Patent Description:
A device according to the present invention is applicable in the context of a sclerosing treatment.

The present invention further relates to a method for treating a blood vessel.

The sclerosing treatment of varices typically includes the use of pharmacological agents with the aim of bringing an effective quantity of drug in contact with the inner wall of the blood vessel to be treated.

Patent <CIT> of the same Applicant discloses an embodiment of a catheter provided with expandable balloons which expand to isolate from the blood circulation an annular chamber inside the blood vessel in which to inject the sclerosing drug in a controlled manner. The presence of such radially expandable balloons, which isolate an annular chamber between the catheter shaft and the vessel wall, avoids having to inject the drug in the entire section of the vessel stretch to be treated, allowing the drug to be injected only in one annular area of the blood vessel in contact with the wall. The device disclosed therein allows performing empty vein sclerotherapy, without blood, therefore without plasma proteins which can neutralize the pharmacological activity of the sclerosing drug; this allows a fine control of the concentration of the drug injected on the inner wall of the vein; it allows positioning the drug comprehensively on the entire inner vein surface and it also allows managing a time of drug contact with the vein wall. The drug-to-part contact time is critical to allow the drug to penetrate the inner wall thickness of the vein and generate an inflammatory vein repair response.

Document <CIT> shows a catheter solution for occlusion of a blood vessel section comprising expandable bellows occlusion elements slidably fitted on the catheter shaft and adapted to radially expand when subjected to a predefined longitudinal compression movement directed along the catheter shaft.

Document <CIT> discloses an expandable balloon having a double layer wall forming a gap, the outer layer of the double wall of the balloon being porous to allow the drug to be sprinkled into the gap directly on the wall.

The solutions mentioned above disclose an essentially pharmacological approach. The treatment of the inner wall of the vessel is performed by the drug, sprinkled by means of the vascular catheter, which reaches the endothelium of the inner wall of the vessel, within a certain time of contact of the drug with the wall, at a certain concentration of the drug near the inner wall of the vessel.

It has also been proposed to use a vascular catheter having a rotating rod to direct the drug towards the blood vessel wall, as shown for example by document <CIT>. The free end of the rotating rod is also capable of damaging the inner wall of the vessel, creating lesions. According to such a disclosure, first mechanical damage is carried out on the healthy wall and then chemical damage on the previously mechanically damaged part. The mechanical damage has the purpose of creating micro-fissures on the vascular wall useful to let the drug enter the thickness of the wall so as to be able to perform a deep treatment, or of the muscular layer which is the layer below the endothelium (typically the layer of endothelium has a thickness of the order of <NUM> micrometers). Therefore, according to these teachings, it is the pharmacological treatment of the muscular layer (the layer below the endothelium) which determines the success of the treatment, as also supported in the study published in the reference: <NPL>.

Document <CIT> discloses a vascular catheter solution capable of dispensing sclerosing drug after an ablation operation of material from the blood vessel wall performed by the rotating head of the distal end of the catheter shaft, so that by the effect of the lesions created on the endothelium of the inner wall of the vessel, the sclerosing drug is favorably absorbed deeper in the wall. However, this solution is by no means without drawbacks or limitations: first of all it is not possible to know if the mechanical damage is homogeneous over the entire inner surface of the vein, and in particular in the case of large-caliber veins, where the angled tip of the catheter which is a few millimeters in length, by rotating, expresses a circumference with a radius of less than about <NUM> millimeters, therefore not able to homogeneously damage the inner wall of large-caliber veins. Furthermore, the debris scraped from the vessel wall is necessarily released into the bloodstream and being mainly dead tissue or substances of endothelial origin such as endothelin, a powerful vasoconstrictor, they are potentially toxic as they can easily cause the onset of pro-coagulative reactions at a distance. In fact, it has been shown that a mechanical, chemical or biochemical insult of the endothelium generates the release of endothelin with an increase in this molecule circulating in the bloodstream. Endothelin is capable of generating a powerful spasm, or closing the arterioles with consequent reduction of the blood supply and therefore of oxygen to the affected organ. Circulating in the bloodstream, the endothelin reaches small vessels of various organs such as: heart, kidneys and brain and at such a level the vasospasm, or closure of the arterioles which carry blood to the parenchyma of such organs, can cause significant symptoms such as angina, heart attacks, cerebral or cerebellar ischemia, etc. A further vascular device of the state of the art is disclosed in <CIT>.

The need is therefore strongly felt to provide a solution of improved efficacy in the context of the sclerosing treatment of a blood vessel, be it of small, medium or large caliber.

The need is also felt to prevent any potential undesirable effects related to the release of dead circulating cells, catabolites, etc. in the bloodstream.

An object of the present invention is to obviate the drawbacks of the known art mentioned up to now and to provide a solution to the need to devise an improvement in the sclerosing treatment of a blood vessel.

This and other objects are achieved by a device according to claim <NUM>.

Some advantageous embodiments are the subject of the dependent claims.

It is clear that the appended claims are an integral part of the present description.

According to an aspect of the invention, a vascular device for treating a blood vessel, for example sclerotherapy, comprises an intraluminal element, for example a catheter shaft, provided with an abrasion element intended to come into contact with the inner wall of the blood vessel to remove material from the inner wall of the blood vessel, in which the abrasion element comprises a collection portion adapted to collect the removed material, avoiding dispersing the removed material as well as residues of pharmacological agent in the circulatory stream.

According to an aspect of the invention, the abrasion element is for example an expandable deformable element, meaning here by expandable even only that the deformable element is, when seen in profile, liftable with respect to the profile of the catheter shaft, adapted to selectively assume a contact configuration in which it is in contact with the inner wall and a rest configuration in which it is spaced from the inner wall. The contact configuration can be determined by the degree of expansion of the abrasion element. For example, the expandable element is an inflatable balloon and by adjusting the inflation of the balloon it is possible to make the inflatable balloon assume the contact configuration, thus acting as an abrasion element of the inner wall of the vessel.

According to an aspect of the invention, the abrasion element comprises at least one surface facing the intraluminal element and configured to face the fluid inside the blood vessel at least in the contact configuration, forming a concave portion adapted to collect the material removed from the inner wall and treated with a pharmacological agent.

Preferably, the vascular device further comprises a vessel treatment assembly adapted to isolate a volume of blood vessel in contact with the inner wall of the vessel in order to inject a certain amount of drug therein in a controlled manner.

According to a preferred operating mode, first a pharmacological treatment is performed, for example using a sclerosing drug, on a certain blood vessel section, and then a mechanical abrasion of the wall is performed in order to scrape the inner wall after the application of the pharmacological agent, thus removing material from the inner wall of the vessel. Preferably, a collection of the mechanically abraded material from the pharmacologically treated inner wall of the blood vessel is also included.

The aforementioned sequence, i.e., first the chemical treatment then the mechanical treatment and at the same time the collection of the abraded material also has another meaning or value in the fact that the removal of the endothelium and part of the muscular layer is necessary to start the reparative process of the vein wall to form a persistent scar which closes the vein. The scarring closure of the vein is the main goal of a sclerotherapy treatment of diseased veins such as varicose veins. A mechanical abrasion of the healthy inner part of the vein performed with balloon catheters, alone or performed before the sclerosing treatment, already described in the literature, did not give positive effects in terms of healing.

The pharmacological treatment is preferably performed by the vessel treatment assembly. The vessel treatment assembly comprises an intraluminal element outlet hole for drug dispensing. The vessel treatment assembly can comprise plug elements adapted to isolate a blood vessel tract from circulation, and a core element adapted to form, together with said plug elements, a blood vessel volume in contact with the blood vessel wall. For example the core element comprises a radially expandable inflatable balloon which is fitted on the intraluminal element, for example a shaft of a vascular catheter, forming a substantially annular chamber, or volume, in contact with the vessel wall and preferably the plug elements partially enclose said annular chamber, in which the outlet hole for dispensing the drug opens into said chamber.

The treatment assembly comprises a path in communication with the chamber or volume, for example placed along the intraluminal element, for example a catheter shaft, so as to supply the chamber or volume with the drug.

One of said plug elements can also act as an abrasion element of the pharmacologically treated portion of the wall which consists of dead cells.

A path can be included inside the intraluminal element, for example a catheter shaft, to manage the expansion degree of the abrasion element. When one of said plug elements also acts as an abrasion element of the pharmacologically treated portion of the wall, a path can be included inside the intraluminal element, for example a catheter shaft, which manages the expansion degree both of the plug and of the abrasion element.

Upon completion of the pharmacological treatment of a blood vessel tract, the chamber or volume delimited by the treatment assembly can be fed along the blood vessel to treat a new blood vessel tract. The abrasion element is preferably placed behind, with respect to the advance direction of the chamber delimited by the treatment assembly, so as to exert an abrasive action on the portion of the inner wall of the blood vessel just treated pharmacologically during the repositioning of the chamber of the treatment assembly. When one of said plug elements also acts as an abrasion element of the damaged inner wall portion, the abrasion can occur while the drug is in contact with the inner wall of the vessel.

The abrasion element can be shaped so as to expose a collection portion to the advance direction to collect the material removed from the inner wall of the vessel. The collection portion can be placed near the intraluminal element, for example a catheter shaft, and around it, and can be obtained by the shape of the abrasion element, for example a concave shape with respect to the advance direction, e.g., conical.

The advance direction can be directed proximally, i.e., towards the surgeon maneuvering the vascular catheter, and in this case the at least one abrasion element is placed distal to the drug dispensing opening, so that by proximally feeding the vascular catheter first a pharmacological treatment and after a mechanical abrasion treatment are obtained on the same circumferential transverse section of the blood vessel.

The abrasion element can be of such shape and material as to form a sail effect during the feeding, so that the abrasion element substantially acts as a sail with respect to the fluid current due to the feeding movement of the abrasion element in the blood vessel, which can be an element which also acts as a chamber plug. Thereby, the abrasion element can expand by the sail effect, obtaining the contact configuration precisely due to the feeding of the vascular device in the patient's blood vessel.

By virtue of the proposed solutions, it is possible to remove the endothelial layer of the inner wall of the blood vessel and part of the muscular layer consisting of dead, damaged or injured cells due to the application of the sclerosing pharmacological agent. Removing the dead cell layer of the inner part of the vein after the sclerosing action is essential to allow the underlying live cell state to be activated so as to generate a homogeneous fibrotic repair tissue which leads to complete and permanent occlusion of the sclerotic blood vessel. Such a process is faster if the body does not have to spend time removing the layer of dead cells due to the drug, and by virtue of the proposed solutions the step of removing the layer of dead cells is performed by the abrasion element of the vascular device. In nature, the dead tissue elimination process is carried out by macrophage cells which are activated by the release of chemical substances related to local inflammatory processes activated by necrotic tissue. The elimination of this dead cellular tissue by means of macrophages can also take quite a long time, thus slowing down the repair and scarring processes of the vein, slowing down healing. An excess inflammatory reaction related to the abundant tissue necrotized by the drug can then in turn generate potentially harmful and annoying local inflammatory reactions in the patient treated with sclerotherapy.

Another aspect to consider is that related to the release of cellular metabolites such as endothelin, which is released in the bloodstream after damage to the endothelial cells. Endothelin is a powerful vasoconstrictor and can generate vasospasm of various arterioles, for example cerebral, cardiac, etc., with neurological or cardiac side effects. The release of dead cells in the bloodstream determines thrombotic micro-aggregation phenomena with the formation of circulating micro-emboli which can reach the lungs and is therefore highly undesirable. By virtue of the proposed solutions, it is advantageously possible to collect the dead tissue removed from the inner wall of the blood vessel.

To obtain an abrasion element, it is possible to proceed by including an expandable balloon made as a through deformable body which delimits a longitudinal through cavity with the surface thereof facing the intraluminal element, fitting the through deformable body on the intraluminal element and fastening it tightly to the intraluminal element by means of a fastening element so that a free edge opposite the fastening element is formed, and subsequently overturning the free edge, and fastening the free edge to the intraluminal element by means of a fastening element, and forming a chamber which can be inflated by inflation fluid.

To make an abrasion element, it is possible to proceed by including an expandable balloon made by molding in a mold cavity having at least one concave portion.

Further features and advantages of the invention will become apparent from the description provided below of preferred exemplary embodiments thereof, given by way of non-limiting example, with reference to the accompanying drawings, in which:.

In accordance with a general embodiment, a vascular device <NUM> is included for treating at least one blood vessel tract <NUM>. Preferably, the vascular device <NUM> is a vascular catheter <NUM>.

The vascular device <NUM> comprises at least one intraluminal element <NUM>, for example a catheter shaft <NUM> of said vascular catheter <NUM>, having at least one opening for dispensing drug <NUM> in the blood vessel tract <NUM>. The intraluminal element <NUM> is intended to be inserted inside a blood vessel <NUM>.

Preferably, the drug dispensing opening <NUM> opens from the intraluminal element <NUM> and is in fluid communication with a drug reservoir containing pharmacological agent D, for example a sclerosing agent D, in which the drug reservoir is mounted on the proximal portion of the vascular catheter <NUM> which preferably comprises a catheter handpiece <NUM>. The intraluminal element <NUM>, for example a shaft <NUM> of a vascular catheter <NUM>, preferably comprises a distal end <NUM> adapted to be received in a blood vessel tract <NUM> and a proximal end adapted to remain outside the blood vessel <NUM>.

The pharmacological agent D can be in liquid form or in the form of a sclerosing foam, for example containing air or nitrogen, and is preferably injected in a blood vessel tract <NUM> of a patient by means of the vascular catheter <NUM>. For this purpose, the vascular catheter <NUM> can comprise a treatment assembly <NUM>, adapted to perform a pharmacological treatment on the inner wall <NUM> of the blood vessel <NUM>, the treatment assembly <NUM> comprising said dispensing opening <NUM>. The at least one dispensing opening <NUM> can be arranged near the distal portion of the intraluminal element <NUM>, for example the distal portion of a catheter shaft <NUM>.

The vascular device <NUM> further comprises at least one abrasion element <NUM> intended to come into contact with the inner wall <NUM> of the blood vessel tract <NUM> to remove material <NUM> from said inner wall <NUM>.

By virtue of the inclusion of the abrasion element <NUM>, the vascular device <NUM> is capable of applying a pharmacological treatment and also applying a mechanical abrasion treatment to the inner wall <NUM> of the blood vessel <NUM>.

According to a preferred operating mode, first the pharmacological treatment is performed, dispensing pharmacological agent D from said drug dispensing opening <NUM> on the inner wall <NUM> of the intraluminal element <NUM>, and then the mechanical abrasion treatment is performed by means of said at least one abrasion element <NUM>. Thereby, the mechanical treatment is aimed at removing biological material already treated pharmacologically and typically, when the endothelial layer of the inner wall of the vessel <NUM> is subjected to a sclerosing treatment, dead endothelial and muscle cells are formed, which are thus removed due to the mechanical abrasion treatment.

The abrasion element <NUM> is connected to the intraluminal element <NUM> and comprises a contact portion <NUM> adapted to remove the material <NUM> treated with the pharmacological agent D from the inner wall <NUM>.

The abrasion element <NUM> comprises at least a first surface <NUM>, <NUM> adapted to face the intraluminal element <NUM> and configured to face the fluid inside the blood vessel.

The abrasion element <NUM> is preferably adapted to perform a scraping operation of the inner wall <NUM> of the blood vessel <NUM> while it scrapes the inner wall <NUM>, like a spatula or a plow.

The inclusion of the abrasion element <NUM> dragged against the inner wall <NUM> allows material <NUM> to be scraped and removed from the inner wall <NUM> after the drug has been dispensed on the inner wall <NUM> and after the dispensed drug has carried out the therapeutic action thereof towards said inner wall <NUM> of the blood vessel <NUM>, for example a vein.

The at least one abrasion element <NUM> is preferably adapted to abrade the entire circumferential transverse section of the inner wall of the blood vessel <NUM>. In other words, the at least one abrasion element <NUM> is preferably adapted to remove material from the entire circumferential transverse section of the inner wall of the blood vessel <NUM>.

It should be noted that the wall material which is abraded by the abrasion element <NUM> consists of dead endothelial cells, basement membrane, dead smooth muscle cells, connective tissue, proteins, mupolysaccharides, proteoglycans, elastin, collagen fibers, endothelin, chemokines, selectins, integrins. etc. which form a sort of biological sludge with the density of mud consisting mainly of dead cells, a kind of aggregate of macromolecules and cells which can easily disperse disintegrated in the bloodstream and thus cannot be collected or extracted as if it were a single compact layer similar to the layer of skin which would be taken with a dermatome.

The abrasion element is configured to expand with respect to the intraluminal element <NUM> at least in a radial direction transverse to the main longitudinal extension direction of the vessel and/or of the intraluminal element <NUM> between at least one configuration between at least one rest configuration and at least one contact configuration, in which, in the contact configuration, the contact portion <NUM> is in contact with the inner wall <NUM>, and, in the rest configuration, the contact portion <NUM> is spaced from the inner wall <NUM>.

In accordance with an embodiment, the abrasion element <NUM> is reversibly and selectively movable between the rest configuration and the contact configuration. In accordance with an embodiment, the rest configuration is a configuration for transporting the device inside a blood vessel until the portion of the vessel to be pharmacologically treated is reached. In accordance with an embodiment, the rest configuration is a configuration for transporting the removed material <NUM> from the portion of the pharmacologically treated vessel out of the blood vessel, avoiding dispersing pharmacological residues and pharmacologically treated material <NUM> into the blood stream.

The at least a first surface <NUM>, <NUM> adapted to face the intraluminal element <NUM> forms, at least in said contact configuration, a concave portion <NUM> adapted to face the fluid inside the blood vessel, in which said collection portion <NUM> comprises said concave portion <NUM> so as to collect the material <NUM> removed from the inner wall <NUM> treated with the pharmacological agent D.

In accordance with an embodiment, the concave portion <NUM> has a concavity facing the at least one opening <NUM> for dispensing the pharmacological agent D, so as to make it possible to remove the material <NUM> from the inner wall <NUM> of the vessel tract after it has been pharmacologically treated, collecting the removed material <NUM> in the concave portion by moving the abrasion element <NUM> in the direction of the at least one opening <NUM> along an advance direction. In accordance with an embodiment, the abrasion element <NUM> comprises an element which is deformable in the outer radial direction RO adapted to selectively assume said at least one contact configuration in which it is in contact with the inner wall <NUM>. The deformation of the deformable element can be an expansion.

In accordance with an embodiment, the abrasion element <NUM> comprises an element which is expandable in the outer radial direction RO adapted to selectively assume said at least one contact configuration in which it is in contact with the inner wall <NUM>.

The expandable element of the abrasion element <NUM> can expand on command.

In accordance with a preferred embodiment, the expandable element of the abrasion element <NUM> is also adapted to assume said at least one rest configuration in which it is not in contact with the inner wall <NUM>.

In accordance with an embodiment, between said contact configuration and said rest configuration, said contact portion <NUM> approaches said intraluminal element <NUM> closing said concave portion <NUM> in the direction of said intraluminal element <NUM> so as to retain the removed material <NUM>.

In accordance with an embodiment, in said rest configuration, said contact portion <NUM> is directly or indirectly in contact with said intraluminal element <NUM> so as to retain the removed material <NUM> inside the collection portion <NUM> avoiding dispersing the removed material <NUM> in the bloodstream.

In accordance with an embodiment, said abrasion element <NUM> is reversibly expandable between said contact configuration and said rest configuration.

In accordance with an embodiment, the abrasion element <NUM> comprises an attachment portion connected to the intraluminal element <NUM>. In accordance with an embodiment, the attachment portion is circumferentially connected to the intraluminal element <NUM>.

In accordance with an embodiment, said first surface <NUM>, <NUM> extends between said attachment portion and said contact portion <NUM> at least in the direction of said at least one opening <NUM> for dispensing the drug. In accordance with an embodiment, said concave portion <NUM> has a concavity facing the at least one opening <NUM> for dispensing the drug. In accordance with an embodiment, the collection portion <NUM> defines an annular collection area around the intraluminal element <NUM>. In accordance with the invention, said collection portion <NUM> forms an annular collection chamber around the portion of intraluminal element <NUM> to which said first surface <NUM>, <NUM> faces.

In accordance with an embodiment, the at least one opening <NUM>, at the end of the treatment, acts as a suction opening <NUM>` for the recovery of the drug previously dispensed in the chamber interposed between the two outer balloons <NUM>. In accordance with an embodiment, said intraluminal element <NUM> comprises a suction opening <NUM>` and a dispensing opening <NUM>. In accordance with an embodiment, the at least one suction opening <NUM>` is configured to suction the material <NUM> removed from the inner wall <NUM> and collected in the collection portion <NUM> of the abrasion element <NUM> which acts as one of the two plug elements <NUM>. By virtue of the inclusion of the suction opening <NUM>' it is possible to suction between the two plug elements <NUM>, substances such as dead cellular material, substances produced and released by the endothelial cells of the vessel wall such as endothelin, a substance which has significant vasoconstrictive power and is responsible for symptoms such as cerebral or cardiac ischemia.

In accordance with an embodiment, said collection portion <NUM> extends at least partially around said at least one opening <NUM> or said at least one suction opening <NUM>'.

In accordance with an embodiment, said collection portion <NUM> extends around the portion of intraluminal element <NUM> which has said at least one opening <NUM> or said at least one suction opening <NUM>'.

The body of the expandable element of the abrasion element <NUM> can comprise said attachment portion, connected to the intraluminal element <NUM>, the contact portion <NUM> with the inner wall <NUM> of the blood vessel <NUM>, in which the body of the expandable element of the abrasion element <NUM> is designed to move the position of the contact portion <NUM> in a radial direction, in order to selectively perform an abrasion of material <NUM> from the inner wall <NUM>. The contact portion <NUM> is preferably a surface having a substantially circumferential extension. For example, the contact portion <NUM> can be formed by a circumferential edge. In accordance with an embodiment, the contact portion <NUM> comprises a circumferential edge of said abrasion element <NUM>.

In accordance with an embodiment, said expandable element comprises the contact portion <NUM> and the first surface <NUM>, <NUM>.

In accordance with a preferred embodiment, the abrasion element <NUM> comprises an inflatable balloon, for example a surgical balloon adapted to be inflated with inflation fluid <NUM>, for example physiological solution <NUM>.

The intraluminal element <NUM> preferably comprises at least one inflation opening <NUM> in fluid communication with the interior of the inflatable balloon for introducing or extracting inflation fluid <NUM> into or from the inflatable balloon. The handpiece <NUM> of the vascular device <NUM> can comprise a control interface having a control for inflating and/or deflating the inflatable balloon on command which forms the abrasion element <NUM>.

The inflatable balloon of the abrasion element <NUM> can comprise on the outer surface <NUM> thereof a contact portion <NUM> adapted to perform the abrasive action on the inner wall <NUM> of the blood vessel <NUM>.

In accordance with an embodiment, the inflatable balloon is adapted to cooperate with said expandable element so as to bring said contact portion <NUM> into contact with said inner wall <NUM> by inflating and/or deflating said inflatable balloon. In accordance with an embodiment, said inflatable balloon comprises an outer surface <NUM>. In accordance with an embodiment, said collection portion <NUM> is defined between a balloon outer surface <NUM> and said radially outer portion <NUM>.

In accordance with an embodiment, said first surface <NUM>, <NUM> comprises a radially inner portion and a radially outer portion <NUM>. In accordance with an embodiment, the balloon outer surface <NUM> is partially in contact with said radially inner portion. In accordance with an embodiment, said collection portion <NUM> is an annular portion radially extending between a circumferential edge of the contact portion <NUM> and a balloon outer surface <NUM>, and longitudinally between the balloon outer surface <NUM> facing the radially outer portion <NUM>, substantially forming an annular niche.

The abrasion element <NUM> can comprise, in addition to the inflatable balloon, a deformable element, the expanding inflatable balloon cooperates with the deformable element to bring a contact portion <NUM> into contact with the inner wall <NUM> of the blood vessel <NUM>. For example as shown in <FIG>, an expandable element is fitted on an inflatable balloon so that the outer wall <NUM> of the inflatable balloon is adapted to push an inner wall <NUM> of the expandable element in an outer radial direction RO so as to bring a contact portion <NUM> of the expandable element in contact with the inner wall <NUM> of the blood vessel <NUM>.

In accordance with an embodiment, the abrasion element <NUM> comprises an expandable mechanism, for example comprising tie-rods <NUM>. The inclusion of tie-rods <NUM> for example operatively connected to radially peripheral parts of the abrasion element <NUM> and to an element slidably fitted on the intraluminal element <NUM> allows forming a reinforced connection between the abrasion element <NUM> and the intraluminal element <NUM>. For example, a slider <NUM> can be included slidably fitted on the intraluminal element <NUM>, tie-rods <NUM> are placed between the slider <NUM> and the peripheral portions of the abrasion element <NUM> so that by acting on the slider <NUM> it is possible to tension such tie-rods <NUM> bringing for example the expandable abrasion element <NUM> into a rest configuration. In accordance with an embodiment, the abrasion element <NUM> comprises an intra-vascular umbrella structure expandable in the outer radial direction RO, as shown for example in <FIG>, which can be fitted on the intraluminal element <NUM>.

The expandable abrasion element <NUM> is further adapted to contract radially.

In accordance with an embodiment, the abrasion element <NUM> comprises a hinge <NUM> or the like near or at the intraluminal element <NUM>, so that the body of the abrasion element <NUM> is hinged near or at the intraluminal element <NUM> and/or the attachment portion. By virtue of such a hinge <NUM>, the expansion in the outer radial direction RO of the abrasion element <NUM> is allowed.

The abrasion element <NUM> can comprise one or more reinforcing elements <NUM> adapted to locally reinforce a portion of the abrasion element <NUM>. For example, said reinforcing elements <NUM> can comprise radial reinforcements and/or circumferential reinforcements. In accordance with an embodiment, the abrasion element <NUM> comprises reinforcing elements <NUM> in order to exert an improved mechanical abrasion action of material from the inner wall <NUM> of the blood vessel <NUM>, such as spurs <NUM>, rostrums <NUM>, and /or the like. The one or more reinforcing elements <NUM> can comprise a sharp edge.

In accordance with an embodiment, said one or more reinforcing elements <NUM> comprise at least one rib <NUM> surrounding the body of the abrasion element <NUM> projecting in the outer radial direction RO. The at least one rib <NUM> can be a helix which wraps around the body of the expandable element, for example an inflatable balloon. The at least one rib <NUM> can be a ring which embraces the body of the expandable element, for example an inflatable balloon.

As shown for example in <FIG> A - B, the reinforcing element <NUM> can be made in the form of an annular spur.

As shown for example in <FIG> A, the intraluminal element <NUM> can comprise a tapered or flared portion <NUM> of reduced radial diameter to receive the abrasion element <NUM> when in the rest configuration, so as to minimize the radial bulk of the abrasion element <NUM> when in the rest configuration.

In accordance with an embodiment, the abrasion element <NUM> comprises an element adapted to radially expand inside the blood vessel <NUM>, i.e., adapted to expand in the outer radial direction RO. For example, bellows processing can be included on a sleeve slidably fitted on the intraluminal element <NUM>.

In accordance with an embodiment, the abrasion element <NUM> comprises an element adapted to radially expand inside the blood vessel by the sail effect. For example, the abrasion element <NUM> comprises a first surface <NUM> facing the fluid inside the blood vessel <NUM> which tends to swell like a sail when the vascular device <NUM> is fed into the blood vessel <NUM>, bringing itself into an expanded contact configuration with the inner wall <NUM> of the vessel <NUM> in a substantially automatic manner as a response to the feeding movement of the abrasion element <NUM> inside the blood vessel <NUM>.

The feeding of the abrasion element <NUM> inside the blood vessel <NUM> is preferably determined by the movement of the intraluminal element <NUM>. For example, the abrasion element <NUM> is fixed integral with a portion of the intraluminal element <NUM>, for example a shaft <NUM> of a vascular catheter <NUM>. By moving the intraluminal element <NUM> in the longitudinal direction inside the blood vessel <NUM>, the feeding of the abrasion element <NUM> is determined.

The term "feeding" is not necessarily meant to indicate distally directed movement. The feeding movement can be directed proximally or distally as needed.

Preferably, the abrasion element <NUM> is placed on a portion of the intraluminal element <NUM> which is more distal with respect to the dispensing opening <NUM> for dispensing the sclerosing drug, and the movement of the intraluminal element <NUM> which determines the feeding of the abrasion element <NUM> occurs in the proximal direction, for example by pulling the intraluminal element <NUM> proximally. This allows performing the mechanical abrasion action on the inner wall of the vein only after the wall has been previously treated with a temporal contact exposure of a drug D on the wall itself.

The abrasion element <NUM> does not necessarily reach the contact configuration by expanding the volume thereof, although according to a preferred embodiment it does, and for example the abrasion element <NUM> can reach the contact configuration by contracting the volume thereof. For example, to reach the contact configuration, the abrasion element <NUM> moves a contact portion <NUM> in the outer radial direction RO, i.e., in the direction from the intraluminal element <NUM> to the inner wall <NUM>. During this movement in the outer radial direction RO, the body of the abrasion element <NUM> can expand radially in volume or it can move radially outward, for example leaving at least one through opening, for example a fine filter, near the intraluminal element <NUM> for the fluid inside the blood vessel <NUM>.

For example, to reach the contact configuration, the abrasion element <NUM> faces said first surface <NUM> to the fluid present in the blood vessel <NUM>, and such a first surface <NUM> can inflate by the sail effect. The sail effect is achieved by the relative movement between the abrasion element <NUM> and the blood vessel <NUM>. For example, the relative movement between the abrasion element <NUM> and the blood vessel <NUM> is achieved by feeding the intraluminal element <NUM> inside the blood vessel <NUM> in a advance direction X. The advance direction X can be directed distally or proximally.

The at least one abrasion element <NUM> comprises said at least one contact portion <NUM>, intended to perform the removal of material from the inner wall <NUM>. Said contact portion <NUM> can have an increased section <NUM> with respect to the rest of the abrasion element <NUM> and the increased section forms a reinforcing element <NUM>. For example, the abrasion element <NUM> is made in the form of a surgical balloon which is inflatable by means of inflation fluid <NUM> through the intraluminal element <NUM>, for example a shaft <NUM> of a vascular catheter <NUM>, and at the contact portion <NUM> intended to remove material <NUM> from the inner wall <NUM> of the blood vessel <NUM>, the balloon has a greater thickness, forming a sort of reinforcement to perform the removal of the material <NUM>. Said contact portion <NUM> preferably has a surface processing aimed at increasing the roughness thereof. For example, the contact portion <NUM> can be corrugated or pleated, to favor the abrasive power on the inner wall <NUM>. For example, the contact portion <NUM> can comprise surface knurling processing.

The abrasion element <NUM> forms a concave portion <NUM> adapted to face the fluid inside the blood vessel <NUM>. The concave portion <NUM> is formed by said first surface <NUM>. The fluid inside the blood vessel <NUM> which faces the concave portion <NUM> does not necessarily comprise blood since it can be an isolated section <NUM> of blood vessel <NUM> temporarily isolated from the circulation of blood.

The abrasion element <NUM> can be made in the form of an expandable surgical balloon overturned on the intraluminal element <NUM> of the vascular device <NUM>, and the concave portion <NUM> can be formed by the shape assumed by the surgical balloon after having fastened it to the intraluminal element <NUM> and overturned.

In accordance with a possible operating mode, a manufacturing method of an expandable balloon <NUM> having at least one concave portion <NUM> comprises the steps of:.

Preferably, a mold can be included for forming an expandable balloon <NUM> suitable for medical-surgical applications having a die <NUM> comprising a first wall which at least partially delimits a concave portion <NUM> of a mold cavity <NUM>; said first wall comprising a protrusion <NUM> adapted to project cantilevered in said mold cavity <NUM> forming a free protrusion end <NUM> and a protrusion root opposite said free end <NUM>, and a mold tapered surface <NUM> which tapers as it approaches said protrusion root. Preferably, said protrusion <NUM> has a substantially cylindrical shape. Preferably, said protrusion root is joined to the tapered surface <NUM>. Preferably, the protrusion <NUM> and the tapered surface <NUM> are made in a single piece. The tapered surface <NUM> is preferably substantially frustoconical. The mold can further comprise at least one counter-die <NUM> which at least partially delimits a convex portion <NUM> of said mold cavity <NUM>. The counter-die <NUM> can comprise side walls <NUM> which delimit the cavity <NUM>. Preferably, the die <NUM> comprises an abutment portion <NUM> and the counter-die <NUM> comprises a counter-abutment portion <NUM>, said abutment portion <NUM> and said counter-abutment portion <NUM> are adapted to mutually abut to delimit the mold cavity <NUM>.

The manufacturing method can comprise at least one but also all of the following further steps of:.

As shown for example in the sequence shown in <FIG> A - F, the abrasion element <NUM> is a surgical balloon, or an expandable balloon, made as a through deformable body, or parison <NUM>, which delimits a through longitudinal cavity <NUM> with a surface <NUM> thereof facing the intraluminal element <NUM> which is fitted on the intraluminal element of the device <NUM>, for example fitted by the distal end <NUM> of the intraluminal element <NUM>, and sealingly fastened to the intraluminal element <NUM> by means of a fastening element <NUM> so that a free margin <NUM> is formed, i.e., not fastened to the intraluminal element <NUM> opposite the fastening element <NUM> with respect to the deformable body of the expandable balloon; subsequently, the free edge <NUM> is overturned and fastened with a fastening element <NUM>' to the intraluminal element <NUM> in a position for example placed distally on the intraluminal element <NUM> with respect to where the fastening element <NUM> is placed; thereby, an inner chamber <NUM> is formed which can be inflated by inflation fluid <NUM>; thereby, the surface <NUM> of the balloon portion which has been overturned will face the outside of the chamber <NUM> and therefore opposite with respect to the intraluminal element <NUM>, due to the effect of the overturning; by inflating the inner chamber <NUM> it is possible to expand the expandable balloon; the local stiffness and/or the shape of the expandable balloon can be chosen so that a collection portion <NUM>, for example a collection niche, is formed as a result of the overturning and subsequent fastening. The collection portion <NUM> can have a concave shape, for example substantially conical and/or a substantially annular conformation.

In accordance with an embodiment, said parison <NUM> and/or said surgical balloon <NUM> is an elastomer or an extensible polymer.

In accordance with an embodiment, said extensible polymer is a thermoplastic elastomer.

In accordance with an embodiment, said extensible polymer comprises individually or in a mixture at least one of polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamides, polyvinyl chloride, latex, silicones, polyurethane copolymers, polyamide copolymers, copolymers of polyamide and polyethers.

In accordance with an embodiment, said surgical balloon <NUM> is made of a compliant and/or semi-compliant material.

In accordance with an embodiment, said parison <NUM> has a multilayer parison body, comprising a first elastomeric layer and a second thermoplastic layer. In accordance with an embodiment, said parison <NUM> comprises a non-compliant layer. In accordance with an embodiment, said parison <NUM> is made of a material adapted to make a compliant or semi-compliant expandable balloon.

In accordance with a preferred embodiment, the surgical balloon is fitted on the intraluminal element <NUM>, and the intraluminal element <NUM> comprises at least one inflation opening <NUM> in fluid communication with the interior of the surgical balloon for introducing into or extracting from the surgical balloon the inflation fluid <NUM> so as to reversibly expand or contract the abrasion element <NUM> between the rest configuration and the contact configuration.

In accordance with an embodiment, the abrasion element <NUM> has a balloon longitudinal extension axis around which the balloon extends. In accordance with an embodiment, the abrasion element <NUM> extends with cylindrical symmetry around said balloon longitudinal extension axis. In accordance with an embodiment, said radial direction RO is transverse with respect to said balloon longitudinal extension axis.

In accordance with an embodiment, the surgical balloon is sealingly fastened on said intraluminal element <NUM> with a first fastening element <NUM> and a second fastening element <NUM>' so as to define a fluid-tight chamber in fluid connection with said inflation opening <NUM> between an inner surface of the surgical balloon and a surface of the intraluminal element <NUM> between the first fastening element <NUM> and the second fastening element <NUM>, in which said concave portion <NUM> extends from said first fastening element <NUM> to said contact portion <NUM>. In accordance with an embodiment, in which said concave portion <NUM>, at least in said contact configuration, has an at least partially conical shape. In accordance with an embodiment, the collection portion <NUM> is joined to the contact portion <NUM> so that the material <NUM> removed from the contact portion <NUM> is directed in the collection portion avoiding interfering with the contact portion <NUM>. In accordance with an embodiment, at least in the contact configuration, the collection portion <NUM> forms a funnel-shaped portion configured to facilitate the collection of the removed material <NUM> by feeding said device <NUM> inside the blood vessel along said advance direction X. In accordance with an embodiment, the collection portion <NUM> and the contact portion <NUM> are integrated in the same element.

In accordance with an embodiment, said abrasion element <NUM> has a first attachment portion and a second attachment portion configured to be connected to said intraluminal element <NUM> by means of said first fastening element <NUM> and said second fastening element <NUM>', in which said first attachment portion and said second attachment portion are circumferential, preferably cylindrical portions adapted to receive the intraluminal element <NUM>, in which said first attachment portion and said second attachment portion are spaced by an attachment distance D along a longitudinal extension direction of the intraluminal element <NUM> or along said longitudinal extension axis of the balloon around which the abrasion element <NUM> extends. In accordance with an embodiment, said attachment distance D is between <NUM> and <NUM>.

In accordance with an embodiment, when said balloon is in said expanded configuration, a projection of the concave portion <NUM> and/or of said first wall <NUM> on the longitudinal extension axis of the balloon defines a segment having a concave portion length C. In accordance with an embodiment said concave portion length C is between <NUM> and <NUM>, preferably between <NUM> and <NUM>. In accordance with an embodiment, said concave portion length C is the height of the truncated cone delimiting the concave portion <NUM>. In accordance with an embodiment, said concave portion length is the height of the truncated cone delimiting the concave portion <NUM>. In accordance with an embodiment, said concave portion length C is between <NUM>/<NUM> and ½ of the attachment distance D.

By virtue of the inclusion of the collection portion <NUM>, it is possible to scrape and transport the removed material <NUM> from the inner wall <NUM> of the blood vessel <NUM> out of the blood vessel <NUM>.

In accordance with an operating mode shown for example in <FIG>, the parison <NUM> or preform <NUM> approaches a protrusion <NUM> of the die <NUM> with a closed margin thereof, i.e., unadapted to allow access to the cavity <NUM> and the parison <NUM> is shaped to the protrusion <NUM>. The counter-die <NUM> is thus abutted against the die <NUM>. The parison <NUM> is subsequently expanded by inflating through the channel <NUM>. The shape of the concave portion <NUM> of the mold cavity <NUM> allows making an expandable balloon <NUM> having a concave portion <NUM>.

In accordance with a preferred embodiment, the abrasion element <NUM> forms a collection portion <NUM> for collecting the removed material <NUM> from the inner wall <NUM>.

The joint inclusion on a single device, such as a vascular catheter <NUM>, of the abrasion element <NUM> and of the collection portion <NUM> allows making a system which at the same time scrapes or scratches the inner wall <NUM> removing material and scraping the removed material <NUM>, avoiding freeing cellular and pharmacological debris in the bloodstream using a single vascular device <NUM> having an intraluminal element <NUM>.

The collection portion <NUM> can be formed by the concave portion <NUM>.

By virtue of the collection of the removed material <NUM> in the collection portion <NUM>, for example a collection niche, debris or other material removed from the inner wall <NUM> of the blood vessel <NUM> is prevented from entering the blood vessel <NUM>, greatly reducing the risk of complications such as inflammations localized or distributed along the vascular path, or in the lung which is the organ of collection of all the venous blood coming from the periphery.

As shown for example in the sequence shown in <FIG> A - C, an inflatable balloon cooperates with an expandable element, shown here as an expandable frustoconical body, so that by inflating the inflatable balloon, the balloon outer surface <NUM> is pushed against a surface <NUM> facing the intraluminal element <NUM> of the expandable frustoconical body, bringing a contact portion <NUM> of the expandable frustoconical body into contact with the inner wall <NUM> of the blood vessel <NUM>. A collection portion <NUM>, for example of an annular mouth, can be formed between the contact portion <NUM> and the balloon outer surface <NUM>.

The at least one opening for dispensing drug <NUM> in the blood vessel tract <NUM> can be made as part of a treatment assembly <NUM> adapted to isolate a blood vessel volume <NUM> in contact with the inner wall <NUM> of the blood vessel <NUM>. By isolating a blood vessel volume <NUM> or chamber <NUM> from the circulation of blood, it is possible to both control the concentration of the pharmacological agent D in such a volume <NUM>, and to control the contact time of the pharmacological agent D against the inner wall <NUM> of the blood vessel <NUM>.

In accordance with a preferred embodiment, said treatment assembly <NUM> further comprises one or more plug elements <NUM> adapted to isolate a blood vessel tract, and at least one core element <NUM>, in which said at least one core element <NUM> determines a blood vessel volume <NUM> intended to come into contact with the inner wall <NUM>. For example, the plug elements <NUM> and the core element <NUM> are all expandable elements, such as inflatable surgical balloons. The inclusion of the core element <NUM> which occupies the neighboring area of the intraluminal element <NUM> allows the pharmacological agent D to be brought into contact with the inner wall <NUM> of the blood vessel <NUM>, reducing the quantity of drug necessary for the treatment. The inclusion of said plug elements <NUM> allows the volume <NUM> or chamber <NUM> to be isolated from the circulation of blood. The plug elements <NUM> preferably delimit said volume <NUM> therebetween. The core element <NUM> can be made in a single piece with a plug element <NUM>, for example they can both be formed by a single inflatable balloon.

Preferably, the core element <NUM> comprises a radially expandable inflatable balloon which is fitted on the intraluminal element of the device <NUM>, forming a substantially annular chamber <NUM>, or volume <NUM>, in contact with the inner wall <NUM>. Such an inflatable balloon which forms the core element <NUM> is adapted to expand during inflation in the outer radial direction RO. In accordance with an embodiment, said core element <NUM> can be inflated so as to over-stretch the inner wall of the vessel, breaking the intercellular bonds.

In accordance with a preferred embodiment, at least one of said plug elements <NUM> also acts as an abrasion element <NUM> of the wall <NUM>. Thereby, a single expandable element, for example an inflatable balloon, acts both as a plug element for isolating a volume <NUM> or a chamber <NUM> of the treatment assembly <NUM> from the circulation of blood and as an element for removing material from the inner wall of the vessel.

Preferably, first the expandable element acts as a plug element <NUM> to isolate a blood vessel tract <NUM> into which the pharmacological agent D is to be injected and then acts as an abrasion element <NUM> to remove material <NUM> from the inner wall <NUM> of that same blood vessel tract <NUM> just treated with the pharmacological agent D.

The intraluminal element <NUM> can be designed to translate inside the blood vessel <NUM>, along the longitudinal extension axis of the vessel <NUM>. The translation can occur both proximally and distally. Preferably, when in operating conditions, the translation occurs in the proximal direction. This translation in the proximal direction inside the blood vessel <NUM> can be achieved by substantially pulling the intraluminal element <NUM>, for example a shaft <NUM> of a vascular catheter <NUM>, in the proximal direction.

In accordance with an embodiment, said at least one abrasion element <NUM> is placed along the intraluminal element of the device <NUM> behind said at least one drug dispensing opening <NUM> in a determinable advance direction X of the device <NUM> in the blood vessel <NUM>. Thereby, when the intraluminal element <NUM> is fed, the same stretch of blood vessel <NUM> is exposed first to the chamber <NUM> of the treatment assembly <NUM> and then to the abrasion element <NUM>. The advance direction X is substantially parallel or coincident with the longitudinal extension axis of the vessel to be treated.

Preferably, said at least one abrasion element <NUM> is placed distally with respect to said at least one opening for dispensing drug <NUM>.

Alternatively, said at least one abrasion element <NUM> can be placed proximally with respect to said at least one opening for dispensing drug <NUM>.

A method for treating a blood vessel will be described below. The method is preferably adapted to the sclerosing treatment of varices.

A method for treating a blood vessel <NUM> comprises the steps of:.

In accordance with a preferred operating mode, the material removal step is performed after the dispensing step.

According to a preferred operating mode, the method further comprises the step of collecting the removed material <NUM>.

The step of collecting the removed material <NUM> avoids the risk of flooding the circulatory stream with debris, for example catabolites or metabolites, as well as residues of the active pharmacological agent D which could have undesirable side effects.

In accordance with an operating mode, the material removal step includes mechanical material removal. Preferably, the material removal step is performed by abrading the inner wall <NUM>.

In accordance with an operating mode, the method is performed by a vascular device <NUM> according to any one of the embodiments described above.

In accordance with an operating mode, the method comprises the step of isolating a blood vessel tract from the circulation of blood. Preferably this isolating step is included prior to the drug dispensing step.

In accordance with an operating mode, the removal step is performed by a deformable element expandable in the outer radial direction RO.

In accordance with an operating mode, both the removal and the collection steps are performed by the same deformable element expandable in the outer radial direction RO which is provided with a contact portion <NUM> and a collection portion <NUM>.

In accordance with an operating mode, the method comprises the step of making two convex balloons, and associating them with each other in a respective edge <NUM>, <NUM>' to form a single balloon having a concave portion <NUM>, avoiding including a mold having a concave portion <NUM>. Preferably, the method comprises the step of providing two parisons <NUM>, <NUM>', each parison <NUM> and <NUM>' being arranged in a respective pre-mold <NUM> and <NUM>', and the step of expanding by inflating each parison <NUM> and <NUM>' in the respective pre-mold <NUM> and <NUM>', making two convex expandable balloons. Preferably, such pre-molds <NUM> and <NUM>' are both convex, i.e., they are intended to form a convex balloon.

The association between the edges <NUM> and <NUM>' of the convex balloons to form a balloon having a concave portion <NUM> preferably occurs by laser welding.

In accordance with an embodiment, such an association is performed by gluing. In accordance with an embodiment, such an association determines the formation of a concave portion <NUM> formed by one of the expandable balloons associated with each other in the respective edge <NUM>, <NUM>'.

Therefore, in accordance with a general embodiment, as shown for example in f<FIG>, a manufacturing method of an expandable balloon <NUM> for medical-surgical applications having at least one concave portion <NUM> comprises the steps of:.

The preforms can in turn be expandable balloons.

By virtue of the features described above provided separately or jointly with each other in particular embodiments, it is possible to obtain a device as well as a method which at the same time satisfy the above described requirements, contrasting each other, and the aforementioned desired advantages, and in particular:.

In order to meet contingent and specific needs, those skilled in the art may make several changes and adaptations to the above-described embodiments, and may replace elements with others which are functionally equivalent, without however departing from the scope of the following claims.

Claim 1:
A vascular device (<NUM>) for treating at least one blood vessel tract (<NUM>) comprising:
- an intraluminal element (<NUM>) having at least one opening (<NUM>) for dispensing a pharmacological agent (D) in the blood vessel tract (<NUM>); and
- at least one abrasion element (<NUM>) connected to the intraluminal element (<NUM>) and adapted to come into contact with an inner wall (<NUM>) of the blood vessel tract (<NUM>) to remove material (<NUM>) treated with the pharmacological agent (D) from said inner wall (<NUM>);
wherein said abrasion element (<NUM>) comprises at least one contact portion (<NUM>) adapted to obtain the removal of the material (<NUM>) from said inner wall (<NUM>), and wherein said abrasion element (<NUM>) comprises at least one collection portion (<NUM>) for collecting material (<NUM>) removed from said inner wall (<NUM>),
wherein said abrasion element (<NUM>) is configured to expand with respect to said intraluminal element (<NUM>) at least in a radial direction (RO) transverse to the longitudinal extension direction of the vessel between at least one rest configuration and at least one contact configuration, wherein, in said at least one contact configuration, said contact portion (<NUM>) is in contact with the inner wall (<NUM>), and, in said at least one rest configuration, the contact portion (<NUM>) is spaced from the inner wall (<NUM>),
wherein said abrasion element (<NUM>) comprises at least a first surface (<NUM>, <NUM>) facing said intraluminal element (<NUM>) and configured to face a fluid inside the blood vessel,
wherein said at least a first surface (<NUM>, <NUM>), at least in said contact configuration, forms a concave portion (<NUM>) adapted to face the fluid inside the blood vessel, wherein said collection portion (<NUM>) comprises said concave portion (<NUM>) so as to collect the material (<NUM>) removed from the inner wall (<NUM>) treated with the pharmacological agent (D),
wherein said collection portion (<NUM>) forms an annular collection chamber around the portion of intraluminal element (<NUM>) to which said first surface (<NUM>, <NUM>) faces,
wherein between said contact configuration and said rest configuration, said contact portion (<NUM>) approaches said intraluminal element (<NUM>) closing said concave portion (<NUM>) towards said intraluminal element (<NUM>) so as to retain the removed material (<NUM>),
and wherein said concave portion (<NUM>) has a concavity facing the at least one drug dispensing opening (<NUM>).