RU2814884C2 - Device for denudation of lumen of body cavity - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to a device for denudation of the lumen of the body cavity, in particular the superficial vein. The device (1, 30, 40, 50, 60) for denudation of a vein contains a head (3) for denudation of a vein, operatively attached to an elongated catheter element (2) and configured for transluminal delivery and deployment in the vein. The vein denudation head comprises a helical coil (4) that is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter element, and a coiled, unfolded configuration that circumferentially contacts the interior lumen of the vein when deployed. The helical coil has an outer contact surface with the lumen of the body cavity that is roughened to shear or permanently damage the internal lining of the lumen of the body cavity for circular denudation of the internal cavity as the coil moves axially along the lumen of the body cavity in a twisted unfolded configuration. The helical coil in the deployed configuration is designed to self-adjust to the changing diameter of the vein as it moves along the vein. The outer surface of the coil contains grooves that provide surface roughness. In accordance with the second version of the device, the helical coil (4) contains lateral teeth and in a twisted deployed configuration has a diameter greater than the vein to be denuded. In accordance with the third version of the device, the helical coil (4) is characterized by a flat inner and outer surface and lateral teeth. According to a fourth embodiment of the device, the helical coil (4) or each element of the coil contains a conductor wire, and the abrasive surface is formed by a second wire wound in a coil around the conductor wire to form a second coil.

EFFECT: invention addresses the need to obtain a device for the treatment of superficial venous reflux that avoids the problems associated with prior art thermal, chemical and adhesive implant treatment methods while providing best-in-class effectiveness compared to thermal options.

54 cl, 75 dwg

Description

Technical field

The present invention relates to a device for denudation of the lumen of a body cavity, in particular a superficial vein. Also provided are methods for denudation of the lumen of a body cavity, in particular a superficial vein, and methods for treating varicose veins.

State of the art

Varicose veins are dilated, tortuous veins that are associated with structural changes in the vessel walls, incompetent venous valves, reflux and blood pooling. They form part of the chronic venous disease (CVD) spectrum. Patients experience symptoms ranging from heaviness, aching pain and swelling to skin irritation, discoloration and ulceration in severe cases. The cause of varicose veins is unknown, but genetic factors are important in their development, leading to weakness of components of the vein walls and valves.

Varicose veins most often occur in the superficial venous network of the lower extremity, but can also occur in the veins of the pelvis and esophagus under certain pathological conditions. Superficial veins drain blood from the skin and subcutaneous tissues into the deep venous network and ultimately back to the heart. The primary superficial vein is the great saphenous vein (GSV), which runs from the ankle to the groin along the medial side of the lower extremity. The small saphenous vein (SSV) runs from the ankle to the knee along the back of the leg. Both the GSV and SSV drain into the deep femoral vein at their junctions in the groin and posterior to the knee, respectively.

The veins have valves that prevent blood from flowing back by increasing the efficiency of the muscle pump in the leg. The valves are characterized by a bicuspid structure formed by folds of endothelium supported by connective tissue and smooth muscle. GSV contains 10 to 20 valves, SSV typically contains 6 to 12 valves. Incompetent valves cause blood to flow in the opposite direction of normal flow, which can be seen with Doppler ultrasound.

Veins are characterized by thinner walls in contrast to the thicker and more elastic walls of arteries. Veins are more pliable (flexible), allowing their lumen to vary from a compressed shape at low pressure to a distended shape when venous pressure increases. The wall thickness of the saphenous vein typically varies from 200 to 700 micrometers (µm). As in arteries, the wall consists of three main layers: the inner lining, the middle lining, and the outer lining. However, unlike arteries, the thickness and composition of the layers vary, resulting in more pliable and less muscular vessels. The inner layer consists of a single layer of flat cells known as endothelium and several thin elastic fibers, collagen and smooth muscle cells. It is important to note that there is an acellular layer of macromolecules known as the glycocalyx that covers the endothelial layer and protects it from shear forces. The glycocalyx, as a rule, is a uniformly distributed structure with a thickness of 0.5-3 μm, which exceeds the thickness of endothelial cells (0.2 μm). The middle layer consists of collagen, elastic fibers and three layers of smooth muscle cells. The tunica externa, or adventitia, is the thickest layer and contains dense collagen, sensory nerves, and elastic fibers.

Blood clotting or thrombosis can occur in both deep and superficial venous networks. Thrombus in superficial veins is usually solitary due to low throughput and rarely extends into the deep venous network. It is not dangerous to the patient and does not require treatment unless there is associated inflammation, known as thrombophlebitis. Deep vein thrombosis of the leg, known as deep vein thrombosis (DVT), is clinically significant because it can cause obstruction of venous outflow, increasing venous pressure and leading to leg swelling. The clot can also travel (embolize) to the lungs, causing a potentially fatal condition known as pulmonary embolism (PE).

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

Treatment options range from conservative compression stockings to surgical procedures. In the United States, between 600,000 and 700,000 procedures are performed annually to treat varicose veins. Here, treatment of varicose veins has moved from open surgery (involving removal of the entire GSV) to less invasive technologies based on thermal endovenous catheter (using radiofrequency or laser energy). In some countries, including Germany and the UK, most open vein extraction procedures are still performed.

Typically, minimally invasive thermal treatments using a guided catheter are currently used to treat superficial vein reflux. A significant limitation of the use of thermal energy is the need for repeated injections of large volumes of local anesthetic mixed with saline (tumescence) to isolate the vein and protect surrounding tissue from thermal damage. It is time-consuming for the doctor and painful for the patient due to the need for multiple needle injections into the leg. Because space is required between the skin and the vein to inject tumescent anesthesia, it also limits treatment when the veins are located near important nerves (as in the case of treatment of veins below the knee), near the skin, or near ulcers in patients with advanced cardiovascular disease ( classification 5 and 6 CEAP).

Thermal damage to surrounding nerves and skin can still occur despite the use of tumescent anesthesia. The incidence of nerve injury leading to persistent paresthesia ranges from 0% to 9% in a number of studies, with higher rates for below-knee GSV or SSV ablations.

Thromboembolic events represent the most serious complication of the treatment of superficial venous reflux. The incidence of DVT and PE in real-world studies ranged from 3% to 4% and 0.2 to 0.3% [2], respectively. All currently used treatments have limitations that may increase the risk of developing DVT and/or RE. It is important that any new treatment for varicose veins aims to further reduce the risk of thromboembolic complications.

An inherent concern with current thermal treatments is the risk of endovenous heat-induced thrombosis (EHIT), which can lead to DVT and PE. This is believed to result from direct transfer of thermal energy from the tip of the thermal ablation device into the deep venous system. The new laser tip fibers emit energy radially, reducing the risk of direct conduction. However, these technologies will not prevent the propagation of vapor bubbles to adjacent non-target sites, which is still considered a possible mechanism of action of thermal ablation in addition to light absorption by tissue [3].

Over the past 10 years, new nonthermal nontumescent (NTNT) treatments for CVD have emerged. Less painful NTNT techniques are more suitable for the clinical office, where approximately 90% of procedures are now performed in the United States. Current NTNT modalities include chemical foam sclerotherapy, mechanochemical ablation (MOCA), and cyanoacrylate glue (CAG) embolization.

Chemical sclerotherapy (injection of a chemical detergent that disrupts endothelial cell membranes, leading to vein occlusion by sclerosis) has been used for many years, but its effectiveness is significantly reduced in large veins due to the dilution effect and deactivation of the sclerosant by blood components. Foaming the sclerosant with gases to form an emulsion of microbubbles is a new method that displaces blood and allows the chemical to remain in contact with the endothelium longer. Despite this enhancement, the effectiveness remains significantly lower than that of thermal methods, most likely due to incomplete endothelial coverage of the chemical sclerosant, as shown in previous histological studies [4]. There is also a potentially increased risk of DVT as the foam can extend into the deep system, damaging the endothelium and forming DVT. Higher concentrations of sclerosing foam mixtures may be more effective but also carry a higher risk of DVT and systemic complications. Systemic complications of chemical sclerosing include transient ischemic attacks (TIA) and even stroke due to sclerosing compounds entering the arterial circulation through a small hole in the septum of the heart (patent foramen ovale). The teratogenicity of chemical sclerosants is also unknown, which is a contraindication for their use in pregnant women.

MOCA involves a combination of a chemical sclerosant and mechanical stimulation from within the vein lumen to improve distribution of the sclerosant and irritate the vein, causing venospasm, which reduces the diameter of the vein. Histological studies show limited mechanical effects on endothelial cell integrity [5]. Medium-term follow-up studies showed clinical effectiveness, but at a level lower than existing thermal methods. The distal end of modern MOCA devices, which causes mechanical stress, may be susceptible to snagging or binding to the vein wall or valves. This results in patient discomfort, bruising, and even accidental vein extraction, as previously reported [6].

Glue embolization involves the injection of cyanoacrylate or an equivalent compound, resulting in an inflammatory response that causes occlusion of the vein. Limitations include the permanent implantation of foreign material into the vein lumen, the subsequent risk of allergic reactions, and the risk of movement of emboli into the deep venous system causing DVT and/or PE.

Venous leg ulcers represent a major health care cost burden of $14 billion annually in the United States [7] and are currently primarily treated with compression bandages. New data from the EVRA trial [8], announced in April 2018, provide Level I evidence to support early endovenous treatment of varicose veins to increase the rate of ulcer healing in patients with CEAP class VI (C6) disease. Thermal methods are less suitable for patients with venous ulcers. The need for multiple injections of tumescent anesthesia prolongs the procedure for older patients and increases the risk of infection and hematoma formation due to poor integrity of the skin adjacent to the ulcer. There is also an increased risk of nerve damage leading to paresthesia when treating veins below the knee, which is often the goal of treatment to prevent venous reflux near the ulcer bed [9].

Devices for treating blood vessels, including varicose veins, are described in the following documents: WO 2017194698, US 2016030719, US 2016030068, US 2016030023, WO 2016102930, US 2011046543, US 2016242790 , JP 2016034485, WO 2004112569, US201705609, US 2017056057 and US 2017056057.

US 6,402,745 discloses a spring electrode characterized by a helical configuration, which has the function of electrically disrupting the internal lumen of a vessel. The electrode is located inside the catheter, and the distal end of the electrode extends from the end of the catheter to contact the inner lumen of the vessel in a spiral manner. This device only partially denudates the internal lumen of the blood vessel due to the contact area between the electrode and the internal lumen of the vessel.

WO 2014140325 describes an implantable bristle embolization device that can denudate a blood vessel for the treatment of various indications, including varicose veins and hemorrhoids. The device contains a guidewire having a plurality of bristles extending radially outward from the guidewire, in which the bristles are configured to contact the lumen of a blood vessel to denudate the vessel by brushing the lumen. Bulky implantable devices can cause patient discomfort in the superficial veins, especially in the groin and knee areas. The use of bristles to denudate the vein leads to incomplete denudation of the internal lumen of the vein. Multiple pointed and/or elongated components significantly increase the risk of entrapment and perforation of the thin, pliable vein walls.

The object of the present invention is to overcome at least one of the problems mentioned above.

The essence of the invention

The present invention addresses the need for a device for the treatment of superficial venous reflux that avoids the problems associated with prior art thermal, chemical and adhesive implant treatment methods while providing best-in-class efficacy compared to thermal options. These objectives are achieved by providing a vein denudation device containing a coil configured to be trans l nominally delivered to the vein to be treated during the procedure (without implantation) and deployed whereby the circumferentially (ideally completely circumferentially) coil is inserted into the inner lumen of the vein. The coil is an oversized coil (i.e., when deployed, it has a diameter larger than the vein being treated) and has a rough surface in contact with the lumen, so that when deployed, the rough surface abuts the internal lumen of the vein and movement in the axial direction of the coil along the vein in an expanded configuration causes the abrasive surface to cut off the inner lumen of the vein. This results in mechanical denudation of the vein along the length of the vein, typically followed by destruction of the endothelial and medial layers of the vein, which ideally ultimately leads to vein occlusion due to the formation of a thrombus that undergoes fibrotic transformation in the absence of the endothelial lining of the blood vessel. Ideally, the endothelium is completely destroyed circumferentially, since if small areas were left intact, the clot might not form and blood would continue to flow, leading to treatment failure, recanalization and/or early relapse. Thus, the device of the present invention contains a helical coil whose size is larger than the diameter of the exposed vein to ensure circumferential contact between the rough surface of the helical coil and the lumen of the vein. In addition, the coil (due to its elastically deformable configuration) can self-adjust to provide continuous circular contact while maintaining an outward radial force along sections of the vein or vessels with varying diameters and tortuous bends (Fig. 59).

In accordance with a first aspect of the present invention, there is provided a body cavity denudation device comprising a body cavity denudation head operably attached to an elongated catheter member and configured for transluminal delivery and deployment in a body cavity lumen, the body cavity denudation head comprising: a coil that is adjustable from an uncoiled delivery configuration suitable for transluminal delivery within a catheter element, and a coiled, unfolded configuration characterized by a diameter equal to or greater than the lumen of the body cavity to be denuded, and which is in circumferential contact with the internal lumen of the body cavity, wherein the coil comprises an abrasive surface configured to denudate the lumen of the body cavity when the helical spiral moves in the axial direction with or without rotation along the lumen of the body cavity in a twisted configuration.

In accordance with a second aspect of the present invention, there is provided a method for denudation of a body cavity, which uses a device comprising a head for denudation of a body cavity, operatively attached to an elongated catheter element and configured for transluminal delivery and deployment in the lumen of a body cavity, a method comprising the following: stages:

transluminal delivery of the head for denudation of the lumen of the body cavity to the lumen of the body cavity to be affected;

deploying a head for denudation of the lumen of the body cavity within the lumen of the body cavity to be affected, wherein the head for denudation of the lumen of the body cavity is characterized by an abrasive surface in circular contact with the inner lumen of the body cavity during deployment;

moving the head for denudation of the lumen of the body cavity along the area of the lumen of the body cavity to be affected, and the abrasive surface is in circumferential contact with the lumen of the body cavity, as a result of which the abrasive surface denudates the lumen of the body cavity;

re-capturing the head for denudation into the catheter element; as well as removing the device from the lumen of the body cavity.

In one embodiment, the helix is a helical helix.

According to one embodiment, the coil is "oversized" relative to the diameter of the body cavity lumen being exposed.

In one embodiment, the diameter of the coil (or maximum diameter in the case of helical coils whose diameter varies along their length) is typically at least about 5% greater than the diameter of the exposed body cavity lumen (or in the case of body cavity lumens with varying diameters along at least about 5% greater than the diameter of the body cavity lumen at its widest point), for example, at least 10%, 15%, 20%, 25% or 30% greater than the diameter of the exposed body cavity lumen, and how usually 5-30% more. It is important that the size of the spiral is oversized for at least one turn of the spiral, and, as a rule, oversized for 1-2 turns.

According to one embodiment, the device is configured to denudate the internal lumen of the vein.

In one embodiment, the helix comprises a shape memory material and is configured to adopt a helix configuration when deployed.

The helix is typically sufficiently elastically deformable to self-adjust to maintain a circumferential radial force acting on a body cavity lumen wall of variable diameter as it moves along the body cavity lumen. In one embodiment, the helical coil is configured to reflexively self-adjust its diameter in response to varying vein diameters and varying axial forces during axial movement along the treatment zone while maintaining an outward radial force on the vein.

The helical spiral in the deployed state is characterized by oversized dimensions in relation to the widest part of the lumen of the body cavity (or that part of the lumen of the body cavity that is subject to impact), thereby applying a radial force along the entire circumference of the lumen of the body cavity along the length of the lumen of the body cavity subject to impact, including into itself its widest part.

A helical helix is typically sufficiently elastically deformable to allow the helix to undergo tortuous bends in the lumen of the body cavity while maintaining a radial force acting on the lumen of the body cavity along the bend.

The helical coil is usually sufficiently elastic to deform so that the coil can pass through a narrowing or obstruction in the lumen of the body, such as a valve in a vein.

According to one embodiment, the device includes an elongated control arm for a head for denudation of the lumen of the body cavity located within the catheter element.

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

The control lever may be a hypotube, such as a hypotube made of stainless steel, polymer, or other material.

In one embodiment, the helix comprises a single helix element.

In one embodiment, a single coil element contains 1-5 turns, 1-4 turns, 1-3 turns, and preferably 1-2 turns, and ideally about 1.5 to 1.7 turns in an unfolded configuration.

According to one embodiment, the diameter of the helical helix varies along its length.

According to one embodiment, the diameter of the helical spiral increases towards one end (ie, tapered).

The increase in diameter can be from proximal to distal or from distal to proximal.

As used herein, the term “proximal” in relation to a helical coil refers to the end of the device that is closest to the point of insertion—the term “distal” should be interpreted accordingly.

According to one embodiment, the diameter of the helical helix increases towards a midpoint along the helix and then decreases.

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

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

In one embodiment, the helical coil comprises a proximal and distal helical coil portion and an intermediate connecting (transition) portion, which is typically non-helical and may be straight or curved.

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

In one embodiment, the proximal portion of the helical coil is a right-handed helical coil and the distal portion of the helical coil is a left-handed helical coil.

In one embodiment, the distal portion of the helical coil is a right-handed helical coil and the proximal portion of the helical coil is a left-handed helical coil.

In one embodiment, the helix comprises a plurality of helix elements, such as 2, 3, 4, 5 or more. Typically, each spiral element is characterized by a spiral shape.

Helical coils can be arranged in a double, triple or quadruple helix.

As a rule, the spiral elements are coaxial.

As a rule, each element of the spiral in the unfolded state is characterized by the same diameter.

As a rule, each element of the spiral is characterized by the same pitch during deployment. In the expanded configuration, many elements of the spiral together provide contact along the circumference of the internal lumen of the body cavity. Thus, each helix element may be configured such that, in its deployed configuration, it is in contact with only a portion of the circumference of the internal lumen, for example, 90°-270°, 90°-180°, 180°-270° in contact with the circumference of the body cavity.

Spiral elements can be connected to one control lever.

In one embodiment, the helix comprises two helical helix elements, such as a double helix.

Typically, each of the two helical elements contains at least 0.5 turns when deployed and typically 0.5 to 1.0 turns or 0.5 to 0.7 turns.

According to one embodiment, the helix comprises three helical elements, such as a triple helix.

Typically, each of the three helical elements contains at least 0.3 turns in the unfolded state and typically 0.3 to 1.0 turns, or about 0.3 to 0.5 turns in the expanded state.

According to one embodiment, the helix comprises four helical helical elements.

Typically, each of the four helical elements contains at least 0.25 turns in the unfolded state and typically from 0.25 to 0.75 turns in the expanded state.

According to one embodiment, a plurality of coil elements are connected together at their distal ends.

According to one embodiment, the plurality of spiral elements are not connected at their distal ends.

In one embodiment, the helix or each element of the helix is helical and is characterized by a configuration with a pitch of approximately 0.5 to 1.5 times the diameter of the helix in a twisted configuration when deployed.

In one embodiment, the helix or each element of the helix is helical and is characterized by a pitch configuration approximately equal to the diameter in a twisted configuration when unrolled.

According to one embodiment, one of the helical elements is axially spaced from the other helical element. Typically, according to this embodiment, the control arm (typically the distal end of the control arm) is bifurcated to provide distal control arms, each of which is connected to one of the helical coils. However, the device may include separate control levers to control the two helical coils independently.

In an embodiment of a vein denudation head comprising axially spaced helical coils, the distal helical control lever generally extends axially through the proximal helical coil (through one, more or all of the coils constituting the proximal helical coil).

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

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

In one embodiment, the pitch of the proximal and distal helix elements is different.

According to one embodiment, a narrower helix has a larger pitch.

According to one embodiment, the distal and/or proximal helical coil is characterized by a conical shape.

According to one embodiment, the distal and proximal helical coils are characterized by a conical shape.

Typically, the diameter of the helical coil increases in the proximal direction (i.e., toward the entry point of the device).

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

In one embodiment, the helical coil or each helical coil is characterized by a conical shape (ie, the diameter of the coil increases or decreases as it approaches the entry point of the device, ie, proximally).

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

In one embodiment, the helix is characterized by a profile selected from round, oval, curved, convex, concave, T-shaped, inverted T-shaped, or any other shape.

In one embodiment, the helix is characterized by a flat inner surface and an outer surface that is characterized by a curved, concave, convex or inverted T-shape. Helical spirals with these profiles are shown in Figs. 34-41.

In one embodiment, the rough surface of the coil or each element of the coil is formed by treating the surface of the coil, typically the outer surface of the coil facing the lumen of the body cavity (and/or the side surface of the coil), to impart surface roughness.

According to one embodiment, the inner surface of the spiral is not rough, but perfectly smooth. This facilitates retraction of the coil into the catheter element, where the smooth surface of the coil comes into contact with the mouth of the catheter.

In one embodiment, surface roughness is achieved through mechanical, electrical, chemical, or other means of abrasion.

According to one embodiment, the outer surface of the spiral contains indentations that provide a rough surface.

According to one embodiment, the recesses are configured to form teeth on the surface. According to one embodiment, the recesses are transverse recesses.

According to one embodiment, the transverse recesses extend entirely along the outer surface of the helix.

According to one embodiment, transverse recesses are located on each side of the outer surface (ie, when the outer surface of the helix is concave).

According to one embodiment, the recesses are longitudinal and extend entirely or at least partially along the length of the helical helix. The longitudinal recesses can be straight, curved, wavy, zigzag, diamond-shaped or any configuration.

According to one embodiment, the helical helix is characterized by an inverted T-shape, in which the teeth from the stem are characterized by an inverted T-shape.

In one embodiment, the tines are characterized by a profile selected from triangular, polygonal, diamond-shaped, or any other profile configured to scrape the endothelial layer of the lumen of a body cavity.

According to one embodiment, the helix includes lateral teeth.

According to one embodiment, the helix is characterized by a flat inner and outer surface and lateral teeth.

According to one embodiment, the helix is formed from a flat wire with a diamond-shaped texture and a rough outer surface and a smooth inner surface.

In one embodiment, the coil contains grooves or pores that serve as reservoirs for therapeutic agents.

In one embodiment, the helix, or each element of the helix, includes a conductor wire, and the abrasive surface is formed by a second wire wound in a spiral around the conductor wire to form a second helix.

According to one embodiment, the second wire has a polygonal cross-section.

According to one embodiment, the second helix has a pitch of 1 to 5 mm.

According to one embodiment, the pitch of the second helix is greater at its proximal end.

According to one embodiment, the pitch of the second helix is smaller at its proximal end.

In one embodiment, the second helix is attached to the conductor wire, typically in multiple locations.

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

In one embodiment, the helical coil includes a proximal portion that is generally coaxial with the longitudinal axis of the helical coil.

In one embodiment, the helical coil comprises a distal portion that is generally coaxial with the longitudinal axis of the helical coil.

According to one embodiment, the control lever for the head for denudation of the lumen of the body cavity is located within the catheter element. Typically, the control arm is connected to the proximal end of the coil. The control lever may be a hypotube, such as a hypotube made of stainless steel, polymer, or other material.

According to one embodiment, the control lever is axially movable to deploy the head for denudation of the body cavity lumen at a predetermined location of the body and withdraw the head for denudation of the body cavity lumen into the catheter element after exposure.

According to one embodiment, the control lever is rotatably movable to rotate the head to denudate the lumen of the body cavity within the lumen of the body.

In one embodiment, the device includes a distal control arm coupled to the distal end of the coil and a proximal control arm coupled to the proximal end of the coil such that the relative axial movement of the distal and proximal arms affects the twisting and unwinding of the coil.

According to one embodiment, the distal end of the coil contains an atraumatic head, for example, a flexible material or a spherical ball.

According to one embodiment, the device includes a handle operably connected to the proximal end of the catheter element and configured to control the deployment and retraction of the coil. According to one embodiment, the handle includes a control element configured to axially adjust the lever or control levers with or without rotation. According to one embodiment, the handle includes a control element configured to adjust the rotation of the lever or control levers.

According to one embodiment, the device is adjustable between:

delivery configuration, in which the helical coil is laid inside the catheter element in an untwisted configuration,

a first configuration of denudation of the lumen of the body cavity, in which, when used, the spiral is deployed in the lumen of the body cavity to be affected in the first axial position and tightly abuts the circumference of the lumen of the body cavity;

a second body cavity denudation configuration in which, when used, the coil is deployed in the body cavity lumen to be affected, proximal to the first axial position, and tightly abuts the circumference of the body cavity lumen; and

a retrieval configuration in which the coil is positioned within the catheter element.

The method of the present invention can be used to treat venous diseases, especially superficial venous reflux and preferably varicose veins. The veins typically treated are the saphenous veins and are usually the greater saphenous vein (GSV) or the small saphenous vein (SSV). According to one embodiment of the method of the present invention, the body cavity lumen denudation head is moved proximally to the access site along the area of the body cavity lumen to be treated.

In one embodiment, the method involves treating a portion of the lumen of a body cavity that is at least 2, 4, 6, 8, 10, 12, 14, 16, 18, or 20 cm in length.

In one embodiment, the method of the present invention is intended to completely occlude a body cavity, such as a vein or artery.

In one embodiment, the method of the present invention is intended to partially occlude a body cavity, such as a vein or artery. Thus, the device and method of the present invention can be used to treat conditions or indications characterized by dysregulated or undesirable volume or velocity of blood flow through a portion of the vasculature by using the device of the present invention to partially occlude the portion of the vasculature.

In another case, the method of the present invention is to thicken the wall of the vein by inducing significant thickening of the wall, such as peripheral hyperplasia of the inner lining. This effect "arterializes" the vein, making it more resistant to higher blood pressure and shear forces. This thickening effect should be self-limiting when it occurs in response to a single mechanical stimulus, as opposed to uncontrolled tunica hyperplasia that occurs when veins are subjected to continuously higher shear forces when used as conduits in the arterial system. Thus, the device and method of the present invention can be used to prepare a vein before transplantation into the arterial circulation.

The lumen of the body cavity may be a vascular network, such as an artery or vein.

According to one embodiment, the method of the present invention is a method of treating varicose veins by denudation of a portion of the superior rectal artery.

In one embodiment, the method of the present invention is a method for treating hemorrhoids by denudating a portion of a vein.

According to one embodiment, the method of the present invention is a method of thrombectomy by denudation of a section of a vein or artery occluded by a thrombus.

In one embodiment, the method of the present invention is a preparation step for initially targeting a target luminal region of a body cavity (ie, a region of the vasculature) prior to implantation of a medical device, such as a valve or stent.

In one embodiment, the method of the present invention is a preparation step to initially target the arterial region prior to transplantation to reduce the risk of type 1 endoleak.

In one embodiment, the body cavity lumen to be denuded is an artery feeding a tumor, such as a solid tumor.

In one embodiment, the body cavity lumen is a portal vein that delivers nutrients from the intestine to the liver. In one embodiment, the subject being treated has a liver disease, such as cancer, and the method is typically performed prior to liver resection.

In one embodiment, the exposed lumen of the body cavity is a blood vessel forming part of an arteriovenous malformation.

In one embodiment, the exposed lumen of the body cavity is the spermatic vein. Thus, methods for treating varicocele are also described.

In one embodiment, the exposed lumen of the body cavity is a blood vessel (ie, a uterine artery) supplying the uterine fibroid.

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

In one embodiment, the exposed lumen of the body cavity is a prostate artery.

In one embodiment, the exposed body lumen is a pelvic vein.

In one embodiment, the method of the present invention is used to treat patent foramen ovale (PFO) by denudation of the contact surface of the arterial septal flaps involved in the PFO.

In one embodiment, the method of the present invention is used to treat patent ductus arteriosus by destroying the mucous membranes of the ileocecal valve and ileum.

According to one embodiment, the method of the present invention is used to treat overgrowth of small intestinal microflora due to denudation of the ductus arteriosus.

In one embodiment, the method of the present invention is used to treat Barrett's esophagus by mechanical ablation or denudation of cells (abnormal cells) in the lower esophagus.

According to one embodiment of the method of the present invention, the method includes the step of delivering a liquid sclerosant into the lumen of a body cavity distal to the catheter element.

According to one embodiment of the method of the present invention, the method includes the step of delivering thermal energy into the lumen of the body cavity due to conduction through the surface of contact with the lumen of the device.

According to one embodiment of the method of the present invention, the method includes the step of using an intravenous ultrasound (IVUS) probe attached or integrated into the denudation head member to determine the response of the vessel to treatment.

According to one embodiment of the method of the present invention, therapeutic agents are coated on the outer surface or embedded in grooves or pores on the device and delivered to the inner surface of the lumen of the body cavity.

According to one embodiment of the method according to the present invention, the method uses a device for denudation of the lumen of a body cavity according to the present invention.

According to another aspect, the present invention provides a method of influencing a vessel (or any lumen of a body cavity) in a subject, comprising the following steps:

advancing the device in the distal direction through the impact zone in the vessel, the device comprising an elongated catheter having a lumen and a distal end, and a radially expanding impact element located in the lumen and configured to move axially relative to the catheter;

deploying a radially expanding impact element protruding beyond the distal end of the catheter to radially expand and press circumferentially into the lumen at the distal end of the impact zone;

removing the deployed radially expanding impact element proximally along the impact zone, wherein the impact element is pressed circumferentially against the lumen of the vessel in order to mechanically and circumferentially denudate the impact zone of the vessel;

re-capturing the radially expanding impact element into the catheter lumen; and

removing the device from the exposed vessel.

In one embodiment, the vessel is a varicose vein, and wherein the method is generally a method of treating a varicose vein by denuding the walls of the lumen of the vein to cause occlusion of the varicose vein.

According to one embodiment, the step of mechanical and circumferential denudation of the affected area of the vessel involves influencing a circumferential effect on the surface of the subendothelial vessel along the affected area.

In one embodiment, the radially expandable impact element is self-adjusting between a non-expanded delivery configuration suitable for transluminal delivery within a catheter and a deployed radially expanded configuration characterized by a diameter greater than the diameter of the vessel in the target area.

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

According to one embodiment, the outer surface of the radially expandable impact element facing the lumen of the vessel is characterized by a rough surface.

According to one embodiment, the outer surface of the radially expandable impact element facing the lumen of the vessel is characterized by a rough surface, wherein the rough surface comprises a macro- and micro-abrasive surface.

In one embodiment, the vessel is a superficial vein, such as a great saphenous vein, a small saphenous vein, a perforating vein, or a branch vein.

In one embodiment, the superficial vessel is a vein selected from the great saphenous vein and the short saphenous vein.

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

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

In one embodiment, the method results in occlusion of the exposed vessel.

According to one embodiment, the method is a method of narrowing, but without occluding the vessel.

In one embodiment, the step of withdrawing the deployed radially expanding treatment element proximally along the treatment zone causes mechanical stretching of the vessel wall, resulting in activation of smooth muscle within the wall, resulting in vasospasm along the treatment zone and possibly preventing the secretion of nitric oxide from endothelial cells and subsequent prolongation of vasospasm.

According to one embodiment, the radially expandable impact element is a helix.

According to one embodiment, the radially expandable impact element is a helical helix.

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

According to one embodiment, the method includes the step of re-engaging the action element in the catheter element, providing for the return of the action element to an undeployed state, allowing repositioning and repeated deployment.

In one embodiment, the method includes the step of deploying a temporary lumen closure element during at least one of the steps to stop blood flow in high-flow vessels.

In another aspect, the present invention provides a method of treating superficial venous reflux in a superficial vein in a subject, comprising the step of mechanically and circumferentially denuding the affected area of the superficial vein.

According to one embodiment, the affected area of the superficial vein that undergoes circumferential denudation is between 5 and 25 cm in length.

According to one embodiment, the stage of mechanical and circular denudation of the zone of influence of the superficial vein involves the implementation of a circumferential effect on the surface of the subendothelial vessel along the zone of influence.

In one embodiment, the mechanical and circumferential vein denudation step involves deploying the vein denudation device at the distal portion of the target portion of the superficial vein to make a circumferential seal against the lumen of the vein, and withdrawing the deployed vein denudation device proximally along the target area, the device making a tight circumferential fit along the vein lumen. circumference to the lumen of the vein.

According to one embodiment, the stage of mechanical and circular denudation of the affected area of the vessel involves applying a circumferential impact to the surface of the subendothelial vessel along the affected area.

In one embodiment, the vein denudation device is self-adjusting from a non-expanded delivery configuration suitable for transluminal delivery within a catheter to a deployed radially expanded configuration characterized by a diameter greater than the diameter of the vessel in the target area.

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

According to one embodiment, the outer lumen-facing surface of the vein denudation device is characterized by a rough surface.

According to one embodiment, the outer lumen-facing surface of the vein injury device is characterized by a rough surface, wherein the rough surface comprises a macro- and micro-abrasive surface.

According to one embodiment, the radially expandable impact element is a helix and preferably an elastically deformable helix.

According to one embodiment, the radially expandable impact element is an elastically deformable helical spiral.

According to one embodiment, the method is performed under ultrasound guidance.

According to one embodiment, the axial movement of the radially expanding impact element (or helix) is automatic or semi-automatic, independent of the operator.

In one embodiment, the device is configured to collect data for feedback to operators or for further interpretation using human, statistical, big data, or machine learning analysis. In this case, the device may include one or more sensors configured to detect in vivo data, for example, temperature, pressure, electrical impedance, etc., tissue or blood. The device may be configured to transmit data in vivo wirelessly or via wires located in the catheter element. The device may be configured to transmit data to a remote processor.

Other aspects and preferred embodiments of the present invention are defined and described in the other claims set forth below.

Brief description of drawings

Figure 1 is an axial plane view of the human vasculature, showing the composition of a typical vein wall, including the inner lining of the vein (tunica interna) with associated endothelium and glycocalyx coverings, the adjacent intermediate layer (tunica media), and the outer layer (tunica adventitia). Also included is the typical thickness in micrometers for an adult vein wall.

Fig. 2 is a histological axial section of a goat vein 28 days after mechanical endovenous treatment in our animal study. The image highlights the importance of peripheral coverage in terms of endothelial cell destruction. In our animal study, it was taken from a partially exposed vein. The upper right corner shows a clot attached to the vein wall with migration of inflammatory cells into the thrombus from the outer layers during the early phases of fibrotic transformation. The endothelium remained intact in the lower left corner. The thrombus did not survive or recanalize due to exposure to intact endothelium. Blood may flow through the channel, resulting in overall ineffectiveness of treatment in this segment.

Figure 3 shows a histological axial section of a goat vein 28 days after mechanical endovenous treatment in our animal study. Circumferential damage to the endothelium and dissection occurred due to frictional forces between the superficial and deep layers. The lumen is filled with attached thrombus, which undergoes fibrotic changes as it is invaded by inflammatory cells, including collagen-producing fibroblasts.

Figure 4 shows a device for denudation of the walls of the lumen of a body cavity according to the first embodiment of the present invention.

Fig. 5 is a side view of the device shown in FIG. 1.

Fig. 6 is a perspective view of the device shown in FIG. 1.

Fig. 7 is a vertical view of the distal end of the device shown in FIG. 1.

Fig. 8 is a detailed view of the helical portion of the device shown in FIG. 4, showing the serrated surface formed by the second wire helically wound around the conductor wire.

Fig. 9 is a detailed view of the distal end of the helix of the device shown in FIG. 4, showing the larger pitch of the second wire and spherical end sleeve.

Fig. 10 is a detailed view of the proximal end of the helical coil of the device shown in FIG. 4, showing the helical coil attached to a steel hypotube that is mounted within the catheter element.

Fig. 11 is a detailed view of the proximal end of the helical helix of the device shown in FIG. 4, showing the shorter pitch of the second wire as it approaches the proximal end of the helix to aid re-engagement.

Fig. 12 is a perspective view of a helical helix forming part of a device according to an alternative embodiment of the present invention, in which the surface of the second lumen contact wire includes a series of helical recesses.

Fig. 13 is a cross-sectional view of the device shown in FIG. 4 with the helical coil in an expanded configuration. This figure shows how the enlarged coil comes into circular contact with the lumen of the body cavity, and that the radial force exerted by the enlarged coil deforms the vein.

Fig. 14 is a similar illustration to FIG. 13 and shows how a smaller diameter coil is used with a smaller diameter vein.

Fig. 15 is a perspective view of the device deployed outside the vein, showing how radial forces exerted by the deployed coil deform the vein.

Fig. 16 is a detailed view of the abrasive surface of the helical coil in contact with the interior lumen of the vein.

17 shows a procedure for endovenous mechanical denudation of a lower extremity vein to cause occlusion and prevent reflux in the treatment of superficial venous disease. The undeployed device in the external catheter is shown adjacent to the saphenofemoral junction after ultrasound-guided navigation.

FIG. 18 shows an unfurled, radially expanding helix during exposure causing vasospasm of the affected area.

FIG. 19 shows re-engagement of the radially expanding member prior to removal of the catheter.

Fig. 20 is a perspective view of a body cavity lumen denudation device in accordance with a further embodiment of the present invention.

Fig. 21 is an end view of the device shown in FIG. 20.

Fig. 22 is a side view of the device shown in FIG. 20 in a partially expanded configuration.

Fig. 23 is a side view of the device shown in FIG. 20 in a fully expanded configuration.

Fig. 24 is another side view of the device shown in FIG. 20 in a fully expanded configuration.

FIG. 25 shows a body cavity lumen denudation device in accordance with a further embodiment of the present invention, in which the helix is composed of two coaxial helical helix elements.

Fig. 26 is an end view of the device shown in FIG. 25.

Fig. 27 is a side view of the device shown in FIG. 25.

FIG. 28 shows a body cavity lumen denudation device in accordance with a further embodiment of the present invention, in which the helix is composed of four coaxial helical helix elements.

Fig. 29 is an end view of the device shown in FIG. 28.

Fig. 30 is a side view of the device shown in FIG. 28.

FIG. 31 shows a body cavity lumen denudation device in accordance with a further embodiment of the present invention, in which the helix consists of four coaxial helical elements that are connected at their distal ends.

Fig. 32 is an end view of the device shown in FIG. 31.

Fig. 33 is a side view of the device shown in FIG. 31.

Fig. 34A and FIG. 34B are perspective and side views of a portion of a helical helix in accordance with the present invention.

Fig. 35A and FIG. 35B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 36A and FIG. 36B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 37A and FIG. 37B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 38A and 38B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 39A and FIG. 39B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 40A and 40B are perspective and side views of a portion of an additional helical coil in accordance with the present invention.

Fig. 41A and FIG. 41B are perspective and end views of a portion of an additional helical coil in accordance with the present invention.

Fig. 42A and FIG. 42B are side and perspective views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

43A and 43B are side and perspective views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 44A and FIG. 44B are side and perspective views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 45A and FIG. 45B are side and perspective views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 46A and FIG. 46B are perspective and side views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 47A and FIG. 47B are perspective and side views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 48A-48C are side and perspective views of an additional embodiment of a helical coil forming part of a device in accordance with the present invention.

Fig. 49A and FIG. 49B are side and perspective views of a vein denudation head forming part of a device in accordance with the present invention having two axially spaced helical coils.

Fig. 49A and FIG. 49B are side and perspective views of a vein denudation head forming part of a device in accordance with the present invention having two axially spaced helical coils.

Fig. 50A and 50B are side and perspective views of a vein denudation head forming part of an accessory device in accordance with the present invention, having two axially spaced helical coils.

Fig. 51A is a perspective view of a vein denudation head forming part of an additional device according to the present invention, having two axially spaced helical coils.

FIG. 52A shows small arteries feeding a tumor, and FIG. 52B is an exploded view of a portion of one of the arteries, showing the device of the present invention used to denudate a portion of the arterial lumen and occlude the artery due to thrombus formation.

FIG. 53A shows the vasculature of the portal vein, and FIG. 53B is an exploded view of a portion of one of the veins showing the device of the present invention used to denudate a portion of the arterial lumen and occlude the artery due to thrombus formation.

FIG. 54 shows a section of a natural arteriovenous shunt of the vasculature including a malformation, and a device in accordance with the present invention in use for denudation of the wall of the shunt section to bridge the deformed shunt by thrombus formation.

FIG. 55 shows the left spermatic vein and varicocele surrounding the left testis and the device of the present invention used to denudate a portion of the left spermatic vein to occlude the vein by forming a blood clot.

Figure 56 shows how the helical coil forming part of the device of the present invention can independently adapt to changing diameter of the vessel, as well as compression or narrowed areas in the vessels, as it is pulled through the vessel: (A) unrolled helical coil in circular contact with the lumen of the vessel, approaching the narrowed area of the vessel; (B) a helical coil passing through the narrowed area and maintaining circumferential contact with the lumen of the vessel immediately proximal to the narrowed area; and (C) a helical coil that moves proximally to the constricted area and self-adjusts to maintain circumferential contact with the vessel lumen.

57 shows how the helical coil forming part of the device of the present invention can move through valves in veins as it is pulled through a portion of the vein: (A) an unrolled helical coil in circular contact with the lumen of the vein distal to the valve; (B) a helical volute passing through the valve without jamming; and (C) a helical coil that moves proximally to the constricted area and self-adjusts to maintain circumferential contact with the vessel lumen.

58 shows how the helical coil, which is part of the device of the present invention, can move through a section of the vasculature that gradually narrows and independently adjusts the diameter of the helix to maintain circular contact with the lumen of the vessel: (A) an unfolded helical coil in circular contact with wide area of the vessel; (B) an unfolded helical spiral in circular contact with a narrower portion of the vessel;

Figure 59 shows how the helical coil forming part of the device of the present invention can independently adapt to the changing diameter of the vessel and move along a tortuous vessel: (A) an unfolded helical coil in circular contact with the lumen of the vessel at a narrowed portion of the vessel; (B) a helical coil moving through a sharp turn in a vessel while maintaining circular contact with the vessel lumen; and (C) a helical coil moving through a sharp turn in a larger diameter vessel while maintaining circumferential contact with the vessel lumen.

60 shows how the helical coil forming part of the device of the present invention can independently adjust the diameter of the helix to maintain circular contact with the lumen of the vessel when the vessel is actively narrowing due to vasospasm or narrowing to a smaller width: (A) deployed helical coil in circular contact with a section of the vessel with length 1 and diameter D until vasospasm; section A-A is an axial view of a spiral wire in contact with the wall of the vessel under the action of the annular force HF created by the pressure from the constriction force P; (B) unfolded helical coil in circular contact at an increased length L inside a narrowed vessel of diameter d during vasospasm.

Figure 61 shows the static force variables on the deployed helix when it is subjected to an axial force FA; (A) before moving at the beginning of extraction in a vessel of diameter D with an outward spiral contact force FC and a constriction force P of the vessel; (B) elongated to length L in a narrowed vessel of diameter d; (C) In a significantly narrowed vessel of diameter e with the coil extended to S. There is loss of vessel wall contact at the proximal portion of the coil to reduce static friction and allow atraumatic passage of the coil.

Figure 62 shows how the device of the present invention can be used to treat a vasculature having an abnormally high blood volume or high blood flow velocity to partially occlude the vessel to normalize the volume or blood flow: (A) shows a pulmonary artery before treatment with the device of the present invention the invention deployed in the artery and extended proximally; (B) shows chronic changes in the pulmonary artery of FIG. 62A following treatment with the device of the present invention, with intimal hyperplasia partially occluding (narrowing) the artery to provide reduced blood volume and flow through the artery.

FIG. 63 is an angled view of an embodiment with a flat wire having a smooth inner surface and a rough outer surface with a diamond pattern in a typical vessel.

FIG. 64 is an angled view of the device in the vessel. Close-up images of external texturing embodiments show (A) a macro-abrasive groove surface that is perpendicular to the vein wall in the exit direction; (B) macro-abrasive surface parallel to the vein wall in the direction of exit; (C) Diamond-shaped configuration of the macro-abrasive surface.

FIG. 65 shows the tip of a modified intravenous cannula modified to hold a miniature coil in an unexpanded state.

FIG. 66 illustrates the use of the modified cannula shown in FIG. 65 to access the target vein and deploy the helical coil after removal of the outer sheath.

FIG. 67 shows access to the branches of the superficial leg veins using the cannula device shown in FIG. 65.

Fig. 68 shows a method for deploying a miniature coil in the branches of veins. (A) Intravenous access is achieved using a guidewire and the sheath is inserted through the guidewire; (B) The sheath is advanced along the vein and the guide wire is removed; (C) The sheath is removed to expose the stored helical abrasive element of the spiral; (D) The sheath and coil are withdrawn together to expose the vein site.

FIG. 69 shows the sheath used in FIG. 68, which holds the undeveloped helical coil around its inner perimeter to allow passage of the conductor wire.

FIG. 70 shows a method of using a peel-off guidewire sheath to deploy a helical coil into a target vein.

Figure 71 shows the use of a helical ablation coil to treat pelvic vein reflux in the left ovarian vein.

Figure 72 shows vein remodeling during arterial fistula formation (A) Normal vein; (B) Intimal hyperplasia with self-limiting thickening of the inner layer. (C) Vein graft failure due to excessive intimal hyperplasia causing luminal occlusion.

FIG. 73 shows the use of a helical coil with a rough inner surface and a smooth outer surface to remove an adherent thrombus in a blood vessel.

FIG. 74 illustrates the use of a helical helix with a partially textured outer surface allowing selective application of the vessel wall with or without rotational force in addition to axial extraction.

Figure 75 shows the use of a helical coil during an endoscopy procedure to restore the surface of the duodenal mucosa in the treatment of diabetes mellitus.

Detailed Description of the Present Invention

All publications, patents, patent applications and other references mentioned herein are herein incorporated by reference in their entirety for all purposes as if each individual publication, patent or patent application had been specifically and individually designated for incorporation by reference. and their contents were quoted in full.

Definitions and general preferences

As used herein, and unless specifically stated otherwise, the following terms have the following meanings in addition to any broader (or narrower) meanings that may be given to the terms in the art:

Unless the context otherwise requires, the use of the singular herein should be read to include the plural and vice versa. A singular number used in relation to an object should be read as referring to one or more objects. As such, the terms “one,” “one or more,” and “at least one” are used interchangeably herein.

As used herein, the term “comprise” or variations thereof such as “comprises” or “comprising” should be read to indicate the inclusion of any enumerated integer (e.g., feature, element, characteristic, property, method/process step or limitation) or a group of integers (eg, features, elements, characteristics, properties, method/process steps or restrictions), but not to the exclusion of any other integer or group of integers. Thus, as used herein, the term “comprising” is inclusive or open-ended and does not exclude additional, not listed integers or method/process steps.

As used herein, the term “disease” is used to define any pathological condition that impairs physiological function and is associated with specific symptoms. The term is broadly used to refer to any disorder, disease, anomaly, pathology, disease, condition or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or, in fact, whether the etiological basis of the disease has been established). Thus, it covers conditions resulting from infection, trauma, damage, surgery, radiological ablation, poisoning or malnutrition.

As used herein, the term “treatment” refers to an intervention (eg, administration of an agent to a subject) that cures, alleviates, or reduces the symptoms of a disease or eliminates (or reduces the impact of) its cause(s) (eg, reducing the accumulation of pathological levels of lysosomal enzymes). In this case, the term is used as a synonym for the term "therapy".

Additionally, the term “treatment” refers to an intervention (eg, administration of an agent to a subject) that prevents or delays the onset or progression of a disease or reduces (or eliminates) its incidence in the population being treated. In this case, the term “treatment” is used as a synonym for the term “prevention”.

As used herein, an effective amount or therapeutically effective amount of an agent defines an amount that can be administered to a subject without undue toxicity, irritation, allergic reaction, or other problems or complications commensurate with a reasonable benefit/risk ratio, but which is sufficient to provide the desired effect, e.g. , treatment or prevention, manifested by permanent or temporary improvement in the condition of the subject. The amount will vary from subject to subject, depending on the age and general condition of the individual, route of administration, and other factors. Thus, although it is not possible to specify a precise effective amount, those skilled in the art will be able to determine the appropriate "effective" amount in any individual case using routine experimentation and general knowledge. Therapeutic outcome in this context includes elimination or reduction of symptoms, reduction of pain or discomfort, increased life expectancy, improved mobility, and other markers of clinical improvement. A therapeutic result does not necessarily mean a complete cure.

In the context of treatment and effective amounts as defined above, the term subject (which should be read to include "individual", "animal", "patient" or "mammal" as the context permits) means any subject, in particular a mammalian subject for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, pets, farm animals, zoo animals, sporting animals, pets such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, goats, cows; primates such as monkeys, marmosets, orangutans and chimpanzees; canids such as dogs and wolves; felids such as cats, lions and tigers; odd-toed ungulates such as horses, donkeys and zebras; meat-producing livestock such as cows, pigs and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human.

As used herein, the term “denudation” should be understood to mean the mechanical removal or irreversible functional destruction of the superficial layer of the inner surface of the lumen of a body cavity along a portion of the lumen of the body cavity. When the lumen of the body cavity is a vessel or vein, the superficial layer of the internal lumen is usually a single layer of flat cells known as the vascular endothelium and associated connective tissue, extending to the superficial cellular layers of the middle layer, but not deeper than the middle layer layer. The endothelium is essential for the survival of the lumen of the body because it provides a selective barrier and antithrombotic surface, the removal of which results in exposure to prothrombotic factors that interact with normal blood constituents to cause coagulation and occlusion of the lumen of the body and release natural vasoconstrictors into the lumen. When the body cavity lumen is a vein, the term refers to the removal of one or more layers of the inner lining and the superficial middle layer. The device and methods of the present invention denudate a longitudinal portion of the body cavity lumen, for example 1-60 cm, and denudate the body cavity lumen circumferentially; this represents a full circle (or partial or nearly full circle) if the lumen of the body cavity is denuded along the exposed area.

As used herein, the term "body cavity" means a cavity in the body and may be an elongated cavity such as a vessel (i.e., artery, vein, lymphatic vessel, urethra, ureter, sinus, auditory canal, nasal cavity, bronchus, fallopian tube, spermatic duct) or annular space in the heart such as left atrial appendage, left ventricular outflow tract, aortic valve, mitral valve, mitral valve continuity, tricuspid valve, pulmonary valve or heart valve, or venous valve or valve orifice. Preferably, the lumen of the body cavity is a vasculature (ie, a vein or artery, or an arteriovenous vessel). The vein may be selected from the saphenous vein (SSV, GSV, AASV), pelvic vein, varicocele or portal vein. The artery may be selected from the aorta, the superior rectal artery, the portion of the artery intended to be stented for complete or partial embolization, the uterine artery, or the ductus arteriosus. The lumen of the body cavity may be part of the gastrointestinal tract, for example, the duodenum, small intestine. The lumen of the body cavity may be the esophagus.

As used herein, the term “elongated catheter element” should be understood to mean an elongated body having a distal end that is operably connected to the body to denudate the lumen of a body cavity. According to one embodiment, the catheter element includes a control lever (eg, a tubular element) operatively coupled to the denudation body for control. The control lever may be of any shape, such as a rod, a wire, or a tubular element such as a hypotube. According to one embodiment, the control lever and denudation housing are axially adjustable relative to the catheter element. The denudation housing is typically unwound and positioned at the distal end of the catheter element during delivery and retrieval. Axial adjustment of the control lever relative to the catheter body causes the denudation body to deploy in its coiled configuration.

"Transluminal delivery" means delivery of a body cavity denudation body to a target site (eg, a varicose vein) through the body cavity, such as delivery through an artery, vein, or gastrointestinal tract.

As used herein, the term “coil” should be understood to mean a loop-shaped member that is adjustable between an untwisted configuration suitable for retraction into a catheter element and a coiled configuration which, when in use, is capable of circumferential contact and depressing its surface into the lumen of a body cavity ( i.e. contact the internal lumen of the vein for at least one full turn of the spiral). The helix in its twisted configuration is typically circular, but may also be oval, square, triangular, or rectangular, provided it is capable of circumferential contact with the inner wall of the lumen of the body cavity.

Since most veins and arteries have a circular or nearly circular profile, a circular coil is preferred because the radial force exerted on the coil in its unfolded configuration is distributed evenly across the lumen wall of the body cavity. A coil having a diameter equal to or greater than the diameter of the exposed lumen of the body cavity, along at least one full turn of the coil, is necessary to achieve circular contact with the internal lumen of the vein and thus achieve circumferential denudation of the vein (see A in Fig. 13) . In a preferred embodiment, the helix is a helical helix comprising at least one full circular turn, and 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 helical coils are preferably round, but may also have other profiles such as oval, square, triangular or rectangular. The helical spiral can be conical. The diameter of the coil is typically 2-20 mm, more preferably 3-12 mm in the relaxed state. The pitch of the helix is usually approximately the same as the diameter, but it can vary from 0.5 to 1.5 times the relaxed diameter. It should be understood that coil dimensions may vary depending on the lumen of the body cavity to ensure that the coil is oversized relative to the diameter of the body cavity lumen. In this regard, the diameter of the coil (or maximum diameter in the case of helical coils that vary in diameter along their length) is typically at least about 5% larger than the diameter of the exposed body cavity lumen, such as at least 10%, 15 %, 20%, 25% or 30% of the diameter of the exposed lumen of the body cavity and, as a rule, 5-30% more. It is important that the helix is oversized by at least one turn of the helix, and usually by 1-2 turns. The spiral may be formed from an elongate element, typically a single elongate element, such as wire or thread. The helix may be formed from a metal (eg stainless steel) or a metal alloy, or it may be formed from a shape memory alloy such as NITINOL, or it may be formed from a natural, synthetic or semi-synthetic polymer such as chitosan, nylon or rayon. The body cavity denudation head ideally consists of a single helix element, although in some embodiments the helix may contain multiple helix elements, for example 2, 3, 4, 5, 6, 7, 8, 9 or 10, and preferably 2-4 spiral element.

The width of the spiral element is at least 0.1 mm. The width is typically 1 to 3 mm to allow delivery through an appropriately sized catheter and sheath.

Typically, the helical helix is elastically deformable enough to maintain a circumferential radial force on the lumen wall of a body cavity of various diameters as it moves along the lumen of the body cavity (i.e., it is designed to be “self-regulating” or “self-regulating capable”). This is illustrated in Fig. 59, which shows the use of the device of the present invention for denudation of a vein with several bends and a diameter that gradually increases. According to this embodiment, the helix, when deployed, will be oversized compared to the widest part of the body cavity lumen, thereby creating a radial force along the entire circumference of the body cavity lumen at its widest point, shown in Fig. 59C, and is sufficiently elastically deformable , so that the diameter of the coil can be adjusted with the changing diameter of the vein, while maintaining the radial denudation force around the circumference of the lumen of the body cavity. The helical coil typically deforms elastically enough to allow the coil to pass through constrictions or valves in the veins, as shown in FIGS. 56 and 57, respectively. These narrowings or changes in vein diameter over the course of treatment may be static (a wider diameter proximal vessel narrows to a narrower distal vessel) or dynamic (contraction of the smooth muscle of the vein wall resulting in a decrease in the diameter of the vein in a physiological process known as venospasm). Reducing the diameter of the vein will increase the radial forces acting on the helix, this in turn will increase the hoop force generated within the helical material, which will be converted into a longitudinal force to increase the length of the helix. This concept is illustrated in Fig. 60, which shows the device deployed in a typical vessel of length 1 and diameter D. The radial force is equivalent to the pressure P acting perpendicular to the vein wall. The pressure that the vessel exerts on the oversized helix, or hoop force (HF), acts to compress the helix and increases when the diameter of the vessel is reduced to d Due to the open design of the helical helix, this increased hoop force will move in the longitudinal direction to extend the helix to a length L This will reduce the radial forces at the point of contact of the outer surface of the device with the vein wall to prevent excessive friction, but maintain sufficient force to keep the surface in contact and press it against the vein.

Excessive friction may result in unwanted entrapment or binding of coil segments and perforation of the wall and/or injury to the connective tissue adjacent to the vein.

As used herein, the term “coil element” refers to the individual and separated coil elements that together form part of the coil of the device of the present invention. As a rule, each element of the spiral is helical. As a rule, the spiral elements are coaxial. As a rule, each element of the spiral in the unfolded state is characterized by the same diameter. As a rule, each element of the spiral is characterized by the same pitch during deployment. In an expanded configuration, many spiral elements together provide circular contact with the internal lumen of the body cavity. Thus, each helix element can be configured such that, in its deployed configuration, it contacts only a portion of the inner lumen circumference, for example, 90° - 270°, 90° - 180°, 140° - 220°, or 180° - 270° , contact with the circumference of the lumen of the body cavity. In one embodiment, the helix comprises two helical helix elements, such as a double helix. Typically, each of the two helical elements when deployed contains at least 0.5 turns and typically 0.5 to 1.0 turns or 0.5 to 0.7 turns. According to one embodiment, the helix comprises three helical elements, such as a triple helix. Typically, each of the three helical elements contains at least 0.3 turns in the unfolded state and typically 0.3 to 1.0 turns, or about 0.3 to 0.5 turns in the expanded state. According to one embodiment, the helix comprises four helical helical elements. Typically, each of the four helical elements contains at least 0.25 turns in the unfolded state and typically from 0.25 to 0.75 turns in the expanded state. In one embodiment, a plurality of coil elements are connected together at their distal ends (closed configuration). In one embodiment, the plurality of coil elements are not connected at their distal ends (open configuration).

As used herein, the term “permanently attached to a catheter element” in relation to a head for denudation of the lumen of a body cavity (or vessel or vein) should be understood to mean that the device is not configured to detach and release the head from the catheter element in the body; in other words, the device is not intended to implant a head for denudation of the lumen of a body cavity into the body.

Implantable devices are not desirable for use in the treatment of superficial venous disease for the following reasons: The superficial veins of the legs are located relatively close to the surface of the skin, where they can be easily palpated by touch. Bulky implantable devices may cause pain, irritation, or local deformation of the skin; implants may inhibit the ability of a vein to reduce its diameter through smooth muscle contraction, known as venospasm. This is important to reduce the diameter of the vein, reduce the amount of thrombus inside the vein and prevent recanalization; implants can cause inflammatory reactions mediated by the immune system.

The contact surface of at least a portion of the helix with the lumen of the body cavity is abrasive to cut or permanently damage the inner layer of the lumen of the body cavity away from the lumen of the body cavity. The surface can be attacked chemically, electrically, or physically/mechanically to make it abrasive. There are several types of machining that can be used to roughen a surface, including mechanical abrasion, shot peening, sandblasting, knurling, electrical discharge machining, and pulsed electrochemical machining. Chemical etching can also be used to roughen the surface of a part. The surface may be jagged. The surface may also include projections that, when in contact with the lumen of the vessel, act as an abrasive surface, these projections may be portions attached to the surface of the abrasive surface, or portions that curve upward from the abrasive surface, or pitted recesses that have a lattice pattern Effect. One way to create a helical spiral with an abrasive surface is to wind a second wire or several wires in a spiral around a conductor wire, as described below and shown in the figures. The second wire may have a round, flat, polygonal, triangular, square, rectangular, X-shaped or star-shaped cross-section, provided that the combination of the elongate element (conductor wire) and the helically wound second wire creates a contact surface with the abrasive lumen capable of denuding the lumen at moving axially along the lumen in an expanded configuration. The wires may not be the only type of material wrapped around the central conductor wire or central body, such as polymer-based moldings, fins, abrasive beads, or spot welding. Another method of making a serrated surface is to cut indentations on the surface of the helix or create convex structures on the surface, such as helical indentations or formations. The surface must be sufficiently abrasive to denudate the lumen after one longitudinal pass of the device to avoid the need for multiple passes, which may be limited by initial vasospasm. The preferred configuration includes surface features to create both a macro and micro abrasive surface. The macro-abrasive surface comprises grooves, depressions or serrations that are at least about 0.5 mm (eg, 0.5 to 1.0 mm) in height from apex to trough. The microsurface contains grooves, depressions or teeth ranging from 5 to 100 microns in height from peak to valley. These grooves cause abrasion and prevent cellular debris from clogging the abrasive surface throughout the application. The orientation of the macro abrasive grooves is important because they should not be parallel, but perpendicular to the axial direction of retraction. This is illustrated in Fig. 64, which shows the device deployed in a vessel. A detailed view of the helix surface is shown in enlarged views (A), (B), and (C). (A) shows a pattern of grooves perpendicular to the vessel wall during retrieval, which is effective for mechanical ablation. (B) shows an orientation that lies parallel to the vein wall during withdrawal and is less efficient. Due to the variability of vessel diameter and tortuosity of venous anatomy, a macro-abrasive texture pattern is required to solve this problem. (C) shows a diamond knurling pattern, which is ideal for ensuring that a portion of the macro-abrasive surface is always perpendicular to the vein wall during contact as the device is axially withdrawn. The microabrasive surface may have a surface roughness or RA value typically between 0.8 and 3.2 to achieve endothelial disruption and prevent excessive static friction. The RA value is the arithmetic mean of the absolute deviations of the profile height from the center line recorded within the estimated length. An RA value of 0.8 corresponds to an average peak-to-valley height of 4 µm. The endothelial cells (ECs) in most vessels are protected from direct exposure to flowing blood by an acellular layer known as the glycocalyx. This gel-like structure is typically 0.5-3 µm thick, which is greater than the thickness of the ECs themselves (0.2-2.0 µm ).

As used herein, the term “shape memory material” should be understood to mean a material, typically a metal alloy, that remembers its original shape and that, when deformed or forced to change configuration, returns to its pre-deformation shape when the deforming forces are released. An example is Nitinol. In one embodiment, the helix or helix conductor element is formed from a shape memory material. Methods for making a helix from a shape memory material typically involve the steps of wrapping the shape memory alloy around a die or heat setting tool so that it forms the desired shape after heat setting, placing the loaded tool in an oven for a predetermined temperature/time, and removing and cooling the part. . It is also possible to form a shape from a cylindrical piece of tube that is laser cut to the desired size. It is also possible to produce this shape memory in other ways, for example, with electroactivated polymers.

As used herein, the term “target zone,” when referring to a body cavity lumen, vessel, or superficial vein, refers to a cylindrical portion of the body cavity lumen that is involved in the pathogenesis of a pathological condition and is typically 1 cm or greater in length. In the context of a superficial vein, the term “target zone” refers to the cylindrical portion of the lumen of the superficial vein that does not effectively circulate blood and is typically 1 cm or more in length. In one embodiment, the treatment zone is 1-50 cm, 1-40 cm, 1-30 cm, 1-25 cm, 1-15 cm, 1-10 cm, 5-50 cm, 5-40 cm, 5-30 cm, 5-25 cm, 5-15 cm, 5-10 cm, 10-50 cm, 10-40 cm, 10-30 cm, 10-25 cm or 10-15 cm in length.

As shown in Figure 1, veins are composed of 3 primary cellular layers: an outer adventitial layer consisting of tough fibrous tissue and unmyelinated nerve fibers, a middle layer consisting of collagen and smooth muscle cells, and an inner endothelial layer consisting of a single layer of squamous cells. and some connective tissue. In addition, the endothelial layer is covered with acellular glycocalyx, which is usually a uniformly distributed structure 0.5-3 μm thick.

Veins are characterized by thinner walls than arteries, less rigid and more pliable. Unlike arteries, which maintain their cylindrical shape at all times, veins can empty of blood and collapse downward, or alternatively, expand significantly to accommodate increased volumes of blood.

Spasm or narrowing of the vein occurs in response to physical stretch activating the nerves on the outside of the vein wall. Constriction also occurs when chemicals such as endothelium-1 are released by the endothelium in response to stretch or disruption.

The endothelial layer prevents blood from clotting in the veins. If the endothelium is destroyed or damaged, prothrombotic factors are exposed, to which platelets immediately adhere, and the coagulation cascade begins. Over time (4-12 weeks, usually 8 weeks on average), the clot in the vein becomes fibrotic as it is invaded by surrounding cells, which deposit fibrin and collagen in a process known as sclerosis or fibrotic transformation. This prevents the reflux of blood into the vein and thus successfully treats varicose veins.

The purpose of the device is to destroy the endothelial and middle layers of the vein, but not the outer adventitia. This requires selective, controlled mechanical destruction to a depth of at least 5 µm to 100 µm, but not more. This ensures destruction of the endothelial and superficial media layers without deeper medial/adventitial destruction that could lead to pain and/or perforation. In deeper layers, further cell death may occur due to the release of intracellular contents, causing apoptosis in neighboring cells and continuing to cascade over time to a depth of 300 μm. The resulting thrombosis or clot and fibrous scar tissue prevents blood from entering the vein and therefore the appearance and symptoms associated with varicose veins. It is important that the endothelium is completely destroyed circumferentially because if small areas are left intact, a clot may not form and blood will continue to flow, leading to treatment failure and/or early relapse. This can occur when liquid or foam chemical sclerosants are used in large veins and is the suspected reason for the low effectiveness of only 70% compared to 90-98% with heat treatment.

Because treatment begins two or more centimeters posterior to the deep vein junction, the attached thrombus created by the present invention is limited to the superficial vein and, since there is no blood flow, it cannot be transferred to the deep system where it can cause complications.

The exact requirements for successful long-term vein ablation are currently unknown. Some specialists in the treatment of superficial venous reflux believe that complete damage to the endothelium is sufficient. This causes a clot to form and stop blood flow, and the body then turns the thrombosed vein into a fibrous cord in a process known as sclerosis or fibrotic transformation, achieving long-term ablation. Others argue that damage to vein wall tissue in the deeper middle layer, in addition to the inner intimal layer, is necessary for long-term vein ablation. Others, such as the proponents of thermal ablation, suggest that complete transmural damage to the vein wall from the intima to the outer adventitia is required.

The present invention achieves complete peripheral endothelial damage through its oversized twisted configuration with an abrasive surface. It also causes damage to the middle layer by at least three separate mechanisms. First, the abrasive polygonal surface of the spiral can penetrate to a depth of more than 50 microns, allowing damage to penetrate deeper than the intimal layer. This can also be further enhanced by using more than one helix, allowing a second abrasive helix positioned more distally on the device to penetrate deeper into a portion of the vessel wall that has already been denuded by a more proximal helix on the device. This can also be achieved by repeating the procedure for the same treatment duration using the same device. Secondly, foam sclerotherapy studies have shown that cell death occurs at depths of up to 300 µm in the vein wall [10]. This is likely due to a cascading effect of cell death caused by the release of molecules by damaged cells, signaling apoptosis in neighboring cells. Thus, damage to the cells of the vein wall can occur deeper to the superficial cells affected by mechanical destruction. Third, the frictional forces caused by the device acting on the superficial layers, combined with the resistance of the deeper middle layers, are characterized by a shear effect within the layers of the vein wall, which leads to deeper damage to the vessel wall. This effect has been reported in previous studies as well as in preclinical trials of the present invention.

The risk of vein rupture and/or device snagging is proportional to the abrasiveness or sharpness of the device in contact with the wall, causing frictional or cutting forces, respectively, and the depth of penetration of the abrasive elements into the wall. Snagging is a common pain point for clinicians and patients following the use of modern mechanochemical devices. There are even documented cases of a vein becoming snagged and accidentally removed, resulting in pain and bruising, known as “inadvertent spontaneous removal” [6]. The venous valve leaflets also present an obstacle where the mechanical tip can become stuck and snagged.

A key issue here is the difficulty of completely removing the endothelial layer and partially damaging the middle layer without causing excessive resistance and/or snagging.

Figure 2 highlights the importance of peripheral coverage in terms of endothelial cell destruction. In our animal study, it was taken from a partially treated vein. The top right shows a clot attached to the vein wall with tissue penetration as it begins to become fibrotic 28 days after the procedure. In the lower left corner there was intact endothelium. The clot has not formed and blood can flow through the canal, resulting in overall treatment failure in this segment. In contrast, Figure 3 shows the results of complete endothelial coverage and damage 28 days after the procedure with the formation of an adherent thrombus obliterating the entire lumen of the vessel, impeding blood flow, leading to treatment success. Migration of inflammatory cells from the adventitia into the thrombus can be identified by microscopic examination. This leads to fibrous transformation of the thrombus and prolonged occlusion.

Examples

The present invention will now be described with reference to specific examples. They are merely illustrative and are presented for illustrative purposes only: they are not intended to limit in any way the scope of the monopoly claimed or the present invention described. These examples represent the best option currently being considered for the practical application of the present invention.

The graphic materials and initially FIGS. 4 to 7 show a device in accordance with the present invention for denudation of the lumen of a body cavity, generally designated by reference number 1. Device 1, which according to this embodiment is a device for denudation of the lumen of a varicose vein in order to cause occlusion of a vein and thereby treat a varicose vein, contains a polyimide catheter element 2 and a denudation head 3 configured for transluminal delivery to the site of the varicose vein to be treated and deployment to a target position in the vein. The denudation head 3 comprises a helical helix 4 having a proximal end 5 and a distal end 6 which are generally aligned with the axis of the helix, and a twisted portion having approximately 1.5 turns, an outer diameter of 13 mm and a pitch of approximately 9 mm.

The coil 4 is axially adjustable relative to the catheter element in a delivery configuration (not shown) in which the coil is unwound and positioned at the distal end of the catheter element 2, and in the deployed coiled configuration shown in FIGS. 4-7. The helical coil contains a shape memory alloy and is displaced to assume a coiled configuration when it extends beyond the distal end of the catheter element. The device is suitable for use with varicose veins having a normal diameter of 4-12 mm (i.e. when the size of the coil exceeds the size of the vein being treated).

It should be noted that the "inflated" diameter of the helix extends along at least one full contour of the helix (360 degrees). This feature, added to the increased diameter of the coil relative to the vein, ensures that the coil contacts and is pressed circumferentially against the inner lumen of the vein, exerting radial pressure evenly across the entire circumference of the vein. An oversized diameter may extend less than one full contour, for example at least 300 degrees, but this runs the risk of incomplete denudation of the internal lumen of the vein, which will lead to partial occlusion of the vein and subsequent recanalization. In this embodiment, the coil has just over one full turn to provide complete coverage even when stretched, but is not too long to cause increased friction against the vein wall and snagging. Adding additional coil turns to a longer coil can be used to further mechanically damage the vein wall. The increased surface area of the device in contact with the vein according to such an embodiment would also increase the risk of snagging and damage to the vein wall. Thus, a spiral with one full turn is the most effective way to achieve complete denudation of the inner surface of the vessel.

The twisted configuration and flexible material of the denudation head allows it to adapt to different vein diameters in a range of sizes that are smaller than the diameter of the coil, while still applying sufficient radial force to cause denudation. These properties also allow the coil to adapt to changes in vein diameter within the same vein over its target treatment length. These changes may be caused by natural narrowing of the vein or by venous valves. The latter can cause significant entanglement and perforation of the vein if rigid structures become caught or trapped by the valve leaflets. Due to the flexible nature of the helix and the minimal projection of the abrasive components, this is unlikely. If the device is caught by the valve flaps, the resulting slight increase in force along the longitudinal axis will automatically reduce the diameter of the helix while increasing its length, allowing the helix to release and avoid snagging or disengaging the valve and associated flaps shown in FIGS. 60 and 61. This occurs automatically during time for normal removal of the device from the vein and does not require adjustment, additional maneuvers or additional visualization by the operator.

Referring to the drawings and initially to FIGS. 8 and 9, the helical coil 4 has an abrasive surface configured to shear the inner lining of the vein (primarily, but not limited to, the endothelial cell layer) away from the vein as the helical coil is moved axially along veins in an expanded configuration. According to this embodiment, the helix includes a 0.01181-inch nitinol conductor wire 8 and a second wire 9 helically wound around the conductor wire 8 to form an abrasive serrated surface on the helix 4. Referring to FIGS. 8 and 9, the second wire 9 represents is a flat wire made of stainless steel or nitinol. According to this embodiment, the wire of the guide wire 8 has a diameter of approximately 1 mm, and the second wire 9 has a width of approximately 0.7 mm and a thickness of approximately 0.02 mm. The pitch of the second wire is approximately 1.5 mm. As shown in FIG. 9, the pitch of the second wire 9 on the guide wire 8 decreases at the distal end 6 of the helix 4, in this case to approximately 0.3 mm. The purpose of the smaller pitch/closed pitch at the distal end is to form a flexible distal element of the device to help guide the device to the target anatomy. As shown in FIG. 10, the pitch of the second wire 9 on the guide wire 8 increases at the proximal end 5 of the helix 4, in this case to a maximum value of approximately 3 mm. The purpose of the higher pitch at the proximal end is to facilitate smooth re-engagement of the distal tip after the procedure. This proximal septum may also have a closed portion with a smaller, narrower pitch to promote recapture.

The thickness of the second wire 9 is from 0.1 to 1 mm. Based on testing using equivalent animal venous tissue, diameters greater than 1 mm carry the risk of forming a surface protrusion that may catch or adhere to the surface of the vein wall.

As shown in FIGS. 10 and 11, the proximal end 5 of the coil 4 is attached to a stainless steel hypotube 12 which extends through the catheter element 2 to its proximal end (not shown). In use, the hypotube 12 may be adjusted axially relative to the catheter element 2 to ensure that the helical coil 4 distal to the catheter element is deployed into a coiled configuration and the helical coil 4 is retracted into the catheter element during transluminal delivery and retrieval of the device. According to this embodiment, the catheter element 2 is a 4Fr extruded polyimide catheter tube having an inwardly tapering neck 14 in FIG. 11 to assist in re-engaging the coil 4 as it is retracted into the catheter element 2.

Referring to FIG. 9, the distal end of the helical coil 4 ends in an atraumatic head, according to this embodiment, a smooth metal ball 15 is provided which serves to prevent the helical coil from snagging on a vein or valve and reduce the risk that the distal tip will cause perforation of the vein wall when deployed and extraction. Additionally, as shown in FIG. 9, the bead 15 is sized to fit into the tapered neck 14 of FIG. 11 of the catheter element 2 when the device is in the delivery configuration.

As shown in Figure 9, between the end of the abrasive spiral and the distal smooth ball there is an elongated straight section approximately 5 mm in length to facilitate navigation and placement of the device. The ball on the distal side of the device forms an atraumatic tip, according to another embodiment, it can be the same diameter as the diameter of the abrasive element, so that not a ball, but a straight atraumatic tip is formed.

FIG. 12 shows a portion of an apparatus according to an alternative embodiment of the present invention, in which the portions identified with reference to the previous embodiments are assigned the same reference numerals. According to this embodiment, the surface of the second wire is serrated with helical grooves 20, which serve to create an abrasive serrated surface on the helical helix 4.

FIGS. 13 to 19 show the use of the device according to the present invention. In the following description, proximal refers to the entry site of the access, and distal refers to distant from the access site in the blood vessel. The device can be delivered and removed through a single injection site and does not require implantation or chemical administration. A method of treating a reflux vein to cause permanent occlusion may involve the following steps.

In the first stage, the device is brought into delivery configuration, with the helical coil 4 being pulled into the end of the catheter element (not shown). In some embodiments, the catheter element is an extruded polyimide. The device is then delivered to the target vein through a separate introducer catheter under visual guidance such as ultrasound.

The device is then moved distally under ultrasound guidance to the desired position. Correct placement with the distal end of the catheter element 2 located at the beginning of the vein to be treated is confirmed by ultrasound, shown in Fig. 17.

The outer catheter 2 extends axially, exposing the helical coil 4 and the hypotube 12 in the deployed coiled configuration shown in FIG. 13. In some embodiments, the helical coil is deployed using a handle with a wheel-controlled element. Using an intuitive one-handed motion, the operator can unroll the helix by turning the dial with the thumb of the hand holding the handle. This allows simultaneous imaging by positioning the ultrasound probe using the opposite hand. This allows the doctor to perform the procedure without an assistant if necessary.

The coil in both the unfolded and deployed configurations should be easily visualized on ultrasound to prevent accidental placement. This is achieved by introducing an echogenic area of material at the tip of the catheter. When deployed, the spiral with its abrasive surface is echogenic in nature.

Because the coil is larger than the size of the exposed vein, it exerts an outward radial force on the lumen of the vein over at least one full circumference of the vein.

Unlike existing treatment options, the device's effect on the vein wall, causing long-term occlusion, occurs only after the device is removed from the affected portion of the vein. This may only occur in a proximal direction, which protects a more distal structure that may include veins in the deep system.

If the device is accidentally placed in the wrong position of the target vessel, it can be recaptured into the external catheter and repositioned without causing vessel injury.

The device is then moved proximally along the portion of the vein to be treated (typically a portion of the vein measuring approximately 10 to 70 cm), where the radial force of the abrasive surface of the coil acts on the internal lumen of the vein, and the axial movement causes the helical coil to remove, disrupt or destroy the superficial layers of the internal vein. parts of the internal lumen of the vein. These layers consist of the glycocalyx, endothelium, subendothelial connective tissue and the superficial layers of the middle layer. Stretch receptors in the vein wall respond to the external radial force of the device, resulting in vasospasm. This is further enhanced by the release of chemicals stored in endothelial cells, mainly endothelin-1, a powerful vasoconstrictor. Exposure to subendothelial collagen leads to platelet adhesion and triggers a cascade activation of prothrombotic factors, leading to thrombotic vascular occlusion. This thrombotic occlusion is further enhanced by significant vasospasm, as shown in FIG. 19, where the affected portion of the vein contracts significantly in the acute phase. This leads to a complete cessation of blood flow in the vessel. This was demonstrated during a preclinical study of the goat lateral saphenous vein, in which a high-pressure manual injection of contrast agent failed to enter the vein 45 minutes after exposure.

Without being limited by theory, disruption of the peripheral endothelial layer allows intraluminal thrombosis to adhere directly to the vessel wall and recruit cells involved in the inflammatory healing response to migrate from the adventitia through the lumen into the thrombus. These cells include fibroblasts, which create collagen in thrombotic occlusion, eventually turning the vessel into a fibrous cord. This leads to prolonged closure of the vessel and the disappearance of symptoms of venous disease.

Contrary to previous belief that complete damage to the transmural cells of the vein wall is required, the inventors have demonstrated that superficial denudation alone can produce a sufficient inflammatory response to cause fibroblasts on the outer adventitial layer to migrate inward. This is advantageous because it provides a mechanism of action that the device can use that does not cause pain to the patient and does not require drug injections via a tumescent needle to prevent pain. This is due to the fact that the sensory pain nerve fibers are located on the adventitial layer of the vessel, which is not directly affected by the device.

The results of the authors' preclinical studies also demonstrated the importance of complete circumferential endothelial disruption to achieve long-term successful occlusion. Thrombotic occlusion without destruction of the endothelium will result in recanalization even if the endothelium is partially damaged, as shown in Fig. 2. This is due to the fact that the endothelium prevents the adhesion of the thrombus, which causes the thrombus to shrink away from the vessel wall. This is further enhanced by the secretion of nitric oxide by endothelial cells, promoting vasodilation, thereby counteracting the effect of venospasm. This may be the main factor for the low effectiveness of methods based on chemical sclerosants. Because the sclerosant is inactivated by the blood and removed by the rate of circulation, it may cause only incomplete endothelial destruction, especially in larger vessels that have more blood and a larger surface area even in a collapsed state.

The embodiments of FIGS. 4-16 have a body cavity lumen denudation head formed from a single helix element which, when deployed, contains one complete helical turn and, when in use, circumferentially denudates the body cavity lumen. Referring to FIGS. 20-24, an alternative embodiment of the apparatus of the present invention is described, generally designated by reference numeral 30, and in which the parts described with reference to the previous embodiments are designated by the same reference numerals. According to this embodiment, the device includes an elongated control arm 31 that extends through the catheter element 2 and is operatively connected to the distal end 6 of the coil 4 and the proximal end 5 of the coil is attached to a stainless steel hypotube 12. Axial movement of the control lever 31 relative to the hypopipe 12 leads to the deployment or unwinding of the spiral. FIG. 22 shows the helix to be in a partially twisted configuration, and FIG. 23 shows the helix to be in a fully coiled configuration. The application of this embodiment is essentially the same as described previously, except that the deployment of the helix can be controlled by adjusting the axial position of the control lever 31 and the hypopipe 12.

In fig. 25-27 describe an alternative embodiment of a device in accordance with the present invention, designated generally by reference number 40, and in which the parts described with reference to the previous embodiments are assigned the same reference numbers. According to this embodiment, coil 4 consists of two coil elements 41a and 41b that operate in tandem to circumferentially denude the internal lumen of the body cavity, each of which is adjustable from an unrolled configuration suitable for placement within the catheter element and transluminal delivery through the lumen of the body cavity. , and the twisted configuration shown in the figures. Each coil element 41a, 41b has a proximal portion, which is generally coaxial with the catheter element, and a coiled portion, which in the deployed configuration contains less than one full turn, such that the coil elements together take the form of a double helix which, when used, circumferentially contacts the lumen to be treated. body cavities. As with previous embodiments, each coil member includes a guide wire 8 having a second wire 9 wound around the guide wire to provide a serrated surface for denudation of the body cavity lumen. The use of this embodiment is the same as described with reference to the previous embodiments.

FIGS. 28-30 describe an alternative embodiment of a device in accordance with the present invention, designated generally by reference number 50, and in which the parts described with reference to the previous embodiments are assigned the same reference numbers. According to this embodiment, the coil 4 consists of four coil elements 51a - 5Id that work in tandem to denudate the circumference of the internal lumen of the body cavity, each of which is adjustable from an unrolled configuration suitable for placement within the catheter element and transluminal delivery through the lumen of the body cavity. and the twisted configuration shown in the figures. Each helix element 51a to 5 Id in its unfolded configuration is approximately one-quarter of a full turn, and the four helix elements together adapt the quadruple helix shape such that the four helix elements together circumferentially contact the target lumen of the body cavity. As with previous embodiments, each coil element includes a guidewire 8 having a second wire 9 wound around the guidewire to provide a serrated surface for denudation of the body cavity lumen. The use of this embodiment is the same as described with reference to the previous embodiments.

In embodiments described above that contain 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 helix may be a closed helix in which the helix elements are joined together at the proximal and distal ends. Such an embodiment is described in FIGS. 31-33, in which the parts described with reference to the previous embodiments are designated by the same reference numerals. According to this embodiment, device 60 comprises a helix formed from four helical helix elements 61a - 6 Id that are joined together at their proximal and distal ends 5, 6, each helix having approximately half a full turn. As with previous embodiments, each coil element includes a guidewire 8 having a second wire 9 wound around the guidewire to provide a serrated surface for denudation of the body cavity lumen. The use of this embodiment is the same as described with reference to the previous embodiments.

FIGS. 34-41 show helical spirals forming part of the devices of the present invention, and in particular, various types of wires forming the spirals, and various types of depressions/formations on the surface of the spiral forming a rough surface. The spirals are made of nitinol wire, and the recesses are cut using the knurling method.

FIGS. 34A and 34B show a portion of the helical helix 67 having a generally flat profile with an outer surface 61 in contact with the lumen with transverse recesses forming teeth 62 having a truncated triangle profile, a flat inner surface 63 and zigzag cut sides forming a plurality of lateral teeth 65.

FIGS. 35A and 35B show a portion of the helical helix 70 having a generally convex profile with an outer surface 71 in contact with the lumen with curved transverse recesses forming teeth 72 having a triangular profile and a smooth convex inner surface 73.

FIGS. 36A and 36B show a portion of the helical helix 80 having a generally flat profile with an outer lumen contact surface 81 with transverse recesses formed on each side 84 of the surface 81 providing two series of teeth 82 having a truncated triangular profile and a smooth curved inner surface 83.

FIGS. 37A and 37B show a portion of the helical helix 90 having a generally convex profile with a convex outer lumen contact surface 91 with indentations formed on the surface 91 providing diamond-shaped teeth 92, some with flat tips and some with pointed tips, and smooth flat inner surface 93.

FIGS. 38A and 38B show a portion of the helical helix 100 having a generally crescent-shaped profile with a convex outer lumen contact surface 101 with curved recesses formed on the surface 101 providing transverse teeth 102 having a versatile triangular profile and a smooth flat inner surface 103 .

FIGS. 39A and 39B show a portion of the helical helix 110 having a generally oval profile with a convex outer lumen contact surface 111 with curved V-shaped recesses formed on the surface 111 providing transverse teeth 112 having a triangular profile and a smooth flat surface. inner surface 113.

Figures 40A and 40B show a portion of the helical helix 120 having a generally flat profile with a flat outer lumen contact surface 121, a flat inner surface 123, and sides cut in a zigzag pattern to provide a plurality of lateral teeth 125.

41A and 41B show a portion of the helical helix 130 having a generally inverted T-shaped profile with a base 131, teeth 132 located on the base, and a smooth, flat inner surface 133.

The above-described surface patterns and shapes are advantageous in that they allow the correct angle, depth and level of cellular disruption to occur during axial impact on the body cavity lumen, with the deployed device automatically deforming in response to changes in body cavity lumen diameter. As described previously, the macroabrasive surface must be in perfect contact with the vessel wall perpendicularly during extraction to have the greatest effect.

FIGS. 42-48 show a series of vein denudation heads forming part of the devices of the present invention, and in particular vein denudation heads comprising a single helical coil, and in which the parts described with reference to the previous embodiments are designated the same position numbers.

FIGS. 42A and 42B show the vein denudation head forming part of the device of the present invention, generally designated 140, and comprising a control lever 31 and a helical coil 141 having approximately three turns, and a proximal portion 142 where the coil increases in diameter. towards the midpoint 143 and towards the distal portion 144, where the diameter of the helix decreases in diameter towards the distal tip 145, which is located on the axis of the helical helix.

FIGS. 43A and 43B show a vein denudation head forming part of the device of the present invention, generally designated 150, and comprising a control lever 31 and a helical coil 151 having approximately three turns 152A, 152B, 152C, each of which is characterized by a slightly different diameter and is slightly offset in the axial direction relative to the previous turn.

Figures 44A and 44B show a vein denudation head forming part of the device of the present invention and generally designated numeral 160, and comprising a control lever 31 and a helical coil 161 having approximately seven turns of variable diameter and including a proximal a region 162 where the helix first decreases and then increases in diameter towards the midpoint 163 and a distal region 164 where the diameter of the helix decreases in diameter towards the distal end 165.

FIGS. 45A and 45B show a vein denudation head forming part of the device of the present invention, generally designated 170, and comprising a control lever 31 and a helical coil 171 having approximately four turns and including a proximal coil member 172. a distal coil element 173 and a transition member 174 connecting the coil elements, and a distal tip 175.

FIGS. 46A and 46B show a vein denudation head forming part of the device of the present invention, generally designated 180, and comprising a helical coil 181 having approximately two turns and comprising a proximal coil member 182, a distal coil member 183 and a transition element 184 comprising a straight portion connecting the helix elements and a distal tip 185.

FIGS. 47A and 47B show a vein denudation head forming part of the device of the present invention and generally designated numeral 190, and comprising a control lever 31 and a helical helix 191 having approximately three turns (helixes), the diameter of which decreases distally. direction towards the distal end 195.

FIGS. 48A, 48B, and 48C show a vein denudation head forming part of the device of the present invention, generally designated 200, and comprising a control lever 31 and a helical helix 201 having approximately three turns and comprising a proximal right-hand helical element. a coil 202 with approximately two turns, a distal left-handed coil member 203 with approximately 1.5 turns, a transition member 204 with a pivot portion 206, and a distal tip 205. The pivot portion 206 allows a smaller diameter right-handed proximal coil 202 to transition into a larger diameter left-handed distal coil 203.

FIGS. 49-51 show a series of vein denudation heads forming part of the devices of the present invention, and in particular the vein denudation heads have two axially spaced apart helical coils in which the parts described with reference to the previous embodiments implementation are designated by the same position numbers.

FIGS. 49A and 49B show a vein denudation head forming part of the device in accordance with the present invention, generally designated 210, and comprising a control lever 31 that is bifurcated at the distal end to provide controls 31A and 31B, proximally a helical coil 211 operatively attached to the control element 31 A, and a distal helical coil 212 axially spaced from the proximal helical coil and operatively attached to a control element 31 B that extends through the proximal helical coil. Each helical coil has slightly more than two turns (spirals) and is typically characterized by a conical shape with a proximally increasing diameter.

FIGS. 50A and 50B show a vein denudation head forming part of the device in accordance with the present invention, generally designated 220, and comprising a control lever 31 that is bifurcated at the distal end to provide controls 31A and 31B, proximally a helical coil 221 operatively attached to the control element 31 A, and a distal helical coil 222 axially spaced from the proximal helical coil and operably attached to a control element 31 B that extends through the proximal helical coil. Each helical coil has slightly more than two turns (spirals) and is typically characterized by a conical shape with a diameter that increases proximally. In addition, the maximum diameter of the proximal helix dl is approximately three times larger than the maximum diameter of the distal helix d2, and the pitch of the distal helical helix pi is approximately twice that of the proximal helical helix p2.

FIG. 51A shows the vein denudation head forming part of the device in accordance with the present invention, designated generally at 230, and comprising a control lever 31 that is bifurcated at the distal end to provide controls 31A and 31B, a proximal helical coil 231 , operatively attached to the control element 31 A, and a distal helical coil 232, spaced axially from the proximal helical coil and operatively attached to the control element 31 B, which extends through a portion of the proximal helical coil. Each helical coil has slightly more than two turns (spirals) and is typically characterized by a conical shape with a diameter that increases proximally. In addition, the maximum diameter of the proximal helix is approximately one third of the maximum diameter of the distal helical coil, and the pitch of the distal helical coil is approximately half that of the proximal helical coil.

Referring to FIG. 61 A, when the coil is deployed and contacts the inner surface of the vessel lumen, static friction occurs between the device and the vessel wall. At rest, the coil contact points (FC) exhibit an outward radial force that is proportional to the stiffness and diameter of the coil and the diameter of the vessel. This is counterbalanced by the vasoconstriction force P. As the user withdraws the device, the axial force FA increases to overcome static friction. In sliding systems between solid objects, the friction force is proportional to the contact force of the load (FC) and the surface roughness, described by Amonton's friction law. Contact surface area has also been shown to be a factor that increases friction [11].

Ideally, as the axial force (FA) increases, the static friction is overcome before the helix begins to elongate. Static friction in veins and arteries is generally low due to the presence of a gel-like glycocalyx layer, which has been shown to reduce static friction [12]. When the force of vessel constriction increases, as in venospasm, a greater axial force is required, which causes the coil to lengthen while maintaining contact with the vessel wall due to its elastic deformability, as shown in Figure 61 B. Axial force required to lengthen the coil , is proportional to the stiffness of the wire, and also depends on the profile of the wire (flat or round).

In some cases, as shown in FIG. 61C, the device is subject to significant constriction forces due to excessive venospasm or natural obstruction from the venous valves. In this situation, the increased constriction force tends to be concentrated at the distal portion of the helix. As the axial force increases further, the helix reduces its diameter enough to lose contact with the vessel wall, as shown in Figure 61C. This significantly reduces static friction and can narrow the distal end to allow it to overcome static friction and/or obstruction. When this occurs, the helix jumps or skips proximally during recoiling, returning to its natural configuration. This can cause small areas of the vein wall to be missed by the abrasive surface. In some cases, such as when passing through very narrow constrictions or venous valves, some deformation of the coil causing loss of contact is desired to allow the coil to reduce static friction before the axial force becomes too great to cause vessel wall damage or vein extraction. Vein extraction occurs when the distal end of the intraluminal device acts as an anchor to transmit axial forces that are large enough to scrape or remove the entire vein segment from the surrounding tissue. This has been documented with previous vein ablation devices, which had a non-deformable, less flexible design and caused significant pain and bruising to the patient and increased the complexity of the procedure [6].

To overcome excessive helix elongation and resulting skipping, variables associated with static friction and helix deformability can be modified by changing the thickness, shape, diameter and/or stiffness of the device element. The surface roughness must remain constant to achieve sufficient mechanical ablation.

The use of other coil configurations may also limit the skipping effect on the endothelial lining. Such embodiments of the device are shown in Figs. 42-51. Fig. 45 and 46 include a connecting segment (174, 184) that can prevent the entire helix from being over-elongated. FIG. 48 shows a connecting segment between helices with opposite clockwise and counterclockwise configurations to resist overextension. FIGS. 49-51 show individual helix elements to provide coverage if any of the helix elements are subject to excessive static friction and lose contact during elongation.

Referring to FIG. 63, according to another embodiment, there is a single flat wire variant. This flat wire is made of nitinol. The outer surface of this wire is textured (roughened) using a rolling process where a shape is pressed into the wire, similarly texture can be applied by other methods such as stamping or micromachining. This creates abrasive particles in the wire. In fig. 37A shows a diamond knurling pattern pressed into a nitinol wire. The outer surface of the wire can also be shot blasted to create a micro-abrasive surface on the wire. This flat wire is subsequently held in a heat setting fixture and forms a helical profile. The helical coil with its abrasive outer surface is configured to shear the inner lining of the vein (primarily, but not limited to, the endothelial cell layer) as the helical coil moves axially along the vein in an expanded configuration.

Vein disease

The device and method of the present invention can be used for the treatment or prevention of venous diseases. The combination of venous valve insufficiency and weakness of the vein wall leads to reflux of blood with subsequent complications of blood pooling in the lower extremities. The goal of treating superficial venous reflux is to remove or block the reflux vein, allowing blood to be diverted to healthy veins and effectively circulate 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. This path runs from the foot to the groin area, where it connects with the deep femoral vein. GSV is the most common cause of venous reflux. Other veins include the small saphenous vein (SSV), anterior accessory saphenous vein (AASV), and numerous tributaries that may also be targets for treatment.

The venous network of the lower extremities is divided into three components: 1) superficial veins, located in the superficial section, superficial to the muscular fascia, draining the skin and subcutaneous tissue 2) deep veins, lying deep in the muscular fascia and draining the muscles of the lower extremity, and 3) perforating veins, which penetrate the muscular fascia and connect the superficial and deep veins.

Understanding the fascial layers and compartments of the leg in which these veins are located is important to understanding the risks associated with current treatment approaches. In people of normal physique, the GSV usually runs close to the skin at a depth of 2 to 5 cm. It is limited from the calf to the groin in a closed fascial space by the muscular fascia below and the subcutaneous fascia above. The latter is part of the membrane layer of subcutaneous tissue. The two fascial layers, including the saphenous fascia above and the muscular fascia below, fuse at each end to form an enclosed space called the subcutaneous compartment. The saphenous section contains the saphenous vein and accompanying arteries and nerves. The saphenous nerve is typically located far from the great saphenous vein (GSV) rather than in the saphenous fascia above the knee. However, the saphenous nerve is in close proximity to the GSV and is found in the saphenous fascia below the knee. The only truncal vein located in the saphenous region is the GSV or its duplicate. All venous branches and accessory veins are located in the saphenous region, external to the saphenous fascia and subcutaneous region.

Segmental hypoplasia of GSV occurs in 25% of patients with superficial venous disease [13]. This hypoplastic segment of the thigh is often overlapped by an accessory vein that extends beyond the saphenous vein closer to the skin. If this or any other part of the GSV passes in close proximity to the skin, it may be difficult to create a plane of tumescent anesthesia around the vein to protect the skin in preparation for thermal treatment of venous disease. In some cases, only non-thermal methods or vein removal may be performed. The venous branches of the thigh extend beyond the saphenous vein and may become varicose when reflux develops. They are also less amenable to heat treatment due to their more superficial location. The two main entrance veins of the thigh are the anterior and posterior circumflex veins. The anterior accessory saphenous vein of the femur runs parallel to the GSV in the saphenous portion, but is not continuous and is present in approximately 14% of patients with varicose veins. The small saphenous vein (SSV) begins at the lateral malleolus and drains into the deep vein in the popliteal region behind the knee. It is adjacent to the sural nerve, which is vulnerable to thermal injury [14]. The fascial relationships of SSV are more stable than GSV.

Perforating veins connect the superficial veins with the deep veins, penetrating the muscular fascia. There are up to 150 perforating veins of varying size and distribution in the lower limb. Medial crural perforators are the most clinically significant and can lead to high-velocity blood flow into the superficial system and venous hypertension. They are difficult to treat with surgical, thermal, adhesive and/or sclerosing techniques due to their short length and close proximity to the deep vein system. Inadvertent spread of heat, adhesive, or chemical sclerosant directly into the deep venous system can lead to DVT and subsequent PE, a potentially fatal complication. Open surgical ligation is technically difficult and results in significant morbidity due to the incision. The connection of the GSV and SSV with the deep femoral veins in the groin and posterior knee, respectively, are also points of connection between the superficial and deep systems, and treatment of an incompetent superficial vein near these areas carries the risk of thromboembolic complications.

Due to these anatomical considerations, the use of thermal energy is limited due to the inherent risk of injury to adjacent skin and nerves. In addition, direct propagation of thermal energy to non-target tissues in the deep venous system is a potential cause of DVT and subsequent PE. Current non-thermal methods are also limited by the risk of damage to adjacent non-target tissues. Cyanoacrylate glue may inadvertently enter the deep venous system without being able to be removed or recaptured. Chemical sclerosants by their nature effectively circulate in the deep veins as they flow from the target site. Foam sclerosants can disperse in cohesive emulsions of sclerosant and air into the deep venous system, potentially damaging the endothelium and leading to DVT. Chemical sclerosants may also be inadvertently injected into subcutaneous tissue, nerves, or arteries, causing significant skin necrosis.

To counteract these limitations, an effective non-thermal device must be capable of gentle and precise deployment using standard ultrasonic techniques. It must also be possible to remove and recapture the device if it was incorrectly positioned prior to exposure. No device currently sold has this dual capability.

For the treatment of lower extremity venous reflux, a mechanical ablation device that can be precisely deployed to the target site is preferred without the risk of uncontrolled forward spread or damage to surrounding tissue. The ability to re-grip and reposition further reduces the risk of user error.

The proposed method of vein occlusion without the use of a permanent implant or toxic agent is preferred because it avoids the risk of infection, immune inflammatory response, neurological side effects, migration of debris secondary to mechanical wear of the implant, and patient discomfort due to volumetric effects.

Bioabsorbable implantation methods previously also did not provide long-term venous occlusion with recanalization after absorption [15].

Surprisingly, the authors discovered that when using a purely mechanical, non-implantable solution, the natural thrombotic occlusion acts as an “implant” and is converted by the natural healing mechanisms of the body cavity into a permanent occlusion in a process known as fibrotic transformation of the thrombus.

In addition to the method of occluding the GSV, SSV, AASV, or large superficial venous network, a method is provided for the treatment of incompetent venous branches of shorter length, which are usually located below the knee. They are currently treated with a procedure known as phlebectomy. It involves making a knife cut in the skin under local anesthesia and using a vein hook to manually remove a short segment of the vein. This procedure is often performed on multiple segments of veins in the leg. This can be painful and uncomfortable for patients due to the need for multiple injections of local anesthetic with a needle and the difficulty in fully anesthetizing each segment of the vein. Often, due to unacceptable patient discomfort or physician preference, a chemical sclerosant is used instead. Increasing the number of injections of a chemical sclerosant may increase the risk of systemic toxic side effects and local complications, including skin necrosis due to accidental injection of sclerosant into the subcutaneous tissue or arterial system.

In one embodiment, a method of treating small branch veins is performed using a miniature coil, as shown in FIGS. 66 and 67. The mechanism of action provided by this embodiment is the same as previously described for treating large veins such as GSV. Once inserted into the target vein, a miniature coil with an abrasive outer surface unfolds, exerting a radial force on the vein wall. This surface denudates the inner layer upon extraction.

Referring to FIG. 65, according to one embodiment, a helical coil is loaded around a needle as part of an intravenous cannula. Changing the current placement of the 14G intravenous cannula to reduce the size of the needle used to enter the vein while maintaining the outer sheath diameter at 2.1 mm allows placement of a helical coil as shown in FIG. 65. Creating a more tapered tip with an external polyurethane catheter allows access to the skin. Using modern methods of intravenous access, such as access to the vein, removal of the needle and advancement of the cannulas is carried out as shown in Fig. 67. The miniature section of the coil can be deployed by partially removing the outer polyurethane cannulas (Fig. 66). Once the end of the treatment zone is reached, the external cannula can be used to recapture and atraumatically remove the coil. This proposed method reduces the need for local anesthesia because no skin incisions are required and no vein traction is required to remove the vein as with hook phlebectomy procedures. There is also no need for a chemical sclerosant, which reduces the associated risk of skin necrosis.

As shown in FIG. 68, in another embodiment, the vein is accessed using a small gauge needle and a guide wire is passed into the vein. An outer sheath, similar to the introducer sheath, extends over the guide wire as shown in FIG. 69. This outer shell is made to hold the coil attached to its inner lining just below the hole in the tip. This allows the guide wire to pass through the coil within the sheath. The spiral is then deployed by partially removing the outer shell, Fig. 68. According to another embodiment, the coil is deployed using a tear-off introducer sheath, as shown in FIG. 70. In one embodiment, the coil can be reloaded into the sheath and used in individual veins.

The following is a description of some lumen-related indications that can be treated using the device and methods of the present invention:

Pelvic vein reflux

Abnormal reflux of blood in the pelvic veins has been shown to be an important but often previously unrecognized cause of recurrent varicose veins in the legs, vulvar/vaginal varices, and a condition known as pelvic venous congestion syndrome (PCS). It is also thought to be associated with hemorrhoids. Reflux in the internal iliac and ovarian veins in women is usually responsible for the development of these conditions.

PCS is characterized by visible congestion in the pelvic veins on venography in women with chronic pelvic pain for more than six months. The most common cause of reflux and pelvic varicose veins is the left ovarian vein. The morbidity associated with PCS can be severe, resulting in significant reduction in quality of life and patient discomfort. PCS presents with a variety of intrapelvic symptoms, including noncyclic pain, urinary frequency, and dyspareunia. Ongoing treatment is typically performed using catheter access through the jugular or femoral vein, after which the ovarian veins and/or internal iliac veins are occluded using metal embolization coils, chemical sclerosants such as 3% sodium tetradecyl sulfate (STS), or their combinations. Disadvantages of wire embolization include the high cost of treatment associated with the use of coil devices and the risk of complications, including coil migration and vein rupture. Coil migration occurs when coils inadvertently migrate to non-target sites such as the renal vein or through the inferior vena cava to the pulmonary veins, causing pulmonary embolism. Helix migration has been reported to occur in 4% of cases and can lead to significant morbidity [16]. Some patients report persistent pelvic discomfort or flu-like symptoms, the cause of which is unknown but may be related to the coil implants. The use of endothermic laser or radiofrequency vein ablation has not been accepted for the treatment of pelvic venous insufficiency. This is primarily due to the risk of thermal damage to important surrounding pelvic structures adjacent to the vessel wall. Although perforation of the transmural vessel and damage to surrounding tissue are rare with endothermic techniques, the consequences during treatment in the pelvis are much greater than in the lower extremities. In addition, large volumes of tumescent anesthesia are injected around the veins of the lower extremities during treatment to protect the surrounding tissue and prevent thermal injury and pain. Obviously, this is impossible in the pelvis. Accordingly, a safe and cost-effective device is still required to treat pelvic vein reflux by occlusion. The optimal solution will be provided in a non-implantable, non-thermal manner to reduce these risks.

In one aspect, the method of the present invention can be used to treat pelvic vein reflux, in which a coil device is used to mechanically denudate the internal iliac and/or ovarian vein to cause permanent occlusion. This occlusion will prevent venous reflux into the leg veins that causes recurrence of varicose veins, venous territories supplying the vagina/vulva, and venous territories involved in PCS. In another embodiment, the denudation procedure may be combined with temporary balloon catheter occlusion to reduce blood flow and promote thrombus adherence to the treated vein site. This may be particularly applicable to pelvic veins with higher volume and reflux rates. In one embodiment, the procedure can be improved by the combined use of a chemical sclerosant and/or embolic particles. Figure 71 schematically illustrates the venous anatomy associated with pelvic vein reflux and the use of a helical coil to denudate the internal iliac veins and prevent backflow to the involved venous territories, thereby treating the symptoms. Deep vein reflux

Deep vein reflux, caused by incompetent venous valves affecting the femoral vein in the lower limb, cannot be treated with ablation and occlusion as it is vital for the circulation of blood from the limb to the heart. Some incompetent venous valves have been obliterated due to DVT, but others have retained normal valve leaflets, but due to wall weakness they no longer oppose correctly to prevent reflux. Current treatments involve invasive surgical procedures to create new valves. Accordingly, there is a need for a less invasive procedure to restore venous valve function. In one aspect, the method of the present invention can be used to treat deep vein reflux in which the coil device is deployed and withdrawn through an existing valve. The outer surface is slightly abrasive to reduce the risk of thrombotic occlusion while maintaining the ability to disrupt the endothelial layer. This causes hypertrophy of the valve leaflets and surrounding tissue with the effect of bringing the valve leaflets closer together and restoring one-way valve function to prevent reflux.

Haemorrhoids

As mentioned earlier, hemorrhoids can be treated with pelvic vein embolization. New techniques also target specific occlusion of the superior rectal artery to prevent filling of the dilated venous plexus causing internal hemorrhoids [17]. The diameter of this artery in most cases is from 3 to 5 mm. To avoid permanent implant placement and provide a more cost-effective solution for this common condition, improved treatment options are needed. In one aspect, the method of the present invention is for the treatment of hemorrhoids, which uses a helical device to mechanically denudate the superior rectal artery to cause permanent occlusion and prevent filling of the venous plexus, thereby treating the condition.

Varicocele

A varicocele is an abnormal enlargement of the veins surrounding the testicles in men. Clinically significant varicoceles occur in up to 15% of adult men, resulting in pain, discomfort, and decreased fertility. Treatment is recommended for young men with testicular atrophy or reduced fertility. Current treatment involves occlusion of the testicular vein, which supplies the abnormally dilated veins around the testicles. Modern methods of occlusion include embolization with a permanent coil, the use of glue, a chemical sclerosant, or a combination of methods. Accordingly, a less invasive and more cost-effective method is still needed to occlude the testicular vein that supplies the dilated veins of varicoceles. In one aspect, a method of the present invention can be used to treat a varicocele, in which a disposable coil is used to mechanically denudate a testicular vein to cause permanent occlusion. Fig. 55 is a schematic representation of venous anatomy and associated procedure for permanent vein occlusion.

Portal vein occlusion

Preoperative portal vein embolization (PVE) is a routine procedure to stop portal vein blood flow to a selected portion of the liver before major liver resection. PVE causes hypertrophy of liver tissue that should remain after planned extensive resection and may allow for more aggressive resection. It is used as an additional stage in the treatment of primary and secondary liver metastases of colorectal cancer. Current techniques involve accessing the portal venous system using a direct transhepatic approach under image guidance followed by injection of embolic agents including glue, polyvinyl alcohol (PVA), and metal spheres or coils. Many of these options are expensive, and the patient may be inoperable during the course leading up to the planned resection. Accordingly, a more cost-effective approach is required. Due to the procoagulant state of most patients undergoing portal vein procedures as an adjunct to tumor resection, a nonimplantation technique based on thrombotic occlusion of selected portal veins may be effective. In one aspect, a method of the present invention is provided for preoperative portal vein occlusion, which utilizes a helical coil device to mechanically denudate the portal veins to cause occlusion. This occlusion will promote hypertrophy of the remaining liver segments and increase the patient's likelihood of survival after elective resection. Fig. 53A is a schematic illustration of portal vein occlusion using a non-implantation mechanical denudation technique.

Vein grafts

Coronary artery bypass grafting (CABG) surgery is the standard of care for patients with left main coronary artery disease (CAD) and three-vessel CAD. Peripheral artery bypass graft (PABG) surgery is performed on patients with advanced peripheral artery occlusive disease. The internal mammary artery is typically used for revascularization in coronary artery bypass grafting, but veins (almost exclusively the great saphenous vein) remain the most commonly used graft, especially in PABG surgery. Incorporation of vein grafts into the arterial system exposes the vein to higher tensile forces and shear stress, which can lead to excessive inflammatory changes in the vein wall known as intimal hyperplasia, leading to occlusion and failure of the vein graft. Patency 10 years after vein transplantation is only 60% [18]. It is not clear why some vein grafts remain open while others remain occluded in the long term. All veins undergo some remodeling or "arterialization" as they pass into the arterial system. However, an excessive and persistent inflammatory response causes graft failure in the long term. A new study shows that the condition of the vein before transplantation may be an important predictor of graft failure. Veins with already hypertrophied synthetic predisposed smooth muscle cells in the medial layer have a worse prognosis. Accordingly, a method for increasing the long-term success rates of vein grafts for arterial diseases is an important clinical need and can be achieved by preconditioning or modifying the vein graft before its use as a conduit in the arterial system. According to one aspect of the present invention, a method is provided for pre-treatment of veins to be used as grafts in the arterial system for the treatment of CAD and PAD. A helical coil with a less abrasive surface or a partially abrasive surface provides thickening of the vein wall without complete thrombotic occlusion and subsequent fibrosis. The depth of vein wall destruction must be specific to develop a proper inflammatory response that does not predispose the vein to graft failure. This additional procedure is ideally performed 4 to 12 weeks before graft implantation to allow the cellular changes involved in vein remodeling to occur and resolve. This may improve the vein's ability to adapt to an arterial environment with higher pressures and higher shear forces because inflammatory changes have already occurred and have ceased after a single mechanical disruption of the impact. In this case, the likelihood of uncontrolled excessive inflammatory and hypertrophic changes when introduced into the arterial system will be lower. This may prevent excessive uncontrolled medial hypertrophy and intimal hyperplasia and reduce the risk of mural atheroma, which is a major cause of cardiac graft failure. FIG. 72 shows the histological differences between a normal vein, an arterialized vein, and a failed vein graft. Ateriovenous (AV) fistula

An AV fistula is a surgically created anastomosis between the arterial and venous bloodstreams, allowing end-stage kidney disease (ESKD) to be treated with dialysis. Patients with a functioning AVF have lower morbidity and mortality rates and lower treatment costs compared with patients who use central venous catheters for dialysis. When creating an AVF of 20 to 60%, there is an unacceptably high rate of primary failure. Failure rates have increased in recent years due to an aging population dependent on AVF for dialysis and higher pump speeds used in dialysis [19].

The main reason for failure is stenosis of the venous segment of the anastomosis. The underlying mechanisms involved in the creation of AVF are poorly understood, but insufficient extrinsic remodeling and excessive intimal hyperplasia are thought to be involved. Accordingly, an improved AVF formation method for use in patients with ESKD is urgently needed. In one aspect of the present invention, a reduced abrasive or partially abrasive coil is used preoperatively to create an anastomosis to produce a vein with a healthy remodeling pattern. Ideally, this procedure should be performed 4-12 weeks before the creation of the AVF to allow cellular changes to occur and resolve. This vein preconditioning may reduce the inflammatory response and uncontrolled remodeling that leads to primary AVF failure when a normal vein is acutely exposed to blood pressure and flow velocity. This may increase the success rate of AVF procedures. This method may also prevent AVF steal syndrome, in which the venous side of the anastomosis becomes excessively enlarged and leads to ischemia in the territories supplied by the arterial side.

Thrombectomy

Thrombotic occlusions can occur anywhere in the arterial or venous system and typically consist of red blood cells, activated coagulation factors, platelets, and inflammatory cells. Over time, from a few minutes to several days, the thrombotic mass becomes organized and adheres to the vessel wall, especially if there is damage to the vessel wall. Previously described embodiments of the present invention have been developed to facilitate this event when vessel occlusion is required, primarily in the setting of superficial venous reflux.

The authors also found that a radially expanding helical coil can also be used to remove thrombus adhered to the vessel wall if the abrasive surface is modified to be present only on the leading edge and inner surface of the coil, while the outer surface remains smooth. to prevent injury to the vein wall.

Acute deep vein thrombosis (DVT) is a potentially life-threatening condition if embolization of the lungs occurs, known as pulmonary embolism (PE). Significantly large DVTs remaining in the peripheral veins can also lead to serious complications from chronic venous hypertension in the lower extremities. Anticoagulants are the cornerstone of treatment, helping to dissolve clots and prevent embolization. Over the past 10 years, new ways to treat patients in the acute setting by removing the clot using mechanical, chemical lysis, or ultrasound have emerged and have been shown to improve outcomes in certain patient populations. Removing a clot that has adhered to the vein wall is technically difficult, and failure can lead to worse results. Some new technologies that use complex mechanical systems, aspiration or ultrasound are not reimbursed due to their high cost. The Fogarty balloon catheter is an inexpensive alternative for clot removal, but it is not effective for adherent clots.

In the arterial system, there is a similar need to remove organized thrombus causing acute limb ischemia. In the neurovascular system, stent retrieval systems are used to retrieve blood clots and prevent stroke. In both cases, the more organized, attached thrombus presents a technical challenge. Therefore, there is a need to develop improved solutions for removing adherent clot or thrombus from vessel walls. According to one embodiment, a method is provided for using a helical coil with abrasive inner and anterior surfaces to dislodge a thrombus from a vessel wall without causing endothelial injury. Figure 73 shows how such a device can remove a thrombus while leaving the endothelial surface intact and less likely to re-thrombosis. The device is deployed distal to the thrombotic occlusion and withdrawn proximally toward the access site. Once the clot has been dislodged, a Fogarty balloon catheter, grasping basket, or suction catheter can be used to remove the clot from the circulation. This will restore blood flow and prevent the consequences of vascular occlusion.

Occlusion inside the stent

Percutaneous vascular stenting is typically performed to restore blood flow in a partially stenotic or occluded arterial or venous circulation. In-stent thrombosis is a relatively rare but potentially life-threatening complication occurring in approximately 1% of cardiac stenting procedures. Stents placed in diseased arteries may have scaffolds covering calcified or atheromatous plaques. Elevated stent frames in these situations can lead to disruption of neointimal coverage, especially in drug-eluting stents [20]. This typically manifests as late or very late onset stent thrombosis within 1 year of implantation. After such procedures, it is necessary to reduce the incidence of stent thrombosis. According to one aspect of the present invention, a helical helix is provided with an outer abrasive surface that covers a portion of the circumference of the helix. This allows selective targeting of an area of the arterial surface that is likely to remain exposed after placement. FIG. 74 shows a method of using a partial abrasive coil to selectively pre-target a section of an artery prior to stent placement. This increases the likelihood of neointimal overlap of the stent frame and reduces the risk of late in-stent restenosis. Imaging technologies such as intravascular ultrasound (IVUS) can be used to orient the device and allow the operator to selectively target the desired region of the vessel wall.

Arterial occlusion

Selective occlusion of arteries and, in general, arterial blood supply to certain tissues is an effective way to treat many pathological conditions. Tumor embolization is a technique in which arteries supplying benign or malignant tumors are occluded using a variety of techniques through a percutaneous approach, including synthetic or bioabsorbable beads, metal spheres, glue, or metal coils. Common complications with these agents include migration into non-target vessels, excessive occlusion causing necrosis of normal tissue, pain, and infection due to the combination of a foreign body with necrotic tissue [21]. Accordingly, there is a need for less invasive, non-implantable treatments with lower complication rates for embolization of arteries supplying benign or malignant tumors.

FIGS. 52A and 52B show a tumor 240 and the arterial supply to the tumor containing small arteries 241. The device of the present invention can be used to occlude one of the small arteries and limit the blood supply to the tumor. 52B shows the vein denudation head 242 of the device of the present invention shown deployed in a small artery where the helical coil circumferentially enters the lumen of the artery. Referring to FIG. 52A, the device is advanced along the artery feeding the tumor and deployed at point 243 and then retracted proximally. Retraction of the helical coil along the artery in combination with circumferential contact between the rough surface of the helical coil and the lumen of the artery leads to denudation of the lumen of the artery with the removal of the epithelial layer of cells and subsequent formation of a thrombus at point 243, leading to occlusion of the artery.

Uterine fibroids

Uterine fibroids are benign growths that can cause severe pelvic pain and dysmenorrhea. They can be treated with hysterectomy or minimally invasive embolization of the uterine arteries supplying the fibroids. The most commonly used embolic agents for uterine artery embolization (UAE) are polyvinyl alcohol (PVA), tris-acrylic gelatin microspheres, and polysen-F hydrogel microspheres. Complications include migration of embolic material into non-target tissues, excessive necrosis causing pain and infection. Accordingly, there is a need for less invasive, non-implantable treatments with lower complication rates for the treatment of uterine fibroids. According to one embodiment, a method is provided for using a helical coil with an abrasive outer surface to partially or completely occlude the uterine artery or distal branches supplying uterine fibroids. Reducing or eliminating blood flow reduces the size and relieves symptoms caused by fibroids. Inducing sufficient vessel stenosis using this technique by inducing intimal hyperplasia may reduce the risk of necrotic complications while maintaining the effect of reducing fibroid size. This method can also be used to treat the following conditions, which include, but are not limited to: arteriovenous malformations (AVM) in the pulmonary, cerebral or hepatic circulation, malignant tumors, benign prostatic hypertrophy (resulting from prostatic artery occlusion).

Patent foramen ovale

Patent foramen ovale (PFO) is a common cardiac wall abnormality found in approximately 30% of the adult population. Although this is generally a benign finding, in some cases the PFO may open, allowing a paradoxical embolus to travel from the venous to arterial circulation, which can cause stroke and systemic embolization. Treatment of patients with a history of cryptogenic stroke involves percutaneous septal closure using occluders. These devices are permanent implants placed across the defect. The anatomy of the PFO involves the overlap of the primordial and secundum atrial septa, which form a flap valve that can open when pressure in the right atrium exceeds pressure in the left atrium, such as when coughing or sneezing. These devices are expensive and can cause complications, including thrombosis and stroke. There is a need for less invasive treatment with less risk of complications. According to one embodiment, a method is provided for using an abrasive device in the form of a spiral or hoop to denudate the contacting surface of involved atrial septal flaps. This results in an inflammatory response that causes adhesion to form between the surfaces of the flap, resulting in eventual closure of the PFO and elimination of the risk of stroke. A similar technique can be used in the heart to create scar tissue and thickening to block nerve conduction at points of aberrant conduction that cause arrhythmia.

Patent ductus arteriosus

The ductus arteriosus (DA) is the fetal vascular connection between the main pulmonary artery and the aorta that drains blood away from the pulmonary bed.

After birth, the DA undergoes active narrowing and eventual obliteration. Patent ductus arteriosus (PDA) occurs when the DA fails to close completely in the postnatal period. Histologically, the tissue of the duct is different from the tissue of the adjacent aorta and pulmonary artery. The intima of the duct is thicker, and its middle layer contains more smooth muscle fibers arranged in a characteristic spiral pattern. DA can take many forms. Small PDAs are typically characterized by a diameter of <3 mm. The optimal way to treat infants with PDA requiring closure remains a matter of controversy and debate. Current percutaneous treatment options include coils and occlusion devices. Limitations of this treatment include high cost and the risk of coil migration causing embolic complications. Occlusion devices can lead to serious complications such as coarctation of the aorta as the child grows if they are not properly sized [22]. Accordingly, there is a need for less invasive, effective transdermal treatments for PDA. In one embodiment, a helical coil with an external abrasive surface is used to denudate the DA, causing thrombosis and fibrous occlusion over time. This would alleviate shunt-related symptoms and reduce the risk of endocarditis by closure of the DA. This technique can also be used to treat small diameter atrial septal defects in a similar manner. Aortic aneurysms

Abdominal aortic aneurysms (AAAs) are abnormal dilations of the aorta that can be complicated by rupture, causing significant morbidity and mortality. Treatment of large aneurysms is aimed at reducing the risk of rupture. Treatment options include open surgery with graft placement or endovascular aneurysm repair using large covered stent grafts (EVAR). EVAR is a less invasive procedure with a significantly faster recovery time and less risk of kidney damage. However, long-term results of EVAR are limited by endoleaks in 20% of patients, requiring radiological monitoring, repeat surgery, or additional procedures [23]. Endoleaks can be classified from type I to type V. Type I endoleaks occur at the proximal or distal sites of the graft attachment. Blood enters through the gaps between the vessel wall and the graft and fills the sac, leading to the risk of rupture. Type II endoleaks occur when there is retrograde flow into the aneurysmal sac through lateral branches from the lumbar or mesenteric vessels, also putting the patient at risk of rupture. Type I and II endoleaks account for the majority of the morbidity associated with postoperative EVAR. Current treatment options for type I endoleaks include miniature screws and the placement of additional stent grafts. Type II endoleaks can be treated with an embolization coil in the lumbar or mesenteric vessels supplying the sac. All of these methods are invasive, expensive and carry complications such as rupture of the aortic wall and infection. Accordingly, there is a need for methods to reduce the risk of Type I and Type II endoleaks. In one embodiment, a method is provided for preparing areas of the aorta adjacent to graft attachment sites to reduce the risk of Type I endoleak. This is accomplished by using a helical coil to denudate the endothelial lining at these specific locations, the locations of which can be easily determined based on preoperative imaging planning. By performing this procedure, the arterial wall is pretreated to promote neointimal proliferation at the graft site and reduce the risk of blood leakage and Type I endoleak. This will reduce the risk of additional procedures that may complicate the postoperative period. A similar technique can be used to treat Type I endoleaks as they occur by inserting an expandable elastic abrasive device into the gap where the endoleak occurs to cause thrombotic occlusion with fibrotic transformation over time. Another method of treating type II endoleaks has been proposed by using an expanding elastic abrasive element to denudate the feeding lumbar or mesenteric arteries, causing occlusion and preventing the risk of sac rupture. Because blood flow in these arteries is retrograde from the anastomotic connections, they are more likely to behave like veins and succumb to thrombotic occlusion when coils are permanently implanted. A similar technique 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 complications and, in some cases, reoperation.

Interventional treatment of diabetes mellitus

Duodenal mucosal resurfacing (DMR) is a new technique that has been shown in early clinical studies to improve blood glucose control in patients with diabetes mellitus [24]. The duodenum is an important conduit for glucose uptake and signaling to endocrine organs. It is believed that the duodenal mucosa becomes hyperplastic in response to a chronic high-sugar diet, creating an insulin-resistant signal that impairs glucose control. By removing this hyperplastic mucosa, the new mucosal surface can be regenerated without harmful signals.

The anatomy of the duodenum shares some important characteristics with the venous system. It has a tortuous, curved path and is very pliable and extensible, and contraction of the muscle wall can cause constriction. The goal of treatment is to safely ablate only the superficial layer of the mucosa, without affecting the deeper muscular layer below. This is performed at a length of the duodenum of approximately 10 cm.

Current methods under development involve the placement of an expandable balloon capable of transferring hydrothermal energy from the fluid within the balloon to the duodenal wall and thereby causing ablation or damage to mucosal cells [22]. This technique requires an experienced endoscopist to create a thermal barrier by lifting the mucosa away from the submucosa. Currently, this is achieved by using suction channels around the circumference of the balloon to hold the superficial layer of mucosa while a needle is inserted under the mucosa to inject saline. If performed incorrectly, there is a risk of perforation of the duodenal wall and damage to the deeper muscle layer. Accordingly, there is a need for a less invasive, easier to perform, cheaper and faster treatment that can selectively remove the superficial layers of the duodenum to a depth of no more than 0.6 mm. According to one embodiment of the present invention, a radially expanding, elastically deformable abrasive device is delivered through a channel in a standard endoscope, as shown in FIG. 75. The abrasive element is deployed to contact the wall of the duodenum in a distal direction near the junction with the jejunum. The abrasive element contains a surface roughness with a maximum peak-to-valley distance of 0.6 mm. The device is removed proximal to the stomach. During withdrawal, it causes denudation or damage around the circumference of the mucous membrane. This allows regeneration and improved glucose control. A similar method can be used in other parts of the gastrointestinal tract to treat pathologies caused by the absorption of lipids, iron, vitamins and minerals, including manganese.

Bacterial overgrowth in the small intestine

Small intestinal bacterial overgrowth (SIBO) occurs when the small intestine becomes colonized with excessive numbers of microbes that are normally found in the colon. Invasive bacterial strains damage the intestinal surface by producing enterotoxins and directly adhering to the wall. Fermentation of unabsorbed carbohydrates causes bloating, bloating and flatulence. Inflammation of the ileum can also cause diarrhea and malabsorption of nutrients. The small intestine (jejunum and duodenum) typically contains significantly lower concentrations of bacteria and other microorganisms compared to the large intestine. The boundary between these parts of the gastrointestinal tract is controlled by the ileocecal valve. When this valve becomes incompetent, it can cause reflux of colon contents into the small intestine. This promotes overgrowth of bacteria that feed on the nutrient-rich contents of the small intestine [25]. Currently, the primary treatment is antibiotic treatment to stop bacterial overgrowth in the small intestine. However, approximately 40 percent of patients with small intestinal bacterial overgrowth (SIBO) experience persistent symptoms after initial antibiotic treatment. Pathological reflux through the ileocecal valve has been demonstrated to be a causative factor in SIBO [25]. Accordingly, there is a need for more effective treatments for SIBO. According to one embodiment of the present invention, a radially expanding abrasive device is used to disrupt the mucous membranes of the ileocecal valve and ileum. This causes an inflammatory response followed by hyperplasia, which can reduce the diameter of the ileocecal valve, reducing the likelihood of reflux of fluid from the colon. A secondary effect may be to remove areas of the ileum colonized by adherent bacteria to allow regeneration of normal or uncolonized mucosa. This method can be used in combination with antibacterial therapy to enhance the effect and reduce the frequency of relapses. A similar method can be used to narrow the gastroesophageal junction, which can cause gastric reflux if the sphincter is weak.

Barrett's esophagus

Barrett's esophagus (BE) is a precancerous condition of esophageal carcinoma in which cellular changes in the lower esophagus occur due to chronic damage and inflammation due to gastroesophageal reflux disease (GORD). It is estimated to be present in 10% of patients with GORD. Early intervention can prevent cancer from developing. Current early intervention options include thermal and radiofrequency ablation of the affected superficial layers to restore normal tissue [26]. Radiofrequency ablation is a currently commonly used technique that involves endoscopic insertion of a radiofrequency probe. The main disadvantage of this method is the high cost of the radio frequency device. Accordingly, there is a need for simpler and more effective treatments for this common condition. In one embodiment, a method is provided for endoscopically deploying a radially expanding abrasive element to mechanically ablate abnormal cells in the lower esophagus, thereby reducing the risk of cancer. Given that histological classification and definitive diagnosis of Barrett's esophagus is challenging for pathologists, another advantage of this technique is that it allows the collection of cells from the exposed glans, which can be analyzed after the procedure. This is in contrast to thermal methods, which completely destroy cells. This cell collection function can also be used to diagnose and treat precancerous or malignant lesions in other parts of the gastrointestinal tract, such as the colon, pulmonary bronchi and bronchioles, uterus, cervix, urinary tract and bladder.

Treatment of perianal fistulas

Perianal fistulas are abnormal connections between the rectum and the skin surrounding the anal canal. They are present in patients with inflammatory bowel disease and cause significant morbidity due to infection, pain, and bleeding. They are difficult to treat with current techniques that involve invasive surgical resection or a suture to gradually remove the canal over a long course of treatment. These treatment options have a high relapse rate [27]. Accordingly, there is a need to develop less invasive and more effective treatment for perianal fistula. According to one embodiment, a radially expanding abrasive device is provided for deployment and extraction in the fistula tract. This caused denudation of the tract lined with endothelial cells. The subsequent inflammatory response causes scarring and blocks the passage of fecal material into the tract and prevents healing.

Subsequent closure of the tract by the fibrotic inflammatory response prevents symptoms. A similar method can be used to seal or close areas of the lung in chronic obstructive pulmonary disease. When inhaled air enters these parts of the abnormal lungs, oxygen exchange does not occur, resulting in low oxygen levels in the blood. In these cases, it is necessary to block or close the bronchioles or alveoli to drain air to healthy lung tissue.

Sterilization

Female sterilization is usually performed by tubal ligation when the patient requires permanent contraception. Current methods range from open surgical ligation, salpingectomy, and minimally invasive clamp placement. Complications of these procedures include pain, bleeding, and infection. A less invasive, reliable method is required to avoid surgical resection or permanent implantation. In one embodiment, a radially expanding coil device is inserted, deployed, and removed into the fallopian tube. This destroys the endothelial and subendothelial layers, initiating an inflammatory response that eventually causes fibrous occlusion of the fallopian tube. This method can also be applied to male sterilization procedures for the lumen of the vas deferens.

FIGS. 52-55 illustrate the use of the device of the present invention for the occlusion of various vessels in the treatment of a disease in a subject.

FIGS. 53A and 53B illustrate the use of the device of the present invention for occluding the portal vein system. This intervention can be used to treat liver cancer by occluding parts of the portal venous system that carry nutrients from the intestine 254 to the liver. In the figures, the vessel denudation head 252 is shown in the portal vein 251 in an expanded configuration. Retraction of the helical coil along the vein, combined with circumferential contact between the rough surface of the helical coil and the lumen of the vein, leads to denudation of the portal vein lumen with removal of the epithelial cell layer and subsequent thrombus formation, leading to occlusion of the vein.

FIG. 54 shows the use of the device of the present invention for the treatment of an arteriovenous malformation, which is an abnormal tangle of blood vessels 261 connecting venous 262 and arterial 263 blood vessels. According to the illustrated embodiment, the device of the present invention is advanced along the artery to the defect, and the helical coil 264 is introduced into circular contact with the vessel 261 and retracted to denudate the lumen of the vessel, causing thrombus formation and occlusion of the vessel 261, thereby closing the shunt between the arterial and venous blood systems .

FIG. 55 illustrates the use of the device of the present invention for the treatment of spermatic vein insufficiency (or varicocele), which is a condition similar to varicose veins that occurs in the veins of the scrotum 272 and which can cause infertility, pain and discomfort for the patient. According to the illustrated embodiment, the device of the present invention is advanced along the left internal spermatic vein 270, and the helical coil 271 is brought into circumferential contact with the vein 270 and displaced back to denudate the lumen of the vessel, causing thrombus formation and occlusion of the vessel 270, thereby occluding the vein and curing the condition .

56A-56C show the use of the device of the present invention and, in particular, the ability of the device to self-adjust its diameter to adapt to vessels of variable diameter. The helix is formed from nitinol and, when relaxed, forms a helical helix having a diameter greater than the exposed vessel. As the coil is deployed into the vessel (typically deployed from a delivery catheter), the catheter expands to conform to the circumference of the vessel, exerting an outward radial force on the circumference of the vessel through at least one turn of the coil. 56A shows an deployed helical coil 280 in a vessel 281 in circular contact with the vessel lumen approaching the constricted portion 282 of the vessel, with the diameter of the proximal portion of the coil self-adjusting in accordance with the smaller diameter of the vessel. FIG. 56B shows a helical coil 280 extending through the constricted portion 282 and maintaining circumferential contact with the lumen of the vessel immediately proximal to the constricted portion. 53C shows a helical coil moving proximally to the constricted area and self-adjusting to maintain circumferential contact with the lumen of the vessel as it dilates.

FIGS. 57A-57C illustrate the use of the device of the present invention, specifically how the coil forming part of the device of the present invention can move through valves in veins as it is pulled through a portion of the vein: (A) deployed coil 290 attached to the control lever 31 and in circular contact with the lumen of the vein 291 distal to the valve 292; (B) a helical coil 290 that retracts proximally, although the coil diameter valve 292 is self-adjusting to prevent the coil from snagging on the valve leaflets; and (C) a helical coil that moves proximal to the constricted region and self-adjusts to maintain circumferential contact with the lumen of the vessel proximal to the valve.

FIGS. 58A-58B show an application of the device of the present invention, in particular how the helical coil forming part of the device of the present invention can self-regulate to move along a portion of the vasculature 300 that gradually tapers as the diameter of the self-adjusting helical coil 301 increases to maintain circular contact with the lumen of the vessel: (A) an unfolded helical spiral 301 in circular contact with a wide portion 302 of the vessel; (B) An unfolded helical coil 301 is in circumferential contact with a narrower portion 303 of the vessel.

FIGS. 59A-59C show the use of the device of the present invention, in particular how the helical coil forming part of the device of the present invention can independently adapt to the changing diameter of the vessel and move along a tortuous vessel: (A) unrolled helical coil 310 in circular contact with the lumen of the vessel in the narrowed area 311 of the vessel; (B) the helical coil 310 passes through a sharp turn 312 in the vessel while maintaining circumferential contact with the lumen of the vessel; and (C) the helical helix 310 passes through a second sharp turn 313 in the larger diameter vessel while maintaining circumferential contact with the lumen of the vessel. The figures show how the helical helix adapts to the changing diameter of the vessel and maintains circular contact with the vessel lumen even when it passes through tortuous turns.

FIGS. 60A and 60B show the use of the device of the present invention, in particular how the helical coil forming part of the device of the present invention can independently adjust the diameter of the coil to maintain circumferential contact with the lumen of the vessel when the vessel narrows due to vasospasm: (A ) an unfolded helical spiral in circular contact along length 1 inside a wide vessel with diameter D before vasospasm of the vessel; section A-A shows the axial view of the spiral inside the vessel under constriction pressure P, which is translated as the hoop force (HF) inside the spiral. This HF causes the helix to elongate, facilitated by its open-ended design (B): an unrolled helical helix in circular contact at an increased length L within a constricted vessel of diameter d during vessel vasospasm.

FIGS. 62A and 62B illustrate the use of the device of the present invention for partial occlusion of a body cavity and, according to the illustrated embodiment, for the specific treatment of vasculature having abnormally high blood volumes or high blood flow velocities to partially occlude the vessel to normalize the volume or blood flow. (A) shows the pulmonary artery 330 before exposure to the device of the present invention, including a helical coil 331, a control lever 31, and a catheter element 2 deployed into the artery and extended in the direction of the arrow indicated by X; (B) shows pulmonary artery 330 following treatment with a device of the present invention with intimal hyperplasia 333 partially occluding the artery to provide reduced blood volume and flow through the artery. Vessel wall assessment

Understanding the biophysical properties of vessel walls in the arterial and venous systems is important both for predicting disease progression and for assessing response to treatment.

Abnormalities of the vascular endothelium are currently considered as early warning signs of vascular diseases [28]. One such marker is how well a vessel can contract or spasm in response to mechanical or chemical stimuli. Chronic high blood pressure and/or chronically uncontrolled blood sugar causes damage to the endothelial layer and can be detected at a much earlier stage than atherosclerosis, arterial stenosis or occlusion. Acetylcholine iontophoresis is a method of testing the endothelial response in combination with measuring blood flow at a site in the vessel. These methods have experimentally shown that endothelial function is suppressed by consumption of sugar-sweetened beverages and chronic high blood pressure conditions [29]. During vascular surgery, there is currently no way to assess endothelial cell function in or adjacent to arterial sclerotic lesions. Accordingly, there is a need to gather more information about endothelial function to guide treatment decisions and prognosis. For example, during intravascular stent placement, physicians currently have no way of knowing how the vessel wall responds to dilation during angioplasty. This can lead to complications including vessel rupture, bleeding and thrombotic occlusion [30]. Currently, the air pressure in the inflated balloon is measured and inflated to standard levels based on experience and angiographic data after inflation. However, due to differences in vessel wall characteristics and differences between patients, the occurrence of complications such as vessel wall rupture remains difficult to predict. In one embodiment, a radially expandable element that contacts the vessel wall at discrete, remote points is used to measure the response of the endothelium to chemical or mechanical stimuli. Mechanical stimuli may be caused by the radial force of the device itself, which may be static or varied by a control lever. Chemical irritants may be caused by the application of pharmacological agents to the surface of the device. In one embodiment, piezoelectric sensors are integrated into the radial expansion element to measure pressure and flow effects on the coil during intraluminal procedures. An expanding element within the lumen of the vein producing an outward radial force will produce a hoop force (HF) within the vessel wall. This HF stretch will cause an opposing hoop compressive force within the lumen device. Thus, measurement of intrinsic compression within the device will act as a surrogate marker for characterizing the response of the vessel wall to tension. This data can be recorded and stored in the central control unit. This data can be used to improve productivity in the future, including the automation of procedures in the vascular system. These data can also be analyzed manually or using machine learning techniques to determine prognosis and validate diagnostic markers for vascular diseases.

Equivalents

The above description describes in detail the currently preferred embodiments of the present invention. It is expected that upon review of these disclosures, numerous modifications and variations will be practiced by those skilled in the art. It is intended that these modifications and variations be covered by the appended claims of the present invention.

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Claims (57)

1. A device (1, 30, 40, 50, 60) for vein denudation, comprising a vein denudation head (3) operatively attached to an elongated catheter element (2) and configured for transluminal delivery and deployment in the vein, the head for denudation vein contains a helical coil (4), which is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter element, and a coiled, unfolded configuration that is in circumferential contact with the internal lumen of the vein in the deployed state, and the helical coil has an outer surface of contact with the lumen of a body cavity, which is characterized by roughness so as to cut or irreversibly damage the internal lining of the lumen of the body cavity for circular denudation of the internal cavity, when the helix moves in an axial direction along the lumen of the body cavity in a twisted unfolded configuration, and in which the helical helix in the unfolded configuration is configured to self-adjustment to the changing diameter of the vein as it moves along the vein, in which the outer surface of the coil contains indentations that provide surface roughness. 2. The device according to claim 1, in which the helical spiral is characterized by a smooth inner surface. 3. The device according to claim 1 or 2, in which the head for vein denudation is attached to the catheter element without the possibility of detachment. 4. The device of claim 1 or 2, wherein the helical coil is configured to reflexively self-adjust its diameter in response to variable vein diameters and variable axial forces during axial movement along the affected area while maintaining an outward radial force on the vein. 5. The device according to claim 1 or 2, in which the spiral contains a shape memory material and is configured to adopt a twisted configuration when deployed. 6. The device of claim 1 or 2, wherein the device includes an elongated control lever for a vein denudation head located within the catheter element. 7. The device according to claim 1 or 2, containing one helical spiral. 8. The device according to claim 1 or 2, in which the helical spiral is characterized by the presence of 1-3 turns in an expanded configuration. 9. The device according to claim 1 or 2, in which the diameter of the helical spiral varies along its length. 10. The device according to claim 1 or 2, in which the diameter of the helical spiral increases towards one end. 11. The device according to claim 1 or 2, in which the diameter of the helical spiral increases towards the proximal end. 12. The device according to claim 9, in which the diameter of the helical spiral increases to the midpoint along the spiral and then decreases. 13. The device according to claim 1 or 2, in which the distal end of the helical helix ends at a point located along the longitudinal axis of the helical helix or near it. 14. The device according to claim 9, in which the helical spiral contains a proximal section of the first diameter, an intermediate section of reduced diameter relative to the proximal section, and a distal section of increased diameter relative to the intermediate section. 15. The device according to claim 1 or 2, in which the helical helix contains a proximal and distal section of the helical helix and an intermediate connecting (transition) section, which is not helical and can be straight or curved. 16. The device according to claim 1 or 2, in which one of the proximal or distal sections of the helical spiral is a right-handed spiral, and the other of the proximal or distal sections of the helical spiral is a left-handed spiral. 17. The device according to claim 1 or 2, in which the proximal portion of the helical helix is a right-handed helix, and the distal portion of the helical helix is a left-handed helix. 18. The device according to claim 16, in which the distal portion of the helical spiral is a right-handed helical spiral, and the proximal portion of the helical spiral is a left-handed helical spiral. 19. The device according to claim 1 or 2, in which the helical spiral contains more than one spiral element. 20. The device according to claim 19, in which the elements of the helical spiral can be arranged in the form of a double, triple or quadruple spiral. 21. The device according to claim 1 or 2, in which the helical helix is configured to be characterized by a pitch of 0.5 to 1.5 times the diameter of the helical helix in a twisted configuration when deployed. 22. The device of claim 1 or 19, wherein the helical helix or helical helix element is configured to have a pitch approximately equal to the diameter in a twisted configuration when deployed. 23. The device according to claim 1 or 2, containing a proximal helical spiral spaced axially from the distal helical spiral, and a control lever for the helical spirals. 24. The apparatus of claim 23, wherein the control arm is bifurcated at the distal end to provide two distal control arms, each of which is connected to one of the helical coils. 25. The device of claim 24, wherein the distal helical control lever extends axially through all or part of the proximal helical coil. 26. The device of claim 23, wherein the proximal helical coil has a maximum diameter greater than the maximum diameter of the distal helical coil. 27. The device according to claim 23, wherein the proximal helical coil has a maximum diameter that is less than the maximum diameter of the distal helical coil. 28. The device according to claim 23, in which the pitch of the proximal and distal elements of the spiral is different. 29. The device according to claim 28, in which a narrower helical spiral is characterized by a large pitch. 30. The device according to claim 23, in which the distal and/or proximal helical spiral is conical. 31. The device according to claim 23, in which the distal and proximal helical spirals are conical. 32. The device according to claim 23, in which the diameter of the helical spiral increases in the proximal direction. 33. The device according to claim 1 or 2, in which the spiral is characterized by a profile selected from round, oval, curved, convex, concave, T-shaped or inverted T-shaped. 34. The device of claim 1 or 2, wherein the helix is characterized by having a flat inner surface and an outer surface that is not flat, curved, concave, convex or inverted T-shaped. 35. The device according to claim 1 or 2, in which the rough surface of the helical helix is formed by treating the surface of the helix to impart surface roughness. 36. A device according to claim 1 or 2, in which the surface roughness is achieved through mechanical, electrical or chemical abrasion. 37. The device according to claim 1 or 2, in which the recesses are configured to form teeth on the surface. 38. The device according to claim 1 or 2, in which the recesses are transverse recesses. 39. The device according to claim 38, in which the transverse recesses extend completely through the outer surface of the spiral. 40. The device according to claim 1 or 2, in which the helical spiral is characterized by a concave profile, and transverse recesses are located on each side of the outer surface. 41. The device according to claim 37, in which the recesses are longitudinal and extend completely or at least partially along the length of the helical spiral. 42. The device according to claim 1, in which the helical spiral is characterized by an inverted T-shaped profile, in which the teeth form an inverted T-shaped leg. 43. The device according to claim 37, in which the teeth are characterized by a profile selected from a triangular, polygonal, diamond-shaped or other profile configured to scrape the epithelial layer of the lumen of the body cavity. 44. The device according to claim 37, in which the teeth are characterized by a diamond shape formed by alternating inclined recesses. 45. The device according to claim 14, in which the distal end of the helical spiral contains an atraumatic head. 46. The device of claim 1 or 2, wherein the device comprises a handle operably connected to the proximal end of the catheter element and configured to control the deployment and retraction of the helical coil by axially adjusting the catheter element relative to the helical coil. 47. The device according to claim 1 or 2, in which the rough outer surface of contact with the lumen of the body cavity of the helical spiral includes a macro-abrasive surface and a micro-abrasive surface. 48. The device according to claim 1 or 2, in which the rough outer surface of contact with the lumen of the body cavity of the helical spiral includes areas that are characterized by roughness and intermediate areas that are not characterized by roughness. 49. The device according to claim 1 or 2, in which the inner surface of the helical spiral is characterized by roughness. 50. A device (1, 30, 40, 50, 60) for denudation of a vein, comprising a head (3) for denudation of a vein, operatively attached to an elongated catheter element (2) and configured for transluminal delivery and deployment in the vein, the head for The vein denudation device contains a helical coil (4), which is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter element, and a coiled deployed configuration having a diameter larger than the vein to be denuded, which is in circumferential contact with the internal lumen of the vein in the deployed state. , wherein the helical helix has an outer surface of contact with the lumen of the body cavity, which is characterized by roughness so as to cut or irreversibly damage the internal lining of the lumen of the body cavity for circular denudation of the internal cavity, when the helix moves axially along the lumen of the body cavity in a twisted unfolded configuration, and in wherein the helical coil in the deployed configuration is configured to self-adjust to the changing diameter of the vein as it moves along the vein, wherein the helical coil includes lateral teeth. 51. A device (1, 30, 40, 50, 60) for vein denudation, comprising a head (3) for vein denudation, operatively attached to an elongated catheter element (2) and configured for transluminal delivery and deployment in the vein, wherein the head for denudation vein contains a helical coil (4), which is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter element, and a coiled, deployed configuration that is in circumferential contact with the internal lumen of the vein in the deployed state, and the helical coil has an outer surface of contact with the lumen of a body cavity, which is characterized by roughness so as to cut off or irreversibly damage the internal lining of the lumen of the body cavity for circular denudation of the internal cavity, when the helix moves in an axial direction along the lumen of the body cavity in a twisted unfolded configuration, and in which the helical helix in the unfolded configuration is configured to self-adjustment to the changing diameter of the vein as it moves along the vein, in which the spiral is characterized by a flat inner and outer surface and lateral teeth. 52. A device (1, 30, 40, 50, 60) for denudation of a vein, comprising a head (3) for denudation of a vein, operatively attached to an elongated catheter element (2) and configured for transluminal delivery and deployment in the vein, the head for denudation vein contains a helical coil (4), which is self-adjustable from an uncoiled delivery configuration suitable for transluminal delivery within the catheter element, and a coiled, unfolded configuration that is in circumferential contact with the internal lumen of the vein in the deployed state, and the helical coil has an outer surface of contact with the lumen of a body cavity, which is characterized by roughness so as to cut or irreversibly damage the internal lining of the lumen of the body cavity for circular denudation of the internal cavity, when the helix moves in an axial direction along the lumen of the body cavity in a twisted unfolded configuration, and in which the helical helix in the unfolded configuration is configured to self-adjusting to the changing diameter of the vein as it moves along the vein, wherein the helix or each element of the helix contains a guide wire and the abrasive surface is formed by a second wire wound in a spiral around the guide wire to form a second helix. 53. The device according to claim 52, in which the second wire is characterized by a polygonal cross-section. 54. The device according to any one of paragraphs. 1 or 50-52, in which the device is adjustable between: delivery configuration, in which the helical coil is laid inside the catheter element in an untwisted configuration, a vein denudation configuration in which, when used, the helical coil is deployed in the vein to be treated in a first axial position and is adjacent to the circumference of the vein; and a retrieval configuration in which the coil is positioned within the catheter element.