Intraluminal vascular devices and methods, particularly for sclerotherapy

Abstract

A vascular device (1) for treating at least one vascular channel (2) comprises: an intraluminal element (3), such as a catheter shaft, having at least one opening (4) for dispensing a drug into the vascular channel (2); at least one abrasive element (5) designed to contact an inner wall (6) of the vascular channel (2) to remove material (7) from the inner wall (6); wherein the abrasive element (5) includes at least one contact portion (14) suitable for removing the material (7) and at least one collection portion (9) for collecting the removed material, wherein the abrasive element (5) is configured to contact at least one static The stop configuration and at least one contact configuration expand relative to the intraluminal element (3) at least in the radial direction (RO) across the longitudinal extension direction of the blood vessel, wherein the abrasive element (5) includes at least a first surface (17, 23) facing the intraluminal element (3) and configured to face the fluid within the blood vessel, wherein the at least one first surface (17, 23) forms a recess (19) at least in the contact configuration, the recess (19) being adapted to face the fluid within the blood vessel, wherein the collection portion (9) includes the recess (19) to collect the material (7) from the inner wall (6) treated with the pharmaceutical preparation (D). Preferably, the drug is dispensed first, and then the inner wall is abraded.

Description

Technical Field

[0001] The subject of this invention is a vascular device for treating blood vessels.

[0002] The device according to the invention is suitable for use in the context of sclerotherapy.

[0003] The present invention also relates to a method for treating blood vessels. Background Technology

[0004] Sclerotherapy for varicose veins typically involves the use of a pharmacochemical agent, the purpose of which is to bring an effective dose of the drug into contact with the inner wall of the blood vessel to be treated.

[0005] Patent EP-2120738-B1 from the same applicant discloses an embodiment of a catheter equipped with an inflatable balloon that expands to isolate an annular chamber within the blood vessel from the blood circulation, in which a sclerosing drug is injected in a controlled manner. The presence of this radially inflatable balloon, isolating an annular chamber between the catheter shaft and the vessel wall, avoids the need to inject the drug across the entire length of the vessel to be treated, allowing injection only in a single annular region of the vessel in contact with the wall. The device disclosed herein allows for empty vein sclerotherapy without blood, thus eliminating the need for plasma proteins that can neutralize the pharmacological activity of the sclerosing drug; the device allows for precise control of the concentration of drug injected onto the inner wall of the vein; the device allows for comprehensive drug targeting across the entire inner surface of the vein, and also allows for management of the duration of drug contact with the vein wall. The duration of drug-site contact is crucial for allowing the drug to penetrate the inner wall thickness of the vein and generate an inflammatory venous recovery response.

[0006] Document US-2013-110081 discloses a catheter scheme for occluding a portion of a blood vessel, the catheter scheme comprising an expandable bellows occlusion element slidably mounted on a catheter shaft and adapted to expand radially upon being subjected to a predetermined longitudinal compressive motion oriented along the catheter shaft.

[0007] Document US-2014-276608 discloses an inflatable balloon having a double-walled structure forming gaps, wherein the outer layer of the double-walled structure is porous to allow direct spraying of drugs into the gaps in the wall.

[0008] The above solution discloses an essentially pharmacological approach. The treatment of the vascular lining is performed using a drug, which is sprayed through a vascular catheter. After a certain period of contact between the drug and the vascular lining, the drug reaches a certain concentration near the vascular lining and then reaches the endothelium of that wall.

[0009] The use of vascular catheters with rotating rods to guide drugs to the vessel wall has also been proposed, for example, as shown in document US-2016-302822. The free end of the rotating rod can also damage the inner wall of the vessel, creating lesions. According to this disclosure, first, mechanical damage is performed on the healthy wall, and then chemical damage is performed on the previously mechanically damaged site. The purpose of mechanical damage is to create microcracks in the vessel wall, which facilitates drug penetration into the wall of a certain thickness for deep treatment, or facilitates drug penetration into the muscle layer (the layer below the endothelium (typically, the endothelium is about 5 micrometers thick) of a certain thickness. Therefore, according to these teachings, the success of treatment depends on the drug treatment of the muscle layer (the layer beneath the endothelium), which is also supported by a study published in the reference: MS Whiteley et al., “Media damage following detergent sclerotherapy appears to be secondary to the induction of inflammation and apoptosis: an immunohistochemical study elucidating previous histological observations,” Eur. J Vasc: Endovasc. Surg., (2016) 51, 421-428.

[0010] Document US-2005-055040 discloses a vascular catheter protocol that dispenses sclerosing agents after performing an ablation operation on material from the vessel wall via a rotating head at the distal end of the catheter shaft. This creates damage to the endothelium of the vessel wall, facilitating deeper absorption of the sclerosing agent into the vessel wall. However, this protocol is not without its drawbacks and limitations: First, it is impossible to know whether the mechanical damage is uniform across the entire venous surface, especially in the case of large-diameter veins, where the angled end of a catheter only a few millimeters long represents a circle with a radius less than about 10 millimeters, thus failing to uniformly damage the inner wall of large-diameter veins. Furthermore, fragments scraped from the vessel wall inevitably enter the bloodstream, and these fragments are primarily dead tissue or endothelial-derived substances (e.g., endothelin, a potent vasoconstrictor), which are potentially toxic as they readily induce procoagulant reactions at a distance. In fact, it has been shown that mechanical, chemical, or biochemical damage to the endothelium results in the release of endothelin, a molecule that circulates in increased amounts in the bloodstream. Endothelin can cause strong spasms or close small arteries, thereby reducing blood supply and consequently reducing oxygen supply to the affected organs. Endothelin circulates in the bloodstream, reaching the small blood vessels of various organs (e.g., the heart, kidneys, and brain). At this level, vasospasm or closure of small arteries in the parenchyma that carry blood to these organs can cause serious symptoms (e.g., angina, heart attack, cerebral or cerebellar ischemia).

[0011] Therefore, there is a strong belief that a solution is needed to improve the efficacy of sclerotherapy for blood vessels (whether small, medium, or large diameter).

[0012] It is also believed that it is necessary to prevent any potential adverse effects related to the release of dead circulating cells, decomposition products, etc. in the bloodstream. Summary of the Invention

[0013] The purpose of this invention is to eliminate the drawbacks of the known technologies mentioned so far and to provide a solution to meet the design needs for improved treatment of vascular sclerosis.

[0014] This and other objectives are achieved by means of the apparatus according to this disclosure.

[0015] According to one aspect of the invention, a vascular device for treating blood vessels (e.g., sclerotherapy) includes an intraluminal element, such as a catheter shaft, which is provided with an abrasive element designed to contact the inner wall of the blood vessel to remove material from the inner wall of the blood vessel. The abrasive element includes a collection portion adapted to collect the removed material, preventing the removed material and pharmaceutical preparation residues from dispersing in the circulating flow.

[0016] According to one aspect of the invention, the abrasive element is, for example, an expandable deformable element, where "expandable" means that the deformable element is liftable relative to the catheter axis, even when viewed only in outline. The deformable element is suitable for selectively employing a contact configuration, in which it contacts the inner wall, and in the static configuration, it is separated from the inner wall. The contact configuration can be determined by the degree of expansion of the abrasive element. For example, the expandable element is an inflatable balloon, and by adjusting the inflation of the balloon, the inflatable balloon can be configured in the contact configuration, thereby serving as an abrasive element for the inner wall of the blood vessel.

[0017] According to one aspect of the invention, the abrasive element includes at least one surface facing the intraluminal element and configured to face the fluid within the blood vessel, at least in the contact configuration, forming a recessed portion suitable for collecting material removed from the inner wall by a pharmaceutical preparation.

[0018] Preferably, the vascular device further includes a vascular processing component adapted to isolate the volume of the blood vessel in contact with the inner wall of the blood vessel for controlled injection of a certain amount of drug into the blood vessel.

[0019] According to a preferred operating mode, a drug treatment, such as using a sclerosing agent, is first performed on a specific portion of the blood vessel, followed by mechanical abrasion of the wall to scrape the inner wall after the application of the drug formulation, thereby removing material from the inner wall of the blood vessel. Preferably, the mechanically abraded material is also collected from the inner wall of the drug-treated blood vessel.

[0020] The aforementioned sequence (i.e., chemical treatment followed by mechanical treatment, while simultaneously collecting the abraded material) also has another significance or value: in fact, removing the endothelium and part of the muscle layer is necessary to initiate the repair process of the vein wall to form a lasting scar for closure of the vein. Scar closure of veins is a primary goal of sclerotherapy for diseased veins (e.g., varicose veins). It has been described in the literature that performing mechanical abrasion alone on healthy vein segments using a balloon catheter, or performing mechanical abrasion prior to sclerotherapy, has not produced positive effects on healing.

[0021] Preferably, drug processing is performed by the vascular processing assembly. The vascular processing assembly includes an intraluminal element outlet orifice for drug dispensing. The vascular processing assembly may include a clogging element adapted to isolate the vascular passage from circulation, and a core element adapted to form a vascular volume in contact with the vessel wall together with the clogging element. For example, the core element includes a radially expandable inflatable balloon mounted on an intraluminal element (e.g., the shaft of a vascular catheter) to form a generally annular chamber or volume in contact with the vessel wall, and preferably, the clogging element partially closes the annular chamber, wherein the outlet orifice for drug dispensing is open into the chamber.

[0022] The processing assembly includes a path communicating with a chamber or volume, for example, a path placed along an intraluminal element (e.g., a catheter shaft) to supply medication to the chamber or volume.

[0023] One of the multiple blocking elements can also serve as a grinding element for the drug-treated portion of the wall composed of dead cells.

[0024] The intraluminal element (e.g., catheter shaft) may include pathways to manage the degree of expansion of the abrasive element. When one of the plurality of occlusive elements also serves as an abrasive element for the drug-treated portion of the wall, the intraluminal element (e.g., catheter shaft) may include pathways that manage the degree of expansion of both the occlusive element and the abrasive element.

[0025] After drug treatment of the blood vessel has been completed, the treatment component can be fed along the blood vessel into the chamber or volume defined by the treatment component to treat new blood vessels. Preferably, the abrasive element is positioned rearward relative to the direction of advance of the chamber defined by the treatment component to apply an abrasive action to the newly drug-treated portion of the blood vessel's inner wall during repositioning of the chamber of the treatment component. When one of the plurality of occluding elements also acts as an abrasive element for the damaged inner wall portion, abrasion may occur upon contact between the drug and the inner wall of the blood vessel.

[0026] The abrasive element can be shaped such that a collection portion is exposed in the direction of propulsion to collect material removed from the inner wall of the blood vessel. The collection portion can be positioned near the intraluminal element (e.g., catheter shaft) and can be obtained by the shape of the abrasive element, such as a concave shape relative to the direction of propulsion, for example, a cone shape.

[0027] The direction of advance can be proximal, i.e., toward the surgeon operating the vascular catheter, and in this case, the at least one abrasive element is placed at the distal end of the drug dispensing opening, thereby first administering the drug by advancing the vascular catheter proximal, and then performing mechanical abrasion on the same circumferential cross-section of the blood vessel.

[0028] The abrasive element can have a shape and material that creates a sail effect during feeding, such that the abrasive element substantially acts as a sail relative to the fluid flow generated by the feeding motion of the abrasive element in the blood vessel. The abrasive element can also function as a ventricular occlusion element. Therefore, the abrasive element can expand through the sail effect, enabling precise contact configuration due to the feeding of the vascular device into the patient's blood vessel.

[0029] The proposed solution allows for the removal of dead, damaged, or necrotic cells from the endothelial and muscular layers of the blood vessel walls by applying a sclerosing drug. Following sclerosing, removing this layer of dead cells from the inner portion of the vein is crucial for activating a potential state of living cells to generate uniform fibrous repair tissue, thereby achieving complete and permanent occlusion of the sclerosed vessel. If the body does not require the time-consuming removal of the drug-induced dead cell layer, the proposed solution, which uses abrasive elements of a vascular device to perform this removal step, would be faster. In nature, the clearance of dead tissue is carried out by macrophages, which are activated by releasing chemicals associated with local inflammatory processes triggered by necrotic tissue. Clearing this dead tissue via macrophages can be time-consuming, thus delaying venous repair and scarring, and thus hindering healing. The excessive inflammatory response associated with the large amount of drug-induced necrosis can, in turn, result in potentially harmful and bothersome local inflammatory reactions in patients undergoing sclerosing treatment.

[0030] Another aspect to consider is the release of cellular metabolites, such as endothelin, which is released into the bloodstream after endothelial cell damage. Endothelin is a potent vasoconstrictor that can cause vasospasm in various small arteries (e.g., the brain, heart, etc.), with neurological or cardiac side effects. The release of dead cells into the bloodstream determines the phenomenon of thrombus microaggregation, forming circulating microemboli that can reach the lungs, which is highly undesirable. The proposed solution allows for the advantageous collection of dead tissue removed from the inner wall of blood vessels.

[0031] To obtain the grinding element, it can be done by including an inflatable balloon, which is manufactured as a through deformable body that defines a longitudinal through cavity with its surface facing the in-lumen element. The through deformable body is mounted on the in-lumen element and is tightly fastened to the in-lumen element by fastening elements to form a free edge opposite to the fastening elements. The free edge is then flipped and fastened to the in-lumen element by fastening elements, forming a chamber that can be inflated by a gas fluid.

[0032] To manufacture grinding elements, it can be done by using an inflatable bladder, which is molded in a mold cavity having at least one recessed portion. Attached Figure Description

[0033] Referring to the accompanying drawings, other features and advantages of the invention will become apparent from the following description of preferred exemplary embodiments of the invention, which are given by way of non-limiting example, wherein:

[0034] - Figure 1 A vascular device according to one embodiment is schematically illustrated;

[0035] - Figure 2A An abrasion element within a blood vessel is schematically shown according to one embodiment, wherein the abrasion element is in a static configuration;

[0036] - Figure 2B It shows Figure 2A The grinding elements are in a contact configuration;

[0037] - Figure 3A and Figure 3B The portion of the grinding element that will come into contact with the inner wall of the blood vessel is shown schematically in cross-section according to some embodiments;

[0038] - Figure 4 A vascular device according to one embodiment is schematically illustrated;

[0039] - Figure 5 A vascular device is schematically shown during the dispensing of a pharmaceutical preparation according to one embodiment;

[0040] - Figure 6 The grinding element of a vascular device according to one embodiment is schematically shown;

[0041] - Figure 7 The inflation of an expandable grinding element according to one embodiment is schematically shown;

[0042] - Figure 8A An intravascular grinding element is schematically shown according to one embodiment, wherein the grinding element is in a static configuration;

[0043] - Figure 8B An intravascular grinding element is schematically shown according to one embodiment, wherein the grinding element is in a static configuration;

[0044] - Figure 9 This is an isometric view according to an embodiment, which schematically shows the grinding element;

[0045] - Figure 10An abrasive element within a blood vessel is schematically illustrated according to one embodiment;

[0046] - Figure 11 An abrasive element within a blood vessel is schematically illustrated according to one embodiment;

[0047] - Figure 12A An intravascular grinding element is schematically shown according to one embodiment, wherein the grinding element is in a static configuration;

[0048] - Figure 12B It shows Figure 12A The grinding elements are in a contact configuration;

[0049] - Figure 13A , Figure 13B and Figure 13C Some steps are shown in the processing sequence according to the possible operating modes;

[0050] - Figure 14A , Figure 14B , Figure 14C , Figure 14D , Figure 14E and Figure 14F Some steps of a method for forming a polishing element according to one embodiment are shown;

[0051] - Figure 15A , Figure 15B and Figure 15C The following steps are shown according to one embodiment for arranging the grinding elements in a contact configuration;

[0052] - Figure 16A and Figure 16B Some steps of a method for forming a polishing element according to one embodiment are shown;

[0053] - Figures 17A to 17D Some steps of a method for forming a polishing element according to one embodiment are shown;

[0054] - Figures 18A to 18C The device according to the invention is illustrated schematically, wherein the grinding element is located within a partially cut blood vessel, and... Figure 18A In the contact configuration, the abrasive element can be seen being fed to remove material from the inner wall of the blood vessel portion and collect the material in the collection section; Figure 18B In the middle, the grinding element is in a static configuration, wherein the contact portion is separated from the inner wall, and the collection portion contains the removed material; Figure 18C In this configuration, the grinding element is in a stationary position, with the contact portion close to the element within the lumen to retain the collected material in the collection portion, preventing tissue and drug preparation residues from circulating in the bloodstream. Detailed Implementation

[0055] According to a general embodiment, in order to process at least one blood vessel tract 2, a vascular device 1 is included. Preferably, the vascular device 1 is a vascular catheter.

[0056] The vascular device 1 includes at least one intraluminal element 3, such as the catheter shaft of the vascular catheter, having at least one opening 4 for dispensing medication into the vascular channel 2. The intraluminal element 3 is intended to be inserted into the vascular channel 2.

[0057] Preferably, the drug dispensing opening 4 opens from the intraluminal element 3 and is in fluid communication with a drug reservoir containing a drug formulation D (e.g., a sclerosing agent), wherein the drug reservoir is mounted on the proximal portion of the vascular catheter, which preferably includes a catheter handle 15. The intraluminal element 3 (e.g., the shaft of the vascular catheter) preferably includes a distal end 24 adapted for reception within the vascular channel 2 and a proximal end adapted for retention outside the vascular channel 2.

[0058] The drug formulation D can be in liquid form or in the form of a sclerosing foam (e.g., containing air or nitrogen). Preferably, the drug formulation is injected into the patient's vascular channel 2 via a vascular catheter. For this purpose, the vascular catheter may include a treatment assembly 10 adapted to perform drug treatment on the inner wall 6 of the vascular channel 2, the treatment assembly 10 including the dispensing opening 4. At least one dispensing opening 4 may be disposed near the distal portion of the luminal element 3 (e.g., the distal portion of the catheter shaft).

[0059] The vascular device 1 also includes at least one abrasive element 5, which is designed to contact the inner wall 6 of the vascular channel 2 to remove material 7 from the inner wall 6.

[0060] The vascular device 1 is capable of applying a drug treatment to the inner wall 6 of the vascular channel 2, and also applies a mechanical abrasion treatment by means of the abrasive element 5.

[0061] According to the preferred operating mode, drug treatment is first performed, dispensing drug formulation D from the drug dispensing opening 4 onto the inner wall 6 of the vascular channel 2, followed by mechanical abrasion treatment by the at least one abrasive element 5. Therefore, the purpose of mechanical treatment is to remove the drug-treated biological material. Typically, when the endothelial layer of the inner wall of the vascular channel 2 is subjected to sclerotherapy, dead endothelial cells and muscle cells are formed, and these dead endothelial cells and muscle cells are removed by mechanical abrasion treatment.

[0062] The grinding element 5 is connected to the element 3 inside the lumen and includes a contact portion 14, which is adapted to remove the material 7 treated with the pharmaceutical formulation D from the inner wall 6.

[0063] The grinding element 5 includes at least a first surface 17, 23, which is adapted to face the intraluminal element 3 and is configured to face the fluid within the blood vessel.

[0064] The grinding element 5 is preferably used to scrape the inner wall 6 of the blood vessel channel 2 when the grinding element scrapes the inner wall 6 like a spatula or plow.

[0065] After the drug has been dispensed onto the inner wall 6 and the dispensed drug has exerted its therapeutic effect on the inner wall 6 of the vascular channel 2 (e.g., vein), the included abrasive element 5 is dragged on the inner wall 6, allowing the material 7 to be scraped off and removed from the inner wall 6.

[0066] Preferably, at least one abrasive element 5 is adapted to abrade the entire circumferential cross-section of the inner wall of the vascular channel 2. In other words, at least one abrasive element 5 is preferably adapted to remove material from the entire circumferential cross-section of the inner wall of the vascular channel 2.

[0067] It should be noted that the wall material ground off by the grinding element 5 consists of dead endothelial cells, basement membrane, dead smooth muscle cells, connective tissue, proteins, polysaccharides, proteoglycans, elastin, collagen fibers, endothelin, chemokines, select proteins, integrase proteins, etc. These substances form a biological sludge, in which the density of mud is mainly composed of dead cells. This biological sludge is an aggregate of macromolecules and cells, which may easily disperse and divide in the bloodstream. Therefore, it cannot be collected or extracted as a single dense layer as if the skin layer were removed with a dermatome.

[0068] The grinding element is configured to expand relative to the intraluminal element 3 at least in the radial direction across the main longitudinal extension direction of the blood vessel and / or intraluminal element 3, between at least one configuration between at least one stationary configuration and at least one contact configuration, wherein, in the contact configuration, the contact portion 14 contacts the inner wall 6, and in the stationary configuration, the contact portion 14 is separated from the inner wall 6.

[0069] According to one embodiment, the grinding element 5 is reversibly and selectively movable between a stationary configuration and a contact configuration. According to one embodiment, the stationary configuration is for transporting the device within the blood vessel up to the portion of the blood vessel to be treated with the drug. According to one embodiment, the stationary configuration is for transporting the material 7 to be removed from the drug-treated portion of the blood vessel out of the blood vessel, avoiding the dispersion of drug residues and the drug-treated material 7 into the bloodstream.

[0070] At least the first surfaces 17, 23 of the element 3 facing the lumen are formed, in the contact configuration, into recesses 19 suitable for fluid facing the blood vessel, wherein the collection portion 9 includes the recesses 19 to collect material 7 removed from the inner wall 6 treated with the pharmaceutical formulation D.

[0071] According to one embodiment, the recessed portion 19 has a concavity facing at least one opening 4 for dispensing the drug formulation D, such that after the inner wall of the vascular tract has been treated with the drug, material 7 can be removed from the inner wall 6 of the vascular tract by moving the abrasive element 5 in the direction of the at least one opening 4 along the advance direction, and the removed material 7 is collected in the recessed portion. According to one embodiment, the abrasive element 5 includes a deformable element in the outer diameter direction RO, which is adapted to selectively present the at least one contact configuration of the abrasive element contacting the inner wall 6. The deformation of the deformable element can be expansion.

[0072] According to one embodiment, the abrasive element 5 includes an element expandable in the outer diameter direction RO, which is adapted to selectively present at least one contact configuration in which the abrasive element contacts the inner wall 6.

[0073] The expandable element of grinding element 5 can expand according to instructions.

[0074] According to a preferred embodiment, the expandable element of the grinding element 5 is also adapted to present at least one static configuration in which the grinding element does not contact the inner wall 6.

[0075] According to one embodiment, between the contact configuration and the stationary configuration, the contact portion 14 approaches the intracavitary element 3 and closes the recessed portion 19 along the direction of the intracavitary element 3 to retain the removed material 7.

[0076] According to one embodiment, in this static configuration, the contact portion 14 is in direct or indirect contact with the intraluminal element 3 to retain the removed material 7 within the collection portion 9, thereby preventing the removed material 7 from dispersing in the bloodstream.

[0077] According to one embodiment, the grinding element 5 is reversibly expandable between the contact configuration and the stationary configuration.

[0078] According to one embodiment, the grinding element 5 includes an attachment portion that is connected to the inner element 3 within the lumen. According to another embodiment, the attachment portion is circumferentially connected to the inner element 3 within the lumen.

[0079] According to one embodiment, the first surfaces 17, 23 extend between the attachment portion and the contact portion 14 at least in the direction of the at least one opening 4 for dispensing the drug. According to one embodiment, the recessed portion 19 has a concave surface facing the at least one opening 4 for dispensing the drug. According to one embodiment, the collecting portion 9 defines an annular collecting area surrounding the intraluminal element 3. According to one embodiment, the collecting portion 9 forms an annular collecting chamber around the portion of the intraluminal element 3 facing the first surfaces 17, 23.

[0080] According to one embodiment, at the end of the treatment, at least one opening 4 serves as an aspiration opening 4' for recovering the drug previously dispensed into the chamber between the two outer balloons. According to one embodiment, the intraluminal element 3 includes an aspiration opening 4' and a dispensing opening 4. According to one embodiment, at least one aspiration opening 4' is configured to aspirate material 7 removed from the inner wall 6 and collected in the collection portion 9 of an abrasive element 5, which serves as one of two plug elements 12. With the inclusion of the aspiration opening 4', substances such as dead cell material, substances produced and released by the endothelial cells of the vessel wall (e.g., endothelin, a substance with significant vasoconstrictive properties and causing symptoms such as cerebral ischemia or myocardial ischemia) can be aspirated between the two plug elements 12.

[0081] According to one embodiment, the collection portion 9 extends at least partially around the at least one opening 4 or the at least one suction opening 4'.

[0082] According to one embodiment, the collection portion 9 extends around the portion of the intraluminal element 3 having at least one opening 4 or at least one suction opening 4'.

[0083] The body of the expandable element of the abrasive element 5 may include the attachment portion connected to the element 3 within the lumen and a contact portion 14 with the inner wall 6 of the blood vessel 2, wherein the body of the expandable element of the abrasive element 5 is designed to allow the position of the contact portion 14 to move radially to selectively perform abrasion on the material 7 from the inner wall 6. The contact portion 14 is preferably a generally circumferentially extending surface. For example, the contact portion 14 may be formed by a circumferential edge. According to one embodiment, the contact portion 14 includes the circumferential edge of the abrasive element 5.

[0084] According to one embodiment, the expandable element includes a contact portion 14 and first surfaces 17, 23.

[0085] According to a preferred embodiment, the grinding element 5 includes an inflatable balloon, for example, a surgical balloon suitable for inflation with an inflation fluid 18 (e.g., a physiological solution).

[0086] The intraluminal element 3 preferably includes at least one inflation opening 30, which is in fluid communication with the interior of the inflatable balloon for introducing or extracting inflation fluid 18 from the inflatable balloon. The handheld component 15 of the vascular device 1 may include a control interface that controls the inflation and / or deflation of the inflatable balloon forming the grinding element 5 according to instructions.

[0087] The inflatable balloon of the abrasive element 5 may include a contact portion 14 on its outer surface 22, which is adapted to perform abrasive action on the inner wall 6 of the vascular channel 2.

[0088] According to one embodiment, the inflatable bladder is adapted to cooperate with the expandable element to bring the contact portion 14 into contact with the inner wall 6 by inflating and / or deflating the inflatable bladder. According to one embodiment, the inflatable bladder includes an outer surface 22. According to one embodiment, the collection portion 9 is defined between the outer surface 22 of the bladder and the radially outer portion.

[0089] According to one embodiment, the first surfaces 17, 23 include radially inner portions and radially outer portions. According to one embodiment, the outer surface 22 of the balloon partially contacts the radially inner portion. According to one embodiment, the collection portion 9 is an annular portion that extends radially between the circumferential edge of the contact portion 14 and the outer surface 22 of the balloon, and longitudinally between the outer surfaces 22 of the balloon facing the radially outer portion, generally forming an annular niche.

[0090] In addition to the inflatable balloon, the abrasive element 5 may include a deformable element, which cooperates with the inflatable balloon to bring the contact portion 14 into contact with the inner wall 6 of the vascular channel 2. For example, as Figure 10 As shown, the expandable element is mounted on the inflatable balloon, such that the outer surface 22 of the inflatable balloon is adapted to push the inner wall of the expandable element in the outer diameter direction RO, so that the contact portion 14 of the expandable element contacts the inner wall 6 of the blood vessel channel 2.

[0091] According to one embodiment, the abrasive element 5 includes an expandable mechanism, for example, a pull rod 8. The pull rod 8 (e.g., operatively connected to a radially peripheral portion of the abrasive element 5 and to an element slidably mounted on an intraluminal element 3) allows for a reinforced connection between the abrasive element 5 and the intraluminal element 3. For example, a slider 16 may be included, slidably mounted on the intraluminal element 3, and the pull rod 8 is disposed between the slider 16 and the peripheral portion of the abrasive element 5 so that by acting on the slider 16, the pull rod 8 can be tightened, for example, to bring the expandable abrasive element 5 to a stationary position. According to one embodiment, the abrasive element 5 includes an intravascular umbrella-like structure expandable in the outer diameter direction RO, for example, as... Figure 9As shown, the intravascular umbrella-shaped structure can be installed on the intraluminal element 3.

[0092] The expandable abrasive element 5 is also suitable for radial shrinkage.

[0093] According to one embodiment, the grinding element 5 includes a hinge 20 or the like near or at the element 3 within the cavity, such that the main body of the grinding element 5 is hinged near or at the element 3 within the cavity, and / or hinged near or at the attachment portion. This hinge 20 allows the grinding element 5 to expand in the outer diameter direction RO.

[0094] The abrasive element 5 may include one or more reinforcing elements 21 adapted to locally reinforce a portion of the abrasive element 5. For example, the reinforcing element 21 may include radial and / or circumferential reinforcements. According to one embodiment, the abrasive element 5 includes reinforcing elements 21 (e.g., spurs, rostrums, and / or the like) to apply an improved mechanical abrasive action to the material from the inner wall 6 of the vascular passage 2. One or more reinforcing elements 21 may include sharp edges.

[0095] According to one embodiment, the one or more reinforcing elements 21 include at least one rib surrounding a body of the abrasive element 5 that protrudes in the outer diameter direction RO. The at least one rib may be a spiral wound around the body of the inflatable element (e.g., an inflatable bladder). The at least one rib may be a loop surrounding the body of the inflatable element (e.g., an inflatable bladder).

[0096] For example, such as Figures 12A to 12B As shown, the reinforcing element 21 can be made in the form of a ring-shaped spur.

[0097] For example, such as Figure 12B As shown, the intracavitary element 3 may include a tapered or expanded portion 31 with a decreasing radial diameter to accommodate the abrasive element 5 when in a static configuration, thereby minimizing the radial volume (bulk) of the abrasive element 5 when in a static configuration.

[0098] According to one embodiment, the abrasive element 5 includes an element suitable for radial expansion within the vascular channel 2, i.e., an element suitable for expansion in the outer diameter direction RO. For example, bellows processing may be included on a sleeve slidably mounted on the luminal element 3.

[0099] According to one embodiment, the abrasive element 5 includes elements adapted to expand radially within the blood vessel via a sail effect. For example, the abrasive element 5 includes a first surface 17 facing the fluid within the blood vessel channel 2, which tends to expand like a sail in response to the feeding movement of the abrasive element 5 within the blood vessel channel 2 when the vascular device 1 is inserted into the blood vessel channel 2, thereby positioning itself in an expanded contact configuration with the inner wall 6 of the blood vessel channel 2 in a generally automatic manner.

[0100] The feed of the abrasive element 5 within the vascular channel 2 is preferably determined by the movement of the intraluminal element 3. For example, the abrasive element 5 is integrally fixed to a portion of the intraluminal element 3 (e.g., the shaft of the vascular catheter). The feed of the abrasive element 5 is determined by moving the intraluminal element 3 longitudinally within the vascular channel 2.

[0101] The term "feed" does not necessarily mean movement directed distally. Feed movement can be directed proximally or distally as needed.

[0102] Preferably, the abrasive element 5 is positioned on a portion of the intraluminal element 3 further from the dispensing opening 4 for dispensing the sclerosing drug, and the movement of the intraluminal element 3, which determines the feeding of the abrasive element 5, occurs in the proximal direction, for example, by pulling the intraluminal element 3 proximally. This allows mechanical abrasion to be performed on the venous wall only after a prior treatment with drug D that has provided temporary contact exposure to the venous wall itself.

[0103] Although, according to the preferred embodiment, the abrasive element 5 achieves a contact configuration by expanding its volume, the abrasive element does not necessarily have to achieve a contact configuration by expanding its volume; for example, the abrasive element 5 can also achieve a contact configuration by shrinking its volume. For example, to achieve a contact configuration, the abrasive element 5 moves the contact portion 14 along the outer diameter direction RO (i.e., along the direction from the intraluminal element 3 to the inner wall 6). During this movement along the outer diameter direction RO, the volume of the body of the abrasive element 5 can expand radially, or the body of the abrasive element can move radially outward, for example, leaving at least one through opening near the intraluminal element 3 for fluid in the vascular channel 2, such as a fine filter.

[0104] For example, to achieve a contact configuration, the abrasive element 5 aligns its first surface 17 with the fluid present in the vessel channel 2, and such a first surface 17 can expand via a sail effect. The sail effect is achieved through relative motion between the abrasive element 5 and the vessel channel 2. For example, this relative motion is achieved by feeding the intraluminal element 3 within the vessel channel 2 along a propulsion direction X. The propulsion direction X can be distal or proximal.

[0105] At least one abrasive element 5 includes at least one contact portion 14 designed to remove material from the inner wall 6. The contact portion 14 may have an increased portion relative to the remainder of the abrasive element 5, and this increased portion forms a reinforcing element 21. For example, the abrasive element 5 is made in the form of a surgical balloon that can be inflated via an inflatable fluid 18 passing through an intraluminal element 3 (e.g., the axis of a vascular catheter), and at the contact portion 14 designed to remove material 7 from the inner wall 6 of the vascular passage 2, the balloon has a greater thickness, forming a reinforcement for performing the removal of material 7. Preferably, the contact portion 14 has a surface treatment designed to increase its roughness. For example, the contact portion 14 may be corrugated or pleated to facilitate abrasion on the inner wall 6. For example, the contact portion 14 may include a surface embossing treatment.

[0106] The grinding element 5 forms a recessed portion 19, which is adapted to face the fluid within the blood vessel channel 2. The recessed portion 19 is formed by the first surface 17. The fluid within the blood vessel channel 2 facing the recessed portion 19 does not necessarily include blood, because the recessed portion 19 may face an isolation portion of the blood vessel channel 2 that is temporarily isolated from blood circulation.

[0107] The grinding element 5 can be made in the form of an inflatable surgical balloon that flips over on the intraluminal element 3 of the vascular device 1, and the recessed portion 19 can be formed by the shape of the surgical balloon after it is fixed on the intraluminal element 3 and flipped over.

[0108] According to possible operating modes, a method for manufacturing an inflatable balloon having at least one recessed portion 19 includes the following steps:

[0109] - Provide a mold cavity 113 having at least one recessed portion 112 defined by a first wall having a protrusion 114 protruding in the mold cavity 113;

[0110] - Provide a preform 120 or preform 120 for the inflatable balloon, for example, the preform or preform defines a cavity 28 that is closed or through at one end;

[0111] - The preform 120 is mounted on the protrusion 114 of the die 110 of the mold.

[0112] Preferably, the device may include a mold for forming an inflatable balloon suitable for medical-surgical applications, the mold having a compression mold 110 including a first wall that at least partially defines a recessed portion 112 of a cavity 113; the first wall includes a protrusion 114 and a tapered surface 117 adapted to cantilever (forming a free protrusion end 115 and a protrusion base opposite to the free end 115) protruding into the cavity 113, the tapered surface tapering as it approaches the protrusion base. Preferably, the protrusion 114 has a generally cylindrical shape. Preferably, the protrusion base is connected to the tapered surface 117. Preferably, the protrusion 114 and the tapered surface 117 are formed as a single piece. Preferably, the tapered surface 117 is generally truncated conical. The mold may also include at least one counter-die 131 that at least partially defines the protruding portion 132 of the mold cavity 113. The counter-die 131 may include a sidewall 133 defining the cavity 113. Preferably, the mold 110 includes an abutment portion 118, and the counter-die 131 includes a counter-die support portion, the abutment portion 118 and the counter-die support portion being adapted to be adjacent to each other to define the mold cavity 113.

[0113] The manufacturing method may include at least one of the following further steps, but may also include all of the following further steps:

[0114] - Flip the blank 120 on the protrusion 114 of the die 110; and / or

[0115] - Insert the preform 120 into the mold cavity 113; and / or

[0116] - This causes the blank 120 to expand in the recessed portion 112 of the mold cavity 113.

[0117] For example, such as Figures 14A to 14FAs shown in the sequence, the grinding element 5 is a surgical balloon or inflatable balloon, manufactured as a through deformable body or preform 120 that defines a through longitudinal cavity 28. The surface 29 of the through longitudinal cavity faces the intraluminal element 3. The through deformable body or preform is mounted on the intraluminal element 3, for example, by the distal end 24 of the intraluminal element 3 and sealed to the intraluminal element 3 by a fastening element 25, thereby forming a free edge 26, i.e., not fastened to the intraluminal element 3 relative to the deformable body of the inflatable balloon opposite to the fastening element 25; subsequently, the free edge 26 is flipped. Edge 26 is fastened to a position on the intraluminal element 3 using fastening element 25', for example, distally positioned on the intraluminal element 3 relative to the position of fastening element 25; thereby forming an inner chamber 27 that can be inflated by inflation fluid 18; thus, due to the flipping action, the surface 29 of the flipped balloon portion will face the outside of the chamber 27, thereby facing the intraluminal element 3; the inflatable balloon can be inflated by inflating the inner chamber 27; the local stiffness and / or shape of the inflatable balloon can be selected to form a collection portion 9 (e.g., a collection niche) due to flipping and subsequent fastening. The collection portion 9 may have a concave shape, for example, a generally conical and / or generally annular structure.

[0118] According to one embodiment, the preform 120 and / or the surgical balloon is an elastomer or a stretchable polymer.

[0119] According to one embodiment, the stretchable polymer is a thermoplastic elastomer.

[0120] According to one embodiment, the stretchable polymer comprises at least one of the following or a mixture of at least one of the following: polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyamide, polyvinyl chloride, latex, silicone, polyurethane copolymer, polyamide copolymer, polyamide and polyether copolymer.

[0121] According to one embodiment, the surgical balloon is made of compliant and / or semi-compliant materials.

[0122] According to one embodiment, the preform 120 has a multi-layer preform body, the multi-layer preform body including a first elastic layer and a second thermoplastic layer. According to one embodiment, the preform 120 includes a non-compliant layer. According to one embodiment, the preform 120 is made of a material suitable for manufacturing compliant or semi-compliant inflatable balloons.

[0123] According to a preferred embodiment, a surgical balloon is mounted on an intraluminal element 3, which includes at least one inflation opening 30 in fluid communication with the interior of the surgical balloon for introducing or extracting inflation fluid 18 into or from the surgical balloon, so that the abrasive element 5 can reversibly expand or contract between a static configuration and a contact configuration.

[0124] According to one embodiment, the grinding element 5 has a longitudinally extending axis of a balloon, around which the balloon extends. According to another embodiment, the grinding element 5 extends in a cylindrically symmetrical manner around the longitudinally extending axis of the balloon. According to yet another embodiment, the radial direction RO is transverse relative to the longitudinally extending axis of the balloon.

[0125] According to one embodiment, a surgical balloon is sealed to the intraluminal element 3 using a first fastening element 25 and a second fastening element 25' to define a fluid-tight chamber fluidly connected to the inflation opening 30 between the inner surface of the surgical balloon and the surfaces between the first fastening element 25 and the second fastening element 26 of the intraluminal element 3, wherein the recessed portion 19 extends from the first fastening element 25 toward the contact portion 14. According to one embodiment, the recessed portion 19 has at least a partial conical shape, at least in the contact configuration. According to one embodiment, a collection portion 9 engages with the contact portion 14 to guide material 7 removed from the contact portion 14 into the collection portion to avoid interference with the contact portion 14. According to one embodiment, at least in the contact configuration, the collection portion 9 forms a funnel-shaped portion configured to facilitate the collection of removed material 7 by advancing the device 1 within the blood vessel along the propulsion direction X. According to one embodiment, the collection portion 9 and the contact portion 14 are integrated into the same element.

[0126] According to one embodiment, the abrasive element 5 has a first attachment portion and a second attachment portion, which are configured to be connected to the intraluminal element 3 via a first fastener 25 and a second fastener 25'. The first and second attachment portions are circumferential portions suitable for accommodating the intraluminal element 3, preferably cylindrical portions. The first and second attachment portions are separated by an attachment distance D along the longitudinal extension direction of the intraluminal element 3 or along the longitudinal extension axis of the balloon surrounding the abrasive element 5. According to one embodiment, the attachment distance D is between 20 mm and 150 mm.

[0127] According to one embodiment, when the balloon is in the inflated configuration, the projection of the recessed portion 19 and / or the first wall 17 onto the longitudinal extension axis of the balloon defines a segment having a recessed portion length C. According to one embodiment, the recessed portion length C is between 2 mm and 30 mm, preferably between 5 mm and 15 mm. According to one embodiment, the recessed portion length C is the height of the frustum defining the recessed portion 19. According to one embodiment, the recessed portion length is the height of the frustum defining the recessed portion 19. According to one embodiment, the recessed portion length C is between 1 / 6 and 1 / 2 of the attachment distance D.

[0128] The removed material 7 can be scraped off from the inner wall 6 of the blood vessel 2, and the material can be transported to the bleeding channel 2 by means of the collection part 9.

[0129] According to, for example Figure 16A and 16B In the operating mode shown, the preform 120 or preform 120 approaches the protrusion 114 of the die 110, the edge of which is closed, i.e., not suitable for allowing entry into the cavity 28, and the preform 120 is adapted to the protrusion 114. Therefore, the anti-convex die 131 abuts the die 110. The preform 120 is then inflated via inflation through the channel 122. The shape of the recessed portion 112 of the mold cavity 113 allows for the manufacture of an inflatable bladder with a recessed portion 19.

[0130] According to a preferred embodiment, the grinding element 5 forms a collection portion 9 for collecting the removed material 7 from the inner wall 6.

[0131] The system includes a grinding element 5 and a collection section 9 on a single device (e.g., a vascular catheter), which allows the system to simultaneously scrape or scratch the inner wall 6 to remove material and scrape off the removed material 7, avoiding the release of cells and drug fragments in the bloodstream by using a single vascular device 1 with an intraluminal element 3.

[0132] The collecting portion 9 can be formed by the recessed portion 19.

[0133] By collecting the material to be removed 7 in the collection section 9 (e.g., collection niche), debris or other materials removed from the inner wall 6 of the vascular channel 2 are prevented from entering the vascular channel 2, greatly reducing the risk of complications (e.g., local or distributed inflammation along the vascular pathway, or inflammation of the lungs, since the lungs are the collection organ for all venous blood from the periphery).

[0134] For example, such as Figures 15A to 15CAs shown in the sequence, the inflatable balloon cooperates with the expandable element (shown here as an expandable truncated cone) so that by inflating the inflatable balloon, the outer surface 22 of the balloon is pushed against the surface 23 of the intraluminal element 3 facing the expandable truncated cone, causing the contact portion 14 of the expandable truncated cone to contact the inner wall 6 of the vascular passage 2. A collection portion 9, such as an annular mouth, may be formed between the contact portion 14 and the outer surface 22 of the balloon.

[0135] At least one opening 4 for dispensing a drug in the vascular channel 2 can be manufactured as part of the processing assembly 10 to isolate the vascular volume 11 in contact with the inner wall 6 of the vascular channel 2. By isolating the vascular volume 11 or chamber from blood circulation, both the concentration of the drug formulation D in this volume 11 and the duration of contact between the drug formulation D and the inner wall 6 of the vascular channel 2 can be controlled.

[0136] According to a preferred embodiment, the treatment assembly 10 further includes one or more occlusion elements 12 suitable for isolating the vascular passage and at least one core element 13, wherein the at least one core element 13 defines a vascular volume 11 intended to contact the inner wall 6. For example, both the occlusion element 12 and the core element 13 are inflatable elements, such as inflatable surgical balloons. The inclusion of the core element 13, which occupies an adjacent region of the luminal element 3, allows the drug formulation D to contact the inner wall 6 of the vascular passage 2, reducing the amount of drug required for treatment. The inclusion of the occlusion element 12 allows the volume 11 or chamber to be isolated from blood circulation. The occlusion element 12 preferably defines the volume 11 among multiple occlusion elements. The core element 13 can be formed integrally with the occlusion element 12; for example, both the core element 13 and the occlusion element 12 can be formed from a single inflatable balloon.

[0137] Preferably, the core element 13 includes a radially expandable inflatable balloon mounted on an intraluminal element of the device 3, forming a generally annular chamber or volume 11 in contact with the inner wall 6. This inflatable balloon forming the core element 13 is adapted to expand RO along its outer diameter during inflation. According to one embodiment, the core element 13 can be inflated to excessively stretch the inner wall of the blood vessel, disrupting intercellular bonding.

[0138] According to a preferred embodiment, at least one of the blocking elements 12 also serves as an abrasive element 5 for the wall 6. Thus, a single expandable element, such as an inflatable balloon, serves both as a blocking element of the processing assembly 10 for isolating the volume 11 or chamber from blood circulation and as an element for removing material from the inner wall of the blood vessel.

[0139] Preferably, firstly, the expandable element serves as a blocking element 12 to isolate the blood vessel 2 into which the drug formulation D is to be injected, and then serves as a grinding element 5 to remove material 7 from the inner wall 6 of the same blood vessel 2 that has just been treated with the drug formulation D.

[0140] The intraluminal element 3 can be designed to translate within the vascular channel 2 along its longitudinal extension axis. Translation can occur both proximally and distally. Preferably, under operating conditions, translation occurs in the proximal direction. This proximal translation within the vascular channel 2 can be achieved by substantially pulling the intraluminal element 3 (e.g., the axis of the vascular catheter) in the proximal direction.

[0141] According to one embodiment, the at least one abrasive element 5 is positioned behind the at least one drug dispensing opening 4 in the vascular channel 2 along the lumen of the device 3 in a determinable advance direction X of the device 1. Therefore, when the lumen element 3 is fed, the same stretching of the vascular channel 2 is first exposed to the chamber of the processing assembly 10, and then to the abrasive element 5. The advance direction X is generally parallel to or coincides with the longitudinal extension axis of the vessel to be processed.

[0142] Preferably, the at least one grinding element 5 is positioned distally relative to the at least one opening 4 for dispensing the drug.

[0143] Alternatively, the at least one grinding element 5 may be positioned proximally relative to the at least one opening 4 for dispensing the drug.

[0144] The following describes a method for treating blood vessels. This method is preferably applicable to sclerotherapy for varicose veins.

[0145] The method for treating vascular channel 2 includes the following steps:

[0146] - Dispense drug formulation D onto the inner wall 6 of vascular channel 2;

[0147] - Remove material from the inner wall 6 of the blood vessel 2.

[0148] According to the preferred operating mode, the material removal step is performed after the allocation step.

[0149] According to the preferred operating mode, the method also includes the step of collecting the removed material 7.

[0150] The step of collecting the removed material 7 avoids the risk of a large amount of surging debris (e.g., decomposition products or metabolites) in the circulating stream, as well as the residue of the active pharmaceutical preparation D that may have adverse side effects.

[0151] According to one operating mode, the material removal step includes mechanical material removal. Preferably, the material removal step is performed by grinding the inner wall 6.

[0152] According to an operating mode, the method is performed by a vascular device 1 according to any one of the above embodiments.

[0153] According to one mode of operation, the method includes the step of isolating the vascular access from the circulation of blood. Preferably, this isolation step is included before the drug dispensing step.

[0154] According to one operating mode, the removal step is performed by a deformable element that can expand in the outer diameter direction RO.

[0155] According to one operating mode, both the removal and collection steps are performed by the same deformable element that is expandable in the outer diameter direction RO, and is provided with contact portion 14 and collection portion 9.

[0156] According to one operating mode, the method includes the steps of: manufacturing two protruding balloons and associating the two protruding balloons with each other in their respective edges 126, 126' to form a single balloon with a recessed portion 109, avoiding the inclusion of a mold with a recessed portion 112. Preferably, the method includes the step of providing two preforms 120, 120', each preform 120 and 120' arranged in its respective pre-mold 123 and 123', and the step of inflating each preform 120 and 120' by inflating it in its respective pre-mold 123 and 123', thereby manufacturing two protruding inflatable balloons. Preferably, such pre-mold 123 and 123' are both protruding, i.e., the pre-mold is designed to form the protruding balloons.

[0157] The edges 126 and 126' of the convex balloon are associated to form a balloon with a recessed portion 109, preferably created by laser welding.

[0158] According to one embodiment, this association is performed by gluing. According to one embodiment, this association defines the formation of a recessed portion 109 formed by one of a plurality of inflatable balloons associated with each other in their respective edges 126, 126'.

[0159] Therefore, according to a general embodiment, for example, as Figures 17A to 17D As shown, a method for manufacturing an inflatable balloon 105 having at least one recessed portion 109 for medical-surgical applications includes the following steps:

[0160] - Create two prefabricated components that are generally raised;

[0161] - The respective edges 126 and 126' of the two protruding preforms are associated with each other to form an inflatable balloon 105 with a recessed portion 109. Preferably, the recessed portion 109 of the inflatable balloon 105 is formed by one of the two associated protruding preforms. For example, the preforms can be made into a sheet of elastic material for the inflatable balloon.

[0162] The prefabricated component can instead be an inflatable balloon.

[0163] By providing the above features individually or in combination in specific embodiments, apparatuses and methods can be obtained that simultaneously satisfy the above requirements, compare with each other, and meet the aforementioned expectations, especially:

[0164] - Material can be removed from the walls of blood vessels that have just been treated with drugs (e.g., just treated with a sclerosing agent);

[0165] - Between drug treatment and material removal, the vessel wall is not exposed to physiological blood circulation, but is largely isolated from circulation;

[0166] -It allows for the selective activation of abrasive elements to remove material from the vessel wall;

[0167] - Create an expandable element that has the dual function of isolating the chamber in contact with the blood vessel wall and removing material from the blood vessel wall;

[0168] - Perform material removal at the second moment after drug treatment, allowing material to be removed from areas of walls that have already been treated with drugs (e.g., hardening drugs);

[0169] - It prevents the removed materials and drug residues from dispersing into the bloodstream.

[0170] To meet temporary and specific needs, those skilled in the art may make some changes and adjustments to the above embodiments, and may replace them with other functionally equivalent elements, without departing from the scope of this disclosure.

[0171] List of reference numerals

[0172]

Claims

1. A vascular device (1) for processing at least one vascular channel (2) of a blood vessel, the vascular device comprising: An intraluminal element (3) having at least one opening (4) for dispensing a drug formulation (D) in the vascular passage (2); as well as At least one abrasive element (5) is connected to the intraluminal element (3) and adapted to contact the inner wall (6) of the vascular channel (2) to remove material (7) treated with the pharmaceutical preparation (D) from the inner wall (6). The grinding element (5) includes at least one contact portion (14) adapted to remove the material (7) from the inner wall (6), and the grinding element (5) includes at least one collection portion (9) for collecting the material (7) removed from the inner wall (6). The abrasive element (5) is configured to expand relative to the intraluminal element (3) in at least a radial direction (RO) across the longitudinal extension direction of the blood vessel between at least one static configuration and at least one contact configuration, wherein in the at least one contact configuration, the contact portion (14) contacts the inner wall (6), and in the at least one static configuration, the contact portion (14) is separated from the inner wall (6). The grinding element (5) includes at least a first surface (17, 23) facing the intraluminal element (3) and configured to face the fluid within the blood vessel. In at least the contact configuration, the at least first surface (17, 23) forms a recessed portion (19) adapted to face the fluid within the blood vessel, wherein the collection portion (9) includes the recessed portion (19) to collect the material (7) removed from the inner wall (6) treated with the pharmaceutical preparation (D). The collecting portion (9) forms an annular collecting chamber around the portion of the first surface (17, 23) of the element (3) within the lumen. Between the contact configuration and the stationary configuration, the contact portion (14) approaches the intraluminal element (3), causing the recessed portion (19) to close toward the intraluminal element (3) to retain the removed material (7). The recessed portion (19) has a concave surface facing the at least one opening (4).

2. The vascular device (1) according to claim 1, wherein, The abrasive element (5) is an inflatable surgical balloon, wherein the inflatable surgical balloon has a first attachment portion fastened to the intraluminal element (3) and a flipped portion flipped onto the intraluminal element (3) to form the recessed portion; and / or wherein the flipped portion has a second attachment portion fastened to the intraluminal element (3), wherein the first attachment portion and the second attachment portion are circumferential portions adapted to accommodate the intraluminal element (3), wherein the first attachment portion and the second attachment portion are separated by an attachment distance (D) along the longitudinal extension direction of the intraluminal element (3).

3. The vascular device (1) according to claim 2, wherein, The circumferential portion is a cylindrical portion.

4. The vascular device (1) according to any one of claims 1 to 3, wherein, In the static configuration, the contact portion (14) is in direct or indirect contact with the intraluminal element (3) to retain the removed material (7) within the collection portion (9) and prevent the removed material (7) from dispersing in the bloodstream, and / or wherein the abrasive element (5) is reversibly expandable along the radial direction (RO) between the at least one contact configuration and the at least one static configuration.

5. The vascular device (1) according to any one of claims 1 to 3, wherein, The grinding element (5) includes an attachment portion circumferentially connected to the element (3) within the lumen, wherein the first surface (17, 23) extends at least toward the at least one opening (4) between the attachment portion and the contact portion (14). And / or wherein the at least one abrasive element (5) is positioned behind the at least one opening (4) in the vascular channel (2) along the luminal element (3) in a determinable advance direction (X) of the vascular device (1).

6. The vascular device (1) according to any one of claims 1 to 3, wherein, The contact portion (14) is a generally circumferentially extending surface, and / or wherein the contact portion (14) includes the circumferential edge of the grinding element (5).

7. The vascular device (1) according to any one of claims 1 to 3, wherein, The grinding element (5) includes an expandable mechanism, and / or wherein, The grinding element (5) includes an element suitable for radial expansion within the blood vessel via the sail effect to form the recessed portion (19).

8. The vascular device (1) according to claim 7, wherein, The expandable mechanism includes a pull rod (8).

9. The vascular device (1) according to any one of claims 1 to 3, wherein, The abrasive element (5) is a surgical balloon mounted on the intraluminal element (3), wherein the intraluminal element (3) includes at least one inflation opening (30) in fluid communication with the interior of the surgical balloon to introduce or extract inflation fluid (18) into or from the surgical balloon, thereby causing the abrasive element (5) to reversibly expand or contract between the static configuration and the contact configuration.

10. The vascular device (1) according to claim 9, wherein, The surgical balloon is sealed to the intraluminal element (3) using a first fastening element (25) and a second fastening element (25') to define a liquid-tight chamber (27) in fluid communication with the inflation opening (30) between the inner surface of the surgical balloon and the surface of the intraluminal element (3) located between the first fastening element (25) and the second fastening element (25'), wherein the recessed portion (19) extends from the first fastening element (25) toward the contact portion (14), wherein the recessed portion (19) has at least a partially conical shape at least in the contact configuration.

11. The vascular device (1) according to any one of claims 1 to 3, wherein, The grinding element (5) includes an expandable element, which includes the contact portion (14) and the first surface (17, 23). The grinding element (5) includes an inflatable bladder adapted to cooperate with the expandable element so that the contact portion (14) contacts the inner wall (6) by inflating and / or deflating the inflatable bladder. The inflatable balloon includes an outer surface (22). The collection portion (9) is defined between the outer surface (22) of the balloon and the radially outer portion (23).

12. The vascular device (1) according to claim 11, wherein, The first surface (17, 23) includes a radially inner portion and a radially outer portion (23), wherein the outer surface (22) of the balloon partially contacts the radially inner portion, wherein the collection portion (9) is an annular portion that extends radially between the circumferential edge of the contact portion (14) and the outer surface (22) of the balloon and extends longitudinally between the outer surface (22) of the balloon and the radially outer portion (23) facing the radially outer portion (23), generally forming an annular niche.

13. The vascular device (1) according to any one of claims 1 to 3, further comprising a processing assembly (10) adapted to isolate the volume (11) of the blood vessel in contact with the inner wall (6) of the blood vessel, the processing assembly comprising: One or more blocking elements (12), said one or more blocking elements being adapted to isolate the vascular tract, and At least one core component (13). The at least one core element (13) determines the volume (11) of the blood vessel intended to contact the inner wall (6). The at least one opening (4) for dispensing the drug in the vascular channel (2) is part of the processing component (10).

14. The vascular device (1) according to claim 13, wherein, The core element (13) includes a radially expandable inflatable bladder mounted on the inner element (3) of the lumen, the inflatable bladder forming a generally annular chamber in contact with the inner wall (6).

15. The vascular device (1) according to claim 13, wherein, At least one of the blocking elements (12) is the grinding element (5) of the inner wall (6). And / or wherein the intraluminal element (3) includes at least one aspiration opening (4') configured to aspirate cell debris or material released by cells of the material (7) treated with a drug formulation (D) contained between two blocking elements (12) at the end of the drug treatment, or wherein the at least one opening (4) is also a aspiration opening (4') configured to aspirate cell debris or material released by cells of the material (7) treated with a drug formulation (D) contained between two blocking elements (12).

16. The vascular device (1) according to any one of claims 1 to 3, wherein, The collecting portion (9) is connected to the contact portion (14) to guide the material (7) removed from the contact portion (14) into the collecting portion. And / or wherein, at least in the contact configuration, the collection portion (9) forms a funnel-shaped portion that is configured to facilitate the collection of the removed material (7) by feeding it into the vascular device (1) within the vascular channel (2). And / or wherein the collecting portion (9) and the contact portion (14) are integrated in the same element.

17. The vascular device (1) according to any one of claims 1 to 3, wherein, The contact portion (14) includes an increased portion relative to the rest of the grinding element (5), and the increased portion forms a reinforcing element (21). And / or wherein the abrasive element (5) includes at least one reinforcing element (21) for applying an improved mechanical abrasive action to the material of the inner wall (6) from the vascular passage (2), wherein the at least one reinforcing element (21) includes a sharp edge.

18. The vascular device (1) according to claim 17, wherein, The reinforcing element is a spur and / or a mouth-shaped protrusion.

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