partial embolization, the uterine artery, or the ductus arteriosus. The body lumen may be a portion of the gastrointestinal tract, such as the duodenum or the small intestine. The body lumen may be the esophagus.

[0186] As used herein, the term "elongate catheter member" should be understood to mean an elongate body having a distal end operably connected to a body lumen ablator. In one embodiment, the catheter member includes a control arm (e.g., a tubular member) operably connected to the ablator for control thereof. The control arm may be of any shape, such as, for example, a rod, wire, or a tubular member such as a hypotube. In one embodiment, the control arm and the ablator are axially adjustable relative to the catheter member. The ablator is generally housed in an uncoiled state at the distal end of the catheter member during delivery and withdrawal. Axial adjustment of the control arm relative to the catheter body results in deployment of the ablator in its coiled configuration.

[0187] "Transluminal delivery" refers to delivery of a lumen ablator to a target site (eg, a varicose vein) via a body lumen, for example, delivery via an artery, vein, or gastrointestinal tract.

[0188] As used herein, the term "coil" should be understood to mean a loop-shaped element that can be adjusted between a non-coiled configuration suitable for retraction onto a catheter member and a coiled configuration capable of circumferentially engaging and pressing its surface against a body lumen during use (i.e., engaging the venous lumen along at least one turn of the coil). Coils in a coiled configuration are generally circular, but may also be oval, square, triangular, or rectangular, as long as they are capable of circumferentially engaging the inner wall of the body lumen. Because most veins and arteries have a circular or nearly circular profile, circular coils are preferred because the radial force exerted by the coil in its deployed configuration is evenly spread around the body lumen wall. It is necessary for the coil to have a diameter equal to or greater than the diameter of the body lumen being treated along at least one turn of the coil in order to achieve circumferential engagement with the venous lumen and thereby achieve circumferential ablation of the vein (see FIG. 13A). In a preferred embodiment, the coil is a helical coil having at least one turn, preferably 1 to 3 turns, e.g., approximately 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, or 2.9 turns. The coil of the helical coil is preferably circular, but may have other profiles, such as oval, square, triangular, or rectangular. The helical coil may also be conical. The diameter of the coil in its relaxed state is typically 2 to 20 mm, more preferably 3 to 12 mm. The pitch of the helical coil is typically approximately the same as the diameter, but may vary from 0.5 to 1.5 times the diameter in its relaxed state. It will be understood that the dimensions of the coil can vary depending on the body lumen to ensure that the coil is "oversized" relative to the diameter of the lumen. In this regard, the diameter of the coil (or the maximum diameter in the case of a helical coil whose diameter varies along its length) is generally at least about 5% larger than the diameter of the body lumen to be treated, e.g., at least 10%, 15%, 20%, 25% or 30% larger than the diameter of the body lumen to be treated, and typically 5-30% larger.It is important that the coil be oversized along at least one turn of the coil, typically one to two turns. The coil may be formed from an elongated element, typically a single elongated element, such as a wire or filament. The coil may be formed from a metal (e.g., stainless steel) or alloy, or a shape-memory alloy such as nitinol, or a natural, synthetic, or semi-synthetic polymer such as chitosan, nylon, or rayon. While the body cavity ablation head ideally comprises a single coil element, in certain embodiments, the coil may include multiple coil elements, e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10 coil elements, preferably 2 to 4 coil elements.

[0189] The coil elements are at least 0.1 mm wide. Widths are typically 1-3 mm to allow delivery through appropriately sized catheters and introducer sheaths.

[0190] Typically, the helical coil is sufficiently resilient and deformable (i.e., configured to be "self-adjusting" or "self-tuning") to maintain a circumferential radial force against body lumen walls of different diameters as it moves along the body lumen. This is shown in FIG. 59, which illustrates the use of a device of the present invention to ablate a vein having multiple bends and gradually increasing diameters. In this embodiment, the helical coil in its deployed state is oversized relative to the widest portion of the body lumen, thereby exerting a radial force around the entire circumference of the body lumen at its widest point, as shown in FIG. 59C, and is sufficiently resilient and deformable to adjust the diameter of the coil to veins of different diameters while maintaining a radial ablation force relative to the circumference of the body lumen. The helical coil is typically sufficiently resilient and deformable to allow the coil to pass through venous stenoses or valves, as illustrated in FIGS. 56 and 57, respectively. The contraction, or change in vein diameter, over the treatment length can be either static (a large-diameter proximal vessel tapering into a narrow distal vessel) or dynamic (contraction of vein wall smooth muscle, resulting in a decrease in vein diameter in a physiological process known as venospasm). The decrease in vein diameter increases the radial force of the helical coil, which in turn increases the hoop force generated within the helical coil material, which translates into longitudinal force and increases the length of the coil. This concept is illustrated in Figure 60, where the device is shown deployed within a typical vessel over a length I and diameter D. The radial force is equal to the pressure P acting perpendicular to the vein wall. The pressure exerted by the vessel on the excess coil, or hoop force (HF), acts to compress the coil and increases as the vessel diameter decreases to d. Due to the open helical coil design, this increased hoop force translates longitudinally, stretching the coil to a length L. This allows for a reduction in radial force at the point of contact between the outer surface of the device and the vein wall, preventing excessive friction, yet maintaining sufficient force to keep the surface engaged and pressed against the vein, which can result in undesirable catching or snagging of the coil portion, as well as perforation of the wall and / or trauma to the connective tissue adjacent to the vein.

[0191] As used herein, the term "coil element" refers to individual, separate coil elements that together create the coil portion of the device of the present invention. Typically, each coil element is helical. Typically, the coil elements are coaxial. Typically, each coil element has the same diameter when deployed. Typically, each coil element has the same pitch when deployed. When in the deployed configuration, the multiple coil elements together provide circumferential engagement with the lumen of the body lumen. Thus, each coil element may be configured to engage with only a portion of the lumen circumference in the deployed configuration, e.g., 90°-270°, 90°-180°, 140°-220°, or 180°-270° of the lumen circumference. In one embodiment, the coil has two helical coil elements, e.g., a double helix. Typically, each of the two helical coil elements has at least 0.5 turns when deployed, typically 0.5-1.0 turns, or 0.5-0.7 turns. In one embodiment, the coil has three helical coil elements, e.g., a triple helix. Typically, each of the three helical coil elements has at least 0.3 turns when deployed, typically 0.3 to 1.0 turns when deployed, or about 0.3 to 0.5 turns when deployed. In one embodiment, the coil has four helical coil elements. Typically, each of the four helical coil elements has at least 0.25 turns when deployed, typically about 0.25 to about 0.75 turns when deployed. In one embodiment, the multiple coil elements are connected together at their distal ends (closed configuration). In one embodiment, the multiple coil elements are not connected together at their distal ends (open configuration).

[0192] As used herein, the term "non-removably attached to a catheter member" as applied to a body lumen (or blood vessel or vein) ablation head should be understood to mean that the device is not configured to be detached and released from the catheter member within the body; in other words, the device is not configured to leave the body lumen ablation head within the body.

[0193] Implantable devices are undesirable for treating superficial venous disease for the following reasons: superficial leg veins are located relatively close to the skin surface, where they can be easily palpated; large implantable devices can potentially cause pain, irritation, or localized skin deformation; implants may inhibit the vein's ability to reduce its diameter through smooth muscle contraction, known as venospasm. This is important for reducing the vein's diameter, reducing the amount of intravenous thrombus, and preventing recanalization; and implants may induce an immune-mediated inflammatory response. At least a portion of the body lumen-engaging surface of the coil is abrasive to shear or irreversibly damage the lining of the body lumen away from the body lumen. The surface can be chemically, electrically, or physically / mechanically treated to create an abrasive surface. Several types of machining processes can be used to roughen the surface, including mechanical abrasion, shot blasting, sandblasting, knurling, electrical discharge machining, and pulsed electrochemical machining. Chemical etching can also be used to roughen the surface of a part. The surface may also be serrated. The surface may also include raised portions that act as an abrasive surface when in contact with the vessel lumen. These raised portions may be pieces attached to the abrasive surface, or folded portions from the abrasive surface, or perforated jagged portions with a lattice effect. One method of providing a helical coil with an abrasive surface is to helically wrap a second wire, or multiple wires, around the core wire, as described and illustrated below. The second wire may have a circular, flat, polygonal, triangular, square, rectangular, X-shaped, or star-shaped cross-section, so long as the combination of the elongated element (core wire) and the helically wrapped second wire creates an abrasive engaging surface that allows for abrasion of the lumen when moved axially along the lumen in the deployed configuration. The wire need not be the only type of material wrapped around the central core wire or central housing; for example, it may be a polymer-based molding, fins, abrasive grains, or spot welds. Another method of creating a sawtooth surface is to cut indentations into the surface of the coil or to create raised formations on the surface, such as spiral indentations or formations.The surface should be sufficiently abrasive to ablate the lumen with a single longitudinal pass of the device, avoiding the need for multiple passes, which may be limited by initial vasospasm. Preferred configurations include surface elements that create both macro- and micro-abrasive surfaces. Macro-abrasive surfaces include grooves, indentations, or teeth with a peak-to-valley height of at least approximately 0.5 mm (e.g., 0.5-1.0 mm). Micro-surfaces include grooves, indentations, or teeth with a peak-to-valley height of approximately 5-100 microns. These grooves induce abrasion and prevent clogging of the abrasive surface with cellular debris over the treatment length. It is important that the orientation of the macro-abrasive grooves be perpendicular to the axial direction of retraction, rather than parallel. This is shown in Figure 64, which shows the device deployed within a vessel. Detailed views of the coil surface are shown in enlarged views (A), (B), and (C). (A) shows the groove pattern perpendicular to the vessel wall during retraction, which is effective in causing mechanical ablation. (B) shows a weaker orientation, lying parallel to the vein wall during retraction. Due to the variability in vessel diameter and tortuosity within the venous anatomy, a macro-abrasive texture pattern is necessary to overcome this problem. (C) shows a diamond knurled pattern ideal for ensuring that a portion of the macro-abrasive surface remains perpendicular to the vein wall during engagement as the device is axially retracted. Micro-abrasive surfaces typically have a surface roughness, or RA, value of 0.8–3.2, which may achieve endothelial disruption and prevent excessive stiction. The RA value is the arithmetic mean of the absolute deviations of the profile height from the mean line recorded within the evaluation length. An RA value of 0.8 corresponds to an average peak-to-valley height of 4 pm. In most blood vessels, the endothelial cells (ECs) are protected from direct exposure to flowing blood by an acellular layer known as the glycocalyx. This gel-like structure is typically 0.5–3 pm thick, exceeding the thickness of the ECs themselves (0.2–2.0 pm).

[0194] As used herein, the term "shape memory material" should be understood to mean a material, typically a metal alloy, that remembers its original shape and, when deformed or forced into a different shape, returns to its pre-deformed shape when the deforming force is released. An example is Nitinol. In one embodiment, the coil, or core element of the coil, is formed from a shape memory material. Methods for fabricating coils from shape memory materials generally include winding a shape memory alloy around a die or heat treatment tool to form the desired shape after heat treatment, placing the loaded tool in an oven at a set temperature / time, and removing and cooling the piece. The shape can also be formed from a piece of cylindrical tubing laser-cut to the desired size. The shape memory body can also be fabricated by other means, such as electroactivated polymers.

[0195] As used herein, the term "treatment zone" as applied to a body lumen, blood vessel, or superficial vein refers to a cylindrical portion of the body lumen involved in the pathogenesis of a disease state, typically 1 cm or greater in length. In the context of superficial veins, the term "treatment zone" should be understood to refer to a cylindrical portion of the superficial venous lumen that cannot effectively circulate blood, typically 1 cm or greater in length. In one embodiment, the treatment zone is 1-50 cm, 1-40 cm, 1-30 cm, 1-25 cm, 1-15 cm, 1-10 cm, 5-50 cm, 5-40 cm, 5-30 cm, 5-25 cm, 5-15 cm, 5-10 cm, 10-50 cm, 10-40 cm, 10-30 cm, 10-25 cm, or 10-15 cm in length.

[0196] As shown in Figure 1, veins are composed of three main cellular layers: the outer tunica adventitia, which is composed of tough fibrous tissue and unmyelinated nerve fibers; the tunica media, which is composed of collagen and smooth muscle cells; and the inner endothelial layer, which contains a single layer of squamous epithelial cells and some connective tissue. Furthermore, the endothelial layer is covered by an acellular glycocalyx, a uniformly distributed structure typically 0.5–3 μm thick.

[0197] Veins have thinner walls than arteries and are less rigid and more flexible: unlike arteries, which always maintain a cylindrical shape, veins can empty blood and collapse, or alternatively stretch significantly to accommodate an increase in blood volume.

[0198] Vein spasm, or constriction, occurs in response to physical stretch, which activates nerves on the outside of the vein wall. Constriction also occurs when chemicals such as endothelin-1 are released from the endothelium in response to stretching or rupture.

[0199] The endothelial layer prevents blood from clotting within the veins. When the endothelium is disrupted or damaged, prothrombotic factors are exposed, platelets immediately adhere, and the clotting cascade begins. Over time (4-12 weeks, typically 8 weeks on average), the clot within the vein becomes invaded by surrounding cells, which deposit fibrin and collagen in a process known as sclerosis or fibrosis. This prevents blood from flowing back into the vein, thus successfully treating varicose veins.

[0200] The purpose of this device is to destroy the endothelial and medial layers of the vein, but not the outer adventitia. This requires selective, controlled mechanical destruction to a depth of at least 5 pm but not more than 100 pm. This ensures destruction of the endothelium and superficial medial layers without disrupting the deeper media / adventitia, which could result in pain and / or perforation. Further cell death may occur in deeper layers due to the release of intracellular contents, triggering apoptosis of adjacent cells and continuing the cascade over time to a depth of up to 300 pm. The resulting thrombosis or clot and fibrous scar tissue prevent blood from entering the vein, thus preventing the appearance and symptoms associated with varicose veins. It is important that the endothelium is completely and circumferentially destroyed, even if a small area remains intact; otherwise, the inability to form a clot could allow blood to continue flowing, potentially leading to treatment failure and / or early recurrence. This is more likely when liquid or foam chemical sclerosing agents are used on large veins and is the suspected reason for the low efficacy rate of only 70% compared to 90-98% with heat therapy.

[0201] Because treatment begins more than 2 cm posterior to the junction into the deep vein, any adherent thrombus produced by the present invention is trapped in the superficial vein and cannot be carried into the deep system where it could cause complications due to the lack of blood flow.

[0202] The exact conditions required for successful long-term venous ablation are currently unknown. Some experts in superficial venous reflux treatment propose that complete endothelial injury is sufficient. This results in the formation of a thrombus, halting blood flow. The body then converts the thrombosed vein into fibrous cords in a process known as sclerosis or fibrotic transformation, achieving long-term ablation. Others argue that long-term venous ablation requires damage to the vein wall tissue, extending to the deeper medial layer in addition to the inner intimal layer. Others, such as thermal ablation advocates, propose that complete transmural damage of the vein wall, from the intima to the outer adventitia layer, is required.

[0203] The present invention achieves complete circumferential endothelial injury through an oversized coiled configuration with an abrasive surface. It also induces medial layer injury through at least three independent mechanisms. First, the abrasive polygonal coil surface allows penetration of more than 50 pm, allowing injury to occur deeper than the intimal layer. This can also be further enhanced by using multiple coils, allowing a second abrasive coil located more distally of the device to penetrate deeper into the portion of the vessel wall already ablated by the more proximal coil of the device. This can also be achieved by repeating the procedure using the same device over the same treatment length. Second, foam sclerotherapy studies have shown that cell death occurs by 300 pm in the venous wall

[10] . This is likely due to a cascade effect of cell death caused by the release of molecules by injured cells that signal apoptosis in neighboring cells. Thus, venous wall injury can occur deeper within the superficial cells affected by mechanical disruption. Third, the frictional forces generated by the device acting on the superficial layers combined with the resistance of the deeper medial layers have a shear effect within the venous wall layers, resulting in deeper vessel wall injury. This effect has been reported in previous studies and was also seen in the preclinical studies of the present invention.

[0204] The risk of vein rupture and / or device snagging is proportional to the roughness or sharpness of the device in contact with the wall, which creates frictional or cutting forces, and the depth to which the abrasive elements penetrate the wall. Snagging is a commonly reported pain point for physicians and patients after the use of current mechano-mechanical devices. There have even been documented cases of inadvertent vein snagging and detachment, known as "inadvertent spontaneous avulsion," resulting in pain and hematoma formation. [6] Venous valve leaflets are also obstacles that can cause mechanical tips to become stuck and snag.

[0205] A key problem there is the difficulty of completely removing the endothelial layer and partially damaging the medial layer without causing excessive resistance and / or snagging.

[0206] Figure 2 highlights the importance of circumferential coverage in terms of endothelial cell destruction. This image was taken from a partially treated vein in our animal study. The upper right corner shows a clot attached to the vein wall with tissue infiltration, with fibrosis beginning 28 days after treatment. The lower left corner shows intact endothelium. No clot has formed, and blood can flow through the channel, resulting in overall treatment failure in this area. Conversely, Figure 3 shows the results of complete endothelial coverage and injury 28 days after treatment, where the formation of an adherent clot prevented blood flow throughout the vessel lumen, resulting in treatment failure. Microscopic examination reveals migration of inflammatory cells from the adventitia into the thrombus. This leads to fibrotic transformation of the thrombus and prolonged occlusion. [Example]

[0207] The present invention will now be described with reference to specific examples, which are merely exemplary and for illustrative purposes only, and are not intended to limit in any way the scope of the claimed proprietary rights or the scope of the described invention, which examples constitute the best mode presently contemplated for carrying out the invention.

[0208] 4-7, there is illustrated an apparatus according to the present invention for ablating a body lumen, generally designated by the reference numeral 1. In this embodiment, apparatus 1 is for ablating varicose veins for the purpose of treating the varicose veins by occluding the veins, and includes a polyimide catheter member 2 and an ablation head 3 configured for transluminal delivery to a portion of the varicose vein to be treated and deployment at a target location within the vein. The ablation head 3 includes a helical coil 4 having proximal and distal ends 5 and 6 generally coaxial with the axis of the helical coil, and a coil portion having approximately 1.5 turns, an outer diameter of approximately 13 mm, and a pitch of approximately 9 mm.

[0209] The helical coil 4 is axially adjustable relative to the catheter member from a delivery configuration (not shown) in which the coil is unwound and stored in the distal end of the catheter member 2, and from a deployed, coiled configuration, as shown in Figures 4-7. The helical coil is made of a shape memory alloy and is biased into the coiled configuration when extended beyond the distal end of the catheter member. The device is suitable for use in varicose veins having a typical diameter of 4-12 mm (i.e., when the coil is oversized for the vein being treated).

[0210] Note that the "oversized" diameter of the helical coil extends along at least one full loop (360 degrees) of the coil. This feature, in addition to the oversized coil diameter relative to the vein, ensures that the coil circumferentially engages and presses against the vein lumen, exerting radial pressure evenly around the entire circumference of the vein. While the oversized diameter could extend along less than one full loop, e.g., at least 300 degrees, this risks incomplete stripping of the vein lumen, resulting in partial occlusion and subsequent recanalization of the vein. In this embodiment, the coil has just more than one full turn, and is not so long as to increase friction and cause snagging against the vein wall, yet allows for complete coverage even when stretched. Adding additional coil turns with a long coil can be used to induce further mechanical damage to the vein wall. In such an embodiment, the increased surface area of ​​the device in contact with the vein would increase the risk of snagging and vein wall damage. Therefore, a coil with just more than one full turn represents the most efficient way to achieve complete stripping of the endovascular surface.

[0211] The coiled configuration and flexible material of the ablation head allow it to accommodate different vein diameters, within a range of sizes smaller than the coil diameter, while still applying adequate radial force to induce ablation. These characteristics also allow the coil to adapt to varying vein diameters within the same vein and over its target treatment length. These variations can be due to the natural tapering of the vein or to the venous valve. The latter can cause significant snagging or vein perforation if rigid structures snag or become trapped on the valve leaflets. Due to the flexibility of the coil and minimal protrusion of the abrasive components, this is unlikely to occur. If the device snags on a valve leaflet, a small increase in force along the longitudinal axis results in an automatic decrease in the coil diameter, while the coil length increases, allowing the coil to release itself, avoiding snagging or detachment of the valve and associated leaflets, as shown in Figures 60 and 61. This occurs automatically during normal withdrawal of the device within the vein and does not require any adjustments, extra manipulations, or auxiliary imaging by the surgeon.

[0212] Referring to the drawings, and initially to FIGS. 8 and 9 , the helical coil 4, when in a deployed configuration, has an abrasive surface configured to shear the vein lining (primarily, but not limited to, the endothelial cell layer) away from the vein as the helical coil moves axially along the vein. In this embodiment, the helical coil includes a 0.01181 inch nitinol core wire 8 and a second wire 9 that is helically wound around the core wire 8 and forms an abrasive sawtooth surface on the helical coil 4. With reference to FIGS. 8 and 9 , the second wire 9 is a flat wire formed from stainless steel or nitinol. In this embodiment, the core wire 8 has a diameter of approximately 1 mm, and the second wire 9 has a width of approximately 0.7 mm and a thickness of approximately 0.02 mm. The pitch of the second wire is approximately 1.5 mm. With reference to FIG. 9 , the pitch of the second wire 9 on the core wire 8 decreases at the distal end 6 of the helical coil 4, in this case to approximately 0.3 mm. The purpose of the smaller / closed pitch at the distal end is to create a flexible distal section of the device and aid in its passage through the target anatomy. Referring to FIG. 10, the pitch of the second wire 9 on the core wire 8 increases at the proximal end 5 of the helical coil 4, in this case up to approximately 3 mm. The purpose of the larger pitch at the proximal end is to aid in smooth recapture of the distal tip after the procedure. This proximal section may also have a smaller, tighter pitch closure to aid in recapture.

[0213] The thickness of the second wire 9 is 0.1 to 1 mm. Tests using comparable animal venous tissue have shown that if the diameter exceeds 1 mm, there is a risk of surface protrusions being generated that may get caught or stick to the surface of the vein wall.

[0214] 10 and 11, the proximal end 5 of the coil 4 is attached to a stainless steel hypotube 12 that extends through the catheter member 2 to its proximal end (not shown). In use, the hypotube 12 is axially adjustable relative to the catheter member 2 to deploy the helical coil 4 into a coiled configuration distal to the catheter member, and to retract the helical coil 4 into the catheter member during transluminal delivery and withdrawal of the device. In this embodiment, the catheter member 2 is a 4 French polyimide extruded catheter tube having an inwardly tapered opening 14, FIG. 11, to aid in recapture of the helical coil 4 when retracted into the catheter member 2.

[0215] 9, the distal end of the helical coil 4 terminates in an atraumatic head (provided in this embodiment by a smooth metal ball 15), which serves to prevent the helical coil from getting caught in a vein or valve and to reduce the risk of the distal tip perforating the vein wall during deployment and retraction of the coil. Further referring to FIG. 9, the ball 15 is dimensioned to nest within the tapered opening 14, FIG. 11, of the catheter member 2 when the device is in the delivery configuration.

[0216] Referring to Figure 9, there is a straight, approximately 5mm elongated section between the end of the abrasive coil and the distal smooth ball to aid in navigation and placement of the device. The distal ball of the device forms the atraumatic tip, and in another embodiment, this may be the same diameter as the abrasive member, forming a straight atraumatic tip without forming a ball.

[0217] 12, there is shown part of an apparatus according to an alternative form of the invention, with parts identified with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the surface of the second wire is inscribed with helical indentations 20 which serve to provide the helical coil 4 with a polished sawtooth surface.

[0218] 13-19, use of the device of the present invention is illustrated. In the following description, proximal means near the access insertion site, and distal means away from the access site in the blood vessel. The device can be delivered and removed through a single injection site and does not require injection or administration of chemical agents. A method for treating and permanently occluding a refluxing vein can include the following steps:

[0219] In a first step, the device is adjusted to a delivery configuration by retracting the helical coil 4 into the end of a catheter member (not shown). In some embodiments, the catheter member is a polyimide extrusion. The device is then delivered to the target vein via a separate introducer catheter under image guidance, e.g., ultrasound.

[0220] The device is then passed distally under ultrasound guidance to the desired location. Correct placement, with the distal end of the catheter member 2 located at the beginning of the vein to be treated, is confirmed by ultrasound, as shown in FIG.

[0221] The outer catheter 2 is retracted axially, exposing the helical coil 4 and hypotube 12 to the deployed coiled configuration shown in FIG. 13. In some embodiments, the helical coil is deployed using a handle with a thumbwheel control element. Using an intuitive one-handed motion, the surgeon can deploy the coil by turning the thumbwheel with the thumb of the hand holding the handle. This allows for simultaneous visualization by positioning the ultrasound probe with the opposite hand. This allows the physician to perform the procedure without an assistant, if desired.

[0222] The coil, in its undeployed and deployed configurations, must be easily visualized with ultrasound to prevent inadvertent placement. This is achieved by incorporating echogenic material into the catheter tip. In the deployed state, coils with polished surfaces are inherently echogenic.

[0223] Because the coil is oversized for the vein being treated, the coil exerts a radially outward force against the venous lumen along at least one complete circumference of the vein.

[0224] Unlike current treatment options, the action of the device on the vein wall to cause long-term occlusion occurs only after withdrawal of the device within the treated venous segment, which can only occur proximally protecting more distal structures, which may include deep system veins.

[0225] If the device is inadvertently misplaced in the target vessel, the device can be recaptured in the outer catheter and repositioned without causing vascular trauma.

[0226] The device is then moved proximally along the vein segment to be treated (typically a vein segment approximately 10–70 cm long). The spiral coil then removes, pulverizes, or disrupts the inner surface layers of the vein lumen through the radial force of the coil's abrasive surface against the vein lumen and axial movement. These layers consist of the glycocalyx, endothelium, subendothelial connective tissue, and the superficial layer of the tunica media. Stretch receptors in the vein wall respond to the device's radial outward force, resulting in vasospasm. Vasospasm is further enhanced by the release of chemicals stored in the endothelial cell bodies, primarily endothelin-1, a potent vasoconstrictor. Exposure of subendothelial collagen leads to platelet adhesion and triggers activation of the prothrombotic factor cascade, resulting in thrombotic occlusion of the vessel. This thrombotic occlusion is further reinforced by significant vasospasm, as shown in Figure 19, where the treated vein segment is significantly constricted during the acute phase. This results in complete cessation of blood flow within the vessel. This was demonstrated during a preclinical study of the goat lateral saphenous vein, where high-pressure manual injection of contrast agent did not enter the vein 45 minutes after treatment.

[0227] Without being limited by theory, circumferential endothelial disruption allows the intraluminal thrombus to directly adhere to the vessel wall, recruiting cells involved in the inflammatory healing response and migrating from the adventitia across the lumen into the thrombus. These cells, including fibroblasts, produce collagen at the thrombotic occlusion, transforming the vessel into a fibrous cord over time. This leads to long-term vascular closure and resolution of venous disease symptoms.

[0228] Contrary to previous belief that complete transvascular cellular injury to the vein wall is necessary, the inventors have demonstrated that superficial ablation alone can induce a sufficient inflammatory response to induce fibroblasts in the outer adventitial layer and migrate inward. This is advantageous because it provides a mechanism of action that can be utilized by a device that does not inflict pain on the patient or require a preparatory injection of a tumescent needle to prevent pain. This is because pain-sensing nerve fibers are located in the adventitial layer of the blood vessel, which is not directly affected by the device.

[0229] The results of our preclinical studies also demonstrate that circumferential endothelial disruption is important for achieving successful long-term occlusion.

[0230] As shown in Figure 2, thrombotic occlusions with partially disrupted endothelium, but not without, can lead to recanalization. This is because the endothelium prevents thrombus adhesion and separates thrombus contraction from the vessel wall. This is further enhanced by nitric oxide secretion from endothelial cells, which promotes vasodilation and thereby counteracts the effects of venospasm. This may be a major factor contributing to the low efficacy rate of techniques based on chemical sclerosing agents. Because sclerosing agents are inactivated by blood and removed by the circulation, incomplete endothelial disruption may occur, especially in large vessels with a large blood volume and large surface area, even in the collapsed state.

[0231] All of the embodiments shown in Figures 4-16 have a body lumen ablation head formed from a single coil element, which in its deployed configuration comprises one complete helical turn and, during use, circumferentially ablates the lumen of a body lumen. With reference to Figures 20-24, an alternative embodiment of the device of the present invention is described and generally designated by reference numeral 30, with parts described with reference to the previous embodiment being assigned the same reference numeral. In this embodiment, the device includes an elongated control arm 31 extending through a catheter member 2 and operably connected to a distal end 6 of a coil 4, the proximal end 5 of which is coupled to a stainless steel hypotube 12. Axial movement of the control arm 31 relative to the hypotube 12 affects the deployment or uncoiling of the coil. Figure 22 shows the coil in a partially coiled configuration, and Figure 23 shows the coil in a fully coiled configuration. Use of this embodiment is substantially the same as that described above, except that coil deployment can be controlled by adjusting the axial position of the control arm 31 and the hypotube 12.

[0232] 25-27, an alternative embodiment of the device of the present invention is described and generally designated by the reference numeral 40, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, a coil 4 is comprised of two coil elements 41a, 41b that cooperate to circumferentially ablate the lumen of a body lumen, each adjustable between a non-coiled configuration suitable for placement within a catheter member and transluminal delivery through a body lumen and the coiled configuration shown. Each coil element 41a, 41b includes a proximal portion that is generally coaxial with the catheter member and a coiled portion that includes less than one turn in its deployed configuration, such that the coil elements together adopt a double helix structure that circumferentially engages the body lumen being treated during use. As with the previous embodiment, each coil element includes a core wire 8 having a second wire 9 wound around it to provide a serrated lumen ablation surface. Use of this embodiment is the same as that described with reference to the previous embodiment.

[0233] 28-30, an alternative embodiment of the device of the present invention is described and generally designated by the reference numeral 50, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, the coil 4 is comprised of four coil elements 51a-51d that cooperate to circumferentially ablate the lumen of a body lumen, each adjustable between a non-coiled configuration suitable for placement within a catheter member and transluminal delivery through a body lumen and a coiled configuration as shown. Each coil element 51a-51d comprises approximately one-quarter of a full rotation in its deployed configuration, and together the four coil elements form a quadruple configuration such that they circumferentially engage the body lumen to be treated. As with the previous embodiment, each coil element includes a core wire 8 having a second wire 9 wound around it to provide a serrated ablation surface. Use of this embodiment is the same as that described with reference to the previous embodiment.

[0234] In the above-described embodiments including multiple coil elements, the coil elements are joined at their proximal ends and have a free distal end (i.e., an open coil). However, it will be understood that the coil may also be a closed coil, in which the coil elements are joined together at their proximal and distal ends. Such an embodiment is shown in FIGS. 31-33, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, device 60 includes a coil formed from four helical coil elements 61a-61d joined together at their proximal and distal ends 5 and 6, each having approximately 1 / 2 turn. As with the previous embodiment, each coil element includes a core wire 8 having a second wire 9 wrapped around the core wire to provide a serrated intraluminal ablation surface. Use of this embodiment is the same as that described with reference to the previous embodiment.

[0235] 34-41 show the helical coils that form part of the devices of the present invention, and in particular the various types of wire that form the coils, and the various types of indentations / compositions on the surface of the coils that create the roughened surface. The coils are formed from nitinol wire, and the indentations are cut using a knurling process.

[0236] Referring to Figures 34A and 34B, a portion of a helical coil 67 is shown to have a generally flat profile, the cross section of which has an outer lumen-engaging surface 61, transverse serrations forming teeth 62 with a truncated triangular profile, a flat inner surface 63, and sides cut in a zigzag pattern to provide a number of transverse teeth 65.

[0237] 35A and 35B, a portion of a helical coil 70 is shown having a generally convex profile, the cross section of which has an outer lumen-engaging surface 71, curved transverse serrations forming teeth 72 having a triangular profile, and a smooth convex inner surface 73.

[0238] 36A and 36B, a portion of a helical coil 80 is shown having a generally flat profile, the cross section of which includes an outer lumen-engaging surface 81, transverse indentations formed on each side 84 of surface 81 with two series of teeth 82 having a truncated triangular profile, and a smooth, concave inner surface 83.

[0239] Referring to Figures 37A and 37B, a portion of a helical coil 90 is shown to have a generally convex profile, the cross section of which has a convex outer lumen-engaging surface 91, serrations formed on surface 91 with diamond-shaped teeth 92 that are partly flat and partly pointed, and a smooth, flat inner surface 93.

[0240] Referring to Figures 38A and 38B, a portion of a helical coil 100 is shown having a generally crescent-shaped profile, the cross-section of which has a convex outer lumen-engaging surface 101, curved indentations formed on surface 101 with transverse teeth 102 having a scalene triangular profile, and a smooth flat inner surface 103.

[0241] 39A and 39B, a portion of a helical coil 110 is shown having a generally elliptical profile, the cross section of which has a convex outer lumen-engaging surface 111, curved V-profile serrations formed on surface 111 with transverse teeth 102 having a triangular profile, and a smooth flat inner surface 113.

[0242] Referring to Figures 40A and 40B, a portion of a helical coil 120 is shown to have a generally flat profile, the cross section of which has a flat outer lumen-engaging surface 121, a flat inner surface 123, and sides cut in a zigzag pattern to provide a number of lateral teeth 125.

[0243] 41A and 41B, a portion of a helical coil 130 is shown having a generally inverted T-shaped profile, the cross section of which includes a base 131, teeth 132 at the base, and a smooth, flat inner surface 133.

[0244] The above surface patterns and shapes are advantageous because they allow both the delivery of the appropriate angle, depth, and level of cell destruction during axial treatment of the body lumen, and the deployed device to automatically deform in response to changes in the body lumen diameter. As previously mentioned, the macro-abrasive surface should ideally contact the vessel wall perpendicularly upon withdrawal for maximum effectiveness.

[0245] 42-48 illustrate a number of venous ablation heads forming part of the device of the present invention, in particular a venous ablation head having a single helical coil, with parts described with reference to the previous embodiment being assigned the same reference numerals.

[0246] 42A and 42B show a vein ablation head forming part of the device of the present invention, generally designated by reference numeral 140, including a control arm 31, a helical coil 141 having approximately three turns, a proximal portion 142 where the coil increases in diameter toward a midpoint 143, and a distal portion 144 where the diameter of the coil decreases toward a distal tip 145 located on the axis of the helical coil.

[0247] 43A and 43B show a vein ablation head forming part of the device of the present invention, generally designated by reference numeral 150, including a control arm 31 and a helical coil 151 having approximately three turns (coils), 152A, 152B, 152C, each turn having a slightly different diameter and slightly axially offset relative to the preceding turn.

[0248] 44A and 44B show a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 160, including a control arm 31 and a helical coil 161 having approximately seven turns (coils) of varying diameter, including a proximal portion 162 where the coil initially decreases in diameter and then increases in diameter towards a midpoint 163, and a distal portion 164 where the diameter of the coil decreases towards a distal tip 165.

[0249] 45A and 45B show a vein ablation head forming part of the device of the present invention, generally designated by reference numeral 170, including a helical coil 171 having approximately four turns with a control arm 31, a proximal coil element 172, a distal coil element 173, and a transition member 174 connecting the coil elements, and a distal tip 175.

[0250] 46A and 46B show a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 180, which includes a helical coil 181 having approximately two turns (coils) with a proximal coil element 182, a distal coil element 183, a transition member 184 including a straight section connecting the coil elements, and a distal tip 185.

[0251] 47A and 47B show a vein ablation head forming part of the device of the present invention, generally designated by reference numeral 190, which includes a control arm 31 and a helical coil 191 having approximately three turns (coils) of decreasing diameter toward a distal tip 195.

[0252] 48A, 48B, and 48C show a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 200, which includes a control arm 31, a helical coil 201 having approximately 3 turns (coils) including a right-handed proximal coil element 202 of approximately 2 turns, a left-handed distal coil element 203 of approximately 1.5 turns, a transition member 204 having a turn portion 206, and a distal tip 205. The turn portion 206 transitions the small diameter right-handed proximal coil 202 to the large diameter left-handed distal coil 203.

[0253] 49-51 illustrate multiple venous ablation heads forming part of the device of the present invention, in particular a venous ablation head having two axially spaced, unconnected helical coils, with parts described with reference to the previous embodiment being assigned the same reference numerals.

[0254] 49A and 49B show a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 210, including a control arm 31 bifurcating at a distal end to provide control elements 31A and 31B, a proximal helical coil 211 operably attached to control element 31A, and a distal helical coil 212 operably attached to control element 31B, axially spaced from and passing through the proximal helical coil. Each helical coil has slightly more than two turns (coils) and is generally conical in shape with a diameter that increases proximally.

[0255] 50A and 50B show a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 220, including a control arm 31 bifurcating at its distal end to provide control elements 31A and 31B, a proximal helical coil 221 operably attached to control element 31A, and a distal helical coil 222 operably attached to control element 31B, axially spaced from and passing through the proximal helical coil. Each helical coil has slightly more than two turns (coils) and is generally conical in shape with a diameter that increases proximally. Furthermore, the maximum diameter d1 of the proximal coil is approximately three times the maximum diameter d2 of the distal coil, and the pitch p1 of the distal helical coil is approximately twice the pitch p2 of the proximal helical coil.

[0256] 51A shows a vein ablation head forming part of a device of the present invention, generally designated by reference numeral 230, including a control arm 31 bifurcating at its distal end to provide control elements 31A and 31B, a proximal helical coil 231 operably attached to control element 31A, and a distal helical coil 232 operably attached to control element 31B, axially spaced from the proximal helical coil and passing through a portion of the proximal helical coil. Each helical coil has slightly more than two turns (coils) and is generally conical in shape with a diameter that increases proximally. Furthermore, the maximum diameter of the proximal coil is approximately one-third the maximum diameter of the distal coil, and the pitch of the distal helical coil is approximately half the pitch of the proximal helical coil.

[0257] Referring to Figure 61A, when the coil is deployed and engages the inner surface of the vessel lumen, there is static friction between the device and the vessel wall. At rest, there is an outward radial force at the coil contact point (FC) that is proportional to the coil's stiffness and diameter and the vessel diameter. This is countered by the vessel's restraining force P. When the user withdraws the device, the axial force FA increases to overcome the static friction. In a sliding system between solid objects, the friction force is proportional to the load contact force (FC) and the surface roughness, and is described by Amontons' law of friction. It has also been shown that the contact surface area is a factor that increases friction

[11] .

[0258] Ideally, increasing axial force (FA) overcomes static friction before the coil begins to elongate. Static friction in veins and arteries is generally low due to the presence of gels, such as glycocalyx layers, which have been shown to reduce static friction

[12] . When vascular constraints increase, such as in venous spasm, a greater axial force is required, resulting in elongation of the coil while remaining in contact with the vessel wall due to its elastic deformability, as shown in Figure 61B. The axial force required to elongate the coil is proportional to the wire stiffness and is also affected by the wire's cross-sectional profile (flat vs. round).

[0259] In some cases, as shown in Figure 61C, significant constraints on the device exist due to excessive venous spasm or natural obstruction by a venous valve. In this case, the increased constraints are typically concentrated at the distal portion of the coil. Further increases in axial force cause the coil to reduce its diameter sufficiently to lose contact with the vessel wall, as shown in Figure 61C. This dramatically reduces stiction, allowing the distal end to narrow enough to overcome stiction and / or obstruction. When this occurs, the coil jumps or skips proximally during recoil to adopt its natural configuration. This can result in small sections of the vein wall being missed by the abrasive surface. In cases such as passing through very narrow stenoses or venous valves, some deformation of the coil is desirable, allowing the coil to lose contact and reduce stiction before the axial force becomes too great and causes vessel wall damage or vein ablation. Vein ablation occurs when the distal tip of the intraluminal device acts like an anchor, transmitting axial forces large enough to ablate or remove an entire vein segment from the surrounding tissue. This has been demonstrated with previous non-deformable and less elastic designs of vein ablation devices, which not only complicate the procedure but also cause significant pain and bruising to the patient [6].

[0260] To overcome excessive coil elongation and resulting skipping, variables related to static friction and coil deformability can be modified by changing the thickness, shape, diameter, and / or stiffness of the device elements. To achieve sufficient mechanical ablation, the surface roughness should be kept constant.

[0261] Other coil configurations may be used to limit the effect of skipping on the endothelial covering. Such embodiments of the device are shown in Figures 42-51. Figures 45 and 46 incorporate connecting portions (174, 184) that can act to prevent overstretching throughout the coil. Figure 48 shows connecting portions between coils with opposing clockwise and counterclockwise configurations to resist overstretching. Figures 49-51 show independent coil elements to provide coverage if either coil element is subjected to excessive stiction and loses contact during stretching.

[0262] Referring to FIG. 63, another embodiment is a single flat wire option. The flat wire is formed from nitinol. The outer surface of the wire is textured (roughened) using a knurling process that presses a shape into the wire; similarly, texture may be applied by other means, such as stamping or micromachining. This creates an abrasive feature in the wire. FIG. 37A shows a diamond-shaped knurling pattern pressed into the nitinol wire. The outer surface of the wire may be shot blasted to create a micro-abrasive surface on the wire. The flat wire is then held in a heat treatment fixture to set the shape into a helical profile. The helical coil with the abrasive outer surface is configured to shear the inner layer of the vein (primarily, but not limited to, the endothelial cell layer) when the helical coil is moved axially along the vein in the deployed configuration.

[0263] venous disease The devices and methods of the present invention can be used to treat or prevent venous disease. A combination of venous valve defects and vein wall defects can lead to blood reflux and the associated complications of blood pooling in the lower extremities. The goal of superficial venous reflux treatment is to eliminate or occlude the refluxing vein so that blood can be diverted to healthy veins and effectively returned to the heart for circulation. The great saphenous vein (GSV) is the longest vein in the body and the most commonly treated vein for venous reflux. It extends from the leg to the groin where it joins with the deep femoral vein. The GSV is the most common cause of venous reflux. Other veins include the small saphenous vein (SSV), the anterior accessory saphenous vein (AASV), and numerous tributary veins that may also be treated.

[0264] The venous network of the lower limbs is divided into three components: 1) superficial veins, located on the surface of the muscle fascia and draining the skin and subcutaneous tissue; 2) deep veins, located deep to the muscle fascia and draining the muscles of the lower limb; and 3) perforating veins, which penetrate the muscle fascia and connect the superficial and deep veins.

[0265] Understanding the fascial layers and compartments of the leg in which these veins are located is important for understanding the risks associated with current treatment approaches. The GSV typically follows a course close to the skin, 2–5 cm deep in normal-sized individuals. From the lower leg to the groin, it is defined in a fascial space surrounded by the underlying muscle fascia and the superior saphenous fascia, which is part of the membranous plate of subcutaneous tissue. The two fascial layers, the superior saphenous fascia and the inferior fascia, meet at their respective ends to form a closed space known as the saphenous vein compartment. The saphenous vein compartment includes the saphenous vein and its associated arteries and nerves. The saphenous nerve is typically separate from the great saphenous vein (GSV) and is not present in the saphenous fascia above the knee. However, the saphenous nerve is located in close proximity to the GSV and within the saphenous fascia below the knee. The only trunk vein located in the saphenous vein compartment is the GSV or its duplicates. All tributary and accessory veins are located in the subcutaneous compartment outside the saphenous fascia and saphenous vein compartment.

[0266] Segmental hypoplasia of the GSV is present in 25% of patients with superficial venous disease.

[13] This hypoplastic portion of the thigh is often bridged by accessory veins that run lateral to the saphenous vein segment close to the skin. When this or any other portion of the GSV runs so close to the skin, it can be difficult to create a tumescent anesthetic plane around the vein to protect the skin in preparation for thermal venous disease treatment. In some cases, only nonthermal methods or vein stripping are feasible. Tributary veins in the thigh flow lateral to the saphenous vein segment and, if reflux occurs, can result in varicose veins in appearance. These veins are also less suitable for thermal treatment due to their more superficial location. The two major tributary veins in the thigh are the anterior circumflex femoral vein and the posterior circumflex femoral vein. The anterior accessory saphenous vein in the thigh flows parallel to the GSV through the saphenous vein segment, but is inconsistent and present in approximately 14% of patients with varicose veins. The small saphenous vein (SSV) originates at the lateral malleolus and drains into the deep veins in the popliteal region behind the knee. It is located close to the sural nerve, which is susceptible to damage by thermal methods.

[14] The fascial relationships of the SSV are more consistent than those of the GSV.

[0267] Perforating veins penetrate the muscular fascia to connect superficial and deep veins. The lower extremities contain up to 150 perforating veins of varying sizes and distribution. Medial calf perforations are the most clinically significant, potentially causing rapid blood flow to the superficial system and venous hypertension. They are difficult to treat using surgical, thermal, adhesive, and / or sclerosing agents due to their short length and proximity to the deep venous system. Inadvertent propagation of heat, adhesive, or chemical sclerosing agents directly into the deep venous system can lead to DVT and subsequent PE, a potentially fatal complication. Open surgical ligation is technically challenging and leads to significant morbidity due to the incision. The junctions of the deep femoral vein with the GSV and SSV, respectively, are also junctions between the superficial and deep venous systems at the groin and posterior knee, respectively, and treatment of incompetent superficial veins near these areas carries a risk of thromboembolic complications.

[0268] Given these anatomical considerations, the use of thermal energy is limited due to the inherent risk of damage to adjacent skin and nerves. Furthermore, forward propagation of thermal energy to non-target tissues in the deep venous system is a potential cause of DVT and subsequent PE. Current non-thermal methods are also limited by the risk of damaging adjacent non-target tissues. Cyanoacrylate adhesives can be inadvertently placed in the deep venous system without the ability to retrieve or recapture them. Chemical sclerosing agents, by their very nature, effectively circulate in the deep venous system when they exit the target site. Foaming sclerosing agent formulations propagate in a coagulated emulsion of sclerosing agent and air that migrates into the deep venous system, potentially damaging the endothelium and leading to DVT. Furthermore, chemical sclerosing agents can lead to significant skin necrosis if inadvertently injected into subcutaneous tissue, nerves, or arteries.

[0269] To counteract these limitations, an effective non-thermal device should be capable of accurate and precise placement using standard ultrasound techniques, and should also allow for device retrieval and recapture if misplaced prior to treatment—two features not currently available on the market.

[0270] For the treatment of lower extremity venous reflux, mechanical ablation devices are preferred because they have the ability to be precisely deployed at the target site without the risk of uncontrolled forward propagation or damage to surrounding tissue. The ability to recapture and reposition further reduces the risk of user-related error.

[0271] A method of providing venous occlusion without the use of permanent implants or toxic drugs is preferable because it avoids the risks of infection, immune-mediated inflammatory response, neurological side effects, secondary debris transfer due to mechanical fatigue of the implant, and patient discomfort due to mass effect.

[0272] Additionally, bioabsorbable implant techniques have been associated with recanalization after absorption and have failed to provide long-term venous occlusion

[15] .

[0273] Surprisingly, the inventors discovered that using a purely mechanical non-implantable solution, the native thrombotic occlusion acts like an "implant" and is converted by the body's natural healing mechanisms into a permanent occlusion in a process known as fibrotic transformation of the thrombus.

[0274] In addition to methods for occluding GSVs, SSVs, AASVs, or large superficial tributary veins, methods are provided for treating shorter incompetent tributary veins, typically located below the knee. These are currently treated with a procedure known as phlebectomy. This is performed under local anesthesia by making a puncture skin incision and manually extracting short vein segments using a vein hook device. This procedure is often performed on multiple venous segments in the leg. It can be painful and uncomfortable for patients due to the need for multiple needle injections of local anesthetic and the difficulty of fully anesthetizing each vein segment. Due to unacceptable patient discomfort or physician preference, chemical sclerosing agents are often used instead. The increased number of chemical sclerosing agent injections can increase the risk of systemic toxic side effects and local complications, including skin necrosis due to inadvertent injection of sclerosing agent into the subcutaneous tissue or arterial system.

[0275] In one embodiment, a method for treating small tributary veins is performed using a miniaturized helical coil, as illustrated in Figures 66 and 67. The mechanism of action provided by this embodiment is similar to that previously described for treating large veins such as the GSV. Following insertion into the target vein, a miniaturized coil having an abrasive outer surface is deployed to exert a radial force on the vein wall. This surface ablates the inner layer upon withdrawal.

[0276] Referring to FIG. 65, in one embodiment, the helical coil is loaded around a needle as part of an intravenous cannula. Modifying the current configuration of an intravenous 14G cannula to reduce the size of the needle used to enter the vein makes it possible to accommodate the helical coil, as shown in FIG. 65, while maintaining the outer diameter of the sheath at 2.1 mm. Creating a more tapered tip with a polyurethane outer catheter allows access to the skin. Using the current intravenous access technique of venous access, needle withdrawal, and cannula advancement, as shown in FIG. 67, the miniaturized coil section can be deployed by partial withdrawal of the outer polyurethane cannula (FIG. 66). Once the end of the treatment zone is reached, the outer cannula can be used for coil recapture and atraumatic removal. This proposed technique reduces the need for local anesthesia because no puncture skin incision is required, nor is any traction on the vein required to extract the vein, as in a hook phlebectomy procedure. It also eliminates the need for chemical sclerosing agents, which reduces the associated risk of skin necrosis.

[0277] Referring to FIG. 68, in another embodiment, the vein is accessed with a small gauge needle and a guidewire is passed into the vein. As shown in FIG. 69, the guidewire is passed through an outer sheath, similar to the introducer sheath. This outer sheath is fabricated to contain a coil attached to its inner layer just below the tip opening. This allows the guidewire to pass through the coil within the introducer. The coil is then deployed by partial retraction of the outer sheath of FIG. 68. In another embodiment, the coil is deployed by using a peel-away introducer sheath, as shown in FIG. 70. In one embodiment, the coil can be reloaded into the sheath and used in a different vein.

[0278] Several indications related to body lumens that may be treated using the devices and methods of the present invention are described below.

[0279] Pelvic venous reflux Abnormal backflow of blood in the pelvic veins has been found to be an important, yet often previously unrecognized, cause of a condition known as recurrent leg varicose veins, vulvar / vaginal varicose veins, and pelvic congestion syndrome (PCS). It is also thought to be associated with hemorrhoids. Backflow of the internal iliac and ovarian veins in women is typically implicated in the development of these disorders.

[0280] PCS is characterized by pelvic venous congestion evident on venography in women with a history of chronic pelvic pain for 6 months or more. Most commonly, the left ovarian vein is the source of reflux and pelvic varicose vein-like swelling. Morbidity associated with PCS can be severe, significantly reducing quality of life and patient discomfort.

[0281] PCS presents with a variety of pelvic symptoms, including non-cyclic pain, urinary frequency, and dyspareunia. Current treatment is typically performed using catheter access via the jugular or femoral vein, followed by occlusion of the ovarian and / or internal iliac veins using metal embolic coils, chemical sclerosing agents such as 3% sodium tetradecyl sulfate (STS), or a combination of both. Disadvantages of coil embolization include the high cost of treatment associated with the coil device and the risk of complications, including coil migration and vein rupture. Coil migration occurs when the coil inadvertently migrates to a non-target site, such as the renal vein, or via the inferior vena cava into a pulmonary vein causing pulmonary embolism. Coil migration has been reported to occur in up to 4% of cases and can lead to significant morbidity.

[16] Some patients report persistent pelvic discomfort or flu-like symptoms, the cause of which is unknown but may be related to the coil implant. The use of endothermic laser or radiofrequency venous ablation has not been employed to treat pelvic venous insufficiency. This is primarily due to the risk of thermal damage to critical surrounding pelvic structures adjacent to the vessel wall. Although transmural vascular perforation and damage to surrounding tissues are rare with endothermic procedures, the impact during treatment in the pelvis is much greater than in the lower extremities. Furthermore, to protect surrounding tissues and prevent thermal damage and pain, large amounts of tumescent anesthesia are injected around the lower extremity veins during treatment. This is obviously not possible in the pelvis. Therefore, a safe and cost-effective device remains necessary for the treatment of obstructive pelvic venous reflux. The optimal solution would be a non-implantable, non-thermal method that reduces these risks.

[0282] In one aspect, the method of the present invention may be used to treat pelvic venous reflux, in which a helical coil device is used to mechanically ablate the internal iliac and / or ovarian veins, resulting in permanent occlusion. This occlusion prevents venous reflux into the lower extremity veins that cause recurrent varicose veins, the venous areas supplying the vaginal / vulvar veins, and the venous areas involved in PCS. In another embodiment, the ablation procedure may be combined with temporary balloon occlusion to reduce blood flow and promote thrombus deposition in the treated portion of the vein. This may be particularly beneficial in pelvic veins with higher amounts and velocities of reflux. In one embodiment, the treatment may be enhanced by the use of chemical sclerosing agents and / or embolic particles. Figure 71 is a schematic diagram illustrating the venous anatomy associated with pelvic venous reflux and the use of a helical coil to ablate the internal iliac vein, preventing reflux into the associated venous areas and curing the condition.

[0283] Deep venous reflux Deep venous reflux, caused by dysfunctional venous valves involving the femoral veins of the lower limbs, is essential for circulatory return of blood from the limbs to the heart and therefore cannot be treated by ablation or occlusion. While some incompetent venous valves are blocked by DVT, others retain normal valve leaflets, but due to wall relaxation, they no longer oppose correctly to prevent reflux. Current treatments require invasive surgical procedures to create new valves. Therefore, less invasive procedures are needed to restore venous valve function. In one aspect, the method of the present invention can be used to treat deep venous reflux, in which a helical coil device is deployed and retracted beyond an existing valve. The outer surface is mildly abrasive to reduce the risk of thrombotic occlusion while maintaining the ability to disrupt the endothelial layer. This thickens the valve leaflets and surrounding tissue, bringing them closer together and restoring one-way valve function to prevent reflux.

[0284] hemorrhoid As previously mentioned, hemorrhoids can be treated with pelvic venous embolization. Current techniques also target specific occlusion of the superior rectal artery to prevent filling of the dilated venous plexus that contributes to internal hemorrhoids.

[17] This artery is most often 3–5 mm in diameter. Improved treatments are needed to avoid the placement of permanent implants and provide a more cost-effective solution to this common condition. In one aspect, the method of the present invention is a method for the treatment of hemorrhoids that uses a helical coil device to mechanically dissect the superior rectal artery, creating permanent occlusion and preventing filling of the venous plexus, thereby curing the condition.

[0285] Varicocele Varicocele is a condition in which the veins surrounding the testicles in men become abnormally dilated. Clinically significant varicoceles are present in up to 15% of adult men, resulting in pain, discomfort, and reduced fertility. Treatment is recommended for young men with testicular atrophy or subfertility. Current treatments involve occlusion of the testicular veins that supply the abnormally dilated veins around the testicles. Current occlusion methods include permanent coil embolization, adhesives, chemical sclerosants, or a combination of techniques. Therefore, there remains a need for less invasive and more cost-effective methods for occluding the testicular veins that supply the dilated veins of varicocele. In one embodiment, the method of the present invention can be used to treat varicocele by mechanically ablating the testicular veins using a single-use helical coil, resulting in permanent occlusion. Figure 55 is a schematic diagram illustrating the venous anatomy and associated procedures for permanent venous occlusion.

[0286] Portal vein obstruction Preoperative portal vein embolization (PVE) is an elective procedure that stops portal vein blood flow to selected portions of the liver before performing a major liver resection. PVE can initiate hypertrophy of remaining liver tissue after a planned major resection, allowing for more aggressive resection. It has been used as an adjunctive step in the treatment of primary and secondary liver metastases from colorectal cancer. Current procedures involve accessing the portal venous system using direct image-guided transhepatic access, followed by injection of embolic agents including glue, polyvinyl alcohol (PVA), and metal spheres or coils. Many of these procedures are costly, and patients may become inoperable during the course of the planned resection. Therefore, a more cost-effective approach is needed. Due to the procoagulant state of most patients undergoing portal vein procedures as adjunctive treatment to tumor resection, a non-implantable procedure that relies on thrombotic occlusion of selected portal veins may be effective. In one aspect, the method of the present invention can be used for preoperative occlusion of the portal vein, in which a helical coil device is proposed to be used to mechanically dissect the portal vein to cause occlusion. This occlusion promotes hypertrophy of the remaining liver portion and improves the patient's chances of survival after the planned resection. Figure 53A is a schematic illustration of portal vein occlusion using a non-implantable mechanical ablation technique.

[0287] vein graft Coronary artery bypass graft (CABG) surgery is the standard treatment for patients with left main coronary artery disease (CAD) and triple-vessel CAD. Peripheral artery bypass graft (PABG) surgery is performed for patients with end-stage peripheral arterial occlusive disease. Although the internal thoracic artery is commonly used for revascularization in coronary artery bypass surgery, veins (almost exclusively the great saphenous vein) remain the most commonly used graft, particularly for PABG surgery. Placement of a vein graft into the arterial system exposes the vein to higher tensile and shear stresses, which can lead to excessive inflammatory changes within the vein wall, known as intimal hyperplasia, leading to occlusion and vein graft failure. The 10-year patency rate after vein graft surgery is only 60%.

[18] Why some vein grafts remain patent long-term while others become occluded is not well understood. All veins undergo some degree of remodeling or "arterialization" when implanted into the arterial system. However, an excessive and persistent inflammatory response can lead to graft failure in the long term. New research has shown that the condition of veins before grafting may be an important predictor of graft failure. Veins with already hypertrophied, synthetically predisposed smooth muscle cells in the medial layer have a poor prognosis. Therefore, methods to improve the long-term success rate of vein grafts for arterial disease are an important clinical need and can be achieved by preconditioning or modifying the vein graft prior to its use as a conduit in the arterial system. In one aspect of the present invention, a method is proposed for preconditioning veins to be used as grafts in the arterial system for the treatment of CAD and PAD. A helical coil with a less abrasive or partially abrasive surface is provided to result in venous wall thickening without complete thrombotic occlusion and subsequent fibrosis. The depth of venous wall destruction must be specific to elicit the correct inflammatory response that does not predispose the vein to graft failure. This adjunctive treatment is ideally performed 4 to 12 weeks before graft placement to allow the cellular changes involved in venous remodeling to occur and subside. This may improve the vein's ability to adapt to the arterial environment of greater pressure and higher shear, since inflammatory changes have already occurred and are halted after the one-time mechanical disruption of the treatment.Uncontrolled excessive inflammatory and hypertrophic changes are less likely to occur when placed within the arterial system. This prevents the development of uncontrolled excessive medial and intimal hypertrophy and reduces the risk of mural atheroma formation, a major cause of cardiac graft failure. Figure 72 shows the histological differences between normal veins, arterialized veins, and failed vein grafts.

[0288] Arteriovenous (AV) fistula An AV fistula is a surgically created anastomosis between the arterial and venous circulation to enable the treatment of end-stage kidney disease (ESKD) with dialysis. Patients with functioning AVFs have lower morbidity and mortality rates and lower treatment costs compared to patients who rely on central venous catheters for dialysis. Primary failure rates due to AVF creation are unacceptably high, ranging from 20% to 60%. Failure rates have risen in recent years due to an aging population dependent on AVFs for dialysis and increasing speeds of pumps used for dialysis

[19] .

[0289] The primary cause of failure is stenosis of the venous portion of the anastomosis. The underlying mechanisms of AVF formation are poorly understood, but insufficient outward remodeling and excessive intimal hyperplasia are thought to be involved.

[0290] Therefore, improved AVF creation methods for use in ESKD patients are urgently needed. In one aspect of the present invention, a helical coil with reduced or partial abrasiveness is used before anastomosis surgery to create a vein with a healthy remodeling pattern. This procedure should ideally be performed 4 to 12 weeks before AVF creation to allow cellular changes to occur and subside. This preconditioning of the vein may reduce the inflammatory response and uncontrolled remodeling that can lead to primary AVF failure when normal veins are suddenly exposed to arterial pressure and flow velocity. This may improve the success rate of AVF procedures. This technique may also prevent AVF steal syndrome, in which excessive hypertrophy of the venous side of the anastomosis leads to ischemia in the area supplied by the arterial side.

[0291] Thrombectomy Thrombotic occlusions can occur anywhere in the arterial or venous system and are typically composed of red blood cells, activated clotting factors, platelets, and inflammatory cells. The thrombotic mass organizes over minutes to days and adheres to the vessel wall, particularly if the vessel wall is damaged. The previously described embodiments of the present invention were designed to facilitate this event when vascular occlusion is required, primarily in the setting of superficial venous reflux.

[0292] The inventors have also discovered that radially expandable helical coils can also be used to remove thrombus adhered to blood vessel walls if modified so that the abrasive surfaces are present only on the leading edge and inner surface of the coil, while the outer surface remains smooth to prevent trauma to the vein wall.

[0293] Acute deep vein thrombosis (DVT) is potentially life-threatening if an embolism to the lungs occurs, known as pulmonary embolism (PE). Furthermore, substantial residual DVT in peripheral veins can lead to significant morbidity due to chronic venous hypertension in the lower extremities. Anticoagulation is the cornerstone of treatment to dissolve the clot and prevent embolism. Newer methods of treating acutely ill patients by removing the clot using mechanical, chemical, or ultrasound techniques have emerged over the past decade and have been shown to improve outcomes in certain patient populations. Removing a clot attached to the vein wall is technically challenging, and failure can result in poor outcomes. Newer techniques using complex mechanical systems, suction, or ultrasound are not reimbursed due to their high cost. Fogarty balloons are a low-cost option for thrombus removal but are ineffective against sessile clots. A similar need exists in the arterial system for removing organized clots that cause acute limb ischemia. In the neurovascular system, stent-recapture systems are used to retrieve clots and prevent stroke. In both of these situations, achieving a more organized and adherent thrombus is a technical challenge. Therefore, there is a need to develop improved solutions for removing adherent clots or thrombi from vessel walls. In one embodiment, a method is provided that uses a helical coil with abrasive inner and leading edge surfaces to remove thrombus from vessel walls without causing endothelial trauma. Figure 73 illustrates how such a device removes thrombus while leaving the endothelial surface intact and reducing the likelihood of rethrombosis. The device is deployed distal to the thrombotic occlusion and withdrawn proximally toward the access site. After thrombus removal, the thrombus can be removed from the circulation using a Fogarty balloon, recapture basket, or aspiration catheter. This restores blood flow and prevents the development of sequelae of vascular occlusion.

[0294] In-stent occlusion Percutaneous vascular stenting is commonly performed to restore blood flow in partially stenosed or occluded arterial or venous circulation. In-stent thrombosis, while relatively rare, occurs in approximately 1% of cases after cardiac stenting procedures and is a potentially life-threatening complication. Stents placed in diseased arteries may have struts covering calcified or atherosclerotic plaques. Stent strut elevation in this situation can lead to neointimal coverage failure, particularly in drug-eluting stents.

[20] This typically manifests as late or very late stent thrombosis one year or more after placement. There is a need to reduce the incidence of in-stent thrombosis after such procedures. In one aspect of the present invention, a helical coil is provided with an outer polished surface that covers a portion of the coil's circumference. This allows for selective treatment of portions of the arterial surface that are likely to remain uncovered after stenting. Figure 74 illustrates a method for selectively pretreating a portion of an artery prior to stent placement using a partially polished coil. This increases the likelihood of stent strut coverage by neointima and reduces the risk of late in-stent restenosis. Imaging techniques such as intravascular ultrasound (IVUS) may be used to position the device, allowing the surgeon to selectively target desired portions of the vessel wall.

[0295] arterial occlusion Selective occlusion of arteries, and generally the arterial supply to specific tissues, is an effective treatment for a variety of disease states. Tumor embolization is a technique for occluding arteries supplying either benign or malignant tumors using a variety of methods via a percutaneous approach, including synthetic or bioresorbable beads, metal spheres, adhesives, or metal coils. Common complications associated with the use of these agents include migration to non-target vessels, excessive occlusion causing necrosis of normal tissue, pain, and infections related to the combination of foreign material and necrotic tissue.

[21] Therefore, there is a need for minimally invasive, non-implantable treatments with lower complication rates for embolizing arteries supplying benign or malignant tumors.

[0296] Referring to Figures 52A and 52B, these show a tumor 240 and its arterial blood supply, including small arteries 241. A device of the present invention can be used to occlude one of the small arteries and starve the tumor of blood supply. Figure 52B shows the venous ablation head 242 of a device of the present invention deployed within a small artery, with the helical coil circumferentially engaging the arterial lumen.

[0297] 52A, the device is advanced along an artery supplying a tumor, deployed at point 243, and then retracted proximally. Retraction of the helical coil along the artery, coupled with circumferential contact between the rough surface of the helical coil and the lumen of the artery, causes a portion of the arterial lumen to be ablated along with removal of the cellular epithelial layer, resulting in thrombus formation at point 243 leading to arterial occlusion.

[0298] uterine fibroids Uterine fibroids are benign lesions that can cause significant pelvic pain and dysmenorrhea. They can be treated by hysterectomy or minimally invasive embolization of the uterine arteries supplying the fibroids. The most commonly used embolic agents for uterine artery embolization (UAE) are polyvinyl alcohol (PVA), tris-acrylic gelatin microparticles, and Polyzene-F hydrogel microparticles. Complications include migration of embolic material to non-target tissues and excessive necrosis leading to pain and infection. Therefore, there is a need for a minimally invasive, non-implantable treatment for uterine fibroids with a lower complication rate. In one embodiment, a method is provided for partially or completely occluding distal branches or uterine arteries supplying uterine fibroids using a helical coil with an abrasive outer surface. Reducing or eliminating blood flow reduces the size and relieves symptoms associated with uterine fibroids. Inducing intimal hyperplasia and achieving sufficient narrowing of the vessels using this method can reduce the risk of necrotic complications while maintaining the effectiveness of fibroid size reduction. This method may also be used to treat the following conditions, including but not limited to: arteriovenous malformations (AVMs) of the pulmonary, cerebral, or hepatic circulation, malignant tumors, benign prostatic hyperplasia (due to prostatic artery obstruction).

[0299] Patent foramen ovale Patent foramen ovale (PFO) is a common heart wall abnormality affecting approximately 30% of the adult population. While typically benign, in some cases, PFO opening can allow paradoxical emboli to migrate from the venous to the arterial circulation, potentially leading to stroke and systemic embolism. Patients with a history of unexplained stroke are treated with percutaneous closure using septal closure devices. These devices are permanent implants placed over the defect. The anatomy of a PFO involves overlapping of the septa primum and secundum, forming a flap valve that opens when right atrial pressure exceeds left atrial pressure, such as during coughing or sneezing. These devices are expensive and can lead to complications, including thrombosis and stroke. A minimally invasive treatment with a lower risk of complications is needed. In one embodiment, a method is provided that uses a coil or hoop-shaped abrasive device to ablate the contact surfaces of the involved atrial septal flaps. This results in an inflammatory response that causes adhesion formation between the flap surfaces, leading to permanent closure of the PFO and elimination of the risk of stroke. A similar method can be used in the heart to create scar tissue and block nerve conduction at aberrant conduction points that cause arrhythmias.

[0300] Patent ductus arteriosus The ductus arteriosus (DA) is a fetal vascular connection between the main pulmonary artery and the aorta, which diverts blood from the pulmonary bed. After birth, the DA undergoes active constriction and eventually occludes. Patent ductus arteriosus (PDA) occurs when the DA fails to close completely after birth. Histologically, the ductal tissue differs from that of the adjacent aorta and pulmonary artery. The ductal intima is thick, while the media contains more smooth muscle fibers arranged in a characteristic spiral pattern. DAs can take on various shapes and morphologies. Small PDAs are typically less than 3 mm in diameter. The optimal treatment for infants with PDAs requiring closure is a subject of controversy and debate. Current percutaneous treatment options include coils and occlusion devices. Limitations of these treatments include high costs and the risk of embolic complications due to coil migration. If occlusion devices are incorrectly sized, they can cause serious complications, such as aortic stenosis, as the child grows.

[22] Therefore, there is a need for less invasive and effective percutaneous treatments for PDAs. In one embodiment, a helical coil with an external polished surface is used to ablate the DA, which over time can cause thrombosis and fibrotic blockage. This would alleviate shunt-related symptoms and reduce the risk of endocarditis by closing the DA. This technology could also be used to treat small atrial septal defects in a similar manner.

[0301] aortic aneurysm An abdominal aortic aneurysm (AAA) is an abnormal dilation of the aorta that can rupture, resulting in significant morbidity and mortality. Treatment of aortic aneurysms aims to reduce the risk of rupture. Treatment options include open surgery with graft placement or endovascular aneurysm repair using a large covered stent-graft (EVAR). EVAR is a minimally invasive procedure with significantly faster recovery times and a lower risk of renal injury. However, long-term outcomes of EVAR are limited by endoleaks in up to 20% of patients, requiring radiological monitoring, reoperation, or adjunctive procedures.

[23] Endoleaks are classified as types I to V. Type I endoleaks occur at the proximal or distal graft attachment site. Blood enters through the gap between the vessel wall and the graft, filling the sac and posing a risk of rupture. Type II endoleaks occur when retrograde flow occurs from lumbar or mesenteric vessels via side branches into the aneurysmal sac, also posing a risk of rupture. Type I and Type II endoleaks account for the majority of morbidity associated with the postoperative course of EVAR. Current treatments for Type I endoleaks include the additional placement of miniature screws and stent grafts. Type II endoleaks can be treated with embolization coils placed in the lumbar region or in the mesenteric vessels supplying the sac. Both of these methods are invasive, costly, and associated with complications such as aortic wall rupture and infection. Therefore, there is a need for techniques to reduce the risk of Type I and Type II endoleaks. In one embodiment, a method is provided for preparing the aortic segment proximal to the graft attachment site to reduce the risk of Type I endoleaks. This is accomplished by using a helical coil to ablate the intima at these specific locations, which can be easily located based on preoperative imaging planning. By performing this procedure, the arterial wall is prepared to generate neointimal proliferation at the graft attachment site, reducing the risk of blood leakage and Type I endoleaks. This benefit reduces the risk of ancillary procedures that may complicate the postoperative course. A similar method can be used to treat type I endoleaks by inserting an expandable, elastic, abrasive device into the leaky gap, causing thrombotic occlusion with fibrotic deformation over time.A further method provides a way to treat Type II endoleaks by using expandable, resilient, abrasive elements to ablate the lumbar or mesenteric supplying arteries to create occlusion and prevent the risk of capsule rupture. Because flow in these arteries is retrograde from the anastomotic connection, they behave like veins and are capable of thrombotic occlusion with permanent coil placement. A similar method can be used to treat paravalvular leaks following percutaneous heart valve replacement. Paravalvular leaks after percutaneous mitral and aortic valve replacement can lead to postoperative morbidity and, potentially, reoperation.

[0302] diabetes intervention treatment Duodenal mucosal resurfacing (DMR) is a novel technique that has been shown in early clinical studies to improve glycemic control in diabetic patients.

[24] The duodenum is an important conduit for glucose absorption and signaling to endocrine organs. The duodenal mucosa becomes hyperplastic in response to a chronic high-carbohydrate diet, which is thought to produce insulin resistance signals and worsen glucose control. Removal of this hyperplastic mucosa allows for the regeneration of a new mucosal surface without the generation of harmful signaling. The anatomy of the duodenum shares several important characteristics with the venous system. The duodenum has a tortuous, curved path, is highly malleable, and distensible, and muscle wall contractions can cause stenosis. The goal of treatment is to safely remove only the superficial mucosal layer without affecting the deeper muscle layer. This is performed over a length of approximately 10 cm of the duodenum.

[0303] Current methods under development involve placing an expandable balloon capable of transmitting hydrothermal energy from the fluid within the balloon to the duodenal wall, thereby causing ablation or damage to the cells of the mucosal lining.

[22] This method requires a skilled endoscopist to create a thermal barrier by moving the mucosa away from the submucosa. This is currently achieved by creating suction channels around the balloon to hold the superficial mucosal layer while a needle is inserted under the mucosa and saline is injected. If this is not done correctly, there is a risk of perforation of the duodenal wall or damage to the deep muscular layer. Therefore, there is a need for a less invasive, easier to perform, less costly, and more rapid treatment method that can selectively ablate the superficial layers of the duodenum to a depth of 0.6 mm or less. In one embodiment of the present invention, a radially expandable, resilient, deformable abrasive device is delivered through the channel of a standard endoscope, as shown in Figure 75. The abrasive elements are deployed to contact the duodenal wall distally, near the junction with the jejunum. The abrasive elements have a surface roughness of 0.6 mm from peak to valley. The device is withdrawn proximally toward the stomach. During withdrawal, the device causes circumferential abrasion or damage to the mucosal layer, allowing for regeneration and improvement of glucose control. Similar methods can be used in other parts of the gastrointestinal tract to treat pathologies affected by the absorption of lipids, iron, vitamins, and minerals, including manganese.

[0304] Small intestinal bacterial overgrowth Small intestinal bacterial overgrowth (SIBO) occurs when excess microorganisms normally present in the large intestine colonize the small intestine. Invasive bacterial strains damage the intestinal surface by producing enterotoxins or by directly adhering to the wall. Fermentation of unabsorbed carbohydrates leads to bloating, distension, and flatulence. Inflammation or ileal inflammation may also occur, causing diarrhea and nutrient malabsorption. The small intestine (jejunum and duodenum) normally contains significantly lower concentrations of bacteria and other microorganisms than the large intestine. The boundary between these parts of the digestive tract is controlled by the ileocecal valve. Dysfunction of this valve can allow reflux of colonic contents into the small intestine, promoting the overgrowth of bacteria that feed on the nutrient-rich contents of the small intestine.

[25] Antibiotic treatment to stop bacterial overgrowth in the small intestine is currently used as first-line treatment. However, approximately 40% of patients with small intestinal bacterial overgrowth (SIBO) experience persistent symptoms even after initial antibiotic treatment. Abnormal reflux through the ileocecal valve has been demonstrated to be a causative factor in SIBO.

[25] Therefore, there is a need for more effective treatments for SIBO. In one embodiment, a radially expandable abrasive device is used to disrupt the mucosal layer of the ileocecal valve and ileum. This causes an inflammatory response and subsequent hyperplasia, which reduces the diameter of the ileocecal valve and the likelihood of reflux of fluid from the large intestine. A secondary effect is the removal of areas of the ileum colonized by adherent bacteria, allowing for the regeneration of normal or uncolonized mucosa. This method can be used in conjunction with antibiotic treatment to enhance efficacy and reduce the high recurrence rate. A similar method can be used to tighten the gastroesophageal junction, which can cause gastric reflux in the presence of sphincter atony.

[0305] Barrett's Esophagus Barrett's esophagus (BE) is a precancerous condition characterized by cellular changes in the lower esophagus due to chronic damage and inflammation caused by gastroesophageal reflux disease (GORD). It is estimated to be present in 10% of GORD patients. Early intervention can prevent progression to cancer. Current early intervention methods include thermal ablation and radiofrequency ablation of the affected superficial layer, allowing for regeneration of normal tissue

[26] . Radiofrequency ablation is a currently used technique involving endoscopic insertion of a radiofrequency probe. A major drawback of this method is the high cost of the radiofrequency device. Therefore, a simpler, more cost-effective treatment for this common condition is needed. In one embodiment, a method is provided for endoscopic deployment of a radially expandable abrasive element to mechanically remove abnormal cells in the lower esophagus, thereby reducing the risk of cancer development. Given that histological grading and definitive diagnosis of Barrett's esophagus are extremely challenging for pathologists, an additional advantage of this method is the ability to collect analyzable cells in the abrasion head after the procedure. This is in contrast to thermal methods, which completely destroy cells. This cell collection capability can also be applied to the diagnosis and management of pre-malignant or malignant lesions in other parts of the gastrointestinal tract, such as the colon, lung and bronchi, uterus, cervix, urinary tract, and bladder.

[0306] Management of perianal fistulas Perianal fistulas are abnormal connections between the rectum and the skin surrounding the anal canal. They exist in patients with inflammatory bowel disease and cause significant morbidity due to infection, pain, and bleeding. Current methods, which involve invasive surgical resection or suturing, involve staged removal of the channel over a long period of time. These treatment options result in a high recurrence rate.

[21] Therefore, there is a need for the development of less invasive and more effective treatments for perianal fistulas. In one embodiment, a radially expandable abrasive device is provided for deployment and retraction within the fistula tract. This causes the endothelial cell-lined tract to become detached. The subsequent inflammatory response leads to scarring, which can cause blockage due to the infiltration of fecal contents into the tract, preventing healing. The subsequent closure of the tract due to a fibrotic inflammatory response prevents symptoms. A similar method can be used to seal or close off portions of diseased lungs, as occurs in chronic obstructive pulmonary disease. When inhaled air enters these diseased areas, pulmonary oxygen exchange is disrupted and blood oxygen levels drop. In such cases, it is necessary to block or seal off the bronchioles or alveoli to direct air towards healthy lung tissue.

[0307] Contraceptive surgery Female sterilization is typically performed by tubal ligation if the patient desires permanent contraception. Current methods include open ligation, salpingectomy, and minimally invasive clip placement. Complications of these procedures include pain, bleeding, and infection. A less invasive and more reliable method that avoids surgical removal or permanent implantation is needed. In one embodiment, a radially expandable spiral device is inserted, deployed, and withdrawn into the fallopian tube. This disrupts the endothelial and subendothelial layers, initiating an inflammatory response and causing fibrotic obstruction of the fallopian tube over time. This technique can also be applied to male sterilization of the vas deferens lumen.

[0308] Figures 52-55 illustrate the use of the device of the present invention to occlude various blood vessels in the treatment of disease in a subject.

[0309] Referring to Figures 53A and 53B, the use of the device of the present invention to occlude the portal venous system is shown. This therapy can be used to treat liver cancer by occluding the portion of the portal venous system that brings nutrients to the liver from the intestine 254. In the figure, the vascular ablation head 252 is shown in a deployed configuration within the portal vein 251. As the helical coil is retracted along the vein, coupled with circumferential contact between the rough surface of the helical coil and the venous lumen, a portion of the portal venous lumen is ablated along with removal of the cellular epithelial layer, resulting in thrombus formation leading to venous occlusion.

[0310] 54, there is shown the use of the device of the present invention to treat an arteriovenous malformation, which is an abnormal tangle of blood vessels 261 connecting venous 262 and arterial 263 vessels. In the illustrated embodiment, the device of the present invention is advanced along the artery into the malformation, and the helical coil 264 is deployed in circumferential contact with the vessel 261 and retracted to ablate the vessel lumen, causing thrombus formation and occlusion of the vessel 261, thereby closing the shunt between the arterial and venous blood systems.

[0311] 55, there is shown the use of the device of the present invention to treat testicular venous insufficiency (or varicocele), a condition similar to varicose veins that occurs in veins within the scrotum 272 and can result in infertility, pain, and discomfort for the patient. In the illustrated embodiment, the device of the present invention is advanced along the left internal testicular vein 270, and the helical coil 271 is deployed in circumferential contact with the vein 270 and retracted to ablate the lumen of the vessel, causing thrombus formation and occlusion of the vessel 270, thereby occluding the vein and treating the condition.

[0312] Referring to FIGS. 56A-56C, the use of the device of the present invention is illustrated, particularly its ability to self-adjust its diameter to accommodate vessels of varying diameter. The coil is formed from nitinol and forms a helical coil in a relaxed state having a larger diameter than the vessel being treated. When the coil is deployed within the vessel (typically from a delivery catheter), the catheter stretches to conform to the vessel's circumference, exerting a radially outward force against the vessel's circumference via at least one turn of the coil. FIG. 56A shows helical coil 280 deployed within blood vessel 281 in circumferential contact with the vessel's lumen approaching a vessel stenosis 282, with the diameter of the proximal portion of the coil self-adjusting to the vessel's smaller diameter. FIG. 56B shows helical coil 280 passing through stenosis 282 and maintaining circumferential contact with the vessel's lumen just proximal to the stenosis. FIG. 53C shows a helical coil that self-adjusts to maintain circumferential contact with the lumen of the blood vessel as it moves proximal to the stenosis and the coil expands.

[0313] Referring to Figures 57A-57C, the use of the device of the present invention is illustrated, particularly showing a helical coil forming part of the device of the present invention passing through a valve in a vein as it is pulled through a portion of the vein: (A) deployed helical coil 290 attached to control arm 31 and in circumferential contact with the lumen of vein 291 distal to valve 292; (B) helical coil 290 being retracted proximally through valve 292, with the coil diameter self-adjusting to prevent the coil from catching on the valve leaflets; (C) helical coil moving proximal to the stenosis and self-adjusting to maintain circumferential contact with the lumen of the vessel proximal to the valve.

[0314] 58A-58B, the use of the device of the present invention is illustrated, particularly how the helical coil forming part of the device of the present invention can self-adjust as it passes through a progressively narrower portion of vasculature 300, with the diameter of helical coil 301 self-adjusting to maintain circumferential engagement with the lumen of the vessel. (A) Deployed helical coil 301 in circumferential contact with a wider portion 302 of the vessel; (B) Deployed helical coil 301 in circumferential contact with a narrower portion 303 of the vessel.

[0315] 59A-59C, the use of the device of the present invention is illustrated, particularly how the helical coil forming part of the device of the present invention can self-adapt to different diameters of blood vessels and traverse tortuous blood vessels: (A) deployed helical coil 310 in circumferential contact with the lumen of a blood vessel at a stenosis 311; (B) helical coil 310 passing through a sharp turn 312 in a blood vessel while maintaining circumferential contact with the lumen of the blood vessel; and (C) helical coil 310 passing through a second sharp turn 313 in a larger diameter blood vessel while maintaining circumferential contact with the lumen of the blood vessel. It can be seen from the figures how the helical coil adapts to changes in blood vessel diameter and maintains circumferential contact with the lumen of the blood vessel while traversing tortuous turns.

[0316] Referring to Figures 60A and 60B, the use of the device of the present invention is illustrated, particularly how the helical coil forming part of the device of the present invention can self-adjust its diameter to maintain circumferential engagement with the lumen of a vessel when the vessel contracts due to vasospasm. (A) A deployed helical coil in circumferential contact over a length I within a wide vessel of diameter D prior to vessel vasospasm; cross section AA shows an axial view of the coil within the vessel under a confining pressure P that translates as a hoop force (HF) within the coil. This HF is facilitated by its open-ended design, stretching the coil. (B) A deployed helical coil in circumferential contact over an elongated length L within a vessel constricted to diameter d during vasospasm.

[0317] 62A and 62B, the use of the device of the present invention to partially occlude a body lumen is illustrated, and in embodiments, the use of the device of the present invention to partially occlude a blood vessel to normalize blood volume or flow, particularly for treating vasculature having abnormally high blood volume or high blood flow. (A) shows a pulmonary artery 330 before treatment, with a device of the present invention including a helical coil 331, control arm 31, and catheter member 2 deployed within the artery and pulled in the direction of arrow X; (B) shows a pulmonary artery 330 after treatment with a device of the present invention, with intimal thickening 333 partially occluding the artery to provide reduced blood volume and flow through the artery.

[0318] Assessment of the vessel wall Understanding the biophysical properties of the vessel walls of the arterial and venous systems is important for both predicting disease progression and assessing response to treatment.

[0319] Abnormalities in the vascular endothelium are now recognized as early precursors of vascular disease.

[28] One such marker is the degree to which blood vessels constrict or spasm in response to mechanical or chemical stimuli. Chronic hypertension and / or chronically uncontrolled blood glucose levels cause damage to the endothelial layer, which can be detected much earlier than atherosclerosis, arterial narrowing, or occlusion. Acetylcholine iontophoresis is a method for examining endothelial responses in conjunction with measuring blood flow across a cross-section of a blood vessel. These methods have experimentally shown that endothelial function is impaired by the consumption of sugar-sweetened beverages and chronic hypertension.

[29] Currently, there are no methods available to assess endothelial cell function within or adjacent to atherosclerotic lesions during vascular intervention procedures.

[0320] Therefore, more information about endothelial function is needed to inform treatment decisions and prognosis. For example, during angioplasty, there is currently no way for physicians to know how the vessel wall is responding to dilation. This can lead to complications, including vessel rupture, bleeding, and thrombotic occlusion.

[30] Currently, the air pressure inside the inflated balloon is measured and inflated to a standard level based on experience and angiographic appearance after inflation. However, due to differences in vessel wall properties and patient-to-patient variability, predicting the occurrence of complications such as vessel wall rupture remains difficult. In one embodiment, a radially expandable element that contacts the vessel wall at discrete points is used to measure the endothelial response to chemical or mechanical stimuli. The mechanical stimulus can be provided by a radial force from the device itself, which can be static or variable via a control arm.

[0321] Chemical stimulation can be provided by coating the device surface with a pharmacological agent. In one embodiment, a piezoelectric sensor is incorporated into the radially expandable element to measure the effects of coil pressure and flow during endoluminal treatment. The expandable element within the venous lumen generates an outward radial force, generating a hoop force (HF) within the vessel wall. This elongation HF creates an opposing compressive hoop force within the endoluminal device. Measuring the intrinsic compression within the device therefore serves as a surrogate marker for characterizing the vessel wall's response to elongation. This data may be recorded and stored in a central controller. This data may be used for future performance improvements, including automation of vascular treatments. This data may also be used manually or using machine learning methods to determine prognosis or validate diagnostic markers for vascular disease.

[0322] Doctrine of Equivalents The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations therein are expected to occur to those skilled in the art in light of these descriptions. These modifications and variations are intended to be encompassed within the scope of the appended claims.

[0323] References 1.Evans CJ,et al.Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population:Edinburgh Vein Study.J Epidemiol Community Health 1999 2.O’Donnell TF,et al.Assessment of thrombotic adverse events and treatment patterns associated with varicose vein treatment J Vase Surg:Venous and Lym Dis 2015 3.Proebstle T.M,et al.Endovenous treatment of the greater saphenous vein with a 940-nm diode laser.Thrombotic occlusion after endoluminal thermal damage by laser-generated steam bubbles.J Vase Surg 2005 4.Ikponmwosa A,et al.The Impact of Different Concentrations of Sodium Tetradecyl Sulphate and Initial Balloon Denudation on Endothelial Cell Loss and Tunica Media Injury in a Model of Foam Sclerotherapy Eur J Vase Endovasc Surg 2010 5. Boersma D, et al. Macroscopic and Histologic Analysis of Vessel Wall Reaction After Mechanochemical Endovenous Ablation Using the ClariVein OC Device in an Animal Model. Eur J Vase Endovasc Surg 2016 6. Lane TR, et al. Retrograde inversion stripping as a complication of the ClariVein® mechanochemical venous ablation procedure. Ann R Coll Surg Engl 2015 7. Rice JB, et al. Burden of venous leg ulcers in the United States. Journal of Medical Economics 2014 8. Gohel MS, et al. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. New Eng J Med 2018 9. Kerver AL, et al. The surgical anatomy of the small saphenous vein and adjacent nerves in relation to endovenous thermal ablation. J Vase Surg 2012 10.Whiteley M,et al.Media Damage Following Detergent Sclerotherapy Appears to be Secondary to the Induction of Inflammation and Apoptosis:An Immunohistochemical Study Elucidating Previous Histological Observations.Eur J Vase Endovasc Surg 2016 11.Chen YM,et ai.Study on the Sliding Friction of Endothelial Cells Cultured on Hydrogel and the Role of Glycocalyx on Friction Reduction.Advanced Engineering Materials 2010 12.Dimitrievska S,et ai.New functional tools for antithrombogenic activity assessment of live surface glycocalyx.Arterioscler Thromb Vase Biol.2016 13.Caggiati A,et al.Segmental hypoplasia of the great saphenous vein and varicose disease.Eur J Vase Endovasc Surg 2004 14.Sanioglu S,et al.Mid-calf level as a puncture site is not safe enough for thermal ablation of the small saphenous vein.SAGE Open Medicine 2017 15.Proebstle T.M,et al.A two-cohort feasibility study on polyglycolic acid yarn implantation for abolition of saphenous vein reflux.J Vase Surg:Venous and Lym Dis 2018 16.Kwon SH,et al.Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome.Cardiovasc Intervent Radiol 2007 17.Zakharchenko A,et al.Safety and efficacy of superior rectal artery embolization with particles and metallic coils for the treatment of hemorrhoids(Emborrhoid technique)Diagnostic and Interventional Imaging 2016 18.Owens,C.D.Adaptive changes in autogenous vein grafts for arterial reconstruction:clinical implications.J.Vase.Surg.2010 19.Beathard GA,et al.Aggressive treatment of early fistula failure.Kidney International 2003 20.Oyabu J,et al.Angioscopic evaluation of neointima coverage:sirolimus drug-eluting stent versus bare metal stent.Am Heart J.2006 21. Leyon JJ, et al. Endovascular Embolization: Review of Currently Available Embolization Agents. Curr Probl Diagn Radiol, January / February 2014 22. Delaney JW, et al. Patent ductus arteriosus closure using the Amplatzer® vascular plug II for all anatomic variants. Catheter Cardiovasc Interv 2013 23. Avgerinos ED, Chaer RA, Makaroun MS. Type II endoleaks. J Vase Surg 2014 24. Haidry RJ, et al. Duodenal mucosal resurfacing: proof - of - concept, procedural development, and initial implementation in the clinical setting. Gastrointestinal Endoscopy 2019 25. Roland BC, et al. Low ileocecal valve pressure is significantly associated with small intestinal bacterial overgrowth (SIBO). Dig Dis Sci. 2014 26. Akiyama J, et al. Managing Barrett’s esophagus with radiofrequency ablation. Gastroenterology Report 1 2013 27. Keogh KM, et al. The proposed use of radiofrequency ablation for the treatment of fistula - in - ano. Med Hypotheses 2016. 28.Boulanger CM,et al.Highlight on Endothelial Activation and Beyond.Arterioscler Thromb Vase Biol 2018 29.Loader J,et al.Effects of Sugar-Sweetened Beverage Consumption on Microvascular and Macrovascular Function in a Healthy Population.Arterioscler Thromb Vase Biol 2017 30.Gruberg L,et al.Incidence,management,and outcome of coronary artery perforation during percutaneous coronary intervention.Am J Cardiol 2000

Claims

1. A device (1, 30, 40, 50, 60) for ablating a vein, comprising: a venous ablation head (3) operably attached to the elongate catheter member (2) and configured for transluminal delivery and deployment within a vein; the vein ablation head includes a helical coil (4) within the catheter member that is self-adjusting from a non-coiled delivery configuration suitable for transluminal delivery to a coiled deployed configuration that circumferentially engages the vein lumen when deployed and has a diameter larger than the vein to be ablated in use; the helical coil is formed from a flat wire having a roughened surface, the outer surface of the roughened flat wire having a plurality of teeth thereon to provide circumferential engagement between the roughened surface and the venous lumen, the plurality of teeth being perpendicular to an axial direction of the venous lumen, and in the coiled, deployed configuration, the coil irreversibly damages and circumferentially ablates the venous lumen when moved axially along the vein; A device wherein the helical coil in its deployed configuration is configured to self-adjust to different vein diameters as it transitions along the vein.

2. The device of claim 1 , wherein the flat wire has a smooth inner surface.

3. 3. The device of claim 1 or 2, wherein the venous ablation head is permanently attached to the catheter member.

4. 4. The device of claim 1, wherein the helical coil is configured to reflexively self-adjust its diameter during axial movement along a treatment zone in response to varying vein diameters and varying axial forces while maintaining an outward radial force on the vein.

5. The device of any one of claims 1 to 4, wherein the helical coil is made of a shape memory material and is configured to assume a coiled configuration when deployed.

6. The device according to any one of claims 1 to 5, wherein the device includes an elongated control arm for the venous ablation head disposed within the catheter member.

7. 7. The device of any one of claims 1 to 6, wherein the coil diameter of the coiled deployed configuration of the helical coil varies along its length.

8. The device of any one of claims 1 to 7, wherein the helical coil comprises a plurality of coil elements.

9. 9. The device of claim 1, wherein the helical coil is configured to have a pitch of about 0.5 to 1.5 times the helical coil diameter in the coiled deployed configuration when deployed.

10. The device according to any one of claims 1 to 9, wherein the roughening is produced by mechanical abrasion, electrical abrasion, chemical abrasion or abrasion by other means.

11. The device of claim 1 , wherein the teeth have a profile selected from a triangle, a polygon, or a diamond.

12. 10. The device of claim 1, wherein the teeth have a peak-to-valley height of between 5 and 100 microns.

13. 13. The device of any one of claims 1 to 12, wherein the device includes a handle operably connected to a proximal end of the catheter member and configured to control the deployment and retraction of the helical coil by axial adjustment of the catheter member relative to the helical coil.

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