Device for stripping a body lumen

Abstract

A device (1, 30, 40, 50, 60) for stripping a vein comprises a vein stripping head (3) operably attached to an elongated catheter member (2) and configured for transluminal delivery and deployment in a vein. The vein stripping head comprises a spiral coil (4) which can achieve self-adjustment between an uncoiled delivery configuration and a coiled deployment configuration, wherein the uncoiled delivery configuration is suitable for transluminal delivery within the catheter member, wherein the coiled deployment configuration has a diameter larger than the vein to be stripped, and wherein the spiral coil (4) circumferentially engages the lumen of the vein when deployed. The spiral coil has an abrasive surface which is configured to circumferentially strip the lumen of the vein when the coil is moved axially along the body lumen in the coiled configuration. The spiral coil can be a single spiral coil element.

Description

Technical Field

[0001] The present invention relates to a device for denuding a body lumen, in particular a superficial vein. Also contemplated are methods for denuding a body lumen, in particular a superficial vein, and methods for treating varicose veins. Background Art

[0002] Varicose veins are dilated, tortuous veins associated with structural changes in the vessel wall, incompetent venous valves, blood backflow and pooling. They form part of the spectrum of chronic venous disease (CVD). Patients experience heaviness, soreness, swelling, and in severe cases, skin inflammation, abnormal skin color, and ulcers. The cause of varicose veins is still unclear, but genetic factors leading to insufficient venous wall components and weak valves are important in the development of this disease.

[0003] Varicose veins most commonly develop in the superficial venous network of the lower extremities, but may also develop in the pelvic and esophageal veins in certain disease states. The superficial veins carry blood from the skin and subcutaneous tissues into the deep venous network and ultimately back to the heart. The major superficial vein is the great saphenous vein (GSV) that runs from the ankle to the groin on the inside of the lower extremity. The small saphenous vein (SSV) runs from the ankle to the knee on the posterior surface of the lower leg. The GSV and SSV join the deep femoral vein at their junctions in the groin and behind the knee, respectively.

[0004] Veins contain valves to prevent blood from flowing backwards by increasing the pumping efficiency of the leg muscles. The valve has a bicuspid structure formed by endothelial folds supported by connective tissue and smooth muscle. GSVs have 10 to 20 valves, and SSVs usually have 6 to 12 valves. Valvular insufficiency causes blood to flow backwards in the opposite direction of normal flow, which can be observed using Doppler ultrasound.

[0005] Veins have thinner walls, while arterial walls are thicker and more elastic. Veins are more compliant (flexible), allowing the venous lumen to contract under low pressure and expand when venous pressure increases. Saphenous vein wall thickness typically ranges from 200 to 700 micrometers (μm). Similar to arteries, vein walls consist of three major layers: the intima, media, and adventitia. However, unlike arteries, the thickness and composition of the layers in veins are different, making the vessels more compliant and less muscular. The intima layer consists of a single layer of squamous cells called the endothelium, with some thin elastic fibers, collagen, and smooth muscle cells. Importantly, there is a large non-cellular layer of macromolecules called the glycocalyx that covers the endothelium and protects it from shear forces. The glycocalyx is usually a uniformly distributed structure with a thickness of 0.5-3μm, which is greater than the thickness of the endothelial cells (0.2μm). The media is composed of collagen, elastic fibers, and three layers of smooth muscle cells. The adventitia is the thickest layer and contains dense collagen, sensory nerves, and elastic fibers.

[0006] Blood clotting or thrombosis can occur in both the deep and superficial venous networks. Because of their low flow, blood clots in superficial veins are usually isolated and rarely spread to the deep venous network. They are not dangerous to the patient and do not require treatment unless there is an associated inflammation called thrombophlebitis. Blood clots that occur in the deep veins of the legs, called deep vein thrombosis (DVT), are clinically relevant because they cause blockage of venous outflow, which increases venous pressure and causes leg swelling. Blood clots can also travel (embolize) to the lungs, causing a potentially fatal condition called pulmonary embolism (PE).

[0007] Varicose veins are the most common peripheral vascular disease, with a prevalence of up to 40% in the adult population [1]. Risk factors include age, family history, obesity, occupations that require prolonged standing, and a sedentary lifestyle.

[0008] Treatment options range from conservative management with compression stockings to surgical intervention. In the United States, approximately 600,000 to 700,000 surgeries are performed each year to treat varicose veins. Treatment of varicose veins has shifted from open surgery, which involves stripping the entire GSV, to less invasive, heated intravenous catheter-based techniques, including radiofrequency or laser energy. Some countries, including Germany and the United Kingdom, still rely on open vein stripping surgery.

[0009] Today, minimally invasive catheter-guided thermal therapy is commonly used to treat superficial venous reflux. A major drawback of using thermal energy treatment is the need for multiple injections of large volumes of local anesthetic mixed with saline (tumescent fluid) to isolate the vein and protect surrounding tissue from thermal damage. This is both time-consuming for the physician and painful for the patient due to the need for multiple needle sticks in the leg. The need for space between the skin and the vein to inject the tumescent fluid also limits treatment when the vein being treated is close to important nerves (such as when treating veins below the knee), close to the skin, or close to ulcers in patients with advanced CVD (CEAP grades 5 and 6).

[0010] Despite the use of tumescent anesthesia, thermal injury to the peripheral nerves and skin may still occur. A series of studies have found that the rate of nerve injury leading to persistent paresthesia is 0%-9%, with a higher rate of injury in ablation treatment of the GSV or SSV below the knee.

[0011] Thromboembolic events are the most serious complication of superficial venous counterflow therapy. Real-world studies have found rates of DVT and PE to be 3%–4% and 0.2%–0.3%, respectively [2]. All currently used treatment techniques have inherent limitations that increase the risk of developing DVT and / or PE. It is important that any new treatment modality for varicose veins is designed to further reduce the risk of thromboembolic complications.

[0012] An inherent problem with current thermal therapies is the risk of endothelial heat-induced thrombosis (EHIT), which can lead to DVT and PE. This is thought to be caused by the forward conduction of thermal energy from the tip of the thermal ablation device into the deep venous system. Newer laser tip fibers emit energy radially, thereby reducing the risk of forward conduction. However, these technologies do not prevent the spread of vapor bubbles to adjacent non-target sites, which, in addition to tissue absorption of light, is also a proposed mechanism by which vapor diffusion may occur during thermal ablation procedures [3].

[0013] In the past 10 years, new non-thermal, non-tumescent (NTNT) technologies have emerged for the treatment of CVD. NTNT technologies, which are less painful, are more suitable for clinic settings, and about 90% of surgeries are now performed in clinics in the United States. Current NTNT technologies include chemical foam sclerotherapy, mechanochemical ablation (MOCA), and cyanoacrylate glue (CAG) embolization.

[0014] Chemical sclerotherapy (injection of a chemical agent that destroys the endothelial cell membrane, thereby hardening the vein and causing it to occlude) has been used for many years, but its efficacy in large veins is greatly reduced due to dilution and blood components that render the sclerosant ineffective. A newer technique is to mix the sclerosant with a gas to produce a foam to form a microbubble emulsion, which displaces blood and allows the chemical to remain in contact with the endothelium for a longer period of time. Despite this improvement, efficacy remains significantly lower than that of thermal techniques, likely due to incomplete coverage of the endothelium by the chemical sclerosant, as previously known from histological studies [4]. The potential risk of DVT is increased because the foam can spread into the deeper system, damage the endothelium, and form a DVT. More concentrated sclerosant-foam mixtures may be more effective but are associated with a higher risk of DVT and systemic complications. Systemic complications of chemical sclerosants include transient ischemic attacks (TIAs) and stroke due to the sclerosant compounds entering the arterial circulation through a small hole in the heart septum (patent foramen ovale). The teratogenicity of chemical sclerosants is also unknown, and they are contraindicated in pregnant women.

[0015] MOCA involves a combination of a chemical sclerosant and a mechanical effect from within the vein lumen that work together to improve the distribution of the sclerosant and stimulate the vein to promote venous spasm, thereby reducing the diameter of the vein. Histological studies have shown that this approach has limited mechanical effects on endothelial cell integrity[5]. Mid-term follow-up studies have shown that this approach has clinical efficacy, but at a level lower than current thermal technologies. The distal end of current mechanical MOCA devices is prone to hooking or entrapment in the vein wall or valve. Previous studies have shown[6] that this can cause patient discomfort, injury, and even inadvertent vein stripping.

[0016] Gel embolization involves the injection of cyanoacrylate or an equivalent compound, which produces an inflammatory response that results in venous occlusion. Disadvantages include permanent implantation of a foreign substance within the lumen of the vein, the subsequent risk of allergic reaction, and the risk of embolism into the deep venous system leading to DVT and / or PE.

[0017] Venous leg ulcers represent a major healthcare cost burden in the United States, costing $14 billion per year[7] and are currently managed primarily with compression bandages. New data from the EVRA study[8], published in April 2018, provide level I evidence to support early intravenous treatment of varicose veins to improve the rate of ulcer healing in patients with CEAP grade VI (C6) disease. Thermal therapy is less suitable for patients with venous ulcers. In the elderly patient population, multiple injections of tumescent anesthesia prolong the procedure and increase the risk of infection and hematoma formation due to poor skin integrity adjacent to the ulcer. When treating veins below the knee, the goal is usually to prevent venous reflux adjacent to the ulcer bed, and thermal therapy also increases the risk of nerve damage leading to paresthesia[9].

[0018] Devices for treating blood vessels including varicose veins are described in WO2017194698, US2016030719, US2016030068, US2016030023, WO2016102930, US2011046543, US2016242790, JP2016034485, WO2004112569, US2017056048, GB2519057 and US5011489.

[0019] US6402745 discloses a spring electrode with a spiral structure for electrically destroying the lumen of a blood vessel. The electrode is housed in a catheter, and the distal end of the electrode route extends from the end of the catheter to contact the lumen of the blood vessel in a spiral manner. Due to the contact area between the electrode and the lumen of the blood vessel, the device only partially denudes the lumen of the blood vessel.

[0020] WO2014140325 describes an implantable embolic bristle device that is capable of stripping 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, wherein the bristles are configured to engage the lumen of the blood vessel to strip the blood vessel by brushing the lumen of the blood vessel. The larger volume of the implantable device in the superficial veins, especially in the groin and knee areas, may cause discomfort to the patient. The use of bristles to strip the veins may result in an incomplete stripping of the lumen of the vein. Multiple pointed and / or elongated components significantly increase the risk of hooking and perforation in the thinner compliant vein wall.

[0021] It is an object of the present invention to overcome at least one of the above problems. Summary of the invention

[0022] The present invention addresses the need for a device for treating superficial venous reflux that avoids the problems associated with prior art thermal, chemotherapeutic and gel implant treatment techniques while providing optimal efficacy comparable to thermal treatment modalities. The above objects are achieved by providing a vein stripping device that includes a coil that is configured to be delivered transluminally to a vein to be treated during surgery (non-implantation) and deployment, whereby the coil circumferentially (ideally completely circumferentially) engages the lumen of the vein. The coil is an oversized coil (i.e., its diameter when deployed is greater than the diameter of the vein to be treated) and has a roughened lumen-engaging surface such that when the coil is deployed, the roughened surface abuts the lumen of the vein, and in the deployed configuration, the coil moves axially along the vein causing the abrasive surface to shear the lumen of the vein. This results in mechanical stripping of the vein along the length of the vein, typically with consequent destruction of the endothelial and medial layers of the vein, and ideally due to the formation of a thrombus, which undergoes fibrotic transformation in the absence of an endothelial lining in the vessel, ultimately resulting in occlusion of the vein. Ideally, the endothelium is completely circumferentially disrupted because if small areas remain intact, thrombi may not form and blood will continue to flow, leading to treatment failure, recanalization, and / or early recurrence. Therefore, the device of the present invention includes a helical coil that is oversized relative to the diameter of the vein to be treated to ensure circumferential engagement between the rough surface of the helical coil and the vein lumen. In addition, the coil (due to its elastically deformable configuration) can self-adjust to allow continuous circumferential engagement while maintaining an outward radial force along veins or vessel segments with different diameters and tortuosity (Figure 59).

[0023] According to a first aspect of the present invention, there is provided a device for stripping a body lumen, comprising a body lumen stripping head operably attached to an elongated catheter member and configured for transluminal delivery and deployment in a body lumen, the body lumen stripping head comprising a coil, the coil being capable of adjusting between an uncoiled delivery structure and a coiled deployment structure, the uncoiled delivery structure being suitable for transluminal delivery within the catheter member, the coiled deployment structure having a diameter equal to or greater than a vein to be stripped, and the coil circumferentially engaging the inner cavity of the body lumen, the coil having an abrasive surface, the abrasive surface being configured to strip the body lumen when the spiral coil in the coiled structure is moved axially along the body lumen with rotation or non-rotation.

[0024] According to a second aspect of the present invention, a method for stripping a body lumen using a device is provided, the device comprising a body lumen stripping head which is operably attached to an elongated catheter member and is configured for transluminal delivery and deployment in a body lumen, the method comprising the steps of: transluminally delivering the body lumen stripping head to a body lumen to be treated; deploying the body lumen stripping head in the body lumen to be treated, wherein the body lumen stripping head has an abrasive surface which is in circumferential contact with the inner cavity of the body lumen when deployed; moving the body lumen stripping head along the segment to be treated of the body lumen, wherein the abrasive surface is in circumferential contact with the body lumen, thereby stripping the body lumen; retracting the stripping head into the catheter member; and removing the device from the body lumen.

[0025] In one embodiment, the coil is a helical coil.

[0026] In one embodiment, the coil is "oversized" relative to the diameter of the body lumen to be treated.

[0027] In one embodiment, the diameter of the coil (or the largest diameter in the case of a helical coil with varying diameters along its length) is typically at least about 5% larger than the diameter of the body lumen to be treated (or at least about 5% larger than the diameter at the widest point of the body lumen in the case of a body lumen with varying diameters), for example at least 10%, 15%, 20%, 25% or 30% larger than the diameter of the body lumen to be treated, typically 5-30% larger. Importantly, at least one turn of the coil is oversized, typically 1-2 turns of the coil are oversized.

[0028] In one embodiment, the device is configured to denature the lumen of a vein.

[0029] In one embodiment, the coil comprises a shape memory material and is configured to adopt a coiled configuration when deployed.

[0030] The helical coil generally has sufficient elastic deformation so that it can maintain self-adjustment of the circumferential radial force against the walls of the body lumens of different diameters as it travels along the body lumen. In one embodiment, the helical coil is configured to reflexively self-adjust its diameter in response to different vein diameters and different axial forces while maintaining an outward radial force against the vein as it moves axially along the treatment region.

[0031] The helical coil in its deployed state is oversized relative to the widest portion of the body lumen (or segment of the body lumen to be treated) so as to apply a radial force around the entire circumference of the body lumen along the length of the body lumen to be treated including its widest point.

[0032] The helical coil typically has sufficient elastic deformation to allow the coil to be routed around tortuosity in a body lumen while maintaining a radial force against the body lumen along the bend.

[0033] Helical coils typically have sufficient elastic deformation to allow the coil to pass through a stenosis or obstruction in a body lumen, such as a valve in a vein.

[0034] In one embodiment, the device includes an elongated control arm disposed within a catheter member for a body lumen stripping head.

[0035] Typically, a control arm is connected to the proximal end of the coil.

[0036] The control arm may be a hypotube, such as one made of stainless steel, a polymer, or other material.

[0037] In one embodiment, the coil has a single coil element.

[0038] In one embodiment, in the deployed configuration, a single coil element has 1-5 turns, 1-4 turns, 1-3 turns, preferably 1-2 turns, ideally about 1.5-1.7 turns.

[0039] In one embodiment, the diameter of the helical coil varies along its length.

[0040] In one embodiment, the diameter of the helical coil increases toward one end (ie, conical).

[0041] The diameter may increase from the proximal end to the distal end, or from the distal end to the proximal end.

[0042] As used herein, the term "proximal" as applied to a helical coil refers to the end of the device closest to the point of introduction, and the term "distal" should be construed accordingly.

[0043] In one embodiment, the diameter of the helical coil increases along the coil toward the midpoint and then decreases.

[0044] In one embodiment, the distal end of the coil terminates at a point disposed along or adjacent to the longitudinal axis of the helical coil.

[0045] In one embodiment, the helical coil has a proximal portion of a first diameter, a middle portion of a reduced diameter relative to the proximal portion, and a distal portion of an increased diameter relative to the middle portion.

[0046] In one embodiment, the helical coil has proximal and distal helical coil portions, and an intermediate connecting (transition) portion which is generally not helical and may be straight or curved.

[0047] In one embodiment, one of the proximal or distal helical coil portions is a right-handed helix and the other of the proximal or distal helical coil portions is a left-handed helix.

[0048] In one embodiment, the proximal helical coil portion is a right-handed helix and the distal helical coil portion is a left-handed helix.

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

[0050] In one embodiment, the coil comprises a plurality of coil elements, for example 2, 3, 4, 5 or more. Typically, each coil element is helical.

[0051] The helical coils may be arranged in two, three or four coils.

[0052] Typically, the coil elements are coaxial.

[0053] Typically, each coil element has the same diameter when deployed.

[0054] Typically, each coil element has the same pitch when deployed. When in the deployed configuration, the plurality of coil elements together provide circumferential engagement of the lumen of the body lumen. Thus, each coil element may be configured to engage only a portion of the lumen circumference in the deployed configuration, such as at 90°-270°, 90°-180°, 180°-270°, with the body lumen circumference.

[0055] Each coil element may be connected to the same control arm.

[0056] In one embodiment, the coil has two helical coil elements, such as a double helix.

[0057] 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.

[0058] In one embodiment, the coil has three helical coil elements, such as a triple helix.

[0059] Typically, each of the three helical coil elements has at least 0.3 turns when deployed, typically 0.3-1.0 turns or about 0.3-0.5 turns when deployed.

[0060] In one embodiment, the coil has four helical coil elements.

[0061] Typically, each of the four helical coil elements has at least 0.25 turns when deployed, and typically 0.25-0.75 turns when deployed.

[0062] In one embodiment, the plurality of coil elements are connected together at their distal ends.

[0063] In one embodiment, the plurality of coil elements are unconnected at their distal ends.

[0064] In one embodiment, the coil or each coil element is helical and is configured such that when deployed in a coiled configuration its pitch is approximately 0.5-1.5 times the diameter of the coil.

[0065] In one embodiment, the coil or each coil element is helical and is configured such that when deployed, in a coiled configuration, its pitch is approximately equal to its diameter.

[0066] In one embodiment, one of the helical coil elements is axially spaced from the other coil element. Typically, in this embodiment, the control arm (typically the distal end of the control arm) is bifurcated to provide distal control arms, each distal control arm being connected to one of the helical coils, respectively. However, the device may include a separate control arm for independently controlling the two helical coils.

[0067] In embodiments of the vein stripping head having axially spaced helical coils, the control arm of the distal helical coil typically passes axially through the proximal helical coil (through one, more, or all of the coils comprising the proximal helical coil).

[0068] In one embodiment, the maximum diameter of the proximal helical coil is larger than the maximum diameter of the distal helical coil (eg, 1.5-4 times larger).

[0069] In another embodiment, the maximum diameter of the proximal helical coil is smaller than (eg, 1 / 4 to 2 / 3 of) the maximum diameter of the distal helical coil.

[0070] In one embodiment, the pitches of the proximal coil elements and the distal coil elements are different.

[0071] In one embodiment, the narrower coils have a larger pitch.

[0072] In one embodiment, the distal helical coil and / or the proximal helical coil are conical in shape.

[0073] In one embodiment, the distal helical coil and the proximal helical coil are conical in shape.

[0074] Typically, the diameter of the helical coil increases in the proximal direction (ie, toward the entry point of the device).

[0075] In one embodiment, the or each coil is configured so that when deployed in the coiled configuration its diameter is at least equal to or greater than the diameter of the vein to be treated.

[0076] In one embodiment, the or each helical coil is conical (ie the diameter of the coil increases or decreases as it approaches the device entry point - ie increases or decreases proximally).

[0077] Typically, the diameter of the helical coil increases in the proximal direction.

[0078] In one embodiment, the coil has a profile selected from circular, elliptical, arcuate, convex, concave, T-shaped, inverted T-shaped, or any other shape.

[0079] In one embodiment, the coil has a flat inner surface, and an outer surface that is curved, concave, convex, or inverted T-shaped. Helical coils having these profiles are shown in Figures 34 to 41.

[0080] In one embodiment, the roughened surface of the coil or each coil element is formed by treating a surface of the coil, typically the outer surface of the coil facing the body lumen (and / or the side of the coil), to roughen the surface.

[0081] In one embodiment, the inner surface of the coil is not rough, and is ideally smooth. This facilitates the retraction of the coil into the catheter member, wherein the smooth inner surface of the coil contacts the mouth of the catheter.

[0082] In one embodiment, the surface is roughened by mechanical abrasion, electrical abrasion, chemical abrasion, or by other means of abrasion.

[0083] In one embodiment, the outer surface of the coil includes indentations configured to provide a roughened surface.

[0084] In one embodiment, the notch is configured to provide a tooth on the surface. In one embodiment, the notch is a transverse notch.

[0085] In one embodiment, the transverse notch extends completely across the outer surface of the coil.

[0086] In one embodiment, the transverse notches are provided on each side of the outer surface (ie when the outer surface of the coil is concave).

[0087] In one embodiment, the notch is longitudinal and extends completely or at least partially along the length of the helical coil. The longitudinal grooves may be straight, curved, wavy, zigzag, diamond-shaped or any configuration.

[0088] In one embodiment, the helical coil has an inverted T-shaped profile, with the teeth arising from the legs of the inverted T.

[0089] 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.

[0090] In one embodiment, the coil includes side teeth.

[0091] In one embodiment, the coil has flat inner and outer surfaces, and side teeth.

[0092] In one embodiment, the coil is formed from a flat wire having a rough outer surface with a diamond texture and a smooth inner surface.

[0093] In one embodiment, the coil has grooves or holes to serve as reservoirs for the therapeutic agent.

[0094] In one embodiment, the or each coil element comprises a core wire and the abrasive surface is formed by a second wire helically wound around the core wire to form a second coil.

[0095] In one embodiment, the second wire has a polygonal cross-section.

[0096] In one embodiment, the pitch of the second coil is 1-5 mm.

[0097] In one embodiment, the pitch of the proximal end of the second coil is larger.

[0098] In one embodiment, the pitch of the proximal end of the second coil is smaller.

[0099] In one embodiment, the second coil is typically bonded to the core wire at multiple locations.

[0100] In one embodiment, the surface of the second wire is treated to roughen the surface.

[0101] In one embodiment, the helical coil has a proximal portion that is generally coaxial with a longitudinal axis of the helical coil.

[0102] In one embodiment, the helical coil has a distal portion that is generally coaxial with a longitudinal axis of the helical coil.

[0103] In one embodiment, a control arm for the body lumen stripping 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 made of stainless steel, polymer, or other material.

[0104] In one embodiment, the control arm is configured to perform axial movement to deploy the body lumen stripping head at a target location within the body and to retract the body lumen stripping head into the catheter member after treatment.

[0105] In one embodiment, the control arm is configured to perform a rotational motion to rotate the body lumen stripping head within the body lumen.

[0106] In one embodiment, the device includes a distal control arm connected to the distal end of the coil and a proximal control arm connected to the proximal end of the coil, whereby relative axial movement of the distal and proximal arms effects coiling and uncoiling of the coil.

[0107] In one embodiment, the distal end of the coil includes an atraumatic tip, such as a flexible material or a sphere.

[0108] In one embodiment, the device includes a handle operably connected to the proximal end of the catheter member and configured to control the deployment and retraction of the coil. In one embodiment, the handle includes a control element configured to axially adjust the control arm with or without rotation. In one embodiment, the handle includes a control element configured to rotationally adjust the control arm.

[0109] In one embodiment, the device is configured to adjust between the following configurations:

[0110] a delivery configuration in which the helical coil is housed within the catheter member in an uncoiled configuration,

[0111] a first body lumen denuding configuration wherein, in use, the coil is deployed in a body lumen to be treated at a first axial position and against a circumference of the body lumen;

[0112] a second body lumen denuding configuration wherein, in use, the coil is deployed in the body lumen to be treated proximate the first axial position and against the circumference of the body lumen; and

[0113] A retracted configuration wherein the coil is housed within the catheter member.

[0114] The method of the present invention can be used for venous diseases, especially superficial venous reflux, preferably varicose veins. The vein treated is generally a saphenous vein, and is usually a great saphenous vein (GSV) or a small saphenous vein (SSV). In one embodiment of the method of the present invention, the body lumen stripping head is moved proximally along the segment to be treated of the body lumen toward the entry point.

[0115] In one embodiment, the method comprises treating a segment of a body lumen that is at least 2, 4, 6, 8, 10, 12, 14, 16, 18, or 20 cm in length.

[0116] In one embodiment, the methods of the invention are used to completely occlude a body lumen, such as a vein or artery.

[0117] In one embodiment, the methods of the present invention are used to partially occlude a body lumen, such as a vein or artery. Thus, using the devices and methods of the present invention, conditions or indications characterized by an imbalance or abnormality in blood volume or flow rate through a segment of the vasculature can be treated by partially occluding a blood vessel segment using the devices of the present invention.

[0118] In another aspect, the method of the present invention thickens the vein wall by inducing a significant thickening of the wall, such as peripheral intimal hyperplasia. This effect "arterializes" the vein, making it more resilient to the effects of higher blood pressure and shear forces. This thickening effect occurs in response to a one-time mechanical stimulus and should be self-limiting, rather than the uncontrolled intimal hyperplasia that occurs when the vein is subjected to sustained higher shear forces when used as a conduit in the arterial system. Thus, the apparatus and method of the present invention can be used to prepare a vein prior to implantation in the arterial circulation system.

[0119] The body lumen may be vasculature, such as an artery or a vein.

[0120] In one embodiment, the method of the present invention is a method of treating varicose veins by stripping a segment of the superior rectal artery.

[0121] In one embodiment, the method of the present invention is a method of treating hemorrhoids by stripping a venous segment.

[0122] In one embodiment, the method of the present invention is a method of performing thrombectomy by stripping a segment of a vein or artery that is blocked by a thrombus.

[0123] In one embodiment, the methods of the invention are performed as a preparatory step to prepare a target region of a body lumen (ie, a segment of the vasculature) prior to implantation of a medical device such as a valve or stent.

[0124] In one embodiment, the methods of the invention prepare the target area of ​​the artery prior to implantation as a preparatory step to reduce the risk of a Type I endoleak.

[0125] In one embodiment, the body lumen being denuded is an artery supplying a tumor, such as a solid tumor.

[0126] In one embodiment, the body lumen is the portal vein that supplies 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 a liver resection.

[0127] In one embodiment, the body lumen treated is a blood vessel forming part of an arteriovenous malformation.

[0128] In one embodiment, the body lumen treated is the varicocele.Accordingly, methods of treating varicocele are also described.

[0129] In one embodiment, the body lumen treated is the blood vessel supplying the uterine fibroid (ie, the uterine artery).

[0130] In one embodiment, the body lumen treated is a portion of the gastrointestinal tract, such as the duodenum, jejunum, or ileum.

[0131] In one embodiment, the body lumen treated is the prostatic artery.

[0132] In one embodiment, the body lumen treated is a pelvic vein.

[0133] In one embodiment, the methods of the present invention treat a patent foramen ovale (PFO) by denuding the contacting surface of the arterial septal valve involved in the PFO.

[0134] In one embodiment, the methods of the present invention treat patent ductus arteriosus by disrupting the mucosal lining of the ileocecal valve and ileum.

[0135] In one embodiment, the methods of the invention treat small intestinal bacterial overgrowth by stripping the ductus arteriosus.

[0136] In one embodiment, the methods of the invention treat Barrett's esophagus by mechanically ablating or denuding cells (abnormal cells) in the lower esophagus.

[0137] In one embodiment of the method of the present invention, the method includes the step of delivering a liquid sclerosant into the body lumen distal to the catheter member.

[0138] In one embodiment of the method of the present invention, the method includes the step of delivering thermal energy to the body lumen by conduction through a lumen-engaging surface of the device.

[0139] In one embodiment of the method of the present invention, the method includes the step of using an intravascular ultrasound (IVUS) probe attached to or incorporated into the ablation head element to determine the response of the vessel to the treatment.

[0140] In one embodiment of the methods of the invention, the therapeutic agent is coated on the exterior surface or embedded in grooves or holes on the device and delivered to the interior surface of the body lumen.

[0141] In one embodiment of the method of the present invention, the method uses the body lumen stripping device of the present invention.

[0142] In another aspect, the present invention provides a method of treating a blood vessel (or any body lumen) in a subject, comprising the steps of:

[0143] advancing a device distally through a treatment region in a blood vessel, wherein the device comprises an elongated catheter having a lumen and a distal end, and a radially expandable therapeutic element disposed in the lumen and configured to move axially relative to the catheter;

[0144] deploying a radially expandable treatment element external to the distal end of the catheter to radially expand and circumferentially press against the lumen at the distal end of the treatment region;

[0145] retracting the deployed radially expandable therapeutic element proximally along the treatment zone to mechanically circumferentially denud the treatment zone of the vessel with the therapeutic element circumferentially pressed against the lumen of the vessel;

[0146] retracting the radially expandable therapeutic element back into the lumen of the catheter; and

[0147] The device is withdrawn from the treated vessel.

[0148] In one embodiment, the blood vessel is a varicose vein, wherein the method is generally treating the varicose vein by denuding the lumen of the vein to cause varicose vein occlusion.

[0149] In one embodiment, the step of mechanically circumferentially denuding the treatment area of ​​the blood vessel includes exposing the subcutaneous blood vessel surface circumferentially along the treatment area.

[0150] In one embodiment, the radially expandable therapeutic element is self-adjustable from an undeployed delivery configuration suitable for transluminal delivery within a catheter and a deployed radially expanded configuration having a diameter greater than a vessel in a treatment area.

[0151] In one embodiment, the radially expandable therapeutic element is elastically deformable, wherein the radially expandable therapeutic element reflexively self-adjusts its diameter in response to varying vessel diameters and varying axial forces during axial movement along the treatment zone while maintaining an outward radial force on the vessel.

[0152] In one embodiment, the outer surface of the radially expandable therapeutic element facing the vessel lumen has a rough surface.

[0153] In one embodiment, the outer surface of the radially expandable therapeutic element facing the vessel lumen has a rough surface, wherein the rough surface includes a coarse-grinded and a micro-grinded surface.

[0154] In one embodiment, the blood vessel is a superficial vein, such as the great saphenous vein, the lesser saphenous vein, a perforating vein, or a branch vein.

[0155] In one embodiment, the superficial blood vessel is a vein selected from the group consisting of the great saphenous vein and the lesser saphenous vein.

[0156] In one embodiment, the method is a method of treating superficial venous reflux in a subject, wherein the blood vessel is a superficial vein.

[0157] In one embodiment, the method is a method of treating varicose veins in a subject, wherein the vein treated is a varicose vein.

[0158] In one embodiment, the method results in occlusion of the treated blood vessel.

[0159] In one embodiment, the method is a method of narrowing a blood vessel without blocking the blood vessel.

[0160] In one embodiment, the step of retracting the deployed radially expandable therapeutic element proximally along the treatment zone mechanically stretches the vessel wall, thereby activating smooth muscle within the wall, thereby causing vasospasm along the treatment zone, optionally preventing nitric oxide secretion from endothelial cells, and subsequently prolonging vasospasm.

[0161] In one embodiment, the radially expandable therapeutic element is a coil.

[0162] In one embodiment, the radially expandable therapeutic element is a helical coil.

[0163] In one embodiment, the method is performed using an imaging modality such as ultrasound guidance.

[0164] In one embodiment, the method includes the step of retrieving the therapeutic element into the catheter member, which includes returning the therapeutic element to an undeployed state, thereby allowing repositioning and redeployment.

[0165] In one embodiment, the method includes the step of deploying a temporary lumen-occluding element in at least one step to stop blood flow in the high-flow vessel.

[0166] In another aspect, the present invention provides a method of treating superficial venous reflux in a superficial vein of a subject, comprising the step of mechanically circumferentially denuding a treatment area of ​​the superficial vein.

[0167] In one embodiment, the length of the treatment area of ​​the circumferentially stripped superficial vein is 5-25 cm.

[0168] In one embodiment, the step of mechanically circumferentially denuding the treatment area of ​​the superficial vein includes exposing the subcutaneous vessel surface circumferentially along the treatment area.

[0169] In one embodiment, the step of mechanically circumferentially stripping a treatment area of ​​the vein includes deploying a vein stripping device in a distal portion of a target segment of a superficial vein to circumferentially press against the venous lumen, and retracting the deployed vein stripping device proximally along the treatment area beneath the circumferential pressing of the device against the venous lumen.

[0170] In one embodiment, the step of mechanically circumferentially denuding the treatment area of ​​the blood vessel includes exposing the subcutaneous blood vessel surface circumferentially along the treatment area.

[0171] In one embodiment, the vein stripping device is self-adjustable from an undeployed delivery configuration suitable for transluminal delivery within a catheter and a deployed radially expanded configuration having a diameter greater than a vessel in a treatment area.

[0172] In one embodiment, the vein stripping device is elastically deformable wherein the radially expandable treatment element reflexively self-adjusts its diameter in response to varying vessel diameters and varying axial forces during axial movement along the treatment zone while maintaining an outward radial force on the vessel.

[0173] In one embodiment, the outer surface of the vein stripping device that faces the lumen of the blood vessel has a rough surface.

[0174] In one embodiment, the outer surface of the vein stripping device facing the blood vessel lumen has a rough surface, wherein the rough surface includes a coarse-abrasive and a micro-abrasive surface.

[0175] In one embodiment, the radially expandable therapeutic element is a coil, preferably an elastically deformable coil.

[0176] In one embodiment, the radially expandable therapeutic element is an elastically deformable helical coil.

[0177] In one embodiment, the method is performed under ultrasound guidance.

[0178] In one embodiment, axial movement of the radially expandable therapeutic element (or helical coil) is automatically or semi-automatically controlled independent of the operator.

[0179] In one embodiment, the device is configured to collect data to feed back to the operator, or to be further interpreted by human, statistical, big data or machine learning analysis. Thus, the device can be combined with one or more sensors configured to detect in vivo data such as tissue or blood temperature, pressure, electrical impedance, etc. The device can be configured to transmit in vivo data wirelessly or along a wire arranged in a catheter member. The device can be configured to transmit data to a remote processor.

[0180] Further aspects and preferred embodiments of the invention are defined and described in the further description set out below. BRIEF DESCRIPTION OF THE DRAWINGS

[0181] Figure 1 is a diagram of the human vasculature in the axial plane showing the composition of a typical vein wall, including the inner lining of the vein (intima) with associated endothelium and glycocalyx covering, the adjacent middle layer (tunica media), and the outer layer (tunica adventitia). Also shown is the typical thickness of an adult vein wall (micrometers).

[0182] Figure 2This is an axial section of tissue from a goat vein 28 days after mechanical endovenous treatment in our animal study. This image highlights the importance of peripheral coverage in terms of endothelial cell disruption. It was taken from a partially treated vein in the animal study. The upper right shows the clot 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 shows the intact endothelium. The thrombus is unable to attach or recanalize due to the intact endothelium. Blood can flow through the channel, resulting in overall treatment failure of this segment.

[0183] Figure 3 A tissue axial section of a goat vein after 28 days of mechanical intravenous treatment in our animal study is shown. Circumferential denudation and shearing of the endothelium occurred due to friction between the superficial and deep layers. The lumen was filled with attached thrombi, which underwent fibrotic changes when invaded by inflammatory cells including collagen-forming fibroblasts.

[0184] Figure 4 A device for denuding a body lumen according to a first embodiment of the invention is shown.

[0185] Figure 5 yes Figure 1 Side view of the device.

[0186] Figure 6 yes Figure 1 Perspective view of the device.

[0187] Figure 7 yes Figure 1 Front view of the distal end of the device.

[0188] Figure 8 yes Figure 4 A detailed view of a portion of the helical coil of the device showing the serrated surface formed by the second wire being helically wound around the core wire.

[0189] Fig. 9 yes Figure 4 Detailed view of the distal end of the helical coil of the device, showing the longer pitch of the second wire and the spherical end hub.

[0190] Fig.10 yes Figure 4 A detailed view of the proximal end of the helical coil of the device showing the helical coil attached to a steel hypotube mounted within a catheter member.

[0191] Fig.11 yes Figure 4 A detailed view of the proximal end of the helical coil of the device, showing its shorter pitch as the second wire approaches the proximal end of the coil to assist in retrieval.

[0192] Fig.12is a perspective view of a helical coil of a device component according to an alternative embodiment of the present invention, wherein the lumen-engaging surface of the second wire comprises a series of helical notches.

[0193] Fig.13 yes Figure 4 Side view of the device in a vein with the helical coil in a deployed configuration. This figure shows how the oversized coil is forced into circumferential engagement with the body lumen and that the radial forces exerted by the oversized coil deform the vein.

[0194] Fig.14 is with Fig.13 A similar illustration shows how a smaller diameter coil can be used in a smaller diameter vein.

[0195] Fig.15 is a perspective view of the deployed device from the outside of the vein, showing how the radial forces applied by the deployed coils deform the vein.

[0196] Fig.16 Detailed view of the abrasive surface of the helical coil engaging the lumen of the vein.

[0197] Fig.17 The procedure of endovenous mechanical stripping of a lower extremity vein to induce occlusion and prevent reflux in the treatment of superficial venous disease is shown. An undeployed device within an external catheter is shown near the saphenofemoral point after ultrasound-guided navigation.

[0198] Fig.18 Deployment of radially expandable coils during treatment is shown to cause vasospasm in the treated segment.

[0199] Fig.19 The radially expandable element is shown being retracted prior to retracting the catheter.

[0200] Fig. 20 is a perspective view of a device for denuding a body lumen according to another embodiment of the present invention.

[0201] Fig.21 yes Fig. 20 End view of the device.

[0202] Fig. 22 yes Fig. 20 Side view of the device in a partially deployed configuration.

[0203] Fig.23 yes Fig. 20 Side view of the device in its fully deployed configuration.

[0204] Fig.24 yes Fig. 20 Another side view of the device in the fully deployed configuration.

[0205] Fig.25 A device for denuding a body lumen according to another embodiment of the present invention is shown, wherein the coil is formed by two coaxial helical coil elements.

[0206] Fig.26 yes Fig.25 End view of the device.

[0207] Fig. 27 yes Fig.25 Side view of the device.

[0208] Fig.28 A device for denuding a body lumen according to another embodiment of the present invention is shown, wherein the coil is composed of four coaxial helical coil elements.

[0209] Fig.29 yes Fig.28 End view of the device.

[0210] Fig.30 yes Fig.28 Side view of the device.

[0211] Fig.31 A device for denuding a body lumen according to another embodiment of the present invention is shown, wherein the coil is composed of four coaxial helical coil elements connected at distal ends.

[0212] Fig.32 yes Fig.31 End view of the device.

[0213] Fig.33 yes Fig.31 Side view of the device.

[0214] Fig.34A and Fig.34B are perspective and side views of a portion of a helical coil of the present invention.

[0215] Fig.35A and Fig.35B are perspective and side views of a portion of another helical coil of the present invention.

[0216] Fig.36A and Fig.36B are perspective and side views of a portion of another helical coil of the present invention.

[0217] Fig.37A and Fig.37B are perspective and side views of a portion of another helical coil of the present invention.

[0218] Fig.38A and Fig.38B are perspective and side views of a portion of another helical coil of the present invention.

[0219] Fig.39A and Fig.39B are perspective and side views of a portion of another helical coil of the present invention.

[0220] Fig.40A and Fig.40B are perspective and side views of a portion of another helical coil of the present invention.

[0221] Fig.41A and Fig.41B are perspective and end views of a portion of another helical coil of the present invention.

[0222] Fig.42A and Fig.42B 2 are side and perspective views of another embodiment of a helical coil that is part of the device of the present invention.

[0223] Fig.43A and Fig.43B 2 are side and perspective views of another embodiment of a helical coil that is part of the device of the present invention.

[0224] Fig.44A and Fig.44B 2 are side and perspective views of another embodiment of a helical coil that is part of the device of the present invention.

[0225] Fig.45A and Fig.45B 2 are side and perspective views of another embodiment of a helical coil that is part of the device of the present invention.

[0226] Fig.46A and Fig.46B 2 are perspective and side views of another embodiment of a helical coil as a component of the device of the present invention.

[0227] Fig.47A and Fig.47B 2 are perspective and side views of another embodiment of a helical coil as a component of the device of the present invention.

[0228] Figures 48A to 48C 2 are side and perspective views of another embodiment of a helical coil that is part of the device of the present invention.

[0229] Fig.49A and 49B Side and perspective views of a vein stripping head that is part of the device of the present invention and has two axially spaced helical coils.

[0230] Fig.49A and 49B Side and perspective views of a vein stripping head that is part of the device of the present invention, the vein stripping head having two axially spaced helical coils.

[0231] Fig.50A and 50B Side and perspective views of another device component of the present invention are of a vein stripping head having two axially spaced helical coils.

[0232] Fig.51A is a perspective view of another device component of the present invention, a vein stripping head having two axially spaced helical coils.

[0233] Fig.52A The arterioles supplying the tumor are shown. Fig.52B is an exploded view of a portion of one of the arteries, showing the use of the device of the present invention to denature a section of the arterial lumen, where the artery is blocked due to thrombosis.

[0234] Fig.53A The portal vasculature is shown. Fig.53B An exploded view of a portion of one of the veins is shown using the device of the present invention to denature a section of the venous lumen, which is blocked by thrombosis.

[0235] Fig.54 A portion of the vasculature containing a malformed natural arteriovenous shunt is shown, as well as the use of the device of the present invention to denature a portion of the shunt to occlude the malformed shunt by thrombosis.

[0236] Fig.55 A varicocele around the left spermatic vein and left testicle is shown, as well as the use of the device of the present invention to strip a section of the left spermatic vein to occlude the vein by thrombosis.

[0237] Figure 56 shows how the spiral coil, which is a component of the device of the present invention, can self-adapt to different vessel diameters and constrictions or narrower segments in a vessel as it is pulled through a vessel: (A) the deployed spiral coil is in circumferential contact with the vascular lumen near the narrower segment of the vessel; (B) the spiral coil passes through the narrower segment and is in circumferential contact with the vascular lumen proximal to the narrower segment; (C) the spiral coil moves proximal to the narrower segment and self-adjusts to maintain circumferential contact with the vascular lumen.

[0238] Figure 57 shows how a spiral coil, which is part of the device of the present invention, is able to advance through a valve in a vein as it is pulled through a segment of the vein: (A) the deployed spiral coil is in circumferential contact with the venous lumen distal to the valve; (B) the spiral coil passes through the valve without becoming snared; (C) the spiral coil moves proximal to the narrower segment and self-adjusts to maintain circumferential contact with the vascular lumen.

[0239] Figure 58 shows how a spiral coil that is part of the device of the present invention is able to advance through a section of vasculature that gradually narrows and self-adjusts the coil diameter to maintain circumferential engagement with the vessel lumen: (A) the deployed spiral coil is in circumferential contact with a wide segment of the vessel; (B) the deployed spiral coil is in circumferential contact with a narrower segment of the vessel.

[0240] Figure 59 shows how the spiral coil, which is a component of the device of the present invention, is able to self-adjust to different blood vessel diameters and advance in tortuous blood vessels: (A) the deployed spiral coil is in circumferential contact with the vascular lumen of a stenotic segment of the blood vessel; (B) the spiral coil advances through a sharp turn in the blood vessel while maintaining circumferential contact with the vascular lumen; (C) the spiral coil advances through a sharp turn in a blood vessel with a larger diameter while maintaining circumferential contact with the vascular lumen.

[0241] Figure 60 shows how the spiral coil that is part of the device of the present invention can self-adjust the coil diameter to maintain circumferential engagement with the vascular lumen when the blood vessel actively contracts or tapers to a smaller width due to vasospasm: (A) Before vasospasm occurs, the deployed spiral coil is in circumferential contact with a blood vessel segment of length I and diameter D; Section AA is an axial view of the spiral wire in contact with the blood vessel wall under the circumferential force HF generated by the pressure from the restraining force P; (B) During vasospasm, the deployed spiral coil is in circumferential contact with an extended length L within a contracted blood vessel of diameter d.

[0242] Figure 61 shows the static force variables acting on the coil when the deployed coil is subjected to an axial force FA; (A) before the start of the retraction movement in a vessel of diameter D, where the vessel has an outward coil contact force FC and a vessel restraining force P; (B) in a narrower vessel of diameter d, the coil is stretched to a length L; (C) in a significantly narrower vessel of diameter e, the coil is stretched to a length S. The vessel wall contact on the proximal portion of the coil disappears, thereby reducing static friction and enabling atraumatic passage of the coil.

[0243] FIG62 illustrates how the device of the present invention can be used to treat abnormally high blood volume or high blood flow in the vasculature to partially occlude a vessel to normalize blood volume or blood flow: (A) shows the pulmonary artery before treatment, with the device of the present invention deployed in the artery and pulled proximally; (B) shows the pulmonary artery after treatment with the device of the present invention. Fig.62A Chronic changes in the pulmonary arteries in which intimal hyperplasia partially blocks (constricts) the arteries, reducing blood volume and flow through the arteries.

[0244] Fig.63 An oblique view of an embodiment of a flat wire having a smooth inner surface and a rough outer surface with a diamond pattern in a typical blood vessel is shown.

[0245] Fig.64An oblique view of the device within a blood vessel is shown. A close-up view of an external texture embodiment shows (A) a roughened grooved surface perpendicular to the vein wall in the retrieval direction; (B) a roughened surface parallel to the vein wall in the retrieval direction; (C) a diamond configuration of the roughened surface.

[0246] Fig.65 Shown is the tip of a modified intravenous cannula modified to accommodate a small helical coil in an undeployed state.

[0247] Fig.66 Shows the use of Fig.65 A modified cannula is shown to access a target vein and deploy a helical coil after withdrawing the outer sheath.

[0248] Fig.67 Shown using Fig.65 The cannula device enters the superficial branch vein of the leg.

[0249] Fig.68 A method of deploying a small coil in a branch vein is shown. (A) A guide wire is used to enter the vein, over which a sheath is inserted; (B) the sheath is advanced into the vein and the guide wire is removed; (C) the sheath is retracted to expose the contained helical abrasive coil element; (D) the sheath and coil are retracted together to complete the treatment of the vein segment.

[0250] Fig.69 Shows Fig.68 A sheath used in the art that houses an undeployed helical coil at its inner circumference to facilitate passage of a guide wire.

[0251] Fig.70 A method of deploying a helical coil in a target vein using a peel-away introducer sheath is shown.

[0252] Fig.71 The use of a spiral ablation coil to treat pelvic venous reflux in the left ovarian vein is shown.

[0253] Fig.72 Figure 2 shows venous remodeling during arterial fistula formation (A) Normal vein; (B) Intimal hyperplasia with self-limited thickening of the intimal layer; (C) Vein graft failure due to lumen obstruction caused by excessive intimal hyperplasia.

[0254] Fig.73 The use of a helical coil having a rough inner surface and a smooth outer surface to remove an attached thrombus in a blood vessel is shown.

[0255] Fig.74 The use of a helical coil with a partially textured outer surface is shown, which allows for selective treatment of the vessel wall with or without rotational forces in addition to axial retrieval.

[0256] Fig.75The use of spiral coils to reconstruct the duodenal mucosal layer during endoscopy in the treatment of diabetes is shown. DETAILED DESCRIPTION

[0257] All publications, patents, patent applications, and other references mentioned in this application are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and was incorporated by reference in its entirety.

[0258] Definition and general preferences

[0259] Unless otherwise indicated, the following terms used in this application have the following meanings, in addition to any broader (or narrower) meanings that the terms may have in the art:

[0260] Unless the context requires otherwise, the singular used in this application shall be understood to include the plural, and vice versa. The term "a" or "an" used with respect to an entity shall be understood to refer to the entity, involving one or more of the entity. Therefore, the terms "a" (or "an"), "one or more" and "at least one" are used interchangeably in this application.

[0261] As used in this application, the term "comprise" or variations thereof, such as "comprises" or "comprising", should be understood to indicate the inclusion of any recited integers (e.g., features, elements, characteristics, properties, method / process steps, or limitations) or groups of integers (e.g., features, elements, characteristics, properties, method / process steps, or limitations), but not the exclusion of any other integers or groups of integers. Therefore, as used in this application, the term "comprising" is inclusive or open-ended, and does not exclude other unrecited integers or method / process steps.

[0262] As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is broadly used to include any disorder, ailment, abnormality, condition, discomfort, symptom or syndrome in which physiological function is impaired regardless of the nature of the cause (or whether the etiological basis of the disease is actually established). Therefore, it includes conditions caused by infection, trauma, injury, surgery, radioablation, poisoning or nutritional deficiency.

[0263] As used herein, the term "treatment" or "treating" refers to intervening (e.g., administering a medicament to a subject) to cure, improve or alleviate a disease syndrome or remove one or more of its causes (or alleviate its effects) (e.g., reducing the accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term "therapy".

[0264] In addition, the term "treatment" or "treating" refers to intervening (e.g., administering a pharmaceutical agent to a subject) to prevent or delay the onset or exacerbation of a disease or reduce its incidence (or eradicate) in a treated population. In this case, the term treatment is used synonymously with the term "prevention".

[0265] As used herein, the effective amount or therapeutically effective amount of a medicament is defined as the amount that can be given to a subject without excessive toxicity, irritation, allergic reaction or other problems or complications, which is commensurate with a reasonable effect / risk ratio, but is sufficient to provide the desired effect, such as treatment or prevention, which is manifested as a permanent or temporary improvement in the subject's condition. The amount will vary from subject to subject, depending on the age and general condition of the individual, the mode of administration and other factors. Therefore, although it is impossible to specify an exact effective amount, those skilled in the art will be able to determine the appropriate "effective" amount in any individual case using experiments and background common sense. The therapeutic outcome in this case includes eradication or alleviation of symptoms, alleviation of pain or discomfort, extension of survival, improvement of activity and other clinically improved indicators. The therapeutic outcome is not necessarily a complete cure.

[0266] In the context of treatment and effective amounts as defined above, the term subject (which is understood to include "individual," "animal," "patient," or "mammal" where the context permits) is defined as any subject in need of treatment, particularly a mammalian subject. Mammalian subjects include, but are not limited to, humans, livestock, farm animals, zoo animals, sport animals, pet animals, such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, goats, cows; primates, such as apes, monkeys, gorillas, 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 cattle, 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.

[0267] As used in this application, the term "stripping" should be understood to refer to mechanically removing the surface layer of the luminal surface of the body lumen along a section of the body lumen or causing it to be irreversibly functionally destroyed. When the body lumen is a blood vessel or vein, the surface layer of the lumen is usually a single layer of squamous cells, called the vascular endothelium, and its associated connective tissue extends to the superficial cell layer of the middle layer, but not deeper than the middle layer. The endothelium is necessary for the survival of the body lumen, because it provides a selective barrier and anti-thrombotic surface, and the removal of the endothelium leads to the exposure of thrombin factors that interact with normal blood components, thereby causing coagulation and obstruction of the body lumen, and releasing its own vasoconstrictors into the lumen. When the body lumen is a vein, the term refers to the removal of the intimal layer and the superficial media layer. The device and method of the present invention strip a longitudinal segment of the body lumen, such as 1-60 cm, and perform circumferential stripping; that is, if the body lumen is stripped along the segment to be treated, the entire circumference (or a portion of the circumference or nearly the entire circumference) is stripped.

[0268] As used in this application, the term "body lumen" refers to a cavity in the body, which may be an elongated cavity, such as a blood vessel (i.e., an artery, a vein, a lymphatic vessel, a urethra, a ureter, a sinus, an ear canal, a nasal cavity, a bronchus, a fallopian tube, a vas deferens) or an annular space in the heart, such as the left atrial appendage, the left ventricular outflow tract, the aortic valve, the mitral valve, the mitral commissure, the tricuspid valve, the pulmonary valve or the heart valve, or a venous valve or valve orifice. Preferably, the body lumen is a vascular system (i.e., a vein or an artery or an arteriovenous vessel). The vein may be selected from the saphenous vein (SSV, GSV, AASV), the pelvic vein, the spermatic vein or the portal vein. The artery may be selected from the aorta, the superior rectal artery, a section of artery for stent placement for complete or partial embolization, the uterine artery or an arterial catheter. The body lumen may be a section of the gastrointestinal tract, such as the duodenum, the small intestine. The body lumen may be the esophagus.

[0269] As used in this application, the term "elongated catheter member" is understood to refer to an elongated body having a distal end operably connected to a stripping body in a body lumen. In one embodiment, the catheter member includes a control arm (e.g., a tubular member) that is operably connected to the stripping body to control it. The control arm can take any form, for example, a rod, a wire, or a tubular member such as a hypotube. In one embodiment, the control arm and the stripping body are axially adjustable relative to the catheter member. During delivery and retrieval, the stripping body is typically deployed and housed in the distal end of the catheter member. Axial adjustment of the control arm relative to the catheter body allows the stripping body to be deployed in its coiled configuration.

[0270] "Transluminal delivery" refers to delivery of the body lumen-stripped subject to a target site (eg, varicose vein) through a body lumen, such as through an artery, vein, or gastrointestinal tract.

[0271] As used herein, the term "coil" is understood to refer to an annular element that is adjustable from an uncoiled configuration suitable for retraction into a catheter member and a coiled configuration that is capable of circumferentially engaging a body lumen and pressing its surface against the body lumen (i.e., engaging the lumen of a vein along at least one full turn of the coil) during use. The coil in its coiled configuration is typically circular, but may also be elliptical, square, triangular, or rectangular, as long as it is capable of circumferentially engaging the inner wall of the body lumen. Since most veins and arteries have a circular or nearly circular profile, circular coils are preferred because the radial force applied by the coil in its deployed configuration can be evenly distributed around the wall of the body lumen. The diameter of the helical coil needs to be equal to or greater than the diameter of the body lumen to be treated along at least one full turn of the helix to achieve circumferential contact with the lumen of the vein, thereby achieving circumferential stripping of the vein (see Fig.13 A in ). In a preferred embodiment, the coil is a helical coil having at least one complete turn of the circumference, preferably 1 to 3 turns, for example about 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 turns of the helical coil are preferably circular, but may also have other profiles, such as elliptical, square, triangular or rectangular. The helical coil may be conical. In the relaxed state, the diameter of the coil is typically 2-20 mm, more preferably 3-12 mm. In the relaxed state, the pitch of the helical coil is typically approximately the same as the diameter, but may also vary between 0.5 and 1.5 times the diameter. It should be understood that the size of the coil may vary depending on the body lumen to ensure that the coil is "oversized" relative to the diameter of the body 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 typically at least about 5% larger than the diameter of the body lumen to be treated, for example, at least 10%, 15%, 20%, 25% or 30% larger than the diameter of the body lumen to be treated, and typically 5-30% larger. Importantly, the coil is oversized along at least one turn of the coil, typically oversized along 1-2 turns. The coil can be formed from an elongated element, typically a single elongated element, such as a wire or filament. The coil can be made of a metal (e.g., stainless steel) or a metal alloy, or it can be made of a shape memory alloy such as NITINOL, or it can be made of a natural, synthetic or semi-synthetic polymer such as chitosan, nylon or rayon. The body lumen stripping head is ideally composed of a single coil element, although in certain embodiments the coil can include multiple coil elements, for example 2, 3, 4, 5, 6, 7, 8, 9 or 10, preferably 2-4 coil elements.

[0272] The width of the coil element is at least 0.1 mm. The width is typically 1 to 3 mm to allow delivery via an appropriately sized catheter and introducer sheath.

[0273] Typically, the helical coil is sufficiently elastically deformable to maintain a circumferential radial force against the wall of a body lumen of varying diameter as it travels along the body lumen (i.e., it is configured to be "self-adjusting" or "self-adjustable"). This is illustrated in FIG. 59 , which shows the use of the device of the present invention to denature a vein having several 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 maintaining a circumferential radial force against the wall of the body lumen of varying diameters as it travels along the body lumen. Fig.59C The radial force is shown to be applied around the entire circumference of the body lumen at its widest point, and the spiral coil has sufficient elastic deformation to adapt the coil diameter to the changing diameter of the vein while maintaining the stripping radial force against the circumference of the body lumen. The spiral coil generally has sufficient elastic deformation to allow the coil to pass through the constriction or valve in the vein, as shown in Figures 56 and 57, respectively. These contractions or changes in the diameter of the vein over the treatment length area can be static (the wider diameter of the proximal vessel gradually tapers to a narrower distal vessel) or dynamic (in a physiological process called venous spasm, the smooth muscle of the vein wall contracts so that the vein diameter decreases). The reduced diameter of the venous tube will increase the radial force on the spiral coil, which in turn increases the hoop force generated within the spiral coil material, which will be converted into a longitudinal force to increase the length of the coil. This concept is illustrated in Figure 60, which shows the device deployed in a general blood vessel of length I and diameter D. The radial force is equal to the pressure P acting perpendicular to the vein wall. The pressure or hoop force (HF) exerted by the vessel on the oversized coil serves to compress the coil, and increases as the diameter of the vessel decreases to d. Due to the open helical coil design, this increased hoop force will be translated longitudinally to stretch the coil to a length L. This reduces the radial force at the point of contact of the outer surface of the device with the vein wall to prevent excessive friction, but maintains sufficient force to maintain surface engagement and compression against the vein. Excessive friction can lead to snags or snagging of the coil segments and wall perforations and / or trauma to connective tissue adjacent to the vein.

[0274] As used in this application, the term "coil element" refers to a single independent coil element, each coil element together forming the coil portion of the device of the present invention. Typically, each coil element is spiral. 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 a deployment configuration, a plurality of coil elements provide circumferential engagement of the lumen of a body lumen together. Therefore, each coil element can be configured to engage only a portion of the lumen circumference in the deployment configuration, such as engaging the circumference of the body lumen at 90 ° -270 °, 90 ° -180 °, 140 ° -220 ° or 180 ° -270 °. In one embodiment, the coil has two spiral coil elements, such as a double helix. Typically, each of the two spiral coil elements has at least 0.5 turns when deployed, and is typically 0.5 to 1.0 turns or 0.5 to 0.7 turns. In one embodiment, the coil has three spiral coil elements, such as a triple helix. In one embodiment, the coil has four spiral coil elements.Usually, each of the three spiral coil elements has at least 0.3 turns when deployed, and has 0.3 to 1.0 turns or about 0.3 to 0.5 turns when deployed.In one embodiment, the coil has four spiral coil elements.Usually, each of the four spiral coil elements has at least 0.25 turns when deployed, and has 0.25 to 0.75 turns when deployed.In one embodiment, a plurality of coil elements are connected together (closed configuration) at its far end.In one embodiment, a plurality of coil elements are not connected (open configuration) at its far end.

[0275] As used in this application, when applied to a body lumen (or blood vessel or vein) stripping head, the term "non-detachably connected to a catheter member" should be understood to mean that the device is configured to remove and release the stripping head from the catheter member without being in the body; in other words, the device is configured to be a body lumen stripping head that is not implanted in the body.

[0276] Implantable devices are not suitable for treating superficial venous disease for the following reasons: the superficial veins of the leg are relatively close to the skin surface and can be easily palpated; larger implantable devices may cause pain, irritation, or local skin deformity; implants may inhibit the ability of the vein to reduce the diameter of the vein by contracting the smooth muscle (called venous spasm), which is important for reducing the diameter of the vein, reducing the amount of thrombus in the vein, and preventing recanalization; implants may cause immune-mediated inflammatory responses. The body lumen-engaging surface of at least a portion of the coil is roughened for shearing or irreversibly destroying the body lumen lining to remove it from the body lumen. The surface can be treated chemically, electrically, or physically / mechanically to make it rough. Several types of processing are available to roughen the surface, including mechanical abrasion, shot peening, sand blasting, knurling, electrical discharge machining, and pulsed electrochemical machining. Chemical etching can also be used to roughen the surface of the component. The surface can be serrated. The surface can also include protrusions, which are used as abrasive surfaces when the protrusions contact the vascular cavity. These protrusions can be fragments bonded to the surface of the abrasive surface, or parts folded from the abrasive surface, or pits with a grid effect. A way to provide a spiral coil with an abrasive surface is described as follows, in which the second wire or multiple wires are spirally wound on the core wire as shown in the accompanying drawings. The second wire can have a circular, flat, polygonal, triangular, square, rectangular, X-shaped or star-shaped cross section, as long as the combination of the elongated element (core wire) and the second wire of the spiral winding generates a rough cavity joint surface, which can strip the cavity when the cavity moves axially along the cavity under the deployment structure. The wire may not be the only material type to wrap the central core wire or the central housing, and for example, a polymer-based molded part, a fin, abrasive particles or spot welding can also be used. Another way to make a serrated surface is to carve a notch in the surface of the coil, or to make a convex forming part, such as a spiral notch or forming part, on the surface. The surface should have sufficient roughness to strip the lumen with a single longitudinal pass of the device, avoiding the need for multiple passes that are limited by initial vasospasm. The preferred construction includes surface elements formed with coarse-abrasive and micro-abrasive surfaces. The coarse-abrasive surface includes grooves, notches or teeth with a height from peak to valley of at least about 0.5 mm (e.g., 0.5-1.0 mm). The micro-abrasive surface includes grooves, notches or teeth with a height from peak to valley of about 5-100 microns. These grooves create roughness and prevent cellular debris from clogging the abrasive surface over the treatment length. The direction of the coarse-abrasive grooves is important and should not be parallel but perpendicular to the retrieval axis. This is important in Fig.64, which shows a device deployed in a blood vessel. Detailed views of the coil surface are shown in enlarged views (A), (B) and (C). (A) shows a groove pattern perpendicular to the vessel wall when retracted, which can effectively form mechanical ablation. (B) shows a direction parallel to the vein wall when retracted, which is less effective. Due to different vessel diameters and tortuous venous anatomy, a rough grinding texture pattern is needed to overcome this problem. (C) shows a diamond knurling pattern, which is ideal for ensuring that a portion of the rough grinding surface is always perpendicular to the vein wall during engagement when the device is axially retracted. The micro-grinding surface has a surface roughness or RA value typically between 0.8 and 3.2 to achieve endothelial damage and prevent excessive static friction. The RA value is the arithmetic mean of the absolute value of the profile height deviation from the midline recorded within the evaluation length. An RA value of 0.8 corresponds to an average peak-to-valley height of 4μm. Endothelial cells (EC) in most blood vessels are protected from direct exposure to flowing blood by a non-cellular layer called glycocalyx. The thickness of this gel-like structure is usually 0.5-3 μm, which exceeds the thickness of EC itself (0.2-2.0 μm).

[0277] As used herein, the term "shape memory material" should be understood to refer to a material, typically a metal alloy, that remembers its initial shape and, when deformed or forced into a different configuration, returns to its pre-deformed shape after the deforming force is released. An example is Nitinol. In one embodiment, the coil or the core element of the coil is formed of a shape memory material. The method of making a coil from a shape memory material generally involves the following steps: winding the shape memory alloy around a mold or heat setting fixture so as to form the desired shape after heat setting, placing the loaded fixture in an oven for a set temperature / time, removing and cooling the component. The shape can also be formed by laser cutting a cylindrical tube to the desired size. Such shape memory can also be manufactured by other means, such as by electro-activated polymers.

[0278] As used herein, the term "treatment zone" when applied to a body lumen, blood vessel or superficial vein refers to a cylindrical portion of a body lumen that is involved in the etiology of a disease state, typically more than 1 cm in length. In the context of superficial veins, the term "treatment zone" is understood to refer to a cylindrical portion of a superficial vein lumen that is not able to effectively circulate blood, typically more than 1 cm in length. In one embodiment, the length of 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.

[0279] like Figure 1As shown, veins consist of three major cell layers: an adventitia composed of tough fibrous tissue and unmyelinated nerve fibers, a middle layer composed of collagen and smooth muscle cells, and an endothelial layer composed of a single layer of squamous cells and some connective tissue. In addition, the endothelial layer is covered by an acellular glycocalyx, which is usually a uniformly distributed structure with a thickness of 0.5-3 μm.

[0280] The walls of veins are thinner, less rigid, and more flexible than those of arteries. Unlike arteries, which always maintain their cylindrical shape, veins can shrink due to lack of blood or stretch significantly to accommodate increased blood volume.

[0281] Vein spasm, or constriction, occurs when stretching the body activates nerves outside the vein wall. Constriction can also occur when cells called the endothelin-1 that line the veins release in response to stretching or rupture.

[0282] The endothelial layer prevents blood from clotting in the veins. If the endothelium is disrupted or damaged, the prothrombin factor is exposed and platelets will immediately adhere and start the coagulation cascade. Over time (4-12 weeks, with an average of 8 weeks in normal cases), the clot in the vein becomes fibrotic due to invasion of surrounding cells, which deposit fibrin and collagen in a process of sclerosis or fibrosis. This prevents the blood in the vein from flowing back, thus successfully treating varicose veins.

[0283] The purpose of the device is to destroy the endothelial and media layers of the vein without destroying the adventitia layer. This requires selectively controlled mechanical destruction to a depth of at least 5 μm and up to but not exceeding 100 μm. This ensures that destruction of the endothelium and superficial media layers is achieved while avoiding deeper media / adventitia destruction that may cause pain and / or perforation. Further cell death may occur in the deeper layers due to the release of cellular contents leading to apoptosis of neighboring cells and continues in a cascade manner over time to depths of up to 300 μm. The resulting thrombosis or clot and fibrous scar tissue prevent blood from entering the vein, thereby avoiding the appearance and symptoms associated with varicose veins. It is important that the endothelium is completely destroyed circumferentially because if there are small areas that remain intact, the clot may not form and blood will continue to flow, resulting in treatment failure and / or early recurrence. This may occur when using liquid or foam chemical sclerosants in large veins and may be the reason for the low treatment efficacy rate of only 70%, while thermal therapy has an efficacy rate of 90%-98%.

[0284] When treatment is initiated more than two centimeters posterior to the deep vein junction, the attached thrombus produced by the present invention is confined to the superficial veins where, due to the lack of blood flow, the thrombus cannot be carried into the deep system where it could cause complications.

[0285] The precise requirements for successful long-term venous ablation are unclear. Some experts who treat superficial venous reflux believe that complete endothelial destruction is sufficient. Complete endothelial destruction allows thrombosis to form, blood flow is interrupted, and the body then transforms the thrombus into a fibrous cord in a process called sclerosis or fibrosis, thereby achieving long-term ablation. Other experts believe that tissue damage to the vein wall into the deeper media layer in addition to the intima layer is necessary for long-term venous ablation. Others, such as proponents of thermal ablation, believe that complete transmural destruction of the vein wall from the intima to the adventitia layer is required.

[0286] The present invention achieves complete circumferential endothelial destruction through its oversized coiled configuration with an abrasive surface. It also causes media damage through at least three separate mechanisms. First, the abrasive polygonal coil surface can penetrate more than 50 μm, allowing damage to occur deeper than the intimal layer. This can be further increased by using more than one coil, allowing a second abrasive coil located more distally on the device to penetrate deeper into the portion of the vessel wall that has been denuded by the coil more proximally on the device. This can also be achieved by repeating the process over the same treatment length using the same device. Second, studies of foam sclerotherapy have shown that cell death occurs as deep as 300 μm into the vein wall

[10] . This may be due to a cascade effect of cell death, which is caused by the release of molecules from damaged cells that signal apoptosis in neighboring cells. In this case, cellular venous wall damage can occur deeper than the superficial cells affected by mechanical damage. Third, the friction created by the device acting on the surface layers combined with the resistance of the deeper media layers has a shearing effect within the vein wall layers, resulting in deeper vessel wall damage. This effect has been reported in previous studies and was also observed in the present preclinical trials.

[0287] The risk of venous rupture and / or device snag is proportional to the abrasiveness or sharpness of the device contact with the wall, generating friction or cutting forces, respectively, and the depth of penetration of the abrasive element into the wall. Snags are a commonly reported pain point for both physicians and patients when using existing mechanochemical devices. There are even documented cases of veins becoming snagged and inadvertently dissected, resulting in pain and hematoma formation, referred to as “inadvertent spontaneous dissection” [6]. Venous valve leaflets are also an obstacle where the mechanical tip can become stuck and cause snags.

[0288] A key problem is the difficulty in completely removing the endothelium and partially disrupting the media without causing excessive resistance and / or obstruction.

[0289] Figure 2Highlighting the importance of circumferential coverage in the context of endothelial cell disruption. This is from a partially treated vein in our animal study. The upper right shows a clot attached to the vein wall with tissue invasion occurring as fibrosis begins 28 days after surgery. The lower left shows intact endothelium. Without clot formation, blood could flow through the channel, leading to overall treatment failure of this segment. In contrast, Figure 3 The results of complete endothelial coverage and destruction 28 days after the procedure were shown, with adherent thrombi forming to occlude the entire vessel lumen, preventing blood flow, making the treatment successful. Migration of inflammatory cells from the adventitia into the thrombus could be confirmed by microscopic examination. This operation achieved fibrotic transformation of the thrombus and long-term occlusion.

[0290] Example

[0291] The present invention will now be described with reference to specific embodiments. These embodiments are merely exemplary and are for illustrative purposes only: they are not intended to limit the scope of the claimed patent rights or the scope of the described invention in any way. These embodiments constitute the best mode currently contemplated for carrying out the present invention.

[0292] Referring to the accompanying drawings, first refer to Figures 4 to 7 , shows a device for stripping a body lumen according to the present invention, which is generally indicated by reference numeral 1. In this embodiment, the device 1 is a device for stripping varicose veins to block the vein and thereby treat varicose veins, comprising a polyimide catheter member 2 and a stripping head 3, the stripping head 3 being configured to be delivered through the lumen to a section of the varicose vein to be treated and deployed at a target location in the vein. The stripping head 3 comprises a helical coil 4 having a proximal end 5, a distal end 6 and a coiled portion, the proximal end 5 and the distal end 6 being generally coaxial with the axis of the helical coil, the coiled portion being about 1.5 turns, an outer diameter of 13 mm, and a pitch of about 9 mm.

[0293] like Figures 4 to 7 As shown, the helical coil 4 is axially adjustable relative to the catheter member from a delivery configuration (not shown) and a deployed coiled configuration, in which the coil is deployed and stored in the distal end of the catheter member 2. The helical coil comprises a shape memory alloy and is biased to assume a coiled configuration when it extends beyond the distal end of the catheter member. The device is suitable for varicose veins of normal diameter 4-12 mm (i.e., where the coil is oversized relative to the vein to be treated).

[0294] It should be noted that the "oversized" diameter of the spiral coil extends along at least one complete loop (360 degrees) of the coil. This feature, coupled with the oversized diameter of the coil relative to the vein, ensures that the coil engages and presses circumferentially against the lumen of the vein, thereby uniformly applying radial pressure around the entire circumference of the vein. The oversized diameter can extend along less than a complete loop, such as at least 300 degrees, but this leads to the risk that the lumen of the vein will not be completely stripped, resulting in partial obstruction of the vein and subsequent recanalization. In this embodiment, the coil is just over a full circle, so that it can be fully covered even when stretched, while not too long to avoid causing increased friction with the vein wall and hooking. Longer coils also increase the number of coil turns can further mechanically damage the vein wall. In this embodiment, the increased surface area of ​​the device in contact with the vein also increases the risk of hooking and vein wall damage. Therefore, a coil just over a full circle is the most effective method for achieving complete stripping of the inner surface of the blood vessel.

[0295] The coiled construction and flexible material of the stripping head enable it to accommodate different vein diameters within a range of sizes smaller than the coil diameter, while still applying sufficient radial force to cause stripping. These properties also enable the coil to accommodate different vein diameters within the same vein over its target treatment length. These variations may be due to the natural taper of the vein or due to the venous valves. If the rigid structure is caught or trapped by the valve leaflets, the venous valves can cause serious snagging and venous perforation. Due to the flexible nature of the coil and the minimal protrusion of the abrasive parts, this is unlikely to occur. In the event that the device is caught by the valve leaflets, a slight increase in force along the longitudinal axis will automatically reduce the diameter of the coil while increasing its length, thereby freeing the coil itself and avoiding snagging or separation of the valve and associated valve leaflets, as shown in Figures 60 and 61. The above will occur automatically during normal retrieval of the device within the vein without the need for adjustment, additional manipulation or additional imaging by the operator.

[0296] Referring to the accompanying drawings, first refer to Figure 8 and 9 , the spiral coil 4 has an abrasive surface, which is configured to shear the vein lining (mainly but not limited to the endothelial cell layer) away from the vein when the spiral coil moves axially along the vein in the deployed configuration. In this embodiment, the spiral coil includes a 0.01181" Nitinol core wire 8 and a second wire 9 spirally wound on the core wire 8, forming a rough serrated surface on the spiral coil 4. Figure 8 and 9 , the second wire 9 is a flat wire formed of stainless steel or nitinol. In this embodiment, the core wire 8 has a diameter of about 1 mm, the second wire 9 has a width of about 0.7 mm, and a thickness of about 0.02 mm. The pitch of the second wire is about 1.5 mm. Fig. 9, the pitch of the second wire 9 on the core wire 8 is reduced at the distal end 6 of the spiral coil 4, reduced to about 0.3 mm in this embodiment. The purpose of setting a smaller pitch / closed pitch at the distal end is to form a flexible distal member of the device so that the device can be advanced to the target site. Fig.10 The pitch of the second wire 9 on the core wire 8 increases at the proximal end 5 of the spiral coil 4, and in this embodiment increases to a maximum of about 3 mm. The purpose of setting a larger pitch at the proximal end is to facilitate smooth retrieval of the distal end after surgery. The proximal region can also have a closed portion with a smaller pitch and tighter closure for retrieval.

[0297] The thickness of the second wire 9 is between 0.1 and 1 mm. Based on tests using equivalent animal vein tissue, a diameter greater than 1 mm carries the risk of creating surface protrusions that may hook or snag on the vein wall surface.

[0298] Reference Fig.10 and 11 , the proximal end 5 of the coil 4 is attached to a stainless steel hypotube 12, which extends through the catheter member 2 to its proximal end (not shown). In use, the hypotube 12 can be axially adjusted relative to the catheter member 2 to enable the helical coil 4 to be deployed in a coiled configuration at the distal end of the catheter member and to retract the helical coil 4 into the catheter member during transluminal delivery and retrieval of the device. In this embodiment, the catheter member 2 is a 4Fr polyimide extruded catheter. Fig.11 In the embodiment, it has a mouth portion 14 which tapers inwardly to assist in retracting the helical coil 4 when the helical coil 4 is retracted into the catheter member 2.

[0299] Reference Fig. 9 The distal end of the helical coil 4 terminates in an atraumatic tip, which in this embodiment is provided by a smooth metal ball 15, which is used to prevent the helical coil from being hooked by the vein or valve and to reduce the risk of the distal end causing perforation of the vein wall when the helical coil is deployed and retrieved. Fig. 9 The ball 15 is sized to nest in the Fig.11 In the tapered mouth 14 of the conduit member 2 in the.

[0300] Reference Fig. 9 , between the end of the abrasive coil and the distal smooth ball, there is an elongated straight section of about 5 mm to facilitate the advancement and placement of the device. The ball at the distal side of the device forms an atraumatic tip, in another embodiment, its diameter can be the same as the diameter of the abrasive member, thus forming no ball but a straight atraumatic tip.

[0301] Reference Fig.12, shows a portion of a device according to an alternative embodiment of the present invention, wherein the components marked with reference to the previous embodiment adopt the same reference numerals. In this embodiment, the surface of the second wire is engraved with spiral notches 20, which are used to provide an abrasive serrated surface on the spiral coil 4.

[0302] Reference Figures 13 to 19 , showing the use of the device of the present invention. In the following description, proximal refers to the entry insertion site toward the blood vessel, and distal refers to the entry site away from the blood vessel. The device can be delivered and removed through a single injection site and does not require the implantation or administration of any chemical agents. The method of treating venous reflux to cause permanent occlusion may include the following steps.

[0303] In a first step, the device is adjusted to a delivery configuration, wherein the helical coil 4 is retracted 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, such as ultrasound.

[0304] The device is then advanced distally to the desired location under ultrasound guidance. Fig.17 Ultrasound is shown to verify correct placement, with the distal end of the catheter member 2 at the beginning of the vein to be treated.

[0305] The outer catheter 2 is axially retracted, exposing the helical coil 4 and the hypotube 12. Fig.13 The deployment coiled structure shown, in some embodiments, uses a handle with a thumb wheel control element to deploy the helical coil. Using a single-handed intuitive movement, the operator can deploy the coil by turning the thumb wheel with the thumb of the hand holding the handle, so that the ultrasound probe can be positioned with the other hand to achieve visualization at the same time, so that the doctor can perform the operation without an assistant when necessary.

[0306] The coil in its undeployed and deployed configurations must be easily visible under ultrasound to prevent accidental placement. This is achieved by incorporating a section of echogenic material on the tip of the catheter. In the deployed state, the coil with the abrasive surface is inherently echogenic.

[0307] Because the coil is oversized relative to the size of the vein being treated, it exerts an outward radial force on the lumen of the vein along at least one complete circumference of the vein.

[0308] Unlike current treatment options, the action of the device to cause long-term occlusion on the vein wall occurs only as the device is withdrawn in the vein segment to be treated. This action can only occur in the proximal direction, protecting more distal structures, including veins in the deep system.

[0309] If the device is accidentally placed in the wrong location in the target vessel, it can be retrieved into the outer catheter and then repositioned without causing vessel damage.

[0310] The device is then moved forward along the segment of vein to be treated (usually a vein segment of about 10 to 70 cm), where the radial force and axial movement of the abrasive surface of the coil against the vein lumen causes the spiral coil to remove, destroy or disrupt the surface layers on the inside of the vein lumen. These layers are composed of the surface layers of the glycocalyx, endothelium, subendothelial connective tissue, and media. Stretch receptors in the vein wall respond to the outward radial force of the device, causing vasospasm. Vasospasm is further enhanced by the release of chemical agents stored in the endothelial cells, primarily endothelin-1, a powerful vasoconstrictor. Exposure of subendothelial collagen causes platelet adhesion and triggers a cascade of activation of prothrombin factors, leading to thrombotic occlusion of the vessel. As Fig.19 As shown, this thrombotic occlusion is further enhanced by marked vasospasm, in which the treated segment of the vein constricts significantly in the acute phase, which leads to a complete cessation of blood flow in the vessel, which was confirmed in a preclinical study on the lateral saphenous vein of goats, where high-pressure artificial injection of contrast agent did not enter the vein 45 minutes after treatment.

[0311] Without being limited by theory, circumferential endothelial disruption allows intraluminal thrombus formation to adhere directly to the vessel wall and causes recruitment of cells involved in the inflammatory healing response, with cells migrating from the adventitia across the lumen into the thrombus. These cells include fibroblasts, which produce collagen in thrombotic occlusions, thereby converting the vessel into a fibrous cord over time. This results in long-term closure of the vessel and regression of venous disease symptoms.

[0312] Contrary to the previous belief that complete transmural cell injury of the vein wall is required, the inventors have demonstrated that only surface exfoliation can induce a sufficient inflammatory response to induce inward migration of fibroblasts on the adventitia layer. This operation is advantageous because it provides a mechanism of action that can use the device without causing pain to the patient or requiring a stab injection of tumescent fluid to prevent pain. Since the pain-sensing nerve fibers are located on the adventitia layer of the blood vessel, they are not directly affected by the device, thereby avoiding pain.

[0313] Results from our preclinical studies also demonstrate the importance of complete circumferential endothelial disruption in achieving long-term successful occlusion. Thrombotic occlusion without endothelial disruption will result in recanalization even if the endothelium is partially disrupted, e.g. Figure 2This is because the endothelium prevents thrombus adhesion, causing it to shrink away from the vessel wall. Adhesion is further prevented by promoting vasodilation through the secretion of nitric oxide from endothelial cells, counteracting the effects of venous spasm. This is probably the main factor involved in the low efficacy of chemical sclerosant-based technologies. Since sclerosants are inactive by the blood and are rapidly removed by the circulation, they can only cause incomplete endothelial destruction, especially in larger vessels that have more blood and a larger surface area even in a contracted state.

[0314] Figures 4 to 16 The embodiments of the present invention all have a body lumen stripping head formed by a single coil element that includes one complete helical turn in a deployed configuration and that circumferentially strips the lumen of a body lumen in use. Figures 20 to 24 , describes an alternative embodiment of the device of the present invention, which is generally indicated by the reference numeral 30, wherein the components described with reference to the previous embodiments are given the same reference numerals. In this embodiment, the device includes an elongated control arm 31, which passes through the catheter member 2 and is operably connected to the distal end 6 of the coil 4, and the proximal end 5 of the coil is connected to the stainless steel hypotube 12. The control arm 31 is axially moved relative to the hypotube 12 to achieve the deployment or expansion of the coil, Fig. 22 The coil is shown as a partially coiled configuration. Fig.23 The coil is shown in a fully coiled configuration. The use of this embodiment is essentially the same as the previous embodiment, except that the deployment of the coil can be controlled by adjusting the axial position of the control arm 31 and hypotube 12.

[0315] Reference Figures 25 to 27 , describes an optional embodiment of the device of the present invention, which is generally represented by the reference numeral 40, wherein the components described with reference to the previous embodiment are marked with the same reference numerals. In this embodiment, the coil 4 is composed of two coil elements 41a and 41b, which work together to circumferentially strip the inner cavity of the body lumen, and each coil element can be adjusted from a deployment configuration and a coiled configuration suitable for being arranged in a catheter member and transported through the body lumen through the lumen, as shown in the figure. Each coil element 41a, 41b has a proximal portion that is generally coaxial with the catheter member, and a coiled portion that includes less than a full turn in its deployment configuration, so that the coil elements together are in a double helix structure, which engages the body lumen to be treated circumferentially during use. As with the previous embodiment, each coil element includes a core wire 8, which has a second wire 9 wound on the core wire to provide a serrated body lumen stripping surface. The use of this embodiment is the same as described with reference to the previous embodiment.

[0316] Reference Figures 28 to 30, describes an optional embodiment of the device of the present invention, which is generally represented by the figure numeral 50, wherein the components described with reference to the previous embodiment are marked with the same figure numerals. In this embodiment, the coil 4 is composed of four coil elements 51a-51d, which work together to circumferentially strip the inner cavity of the body lumen, and each coil element can be adjusted from a deployment configuration and a coiled configuration suitable for being disposed in a catheter member and transported through the body lumen through the lumen, as shown. Each of the coil elements 51a to 51d in the deployment configuration includes approximately one-quarter of a full turn, and the four coil elements together form a quadruple helix structure, so that the four coil elements together circumferentially engage the body lumen to be treated. As with the previous embodiment, each coil element includes a core wire 8, which has a second wire 9 wound on the core wire to provide a serrated body lumen stripping surface. The use of this embodiment is the same as described with reference to the previous embodiment.

[0317] In the above embodiments comprising more than one coil element, the coil elements are connected at their proximal ends and have free distal ends (ie, open coils). However, it should be understood that the coil may be a closed coil in which the coil elements are connected together at the proximal and distal ends. Figure 31-Figure 33 Such an embodiment is described in , wherein the components described with reference to the previous embodiment are labeled with the same reference numerals. In this embodiment, the device 60 comprises a coil formed by four helical coil elements 61a-61d connected together at their proximal end 5 and distal end 6, each coil having about one-half full turn. As in the previous embodiment, each coil element comprises a core wire 8 having a second wire 9 wound around the core wire to provide a serrated body lumen stripping surface. The use of this embodiment is the same as described with reference to the previous embodiment.

[0318] Figures 34 to 41 show a spiral coil as part of the device of the present invention, specifically showing different types of wires used to form the coil, and different types of notches / formations on the surface of the coil that form a rough surface. The coil is formed from a Nitinol wire, and the notches are cut by a knurling process.

[0319] Reference Fig.34A and 34B , shows a portion of a helical coil 67 having a generally flat profile, having a cavity engaging outer surface 61 in which transverse recesses form teeth 62 having a truncated triangular profile; a flat inner surface 63; and sides cut into a serration to provide a plurality of side teeth 65.

[0320] Reference Fig.35A and 35B, shows a portion of a helical coil 70 having a generally convex profile, with a cavity-engaging outer surface 71 in which curved transverse recesses form teeth 72 having a triangular profile; and a smooth convex inner surface 73.

[0321] Reference Fig.36A and 36B , shows a portion of a helical coil 80 having a generally flat profile, having a cavity engaging outer surface 81 with transverse notches formed on each side 84 of the surface 81 providing two sets of teeth 82 having a truncated triangular profile; and a smooth concave inner surface 83.

[0322] Reference Fig.37A and 37B , shows a portion of a spiral coil 90 having a generally convex profile, having a convex lumen-engaging outer surface 91, wherein recesses are formed on the surface 91, providing rhombus-shaped teeth 92, some with flat tips and some with pointed tips; and a smooth flat inner surface 93.

[0323] Reference Fig.38A and 38B , shows a portion of a helical coil 100 having a generally crescent-shaped profile, having a convex cavity-engaging outer surface 101 with curved recesses formed on the surface 101 providing transverse teeth 102 having a scalene triangular profile; and a smooth planar inner surface 103.

[0324] Reference Fig.39A and 39B , shows a portion of a helical coil 110 having a generally elliptical profile, having a convex cavity-engaging outer surface 111, wherein recesses having a curved V-shaped profile are formed on the surface 111, providing transverse teeth 102 having a triangular profile; and a smooth flat inner surface 113.

[0325] Reference Fig.40A and 40B , shows a portion of a helical coil 120 having a generally flat profile with a flat cavity-engaging outer surface 121 , a flat inner surface 123 , and sides cut into a serrated shape to provide a plurality of side teeth 125 .

[0326] Reference Fig.41A and 41B , shows a portion of a helical coil 130 , which has a generally inverted T-shaped profile, having a base 131 , teeth 132 disposed on the base, and a smooth and flat inner surface 133 .

[0327] The above-described surface patterns and shapes are advantageous because they enable delivery at the proper angle, depth, and level of cell destruction during axial treatment of a body lumen, wherein the deployed device automatically deforms in response to changes in the diameter of the body lumen. As previously mentioned, upon retrieval, the roughened surface should ideally contact the vessel wall perpendicularly for optimal effect.

[0328] 42 to 48 show a plurality of vein stripping heads as components of the device of the present invention, in particular, a vein stripping head having a single helical coil, wherein the components described with reference to the previous embodiments are given the same reference numerals.

[0329] Fig.42A and 42B A vein stripping head as a component of the device of the present invention is shown, which is generally indicated by the reference numeral 140 and includes a control arm 31; a helical coil 141 having approximately three turns; a proximal portion 142, wherein the diameter of the coil increases toward a midpoint 143; and a distal portion 144, wherein the diameter of the coil decreases toward a distal end 145 disposed on the axis of the helical coil.

[0330] Fig.43A and 43B A vein stripping head as part of the device of the present invention is shown, generally indicated by the reference numeral 150, comprising 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 previous turn.

[0331] Fig.44A and 44B A vein stripping head, which is a component of the device of the present invention, is shown, which is generally indicated by the reference numeral 160, and includes a control arm 31 and a spiral coil 161. The spiral coil 161 has about seven turns (coils) of different diameters and includes a proximal portion 162, where the diameter of the coil initially decreases and then increases toward a midpoint 163; and a distal portion 164, where the diameter of the coil decreases toward a distal end 165.

[0332] Fig.45A and 45B A vein stripping head as a component of the device of the present invention is shown, which is generally indicated by the reference numeral 170 and includes a control arm 31 and a spiral coil 171, which has approximately four turns (coils) and includes a proximal coil element 172, a distal coil element 173, a transition member 174 connecting the coil elements, and a distal end 175.

[0333] Fig.46A and 46BA vein stripping head as a component of the device of the present invention is shown, which is generally indicated by the reference numeral 180 and includes a helical coil 181 having approximately two turns (coils) and including a proximal coil element 182, a distal coil element 183, a transition member 184 connecting the straight portions of the coil elements, and a distal end 185.

[0334] Fig.47A and 47B A vein stripping head, which is part of the device of the present invention and is generally indicated by the reference numeral 190, is shown including a control arm 31 and a helical coil 191 having approximately three turns (coils) with a diameter that decreases distally toward a distal end 195.

[0335] Fig.48A , 48B 48C shows a vein stripping head as a component of the device of the present invention, which is generally indicated by reference numeral 200, including a control arm 31 and a spiral coil 201, which has about three turns (coils) and includes a proximal right-handed coil element 202 of about two turns, a distal left-handed coil element 203 of about 1.5 turns, a transition member 204 having a turn portion 206, and a distal end 205. The turn portion 206 allows the smaller diameter right-handed proximal coil 202 to transition to the larger diameter left-handed distal coil 203.

[0336] 49 to 51 show a plurality of vein stripping heads as components of the device of the present invention, in particular, a vein stripping head having two unconnected spiral coils spaced axially apart, wherein the components described with reference to the previous embodiments are marked with the same reference numerals.

[0337] Fig.49A and 49B A vein stripping head forming part of a device according to the invention is shown, generally indicated by reference numeral 210, comprising a control arm 31 bifurcated 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 axially spaced from the proximal helical coil and operably attached to control element 31B 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 increasing proximally.

[0338] Fig.50A and 50BA vein stripping head forming part of a device according to the present invention is shown, which is generally indicated by reference numeral 220, and includes a control arm 31 bifurcated at the distal end to provide control elements 31A and 31B, a proximal helical coil 221 operably attached to the control element 31A, and a distal helical coil 222 axially spaced from the proximal helical coil and operably attached to the control element 31B passing through the proximal helical coil. Each helical coil has slightly more than two turns (coils) and is generally conical with a diameter increasing toward the proximal end. In addition, the maximum diameter d1 of the proximal coil is about three times the maximum diameter d2 of the distal coil, and the pitch P1 of the distal helical coil is about twice the pitch P2 of the proximal helical coil.

[0339] Fig.51A A venous blood stripping head forming part of a device according to the present invention is shown, which is generally indicated by reference numeral 230, and includes a control arm 31 bifurcated at the distal end to provide control elements 31A and 31B, a proximal helical coil 231 operably attached to the control element 31A, and a distal helical coil 232 axially spaced from the proximal helical coil and operably attached to the control element 31B 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 increasing toward the proximal end. In addition, the maximum diameter of the proximal coil is approximately one-third of the maximum diameter of the distal coil, and the pitch of the distal helical coil is approximately half of the pitch of the proximal helical coil.

[0340] Reference Fig.61A , when the helical coil is deployed and engages the inner surface of the vessel lumen, static friction exists 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 stiffness and diameter of the coil and the diameter of the vessel, which is balanced by the restraining force P of the vessel. When the user retracts the device, the axial force FA increases to overcome the static friction. As described by Amonton's law, in a sliding system between solid objects, the friction force is proportional to the load contact force (FC) and the surface roughness. It has also been shown that the contact surface area is a factor that increases friction

[11] .

[0341] Ideally, as axial force (FA) increases, static friction is overcome before the coil begins to elongate. Static friction is typically low in veins and arteries due to the presence of a gelatinous glycocalyx layer that has been shown to reduce static friction

[12] . When vessel restraint forces increase, as in venous spasm, greater axial force is required, which causes the coil to lengthen while still maintaining contact with the vessel wall due to its elastic deformability, as in Fig.61B The axial force required to cause the coil to elongate is proportional to the wire stiffness and is also affected by the wire shape (flat vs. round).

[0342] In some cases, such as Fig.61C As shown in Figure 2, there is significant restraining force on the device due to excessive venous spasm or natural obstruction caused by the venous valve. In this case, the increased restraining force is usually concentrated on the distal portion of the coil. As the axial force increases further, the coil reduces its diameter enough to lose contact with the vessel wall, as shown in Figure 2. Fig.61C as shown. This significantly reduces static friction and the distal end can be narrowed to allow it to overcome static friction and / or obstruction. When this occurs, the coil jumps or skips proximally during rewinding to return to its natural configuration. This can cause a small portion of the vein wall to miss the abrasive surface. In some cases, such as crossing a very narrow constriction or venous valve, some coil deformation resulting in loss of contact is required to reduce static friction before the axial forces become too high to cause vessel wall damage or vein dissection. Venous dissection occurs when the distal tip of the endoluminal device acts like an anchor to transmit axial forces that are large enough to dislodge or remove the entire vein segment from the surrounding tissue. This situation has been documented using previous devices for venous ablation that used non-deformable, less elastic designs and caused significant pain and bruising to the patient as well as complicating the procedure [6].

[0343] To overcome excessive coil elongation and resulting skipping, variables related to stiction and coil deformability can be modified by changing the thickness, shape, diameter, and / or stiffness of device elements.Surface roughness should remain constant to achieve adequate mechanical ablation.

[0344] The use of other coil configurations may also limit the effects of skipping on endothelial coverage. Such an embodiment of the device is shown in Figures 42 to 51, with Figures 45 and 46 comprising coupling segments (174, 184) that can be used to prevent over-extension of the entire coil. Figure 48 shows coupling segments between coils having opposite clockwise and counterclockwise configurations to resist over-extension. Figures 49 to 51 show independent coil elements to provide coverage if any coil element is exposed to excessive static friction and loses contact during extension.

[0345] Reference Fig.63 In another embodiment, there is a single flat wire selection. The flat wire is formed of Nitinol. The outer surface of the wire is textured (roughened) using a knurling process that presses a shape into the wire, similarly, the texture can be applied by other means, such as stamping or micromachining. This operation forms abrasive features in the wire. Reference Fig.37A, which shows a diamond knurl pattern pressed into a nitinol wire. The outer surface of the wire may also be shot peened to form a micro-abrasive surface on the wire. The flat wire is then held in a heat setting fixture and formed into a spiral profile. The spiral coil with an abrasive outer surface is configured to shear the lining of the vein (primarily but not limited to the endothelial cell layer) when the spiral coil is moved axially along the vein in a deployed configuration.

[0346] Venous disease

[0347] The devices and methods of the present invention can be used to treat or prevent venous disease. The combination of venous valve failure and venous wall weakness leads to blood reflux, which subsequently leads to complications of blood pooling in the lower extremities. The goal of superficial venous reflux treatment is to remove or block the reflux veins, thereby diverting blood to healthy veins and circulating efficiently back to the heart. The great saphenous vein (GSV) is the longest vein in the body and is the most commonly treated vein for venous reflux disease. Its path extends from the foot to the groin, where it connects 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 many branch veins, which can also be targets of treatment.

[0348] The venous network of the lower limbs is divided into three parts: 1) superficial veins located in the superficial compartment superficial to the myofascia, draining the skin and subcutaneous tissue; 2) deep veins located deep to the myofascia, draining the muscles of the lower limbs; 3) perforating veins, which penetrate the myofascia and connect the superficial and deep veins.

[0349] Understanding the specific fascial layers and compartments of the leg where these veins are located is important for understanding the risks involved in current treatment methods. The GSV usually extends from the calf to the groin in a fascial space surrounded by the myofascia below and the saphenous fascia above, along a path close to the skin of a normal person. The saphenous fascia is part of the membrane layer of subcutaneous tissue. Two fascial layers, the saphenous fascia above and the muscle fascia below, merge at each end to form a closed space called the saphenous compartment. The saphenous compartment contains the saphenous vein and the accompanying arteries and nerves. When above the knee, the saphenous nerve is usually away from the great saphenous vein (GSV) and is not in the saphenous fascia. However, when below the knee, the saphenous nerve is close to the GSV and is located in the saphenous fascia. The only trunk vein located in the saphenous compartment is the GSV or its replacement. All branch veins and accessory veins are located in the subcutaneous compartment outside the saphenous fascia and the saphenous compartment.

[0350] The incidence of GSV segmental agenesis in patients with superficial venous disease is 25%

[13] . This agenetic segment in the thigh is often bridged by accessory veins that run close to the skin outside the saphenous compartment. If this segment or any other part of the GSV runs very close to the skin, it may be difficult to create a tumescent anesthetic plane around the vein to protect the skin in preparation for thermal treatment of venous disease. In some cases, only non-thermal methods or vein stripping can be performed. Branch veins in the thigh run outside the saphenous compartment and may become varicose in appearance if reflux occurs. Due to their more superficial location, these are less suitable for thermal treatment. The two main branch veins in the thigh are the anterior and posterior circumflex veins of the thigh. The anterior accessory saphenous vein of the thigh runs parallel to the GSV in the saphenous compartment, but not always, a problem found in approximately 14% of patients with varicose veins. The small saphenous vein (SSV) begins at the lateral malleolus and drains into the deep veins in the popliteal space behind the knee. The small saphenous vein is close to the sural nerve, which can be easily damaged using thermal methods

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

[0351] Perforating veins connect the superficial veins to the deep veins by penetrating the myofascia. There are up to 150 perforating veins of different sizes and distributions in the lower extremities. The medial sural perforation is the most important clinically, causing high blood flow into the superficial system and venous hypertension. Due to its short length and proximity to the deep venous system, it is difficult to treat with surgery, heat, glue and / or sclerosing methods. Inadvertent direct transmission of heat, glue or chemical sclerosing agents into the deep venous system can lead to DVT and subsequent PE, which is a potentially fatal complication. Open surgical ligation is technically difficult and results in a high morbidity rate of the incision. The connection of the GSV and SSV to the deep femoral veins in the groin and posterior knee, respectively, is also a connection point between the surface and deep systems, and treatment of incompetent upper veins close to these areas has the risk of thromboembolic complications.

[0352] Given these anatomical considerations, the use of thermal energy is limited due to the inherent risk of damage to adjacent skin and nerves. In addition, the forward transfer 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 glue may be inadvertently placed in the deep venous system and cannot be retrieved or recovered. Chemical sclerosants, due to their nature, are efficiently circulated into the deep venous system when they flow from the target site. Foam sclerosant preparations can spread as a clumping emulsion of sclerosant and air, enter the deep venous system, potentially damaging the endothelium and causing DVT. Chemical sclerosants may also be inadvertently injected into the subcutaneous tissue, nerves, or arteries, causing severe skin necrosis.

[0353] To counteract these limitations, an effective non-thermal device should be able to be accurately and precisely deployed using standard ultrasound techniques. It should also be possible to retrieve and retract the device if it is misplaced prior to treatment. Currently there are no devices on the market that have this dual capability.

[0354] A mechanical ablation device that can be precisely deployed at a target location without uncontrolled forward propagation or damage to surrounding tissue, preferably for treating venous reflux in the lower extremities. The ability to retract and reposition further reduces the risk of user-related error.

[0355] Providing a method of venous occlusion that does not use permanent implants or toxic agents is preferred because it avoids infection, immune-mediated inflammatory responses, neurological side effects, debris migration secondary to mechanical fatigue of the implant, and patient discomfort due to mass effect.

[0356] Bioresorbable implant technologies have also previously failed to provide long-term venous occlusion, with recanalization occurring after absorption

[15] .

[0357] Surprisingly, the authors found that by using a purely mechanical, non-implantable solution, the natural thrombotic blockage acted like an "implant" and was converted into a permanent blockage by the body's natural healing mechanism in a process known as fibrotic transformation of thrombus.

[0358] In addition to methods for blocking GSV, SSV, AASV or large superficial branch veins, a method for treating smaller, incompetent branch veins that are typically present below the knee is also provided. Currently, these are treated by a surgery called phlebectomy. It involves operating under local anesthesia to form a skin puncture incision and using a venous hook device to manually extract a short vein segment. This surgery is typically performed on multiple vein segments in the leg. Because multiple injections of local anesthetics are required and it is difficult to adequately anesthetize each vein segment, it is painful and uncomfortable for the patient. Often due to unacceptable patient discomfort or physician preference, chemical sclerosants are used instead. The increased number of chemical sclerosant injections increases the risk of systemic toxic side effects and local complications, including skin necrosis caused by inadvertent injection of sclerosants into the subcutaneous tissue or arterial system.

[0359] In one embodiment, a method of treating a small branch vein is to use Fig.66 and 67 The invention is performed by a small helical coil as shown, which provides the same mechanism of action as previously described for the treatment of large veins such as GSV. After insertion into the target vein, a small coil with an abrasive outer surface is deployed, thereby applying radial force to the vein wall. This surface strips the inner layer when retracted.

[0360] Reference Fig.65In one embodiment, the helical coil is loaded around the needle as part of an intravenous cannula. The current arrangement of the intravenous 14G cannula is adapted to reduce the size of the needle used to enter the vein while maintaining the outer diameter of the sheath at 2.1 mm, which allows for the accommodation of Fig.65 The spiral coil shown has a more tapered tip with a polyurethane outer catheter to allow for skin entry. Using current venous access techniques such as venous entry, needle withdrawal, and cannula advancement, Fig.67 As shown, by partially withdrawing the outer polyurethane sleeve, a small coil section can be deployed ( Fig.66 ). When the end of the treatment area is reached, the outer sleeve can be used for the retrieval and atraumatic removal of the coil. The proposed technique reduces the need for local anesthetics as neither a puncture skin incision nor traction on the vein to pull it out as in hook phlebectomy is required. Chemical hardeners are also not required, reducing the associated risk of skin necrosis.

[0361] Reference Fig.68 In another embodiment, a small gauge needle is used to enter the vein and a guide wire is passed into the vein. Fig.69 As shown, an outer sheath similar to the introducer sheath is passed over the guide wire. The outer sheath is manufactured to contain a coil attached to its inner liner, which is located just below the hole at the tip. This allows the guide wire to pass through and past the coil within the introducer. The coil is then deployed by partially withdrawing the outer sheath 68, and in another embodiment, by using a Fig.70 The peel-away introducer sheath shown is used to deploy the coil, and in one embodiment, the coil can be reloaded into the sheath and used on a separate vein.

[0362] Some of the indications associated with body lumens that can be treated with the devices and methods of the present invention are described below:

[0363] Pelvic venous reflux

[0364] Abnormal backflow of blood in the pelvic veins has been shown to be an important but previously often overlooked cause of recurrent varicose veins in the legs, vulvar / vaginal varicose veins, and a condition called pelvic congestion syndrome (PCS). It is also thought to be associated with hemorrhoids. Backflow in the internal iliac and ovarian veins in women is often responsible for the development of these conditions.

[0365] PCS is characterized by marked congestion of the pelvic veins on venography in women with a history of chronic pelvic pain of more than six months. Most commonly, the left ovarian vein is responsible for reflux and pelvic varicose veins. Symptoms associated with PCS can be very severe, leading to a significant reduction in quality of life and patient discomfort.

[0366] PCS presents with a variety of intrapelvic symptoms, including non-cyclic pain, urinary frequency, and dyspareunia. Current treatment is typically performed using a catheter accessed via the jugular or femoral vein, followed by occlusion of the ovarian and / or internal iliac veins using metal embolic coils, chemical sclerosants 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 venous rupture. Coil migration occurs when the coil inadvertently migrates to a non-target location such as the renal vein or via the inferior vena cava to the pulmonary veins, resulting in pulmonary embolism. Coil migration has been reported to occur in up to 4% of cases and can result in severe symptoms

[16] . Some patients have reported persistent pelvic discomfort or flu-like symptoms, the cause of which is unknown but may be related to the coil implant. Endothermic laser or radiofrequency venous ablation has not been used 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 vessel perforation and damage to surrounding tissue are rare with endothermic techniques, the consequences are far greater when treated in the pelvis than in the lower extremities. In addition, during treatment, large amounts of tumescent anesthetic are injected around the veins of the lower extremities to shield the surrounding tissue and prevent thermal injury and pain. This is obviously not possible in the pelvis. Therefore, there remains a need for a safe and cost-effective device to treat pelvic venous reflux by occlusion. The best solution is provided by a non-implantable, non-thermal approach to reduce these risks.

[0367] In one aspect, the methods of the present invention can be used for the treatment of pelvic venous reflux, wherein a spiral coil device is used to mechanically strip the internal iliac vein and / or the ovarian vein to cause a permanent occlusion. This occlusion will prevent venous reflux into the leg veins that cause recurrent varicose veins, the venous regions supplying the vagina / vulva, and the venous regions involved in PCS. In another embodiment, the stripping procedure can be combined with a temporary balloon occlusion to reduce blood flow and promote thrombus adhesion to the treated segment of the vein. This may be particularly advantageous in pelvic veins with higher reflux volumes and velocities. In one embodiment, the method can be enhanced by combining the use of chemical sclerosants and / or embolic particles. Fig.71 Schematic diagram showing the venous anatomy associated with pelvic venous reflux and the use of spiral coils to strip the internal iliac vein and prevent reflux to the involved venous territory, thereby curing the symptoms.

[0368] Deep venous reflux

[0369] Deep venous reflux caused by incompetent venous valves in the femoral veins of the lower extremities cannot be treated by ablation and occlusion, because it is very important for blood to return from the limb circulation to the heart. DVT has eliminated some incompetent venous valves, but other valves maintain normal valve leaflets, but due to wall relaxation, they no longer properly resist and prevent reflux. Current treatment methods involve invasive surgery to create new valves. Therefore, a less invasive method is needed to restore venous valve function. In one aspect, the method of the present invention can be used for the treatment of deep venous reflux, wherein the spiral coil device is deployed and retracted across the existing valve. The outer surface is slightly abrasive to reduce the risk of thrombotic obstruction while maintaining the ability to destroy the endothelium. This causes hypertrophy of the valve leaflets and surrounding tissues, which has the effect of bringing the valve leaflets closer together and restoring the one-way valve function to prevent reflux.

[0370] hemorrhoid

[0371] As previously described, hemorrhoids can be treated with pelvic vein embolization. Newer techniques also target specific occlusion of the superior rectal artery to prevent filling of the dilated venous plexus leading to internal hemorrhoids

[17] . In most cases, the diameter of this artery is between 3 and 5 mm. 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 used to treat hemorrhoids, wherein a spiral coil device is used to mechanically denature the superior rectal artery to cause permanent occlusion and prevent filling of the venous plexus, thereby curing the condition.

[0372] Varicocele

[0373] Varicocele is an abnormal dilation of the veins around the male testicles. The prevalence of clinically significant varicocele in adult males is as high as 15%, which causes pain, discomfort and reduced fertility. Treatment is recommended for young men with testicular atrophy or reduced fertility. Current treatments include blocking the testicular veins that provide the abnormally dilated veins around the testicles. Current methods of blocking include permanent coil embolization, glue, chemical sclerosing agents, or a combination of techniques. Therefore, there remains a need for a less invasive, cost-effective method to block the testicular veins that provide the dilated veins in varicocele. In one aspect, the method of the present invention can be used to treat varicocele, wherein the testicular veins are mechanically stripped using a disposable spiral coil to cause permanent blockage.

[0374] Fig.55 is a schematic diagram showing the venous anatomy and associated processes leading to permanent venous occlusion.

[0375] Portal vein obstruction

[0376] Preoperative portal vein embolization (PVE) is an elective procedure to terminate portal vein blood flow to a selected portion of the liver before major hepatectomy. PVE induces hypertrophy of liver tissue, which is retained after the planned major resection and can allow for more aggressive resection. It is used as an auxiliary step in the treatment of primary and secondary liver metastases from colorectal cancer. Current technology involves the use of direct image-guided transhepatic access to enter the portal vein system, followed by injection of embolic agents, including glue, polyvinyl alcohol (PVA) and metal balls or coils. Many of these technologies are expensive, and patients may not be able to undergo surgery during the course of the disease before planned resection. Therefore, a more cost-effective method is needed. Since most patients are in a procoagulant state when undergoing portal vein surgery as an aid to tumor resection, non-implantation methods that rely on thrombotic occlusion of the selected portal vein may be effective. In one aspect, the method of the present invention can be used to block the portal vein before surgery, wherein a spiral coil device is used to mechanically strip the portal vein to cause occlusion. This occlusion will promote hypertrophy of the remaining liver segment and increase the likelihood of survival of the patient after planned resection. Fig.53A is an illustration of an occluded portal vein utilizing a non-implant mechanical stripping approach.

[0377] Vein graft

[0378] Coronary artery bypass grafting (CABG) is the standard of care for patients with left main coronary artery disease (CAD) and triple-vessel CAD, and peripheral artery bypass grafting (PABG) is performed in patients with advanced peripheral arterial obstructive disease. The internal mammary artery is commonly used for revascularization in CABG surgery, however, veins (almost exclusively the great saphenous vein) remain the most commonly used graft, especially for PABG surgery. Insertion of vein grafts into the arterial system exposes the vein to increased tensile and shear stresses, which can lead to excessive inflammatory changes within the vein wall, known as intimal hyperplasia, leading to obstruction and vein graft failure. The patency rate of vein grafts is only 60% 10 years after vein graft surgery

[18] . It is not well understood why some vein grafts remain patent while others become chronically obstructed. The AH vein undergoes some remodeling or “venous arterialization” when it is transferred to the arterial system. However, the long-term excessive and persistent inflammatory response leads to graft failure. New research suggests that the condition of the vein prior to grafting may be an important predictor of graft failure. Veins that already have hypertrophic, synthetically prone smooth muscle cells in the media 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 pretreating or conditioning vein grafts before use as conduits in the arterial system. In one aspect of the present invention, a method for pretreating veins for use as grafts in the arterial system to treat CAD and PAD is proposed. A spiral coil with a less abrasive surface or a partially abrasive surface is provided to cause thickening of the vein wall without complete thrombotic occlusion and subsequent fibrosis. The depth of vein wall destruction must be specific to produce an appropriate inflammatory response that does not make the vein susceptible to graft failure. Ideally, this auxiliary surgery is performed 4 to 12 weeks before graft implantation to allow cellular changes involved in vein remodeling to occur and subside. Since inflammatory changes have already occurred and stopped after a mechanical disruption of the treatment, this can improve the ability of the vein to adapt to the arterial environment of greater pressure and higher shear forces. When placed in the arterial system, there is little possibility of uncontrolled excessive inflammation and hypertrophic changes occurring. This may prevent the development of excessive, uncontrolled medial hypertrophy and intimal hyperplasia and reduce the risk of mural atheroma formation, a major cause of cardiac allograft failure. Fig.72 The histological differences between normal veins, arterialized veins, and failed vein grafts are shown.

[0379] Arteriovenous (AV) fistula

[0380] AV fistulas are surgically created to anastomose between the arterial and venous circulations to enable dialysis for the treatment of end-stage renal disease (ESKD). Patients with working AVFs have lower morbidity and mortality and lower costs of care compared with patients who rely on central venous catheters for dialysis. However, the primary failure rate of AVF formation is unacceptably high, ranging from 20% to 60%. In recent years, failure rates have increased due to the aging of the population relying on AVFs for dialysis and the use of higher pump speeds during dialysis

[19] .

[0381] The main cause of failure is stenosis at the anastomosed venous segment. The underlying mechanisms involved in AVF formation are poorly understood but are thought to be related to insufficient outward remodeling and excessive intimal hyperplasia. Therefore, there is an urgent need for an improved method of forming an AVF for ESKD patients. In one aspect of the present invention, a spiral coil with reduced or partially abrasive properties is used prior to surgery to form the anastomosis to produce a remodeled vein with a healthy pattern. Ideally, the procedure should be performed 4 to 12 weeks before AVF creation to allow cellular changes to occur and subside. This pretreatment of the vein can reduce the inflammatory response and uncontrolled remodeling that can lead to primary failure of the AVF when normal veins are violently exposed to arterial pressure and flow rate. The above operation can increase the success rate of AVF surgery. This technique can also prevent AVF steal syndrome, which is the venous side of the anastomosis becomes over-enlarged and causes local ischemia in the area supplied by the arterial side.

[0382] Thrombectomy

[0383] Thrombotic occlusions can occur anywhere in the arterial or venous system and are typically composed of red blood cells, activated coagulation factors, platelets, and inflammatory cells. Over time, from minutes to days, the thrombus mass becomes organized and adheres to the vessel wall, especially if there is vessel wall damage. The foregoing embodiments of the present invention are designed to facilitate this thrombotic situation, primarily in the case of superficial venous reflux, when vessel occlusion is desired.

[0384] The authors also found that radially expanded helical coils could also be used to remove thrombi adherent to the vessel wall if the abrasive surface was tailored to be present only on the leading edge and inner surface of the coil while the outer surface remained smooth to prevent trauma to the vein wall.

[0385] Acute deep vein thrombosis (DVT) is a potentially life-threatening condition if an embolism occurs in the lungs, known as pulmonary embolism (PE). Significantly large DVTs retained in peripheral veins can also lead to a high incidence of chronic venous hypertension in the lower extremities. Anticoagulation is the basis of treatment to help dissolve clots and prevent embolism. New approaches to treat patients in acute situations using mechanical, chemical dissolution or ultrasound techniques to remove clots have emerged in the past 10 years, showing improved results in certain patient groups. Removing clots that have become adherent to the vein wall is technically difficult, and failure can lead to worse outcomes. Some newer technologies that use complex mechanical systems, aspiration or ultrasound are compromised by their high cost. The Fogarty balloon is a low-cost alternative for thrombus removal, but is ineffective for adherent thrombi. In the arterial system, there is a similar need to remove organized thrombi that cause acute limb ischemia. In the neurovascular system, stent retrieval systems are used to retrieve thrombi and prevent stroke. In both cases, more organized adherent thrombi present technical challenges. 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 for removing thrombi from a vessel wall using a helical coil having abrasive inner and leading edge surfaces without causing endothelial trauma. Fig.73 It shows how this device can remove thrombus while leaving the endothelial surface intact and with a low likelihood of rethrombosis. The device is deployed distal to the thrombotic occlusion and retracted proximally toward the entry site. After the thrombus is dislodged, the thrombus can be removed from the circulation using a Fogarty balloon, retrieval basket, or aspiration catheter, which will restore blood flow and prevent the occurrence of sequelae of vascular occlusion.

[0386] Stent obstruction

[0387] Percutaneous stenting of the vasculature is commonly performed to restore blood flow in a partially narrowed or obstructed arterial or venous circulation. Stent thrombosis is relatively uncommon, but a potentially life-threatening complication that occurs at an incidence of approximately 1% following cardiac stenting procedures. Stents placed in diseased arteries may have struts covering calcified or atheromatous plaques. In these cases, elevated stent struts may result in failure of neointimal coverage, particularly in drug-eluting stents

[20] . This typically manifests as late or very late stent thrombosis one year after implantation. There is a need to reduce the probability of stent thrombosis following such procedures. In one aspect of the invention, a helical coil having an outer abrasive surface covering a portion of the coil circumference is provided. This allows for selective treatment of a portion of the arterial surface that may remain uncovered in a later state. Fig.74A method is shown for selectively pre-treating a portion of an artery using partially abrasive coils prior to stent placement. This increases the likelihood that the stent struts will be covered with neointima and reduces the risk of late stent restenosis. Imaging techniques such as intravascular ultrasound (IVUS) can be used to orient the device and enable the operator to selectively target the desired portion of the vessel wall.

[0388] Blocked arteries

[0389] Selective occlusion of arteries and often of arterial supply to specific tissues is an effective treatment modality for a variety of disease states. Tumor embolization is a technique for occluding arteries supplying benign or malignant tumors using a variety of methods via a percutaneous approach, including synthetic or bioresorbable beads, metal spheres, gels, or metal coils. Common complications of the use of these agents include migration into non-target vessels, excessive occlusion leading to necrosis of normal tissue, pain, and infection associated with the combination of foreign material and necrotic tissue.

[21] Therefore, there is a need for a less invasive, non-invasive, and less complication-prone treatment for embolization of arteries supplying benign or malignant tumors.

[0390] Reference Fig.52A and 52B , showing a tumor 240 and arteries supplying blood to the tumor, including arterioles 241, the device of the present invention can be used to occlude one of the arterioles and deprive the tumor of blood supply. Fig.52B The vein stripping head 242 of the device of the present invention is shown deployed in an arteriole with the helical coil circumferentially engaging the arterial lumen.

[0391] Reference Fig.52A , the device is advanced along the artery supplying the tumor and deployed at point 243, then retracted proximally. The retraction of the helical coil along the artery, coupled with the circumferential contact between the rough surface of the helical coil and the lumen of the artery, results in denudation of a portion of the lumen of the artery, removal of the epithelial cell layer, and subsequent thrombosis at point 243, resulting in occlusion of the artery.

[0392] Uterine fibroids

[0393] Uterine fibroids are benign lesions that can cause significant pelvic pain and dysmenorrhea. Uterine fibroids can be treated by hysterectomy or by minimally invasive embolization of the uterine artery that supplies the fibroid. The most commonly used embolic agents for uterine artery embolization (UAE) are polyvinyl alcohol (PVA), tripropylene gelatin microspheres, and Polyzene-F hydrogel microspheres. Complications include migration of embolic materials to non-target tissues, excessive necrosis causing pain and infection. Therefore, a less invasive, non-implantable, and low complication rate treatment method is needed to treat uterine fibroids. In one embodiment, a method using a spiral coil with an abrasive outer surface is provided to partially or completely block the uterine artery or distal branch that supplies the uterine fibroid. Reducing or eliminating blood flow can reduce size and alleviate symptoms caused by fibroids. Using this method to induce endometrial hyperplasia to cause sufficient stenosis of blood vessels can reduce the risk of necrosis complications while maintaining a size reduction effect on fibroids. The method may also be used to treat conditions including, but not limited to, arteriovenous malformations (AVMs) in the pulmonary, cerebral or hepatic circulation, malignant tumors, benign prostatic hypertrophy (caused by obstruction of the prostatic arteries).

[0394] Patent foramen ovale

[0395] Patent foramen ovale (PFO) is a common heart wall abnormality with a prevalence of about 30% in the adult population. And the benign findings that are usually found in some PFOs can open, allowing abnormal emboli to move from the venous circulation to the arterial circulation, potentially causing sudden brain loss of function and systemic embolism. The treatment of individuals with a history of cryptic stroke is percutaneous closure using a septal occluder. These devices are permanent implants deployed across the defect. The anatomy of PFO involves the overlap of the first and second atrial septa, which form a flap valve that can open when the right atrial pressure exceeds the left atrial pressure, such as when coughing or sneezing. These devices are expensive and may cause complications, including thrombosis and stroke. A less invasive treatment with a lower risk of complications is needed. In one embodiment, a method is provided, using an abrasive device in the shape of a coil or hoop to peel off the contact surface of the atrial septal flap involved, which causes an inflammatory reaction, so that adhesion is formed between the valve surfaces, causing the PFO to be permanently closed to eliminate the risk of sudden brain loss of function. A similar approach can be used within the heart to create scar tissue and thickening to block nerve conduction at the point of abnormal conduction causing the arrhythmia.

[0396] Patent ductus arteriosus

[0397] The ductus arteriosus (DA) is a fetal vascular connection between the main pulmonary artery and the aorta that diverts blood from the pulmonary artery bed. After birth, the DA undergoes active constriction and eventually obliterates. Patent ductus arteriosus (PDA) occurs when the DA fails to close completely postnatally. Histologically, the ductal tissue is distinct from that of the adjacent aorta and pulmonary arteries. The ductal intima is thicker, and the media contains more smooth muscle fibers arranged in a characteristic spiral pattern. The DA can take on a variety of shapes and forms. Small PDAs are typically less than 3 mm in diameter. The optimal treatment for infants with PDAs that must be closed remains a subject of debate. Current percutaneous treatment options include coils and occlusion devices. Limitations of these treatments include high cost and the risk of embolic complications from coil migration. If not properly sized, occlusion devices may lead to serious complications, such as coarctation of the aorta as the child grows

[22] . Therefore, there is a need for a less invasive and effective percutaneous treatment for PDAs. In one embodiment, a spiral coil with an outer abrasive surface is used to denudate the DA, leading to thrombosis and fibrotic occlusion over time. This will relieve shunt-related symptoms and reduce the risk of endocarditis by closing the DA. This technique can also be used to treat small diameter atrial septal defects in a similar manner.

[0398] Aortic aneurysm

[0399] Abdominal aortic aneurysm (AAA) is an abnormal dilation of the aorta that can be complicated by rupture, resulting in significant morbidity and mortality. Treatment of large aneurysms aims to reduce the risk of rupture. Treatment options are open surgery with graft placement or endovascular aneurysm repair (EVAR) using a large covered stent graft. EVAR is a less invasive procedure with a faster recovery time and a lower risk of renal injury. However, the long-term efficacy of EVAR is limited, with endoleak rates as high as 20% requiring radiographic surveillance, revision surgery, or adjunctive surgery

[23] . Endoleaks can be classified as type I to type V, with type I endoleaks occurring at the proximal or distal graft attachment site. Blood enters and fills the sac through the gap between the vessel wall and the graft, leading to the risk of rupture. Type II endoleaks occur when retrograde flow occurs from lumbar or mesenteric vessels into the aneurysm sac via side branches and also leads to the risk of rupture. Type I and II endoleaks account for the majority of morbidity associated with the post-EVAR course. Current treatments for type I endoleaks include small screws and additional stent graft placement. Type II endoleak can be treated by placing embolic coils in the lumbar or mesenteric vessels supplying the capsule. All of these methods are invasive, expensive and carry complications of aortic wall rupture and infection. Therefore, there is a need for a technology that reduces the risk of type I and type II endoleaks. In one embodiment, a method for preparing a portion of the aorta near the graft attachment site to reduce the risk of type I endoleak is provided. This is performed by stripping the endothelial lining of these specific locations using a spiral coil, which can be easily determined based on preoperative imaging planning. By performing this operation, the arterial wall is triggered to form new intimal proliferation at the graft attachment site and reduce the risk of blood leakage and type I endoleak. This benefit will reduce the risk of auxiliary surgery that may complicate the postoperative course. Similar methods can be used to treat type I endoleaks because they occur by inserting an expandable elastic abrasive device into the gap, in which the endoleak occurs over time, resulting in thrombotic obstruction with fibrotic transformation. Another method for treating type II endoleak is provided, which uses an expanded elastic abrasive element to strip the artery supplying the lumbar or mesenteric artery, thereby causing obstruction and preventing the risk of capsule rupture. Since flow in these arteries is retrograde from the anastomotic connection, they are more likely to behave like veins and are prone to thrombotic obstruction due to the permanent implantation of the coils. A similar approach can be used to treat paravalvular leaks associated with percutaneous heart valve replacement. Paravalvular leaks after percutaneous mitral and aortic valve replacement procedures lead to postoperative morbidity and, in some cases, revision surgery.

[0400] Diabetes intervention therapy

[0401] Duodenal mucosal resurfacing (DMR) is a new technique that has been shown in early clinical studies to improve glycemic control in patients with diabetes

[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-glycemic diet that produces insulin resistance signals, thereby worsening glucose control. By ablating this hyperplastic mucosa, a new mucosal surface can be regenerated without harmful signaling. The anatomy of the duodenum shares some important features with the venous system. It has a tortuous path, is highly compliant, is distensible, and can be induced to contract by contraction of the muscular wall. The goal of the treatment is to safely ablate only the surface mucosal layer without affecting the underlying deeper muscular layer, which is performed over approximately 10 cm of duodenum length.

[0402] Currently developed methods involve placement of an expandable balloon capable of transferring hydrothermal energy from a fluid within the balloon to the duodenal wall, thereby causing ablation or damage to cells on the mucosal lining

[22] . This method requires a skilled endoscopist to create a thermal barrier by lifting the mucosa from the submucosal layer. This is currently accomplished by maintaining the surface mucosal layer through a circumferential suction channel around the balloon while a needle is inserted submucosally to inject saline. If not performed properly, there is a risk of duodenal wall perforation and damage to the deeper muscular layers. Therefore, there is a need for a less invasive, easier to perform, less expensive, and faster treatment method that can selectively ablate the superficial layers of the duodenum to a depth of no more than 0.6 mm. In one embodiment of the present invention, a radially expanding elastically deformable abrasive device is delivered through a channel in a standard endoscope, such as Fig.75 As shown, the abrasive element is deployed to contact the duodenal wall distally near the jejunal junction. The abrasive element has a surface roughness with a maximum peak-to-valley distance of 0.6 mm. The device is retracted toward the proximal stomach. During the retraction process, it causes circumferential exfoliation or destruction of the mucosal layer. This allows glucose control to be restored and improved. Similar methods can be used in other parts of the gastrointestinal tract to treat lesions that affect the absorption of lipids, iron, vitamins and minerals including manganese.

[0403] Small Intestinal Bacterial Overgrowth

[0404] Small intestinal bacterial overgrowth (SIBO) occurs when an excess of microorganisms that normally reside in the colon colonize the small intestine. Invasive bacterial strains damage the intestinal surface by producing enterotoxins and by direct wall adhesion. Fermentation of unabsorbed carbohydrates results in bloating, distension, and flatulence. Ileal inflammation may also occur, causing diarrhea and nutrient malabsorption. The small intestine (jejunum and duodenum) normally has significantly lower concentrations of bacteria and other microorganisms than the colon. The boundary between these parts of the gastrointestinal tract is controlled by the ileocecal valve. When this valve is not fully closed, it can allow large intestinal contents to flow back into the small intestine. This promotes bacterial overgrowth, which ingests the nutrient-rich components of the small intestine

[25] . Antibiotic therapy is currently used in initial treatment to prevent bacterial overgrowth in the small intestine. However, approximately 40% of patients with small intestinal bacterial overgrowth (SIBO) have persistent symptoms after initial antibiotic treatment. Abnormal backflow through the ileocecal valve has been shown to be a cause of SIBO

[25] . Therefore, more effective SIBO treatments are needed. In one embodiment, a radially expandable abrasive device is used to disrupt the mucosal layer of the ileocecal valve and ileum, causing an inflammatory response followed by hyperplasia, which can reduce the diameter of the ileocecal valve, greatly reducing the possibility of fluid backflow from the colon. A second effect can be to ablate areas of the ileum colonized by attached bacteria to allow regeneration of normal or non-colonized mucosa. This method can be used in conjunction with antibiotic therapy to enhance the effect and reduce the high recurrence rate. A similar method can be used to tighten the gastroesophageal connection that can cause gastric reflux when the sphincter is relaxed.

[0405] Barrett's esophagus

[0406] Barrett's esophagus (BE) is a premalignant condition of esophageal cancer, in which cellular changes occur in the lower esophagus due to chronic injury and inflammation caused by gastroesophageal reflux disease (GORD). The incidence in patients with GORD is estimated to be 10%. Early intervention can prevent the development of cancer. Current early intervention methods include thermal and radiofrequency ablation of the affected superficial layers to regenerate normal tissue

[26] . Radiofrequency ablation is a currently used technique involving endoscopic insertion of a radiofrequency probe. The main disadvantage of this method is the high cost of the radiofrequency device. Therefore, there is a need for a simpler, more cost-effective method to treat this common condition. In one embodiment, a method is provided for endoscopic deployment of a radially expandable abrasive element to mechanically ablate abnormal cells in the lower esophagus to reduce the risk of cancer development. Given that the histological grading and ultimate diagnosis of Barrett's esophagus are highly challenging for pathologists, another advantage of this method is that it allows the collection of cells on the ablation head, which can be analyzed after the procedure. This is in contrast to thermal methods that completely destroy the cells. This cell collection capability may also be used to diagnose and manage premalignant or malignant lesions in other parts of the gastrointestinal tract, such as the colon, lung bronchi and bronchioles, uterus, cervix, urinary tract, and bladder.

[0407] Management of perianal fistula

[0408] Perianal fistulas are abnormal connections between the skin around the rectum and anal canal that are present in patients with inflammatory bowel disease and are associated with high morbidity due to infection, pain, and bleeding. Perianal fistulas are difficult to treat with current methods, which include invasive surgical excision or the application of sutures to gradually remove the passageway over the course of long-term treatment. These treatment options have high recurrence rates

[27] . Therefore, there is a need to develop a less invasive and more effective treatment for perianal fistulas. In one embodiment, a radially expandable abrasive device for deployment and retrieval in the gastrointestinal tract is provided, causing the duct lined with endothelial cells to denudate. An inflammatory response subsequently occurs, resulting in scarring, and preventing fecal contents from entering the duct, which inhibits healing. Closure of the duct by a fibrotic inflammatory response then prevents disease. Similar methods can be used to seal or close portions of lung disease that occur in chronic obstructive pulmonary disease. When inspired air enters these portions of lung disease, oxygen exchange with the lungs does not occur, resulting in a decrease in blood oxygen levels. In these cases, it is necessary to block or seal the bronchioles or alveoli to transfer air to healthy lung tissue.

[0409] sterilization

[0410] When patients require permanent contraception, female sterilization is often performed by tubal ligation. Current methods include open surgical ligation, salpingectomy, and minimally invasive clip placement. Complications of these surgeries include pain, bleeding, and infection. A less invasive, reliable method that avoids surgical resection or permanent implantation is needed. In one embodiment, a radially expanding spiral device is inserted, deployed, and retracted into the fallopian tube. This disrupts the endothelial and subendothelial layers, triggering an inflammatory response that causes fibrotic obstruction of the fallopian tube over time. The technology can also be applied to male sterilization surgery on the lumen of the vas deferens.

[0411] 52 to 55 illustrate the use of the device of the present invention to occlude different blood vessels in a subject in the treatment of a disease.

[0412] Reference Fig.53A and 53B , shows the use of the device of the present invention to occlude the portal vein system. This treatment can be used to treat liver cancer by occluding the portion of the portal vein system that brings nutrients from the intestine 254 to the liver. In the figure, the vascular stripping head 252 is shown in the portal vein 251 in a deployed configuration. The helical coil is retracted along the vein, and the rough surface of the helical coil is in circumferential contact with the vein lumen, causing a segment of the portal vein lumen to be stripped with the removal of the epithelial cell layer, and thus thrombus formation, resulting in vein occlusion.

[0413] Reference Fig.54, shows the use of the device of the present invention to treat an arteriovenous malformation, which is an abnormal vascular tangle 261 connecting a vein 262 and an artery 263 vessel. In the embodiment shown, the device of the present invention is advanced along the artery into the malformation, and the helical coil 264 is deployed into circumferential contact with the vessel 261 and retracted to denudate the vessel lumen, thereby causing thrombosis and occlusion of the vessel 261, thereby closing the branch between the arterial and venous blood systems.

[0414] Reference Fig.55 , the figure shows the use of the device of the present invention to treat varicocele (or varicocele), which is a condition similar to varicose veins occurring in the veins of the scrotum 272, which can cause infertility, pain and discomfort to the patient. In the embodiment shown, the device of the present invention is advanced along the left internal spermatic vein 270, and the helical coil 271 is deployed into circumferential contact with the vein 270 and retracted to denudate the vessel lumen, thereby causing thrombosis and occlusion of the vessel 270, thereby blocking the vein and treating the condition.

[0415] Reference Figures 56A to 56C , showing the use of the device of the present invention, particularly the device being able to self-adjust its diameter to accommodate vessels of varying diameters. The coil is formed of nitinol and in a relaxed state forms a helical coil having a diameter greater than the vessel to be treated. When the coil is deployed in the vessel (typically from a delivery catheter), the catheter expands to accommodate the circumference of the vessel, applying an outward radial force to the circumference of the vessel through at least one turn of the coil. Fig.56A A helical coil 280 is shown deployed in a blood vessel 281 in circumferential contact with the vessel lumen proximate a narrower segment 282 of the vessel, with the diameter of the proximal portion of the coil self-adjusting to the smaller diameter of the vessel. Fig.56B The helical coil 280 is shown having passed through the narrower segment 282 and maintaining circumferential contact with the vessel lumen proximal to the narrower segment. Figure 53C shows the helical coil moving proximal to the narrower segment and self-adjusting to maintain circumferential contact with the vessel lumen as the vessel widens.

[0416] Reference Figures 57A to 57C , showing the use of the device of the present invention, and in particular how the helical coil, which is a component of the device of the present invention, can pass through a valve in a vein as it is pulled through a segment of the vein: (A) the deployed helical coil 290 is attached to the control arm 31 and is in circumferential contact with the venous lumen 291 distal to the valve 292; (B) the helical coil 290 is retracted proximally through the valve 292, and the diameter of the coil self-adjusts to prevent the coil from being hooked by the valve leaflets; (C) the helical coil moves proximally to the narrower segment and self-adjusts to maintain circumferential contact with the vascular lumen proximal to the valve.

[0417] Reference Figures 58A to 58B, showing the use of the device of the present invention, and in particular how the helical coil forming part of the device of the present invention can self-adjust to travel through a segment of the vascular system 300 that gradually narrows, with the diameter of the helical coil 301 self-adjusting to maintain circumferential engagement with the vascular lumen: (A) the deployed helical coil 301 is in circumferential contact with a wide segment 302 of the blood vessel; (B) the deployed helical coil 301 is in circumferential contact with a narrower segment 303 of the blood vessel.

[0418] Reference Figures 59A to 59C , showing the use of the device of the present invention, and in particular how the helical coil forming part of the device of the present invention can self-adjust to different vessel diameters and through tortuous vessels: (A) The deployed helical coil 310 is in circumferential contact with the vessel lumen at a narrower segment 311 of the vessel; (B) The helical coil 310 travels through a sharp turn 312 in the vessel while maintaining circumferential contact with the vessel lumen; (C) The helical coil 310 travels through a second sharp turn 313 in a larger diameter vessel while maintaining circumferential contact with the vessel lumen. From the figures it can be seen how the helical coil adapts to different diameters of the vessel and maintains circumferential contact with the vessel lumen even when it travels through tortuous turns.

[0419] Reference Fig.60A and 60B , shows how a helical coil forming part of the device of the invention can self-adjust the diameter of the coil to maintain circumferential engagement with the vessel lumen when the vessel is constricted due to vasospasm, in particular when the vessel is constricted due to vasospasm: (A) Before vasospasm, the deployed helical coil is in circumferential contact over a length I within a wide vessel of diameter D; Section AA shows an axial view of the coil within the vessel under a restraining pressure P, which is converted into a hoop force (HF) within the coil. This HF causes the coil to stretch due to its open-end design. (B) During vasospasm, the deployed helical coil is in circumferential contact over a stretched length L within a constricted vessel of diameter d.

[0420] Reference Fig.62A and 62B , using the device of the present invention to partially block a body lumen, in the embodiment shown, specifically treats vascular systems with abnormally high blood volume or high blood flow, partially blocks blood vessels, and thus normalizes blood volume or blood flow. (A) shows a pulmonary artery 330 before treatment, the device of the present invention includes a spiral coil 331, a control arm 31, and a catheter member 2, the above components are deployed in the artery and pulled in the direction indicated by the arrow X; (B) shows a pulmonary artery 330 after treatment with the device of the present invention, intimal hyperplasia 333 partially blocks the artery to provide reduced blood volume and flow through the artery.

[0421] Vessel wall assessment

[0422] Understanding the biophysical properties of the vessel wall in both the arterial and venous systems is important for predicting disease progression and assessing treatment response.

[0423] Abnormalities in the vascular endothelium are now considered to be early precursors of vascular disease

[28] . One such marker is the effect of the blood vessels contracting or spasming in response to mechanical or chemical stimulation. Chronic hypertension and / or chronic uncontrolled blood glucose levels damage the endothelial layer, which can be detected at an earlier stage than atherosclerosis, arterial stenosis or blockage. Acetylcholine iontophoresis is a method that combines the measurement of blood flow through a cross-section of the vessel to test endothelial responses. These methods have experimentally shown that endothelial function is suppressed by drinking sugar-sweetened beverages and being in a state of chronic hypertension

[29] . During vascular interventional procedures, there is currently no method to assess endothelial cell function in or near atherosclerotic lesions. Therefore, more information about endothelial function needs to be collected to inform treatment decisions and to inform prognosis. For example, during intravascular stent placement, there is currently no way for the physician to know how the vessel wall responds to dilation during angioplasty. This can lead to complications including vessel rupture, bleeding, and thrombotic occlusion

[30] . Current methods are based on experience and the angiographic appearance after inflation to measure the air pressure in the inflation balloon and inflate it to a standard level. However, due to differences in vessel wall characteristics and differences between patients, the occurrence of complications such as vessel wall rupture is still difficult to predict. In one embodiment, a radially expandable element that contacts the vessel wall at a discrete distal point is used to measure the response of the endothelium to chemical or mechanical stimulation. Mechanical stimulation can be provided by the radial force of the device itself, which can be static or adjustable via a control arm. Chemical stimulation can be provided by coating drugs on the device surface. In one embodiment, a piezoelectric sensor is incorporated into a radial expansion element to measure the pressure and flow effects on the coil during intracavitary surgery. The expansion element that generates an outward radial force in the vein cavity will generate a circumferential force (HF) in the vessel wall. This stretching HF will generate an opposite compression circumferential force in the intracavitary device. Therefore, the inherent pressure in the measuring device will serve as a surrogate marker to characterize the response of the vessel wall to stretching. The data can be recorded and stored in a central control unit. The data can be used for further performance enhancement, including the automation of surgery in the vascular system. The data can also be analyzed manually or by using machine learning methods to determine the prognosis of vascular disease and verify the diagnostic markers of vascular disease.

[0424] Equivalent Examples

[0425] The above description shows the current preferred embodiment of the present invention in detail. After considering these descriptions, it is expected that many modifications and variations will occur to those skilled in the art when they are practiced. These modifications and variations are intended to be included in the appended claims.

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Claims

1. A device (1, 30, 40, 50, 60) for stripping a vein, comprising a vein stripping head (3) operably attached to an elongated catheter member (2) and configured for transluminal delivery and deployment in a vein, the vein stripping head comprising a helical coil (4) capable of self-adjusting between an uncoiled delivery configuration and a coiled deployment configuration, the uncoiled delivery configuration being suitable for transluminal delivery within the catheter member, the coiled deployment configuration being configured to circumferentially engage the lumen of the vein when deployed, wherein the helical coil (4) is configured to self-adjust between an uncoiled delivery configuration and a coiled deployment configuration, the uncoiled delivery configuration being suitable for transluminal delivery within the catheter member, the coiled deployment configuration being configured to circumferentially engage the lumen of the vein when deployed, wherein the helical coil (4) is configured to self-adjust between an uncoiled delivery configuration and a coiled deployment configuration, the uncoiled delivery configuration being suitable for transluminal delivery within the catheter member, the coiled deployment configuration being configured to circumferentially engage the lumen of the vein when deployed, wherein the helical coil (4) is configured to self-adjust between an uncoiled delivery configuration and a coiled deployment configuration, the uncoiled delivery configuration being suitable for transluminal delivery within the catheter member, the coiled deployment configuration being configured to self-adjust between an uncoiled delivery configuration and a coiled deployment configuration ... The spiral coil has a body lumen engaging outer surface, which is rough so as to irreversibly damage and circumferentially strip the vein lumen including the endothelial layer and the media layer of the vein through circumferential engagement between the rough surface and the vein lumen when the spiral coil moves axially along the vein in a coiled deployment configuration without rotating the spiral coil, wherein the spiral coil is configured to self-adjust to different diameters of the vein as it travels along the vein in its deployment configuration, and the rough surface includes teeth, which are configured to damage the endothelial layer and the media layer of the vein.

2. The device of claim 1, wherein the helical coil has a smooth inner surface.

3. The device according to claim 1 or 2, wherein the vein stripping head is non-detachably attached to the catheter member.

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

5. The device of claim 1, wherein the helical coil comprises a shape memory material and is configured to adopt a coiled configuration when deployed.

6. The device of claim 1, wherein the device comprises an elongated control arm disposed within the catheter member for the vein stripping head.

7. The device of claim 1 comprising a single helical coil.

8. The device of claim 1, wherein the helical coil has 1-3 turns in a deployed configuration.

9. The device of claim 1, wherein the diameter of the helical coil varies along its length.

10. The device of claim 1, wherein the diameter of the helical coil increases toward one end.

11. The device of claim 1, wherein the diameter of the helical coil increases toward the proximal end.

12. The device of claim 1, wherein the diameter of the helical coil increases toward a midpoint along the helical coil and then decreases.

13. The device of claim 1, wherein the distal tip of the helical coil terminates at a point disposed along or adjacent to a longitudinal axis of the helical coil.

14. The device of claim 1, wherein the helical coil has a proximal portion of a first diameter, a middle portion of a reduced diameter relative to the proximal portion, and a distal portion of an increased diameter relative to the middle portion.

15. The device according to claim 1, wherein the helical coil has a proximal helical coil portion and a distal helical coil portion and an intermediate connecting portion, wherein the intermediate connecting portion is not helical and can be straight or curved.

16. The device of claim 15, wherein one of the proximal helical coil portion or the distal helical coil portion is a right-handed helix and the other of the proximal helical coil portion or the distal helical coil portion is a left-handed helix.

17. The device of claim 15, wherein the proximal helical coil portion is a right-handed helix and the distal helical coil portion is a left-handed helix.

18. The device of claim 15, wherein the distal helical coil portion is a right-handed helix and the proximal helical coil portion is a left-handed helix.

19. The device of claim 1, wherein the helical coil comprises a plurality of coil elements.

20. The device of claim 19, wherein the coil element is arranged in two, three or four coils.

21. The device of claim 1, wherein the helical coil is configured such that when deployed, in a coiled configuration, its pitch is 0.5-1.5 times the diameter of the helical coil.

22. The device of claim 1, wherein the helical coil is configured such that when deployed in a coiled configuration, its pitch is approximately equal to the helical coil diameter.

23. The device of any one of claims 1-2 or 4-6 or 8-22, comprising a proximal helical coil, an axially spaced distal helical coil, and a control arm for the helical coil.

24. The device of claim 23, wherein the control arm bifurcates at a distal end to provide two distal control arms, each distal control arm connected to one of the helical coils.

25. The device of claim 24, wherein a control arm of the distal helical coil extends axially through all or part of the proximal helical coil.

26. The device of claim 23, wherein the maximum diameter of the proximal helical coil is greater than the maximum diameter of the distal helical coil.

27. The device of claim 23, wherein the maximum diameter of the proximal helical coil is smaller than the maximum diameter of the distal helical coil.

28. The device of claim 23, wherein the pitch of the proximal helical coil and the distal helical coil are different.

29. The device of claim 28, wherein the narrower helical coil has a larger pitch.

30. The device of claim 23, wherein the distal helical coil or the proximal helical coil is conical.

31. The device of claim 23, wherein the distal helical coil and the proximal helical coil are conical in shape.

32. The device of claim 23, wherein the diameter of the helical coil increases in the proximal direction.

33. The device of claim 1, wherein the helical coil has an arcuate profile.

34. The device of claim 1, wherein the helical coil has a circular profile.

35. The device of claim 1, wherein the helical coil has an elliptical profile.

36. The device of claim 1, wherein the helical coil has a convex or concave profile.

37. The device of claim 1, wherein the helical coil has a T-shaped or inverted T-shaped profile.

38. The device of claim 1, wherein the helical coil has a flat inner surface and a non-flat outer surface.

39. The device of claim 1, wherein the helical coil has a flat inner surface and a curved outer surface.

40. The device of claim 1, wherein the helical coil has a flat inner surface and a concave or convex outer surface.

41. The device of claim 1, wherein the helical coil has a flat inner surface and an inverted T-shaped outer surface.

42. The device according to claim 1, wherein the rough surface of the spiral coil is formed by treating a surface of the spiral coil to make the surface rough.

43. The device of claim 1, wherein the surface roughness is formed by mechanical abrasion, electrical abrasion, chemical abrasion, or abrasion by other means.

44. The device of claim 1, wherein an outer surface of the helical coil comprises recesses configured to provide a roughened surface.

45. The device of claim 44, wherein the recesses are configured to provide teeth on the surface.

46. ​​The device of claim 45, wherein the notch is a transverse notch.

47. The device of claim 46, wherein the transverse notch extends completely across the outer surface of the helical coil.

48. The device of claim 46, wherein the helical coil has a concave profile with transverse notches disposed on each side of the outer surface.

49. The device of claim 45, wherein the notch is longitudinal and extends completely or at least partially along the length of the helical coil.

50. The device of claim 37, wherein the helical coil has an inverted T-shaped profile, wherein the teeth arise from the legs of the inverted T.

51. The device of any one of claims 45 to 50, wherein the teeth have a profile selected from triangular, polygonal, or any other profile configured to scrape the endothelial layer of a body lumen.

52. A device according to any one of claims 45 to 50, wherein the teeth are rhombus-shaped formed by alternating oblique notches.

53. The device of claim 1, wherein the helical coil comprises side teeth.

54. The device of claim 1, wherein the helical coil has flat inner and outer surfaces, and side teeth.

55. Apparatus according to claim 19 wherein the or each helical coil element comprises a core wire and the abrasive surface is formed by a second wire helically wound around the core wire to form a second coil.

56. The device of claim 55, wherein the second wire has a polygonal cross-section.

57. The device of claim 1 wherein the distal end of the helical coil comprises an atraumatic tip.

58. The device of claim 1, wherein the device comprises a handle operably connected to a proximal end of the catheter member and configured to control deployment and retraction of the helical coil by axial adjustment of the catheter member relative to the helical coil.

59. The device of claim 1, wherein the rough body lumen engaging outer surface of the helical coil comprises a coarse abrasive surface and a micro-abrasive surface.

60. The device of claim 1, wherein the roughened body lumen engaging outer surface of the helical coil comprises a roughened portion and a non-roughened middle portion.

61. The device of claim 1, wherein an inner surface of the helical coil is rough.

62. The apparatus of claim 1, wherein: The device is configured to adjust between: a delivery configuration, wherein the helical coil is housed within the catheter member in an uncoiled delivery configuration, a vein stripping configuration wherein, in use, the helical coil is deployed in a vein to be treated at a first axial position and against the circumference of the vein; and A retracted configuration wherein the helical coil is housed within the catheter member.

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