Embolization devices and methods of manufacturing

Abstract

A self-expandable embolization device for promoting clot formation in a bodily lumen is provided. The embolization device is configured to have a collapsed delivery configuration and an expanded deployed configuration in which the self-expandable embolization device is radially expanded relative to a longitudinal axis of the embolization device. The embolization device comprises a plurality of flexible bristles, each of the bristles generally having, in the expanded deployed configuration, a U-shape with two legs connected by an intermediate section, wherein the legs connected by an intermediate section. The legs of the U are substantially parallel to the longitudinal axis, wherein the U defines an inside of the bristles between the U and the longitudinal axis, and an outside of the bristles between the U and the bodily lumen. The embolization device comprises at least in part a hydrogel inside, outside and / or between the bristles.

Description

[0001] EMBOLIZATION DEVICES AND METHODS OF MANUFACTURING

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to emboli zation devices and methods for manufacturing an emboli zation device .

[0004] BACKGROUND

[0005] Emboli zation devices may be deployed in the vasculature at a particular site by a user (medical practitioner ) so as to promote blood clot formation and to occlude the blood vessel . Typically, an emboli zation device may be pushed through a guiding delivery catheter ( delivery system) , which has been positioned in the blood vessel , using a delivery wire until the emboli zation device reaches the distal tip of the delivery catheter . The device is then deployed from the tip of the delivery catheter, for example by pinning (holding static ) the delivery wire and retracting the delivery catheter .

[0006] It is desired to increase the occlusion ef ficiency and to shorten the time between deployment of the emboli zation device and establishment of the occlusion .

[0007] SUMMARY

[0008] An advantage of the disclosure may be that the occlusion time ( the time after deployment until the desired occlusion is reached) may be shortened and / or that the occlusion ef ficiency may be improved .

[0009] According to the disclosure , a sel f-expandable emboli zation device for promoting clot formation in a bodily lumen is provided . The emboli zation device is configured to have a collapsed delivery configuration and an expanded deployed configuration in which the self-expandable embolization device is radially expanded relative to a longitudinal axis of the embolization device. The embolization device comprises a plurality of flexible bristles, each of the bristles generally having, in the expanded deployed configuration, a U-shape with two legs connected by an intermediate section. The legs of the U are substantially parallel to the longitudinal axis, wherein the U defines an inside of the bristles, such as directed towards the longitudinal axis and / or between the U and the longitudinal axis, and an outside of the bristles, such as (configured to be) directed towards the bodily lumen and / or between the U and the bodily lumen. The embolization device comprises (at least in part, such as not necessarily in its entirety) a hydrogel on the inside, the outside and / or between the bristles. In other terms, the embolization device comprises (at least in part a hydrogel) in connection with the bristles. The hydrogel may be (coated) inside, outside and / or between the bristles.

[0010] In embodiments, the hydrogel may be provided in connection with the bristles, such as directly on the bristles or, indirectly, on an entity associated with the bristles, such as a membrane. Hence, the hydrogel may be comprised by the bristles themselves, or the membrane, for example.

[0011] Generally, hydrogels swell in water or by contact with liquids. Hence, the hydrogel can fill spaces between the bristles so as to cover spaces between the bristles after deployment and upon contact with bodily fluid, such as blood. In embodiments, hydrogel may be between (spaces between) adjacent bristles, in particular radially and or longitudinally between adjacent bristles.

[0012] By way of providing the hydrogel on the inside, the outside and / or between the bristles, occlusion between the bristles and the bodily lumen may be reached faster. In particular, spaces between the bristles may be promptly filled up by way of the hydrogel after deployment , so that the bodily lumen can be occluded faster . By way of the hydrogel , a tighter seal against the bodily lumen, in particular the vessel wall , may be achieved .

[0013] Optionally, the intermediate sections of the bristles are located next to each other along the longitudinal axis so as to form two outer sections of the intermediate sections and an inner section of the intermediate sections between the outer sections , wherein the intermediate sections are viewed along the longitudinal axis . The hydrogel is provided on the bristles having the intermediate section in the inner section, wherein optionally bristles having an intermediate section in one of the outer sections , more optionally both outer sections , are free of hydrogel .

[0014] In some embodiments , hydrogel is speci fically provided in the middle , namely on an inner section, of neighboured bristles . The outer sections of the intermediate sections may but do not necessarily need to be free of hydrogel . An advantage of providing hydrogel in the middle of a set of bristles may be that the hydrogel is protected during deployment , since the outer bristles are folded over the bristles having the hydrogel coating . Put di f ferently, the hydrogel may be protected by the outer sections of the intermediate sections , when the hydrogel is provided on an inner section of the intermediate sections .

[0015] Alternatively or additionally, the hydrogel may be provided on the outside of the bristles at the intermediate sections of the bristles , wherein optional ly the legs of the bristles are free of hydrogel .

[0016] In one embodiment , the hydrogel may be provided at the intermediate section, i . e . the section between the legs , on the outer surface of the U-shape , i . e . on the outside of the bristles . Speci fically, in this case , hydrogel is on the outside of the bristles during deployment , which may reduce friction during deployment .

[0017] Further optionally, the emboli zation device may comprise a membrane alongside at least a part of the bristles , optionally the membrane located at least partially along the intermediate section and / or inside the intermediate section .

[0018] A membrane may be provided alongs ide at least a part of the bristles , for example inside at least a part of the bristles . The membrane may support occlusion of the bodily lumen in that it covers at least a part of the spaces between the bristles . Speci fically, as the intermediate sections extend through the lumen of the vessel when viewed in a crosssection, i . e . the intermediate sections at least partially extend in the direction perpendicular to the extension of the vessel , the membrane may be ef ficient to close spaces between the bristles in the intermediate sections .

[0019] Optionally, the membrane may be made of hydrogel and / or the membrane has ( at least partially, e . g . not in its entirety) a hydrogel coating . I f the membrane comprises hydrogel , for example by way of a coating, or consists of hydrogel , the ef fect of the membrane , namely occlusion, can be improved, as regards the speed of the occlusion .

[0020] The bristles may be arranged in proximal and distal U-shaped segments opposing each other along the longitudinal axis . Speci fically, the intermediate sections forming the distal U- shaped segment may be neighboured to the intermediate sections forming the proximal U-shaped segment . The legs forming the distal U-shaped segment face away from the legs forming the proximal U-shaped segment . In an embodiment , one proximal and one distal U-shaped segment are provided . The proximal U-shaped segment is open towards the proximal direction in that the legs point towards the proximal direction . The distal U-shaped segment is open towards the distal direction . Hence , the intermediate sections of the proximal and distal U-shaped segments may be regarded as neighboured, whilst the legs of the distal and proximal U- shaped segments point in opposite directions , away from each other .

[0021] Speci fically, advantages in connection with the hydrogel are expected for hydrogel in the proximal U-shaped segment . In such embodiment , the flexible bristles having the hydrogel inside , outside , and / or between the bristles are part of the proximal U-shaped segment . Primarily, the proximal U-shaped segment may serve for occlusion, whilst the distal U-shaped segment may primarily anchor the emboli zation device to the bodily lumen .

[0022] The hydrogel may be provided inside , outside and / or between the bristles of the proximal U-shaped segment , wherein optionally the distal U-shaped segment is free of hydrogel . This may be a particularly ef ficient embodiment , as , for the anchoring by way of the distal U-shaped segment , hydrogel may not be necessary, whilst hydrogel is speci fically helpful to promote occlusion of the bodily lumen by way of the proximal U-shaped segment .

[0023] The hydrogel may be a biocompatible hydrogel . Examples are agarose , carotin, PEG and polysaccharide . The hydrogel may form crosslink structure after coated on the inside , the outside and / or between the bristles either by thermal polymeri zation or light polymeri zation .

[0024] Di f ferent ways for manuf cturing an emboli zation device of the disclosure are also described herein . For example , a method of manufacturing an emboli zation device for promoting clot formation in a bodily lumen, optionally for the emboli zation device of the disclosure may comprise dipping or spray coating . Speci fically, the emboli zation device comprises a plurality of flexible bristles and / or a membrane , wherein at least a part of the plurality of flexible bristles and / or of the membrane is either dipped into a solution containing hydrogel dissolved in the solution or is spray- coated with a coating containing hydrogel dissolved in a solution . By way of dipping or spray-coating, an ef ficient way to provide bristles and / or the membrane with hydrogel i s provided .

[0025] I f the membrane is dipped into the solution, the membrane may be installed at the bristles afterwards , so that the membrane is provided with the hydrogel separate from the bristles . This is also conceivable when spray coating the membrane .

[0026] The bristles may, during manufacture , be generally straight ( i . e . not in a U-shape ) and point along a longitudinal axis ( i . e . extend in the longitudinal direction) so as to form at least a first section and a second section of bristles , wherein the bristles in the first section are housed by a housing, while the bristles in the second section are at least partially dipped into the solution while being rotated around the longitudinal axis . The bristles in the second section are not housed by the housing and are not covered, so that the bristles in the second section are submerged into the solution . However, as the bristles in the first section are housed in a housing, they are not dipped into a solution while they rotated around the longitudinal axis .

[0027] In some embodiments of manufacture , optionally for the emboli zation device of the di sclosure , a plurality o f flexible bristles is provided along a longitudinal axis , the bristles being substantially straight (not in a U- form) and forming at least first and second sections when viewed along the longitudinal axis . In a second step, the bristles in the first section are separated from the bristles in the second section . While the bristles in the second sections are , in a third step, coated with hydrogel , the bristles in the first section are not coated with hydrogel . In a fourth step, the plurality of bristles are formed in a U-shape , so that each of the bristles has a generally U-shape with two legs connected by an intermediate section in the expanded deployed configuration, wherein the legs of the U are substantially parallel to the longitudinal axis .

[0028] Optionally, in the second and third steps , the bristles in the first section are bent towards the longitudinal axis and / or are housed in a housing . This allows for avoiding coverage of the bristles of the f irst section with hydrogel . Speci fically, separating the bristles in the first section may mean that the bristles in the first section are bent towards the longitudinal axis , or may mean that the bristles of the first section are housed in a housing . The bristles of the second section are not bent towards the longitudinal axis in the second and third steps , and / or are not housed in a housing .

[0029] In some methods of the disclosure , the emboli zation device for promoting clot formation in a bodily lumen is manufactured as follows . In a first step, the plurality of flexible bristles are lined-up along a longitudinal direction and are in a U-shape , so that the bristles generally have , in an expanded deployed configuration, a U-shape with two legs connected by an intermediate section, wherein the legs of the U are substantially parallel to the longitudinal direction .

[0030] In a second step, the bristles are at least covered at the legs , while the bristles are uncovered at the intermediate section . In a third step, coating is provided to the uncovered intermediate sections o f the bristles , the coating comprising hydrogel , while the bristles are not being coated with hydrogel at the covered legs . Generally, each bristle may have a ( substantially two- dimensional ) U-shape . The plurality of bristles forms a three-dimensional structure , wherein the plurality of bristles forms an umbrella-like structure . For this , the various U-shapes are distributed in an angular fashion .

[0031] Hence , the U-shape of the respective bristle leads to an umbrella-shape of the plurality o f bristles . Basically, each of the bristles has an angular displacement relative to the adj acent bristle , when looking at the circumferential distribution of the bristles .

[0032] In the straight configuration or the intermediate section in the U-shaped configuration of the bristles , the bristles may extend radially outwardly from a core or stem, which is an elongated element extending in a longitudinal direction along the length of the emboli zation device .

[0033] The intermediate sections may be rounded / curved, so that the bristles extend in their respective intermediate section substantially perpendicularly from the stem and, when reaching the legs of the bristles , have undergone a curve / curvature of about 90 ° so as to extend substantially parallel to the stem .

[0034] Throughout this disclosure , the term ' emboli zation device ' may refer to a device which may be permanently or semipermanently implanted in a bodily lumen to promote occlusion of the bodily lumen to emboli ze the bodily lumen . Accordingly, the ' emboli zation device ' may be configured to be disposed within the bodily lumen for a period of time , such as a number of days , or disposed in the lumen indefinitely, to promote occlusion of the lumen . To this end, the ' emboli zation device ' may be configured to be selectively detached from a delivery element so that it may be implanted in the bodily lumen in isolation . Throughout this disclosure , the term 'bodily lumen' or 'body lumen' may refer to the inside space within a tubular structure of the human or animal body . The 'bodily lumen' may be , for example , an artery or vein .

[0035] Throughout this disclosure , the term ' collapsed delivery configuration' of an element may refer to a configuration o f the element which has a smaller radial extent than an expanded deployed configuration of the element .

[0036] Throughout this disclosure , the term ' to anchor' may refer to partly or fully securing an element in a position .

[0037] The sel f-expandable emboli zation device may comprise bristle segments having a core and a plurality of flexible bristles extending radially outwardly of the core . The core may be a stem . The term ' stem' may refer to an elongate element which extends longitudinally along the length of the emboli zation device or bristle segment to act as a backbone for the device or segment , and has a signi ficantly smaller radial extent than the further elements of the emboli zation device ( for example , the plurality of flexible bristles ) . The stem may extend along substantially the whole longitudinal extent of the plurality of flexible bristles of the device or segment ( e . g . when the emboli zation device is in an unrestrained configuration, collapsed delivery configuration and / or expanded deployed configuration) . The stem may extend along substantially the whole length of the emboli zation device . The bristle segments of each bristle section may be formed on a single core or may be formed on separate connected cores .

[0038] The term 'bristle ' may refer to an elongate strand of material formed substantially a single piece . The 'bristle ' may be a resilient bristle . The resilient bristle may be biased towards a particular curvature . Throughout this disclosure , the term ' radially outwardly' does not exclude the element additionally extending in the longitudinal direction of the device . For example , the element may extend radially outwardly and longitudinally .

[0039] Throughout this disclosure , the term "bristle segment" may refer to a group of bristles wherein the spacing between adj acent bristles is less than a predetermined distance . When two bristle segments are " spaced apart" , the spacing between the bristle segments ( i . e . the spacing between the most distal bristle of the first segment and the most proximal bristle of the second segment ) is greater than the spacing between adj acent bristles within at least one of the bristle segments .

[0040] For devices comprising a plurality of bristles , the plurality of flexible bristles may have a collapsed configuration in the collapsed delivery configuration . The plurality of flexible bristles may have an expanded configuration in the expanded deployed configuration . The plurality of bristles may extend radially outwardly from the core or stem in a plurality of circumferential directions about the core or stem .

[0041] In the expanded configuration, the plurality of flexible bristles may be configured to anchor the device in the bodily lumen . The plurality of flexible bristles may be configured to provide substantially all of the anchoring force for the emboli zation device or the bristle segment in the bodily lumen .

[0042] In the expanded configuration, the plurality of flexible bristles may be configured to contact the bodily lumen .

[0043] The device adopts the collapsed delivery configuration when the device is positioned inside the delivery catheter . More particularly, in the collapsed delivery configuration, device has a radial extent which is less than the radial extent of the device in the expanded deployed configuration.

[0044] The bristles may be made of a flexible or resiliently deformable material such as stainless steel, Elgiloy or Nitinol. Other suitable materials may also be used, such as any suitable polymer or any other shape memory metal or metal alloy .

[0045] The membrane may be a metallic mesh membrane made of materials such as stainless steel or Nitinol. The membrane support may be made of any self-expanding material, such as a polymer, Nitinol or stainless steel. The membrane may comprise or consist of polyurethane or polyethylene.

[0046] The stem may be made of stainless steel or other suitable material and may comprise a twisted wire from which the bristles extend and on which the flow restrictor is mounted. The stem may alternatively comprise a hollow tube wherein the walls of the hollow tube hold the radially extending bristles in place. For example, the tube may be formed from a heat shrinkable material as is well known in the art. Alternatively or additionally, the bristles may be held by the stem using other means such as adhesives.

[0047] The diameter of an individual flexible bristle may range from 0.036mm (0.0014 inches) to 0.053mm (0.0021 inches) . For example, the diameter of an individual flexible bristle may be 0.381mm (0.015 inches) , 0.445mm (0.0175 inches) or 0.508mm (0.02 inches) . The overall radial diameter of the expanded flexible bristles may range from 5mm to 30mm.

[0048] A thickness of the hydrogel (coating) may depend e.g. on the distance between the bristles when deployed in the maximum indicated vessel diameter. The applied coating thickness may ensure that when deployed and the hydrogel has reached maximum swelling, the gaps between the bristles are minimal in order to restrict / prohibit blood flow.

[0049] Generally, a thickness of the hydrogel (coating) may be about 5 to 50% of the diameter of the bristles, prior to swelling. For example, the thickness of the hydrogel (coating) may be between 0.002 to 0.020 mm prior to swelling.

[0050] A thickness of the hydrogel after swelling may be 10 to 100% of the diameter of the bristles. For example, the thickness of the hydrogel (coating) may be between 0.004 to 0.040 mm after swelling.

[0051] The occluding membrane may be a thin film membrane. For example, the occluding membrane may have a thickness of 4pm to 35pm and a radial diameter, in the deployed configuration, of 5mm to 20mm. For example, the diameter of the membrane may be 6.5mm, 9mm or 16mm.

[0052] The membrane may comprise or consist of polyurethane or polyethylene .

[0053] BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Fig. 1 schematically depicts a cross-sectional view of an embolization device in a vessel, according to one or more embodiments shown and described herein;

[0055] Fig. 2 schematically depicts a part of an embolization device, according to one or more embodiments shown and described herein;

[0056] Fig. 3 schematically depicts another embolization device, according to one or more embodiments shown and described herein;

[0057] Fig. 4 schematically depicts yet another embolization device, according to one or more embodiments shown and described herein; Fig . 5 schematically depicts a delivery system, according to one or more embodiments shown and described herein; and

[0058] Figs . 6a and 6b schematically depicts a method of manufacture of an emboli zation device ; according to one or more embodiments shown and described herein

[0059] DETAILED DESCRIPTION

[0060] Fig . 1 schematically depicts an emboli zation device 1 in the expanded deployed configuration 4 . The sel f-expandable emboli zation device 1 promotes clot formation in a bodily lumen 2 , such as a vessel . The emboli zation device 1 is sel fexpandable and expands when moving from the collapsed delivery configuration 3 ( indicated in Fig . 5 ) to the expanded deployed configuration 4 shown in Fig . 1 . In the expanded deployed configuration 4 , the emboli zation device 1 is radially expanded relative to a longitudinal axis A of the emboli zation device 1 . In Fig . 1 , the longitudinal direction L points in the distal direction .

[0061] The emboli zation device 1 comprises a plurality of flexible bristles 5 . Each of the bristles 5 has a general U-shape with two legs 6 connected by an intermediate section 7 . A portion of the legs 6 are substantially parallel to the longitudinal axis A and conform to the vessel wall or bodily lumen 2 when in the deployed configuration 4 within the lumen 2 . Fig . 1 shows a stem or core 22 , from which the bristles 5 extend . Speci fically, the bristles 5 are arranged in proximal and distal U-shaped segments 12 , 13 . These segments 12 and 13 oppose each other along the longitudinal axis L . This means that the intermediate sections 7 which form the distal U- shaped segment 13 are neighboured to , but distanced from the intermediate sections 7 forming the proximal U-shaped segment 12 . The legs 6 forming the distal U-shaped segment 13 face away from the legs 6 forming the proximal U-shaped segment 12. Hence, from the core 22, two opposite U-shaped segments emerge .

[0062] The bristles 5 in their entirety define an inside I of the bristles towards the longitudinal axis A, and an outside 0 of the bristles 5 towards the bodily lumen 2. As such, an inside I of the bristles (of a segment 12, 13) extends from the bristles 5 towards the stem 22, and an outside 0 of the bristles 5 (of a segment 12, 13) extends from the bristles 5 towards the bodily lumen 2 or relative to the opposite bristle segment 12, 13.

[0063] A hydrogel 10 is provided in connection with the bristles 5, cf. Figures 2,3 and 4. Specifically, the embolization device 1 comprises at least in part the hydrogel 10 on the inside I, the outside 0 and / or between the bristles 5 (not shown in Fig. 1) .

[0064] In a first embodiment, as shown in Fig. 2, the intermediate sections 7 of the bristles 5 of one segment, here the proximal segment 12, are located next to each other along the longitudinal axis L, so as to form, along the longitudinal axis L, two outer sections 8 and an inner section 9 sandwiched between the outer sections 8. The hydrogel 10 is provided on the bristles 5 of the inner section 9. The outer sections 8 may be free or substantially free of hydrogel. By doing so, namely when bristles 5 (in their entirety or partially) of only the middle or inner section 9 of the intermediate sections 7 are coated with hydrogel 10, the hydrogel 10 is protected by way of the "surrounding" bristles 5, as the hydrogel 10 is basically covered by bristles 5 having the intermediate section 7 in an outer section 8.

[0065] In some embodiments, as shown in Fig. 3, which is compatible with the embodiment of Fig. 2, the hydrogel 10 is provided on the outside 0 the bristles 5 at the intermediate sections 7 of the bristles 5. Hence, the hydrogel 10 can be regarded as provided on the outside 0 the bristles 5. Fig. 3 shows that the hydrogel 10 is only provided at the intermediate section 7 of the proximal segment 12. The legs 6 of the proximal segment 12 are free of hydrogel. Also, the distal segment 13 is free of hydrogel. In alternative embodiments, the hydrogel may be positioned on the distal segments and / or on the legs.

[0066] In some embodiments, such as illustrated in Fig. 4, the embolization device 1 comprises a membrane 11. The membrane 11 is at least in part on the inside of the bristles 5, specifically the membrane 11 is at least on the inside of the intermediate sections 7.

[0067] While the membrane 11 may be free of hydrogel 10, it is contemplated that the membrane 11 is made of hydrogel 10 and / or that the membrane 11 has a hydrogel coating. If the membrane 11 is made of hydrogel 10 or has a hydrogel coating, the embolization device 1 may be regarded as comprising a hydrogel 10 at least in part between the bristles 5, if the membrane 11 is provided between spaces between the bristles 5 and / or is on the inside or on the outside of the bristles 5.

[0068] Fig. 4 shows that the membrane 11 is in the proximal segment 12 inside the intermediate sections 7. The distal segment 13 is free of a membrane 11 and may be free of a hydrogel 10. In alternative embodiments, the distal segment 13 may comprise hydrogel .

[0069] Fig. 4 also shows a delivery system 14 for delivery of the embolization device 1 (of any embodiment of the disclosure) . The delivery device 14 has, as shown in Fig. 5, a haemostasis valve 15, a loader 16, a Tuohy borst 17 and a distal end 18. However, a greater or fewer number of components are contemplated and possible. The distal end 18 is configured to house the embolization device 1 in its collapsed delivery configuration 3 and comprises a distal orifice 19 as shown in Fig. 4. The distal orifice 19 of the delivery system 14 is configured to allow the embolization device 1 to emerge from the distal end 18 for deployment of the embolization device 1. In Fig. 4, the situation is shown after the embolization device 1 has emerged from the delivery system 14, the delivery system 14 being retracted along the bodily lumen 2 in the proximal direction, after deployment of the embolization device 1.

[0070] The distal end 18 of the delivery system 14, as shown in Fig. 5, accommodates the embolization device 1 during delivery .

[0071] An embolization device 1 of the disclosure may be manufactured by way of dipping or spray coating with hydrogel 10. For example, at least a part of the plurality of flexible bristles 5 and / or of the membrane 11 may comprise hydrogel

[0072] 10.

[0073] The flexible bristles 5 and / or the membrane 11 may, at least partially, be dipped into a solution containing hydrogel 10 dissolved in the solution. Alternatively, at least a part of the plurality of flexible bristles 5 and / or of the membrane

[0074] 11 may be spray-coated with a coating containing hydrogel 10 dissolved in the solution.

[0075] In embodiments, if the membrane 11 is dipped into the solution or spray-coated with the solution, the membrane 11 may be installed in the bristles 5, i.e. the embolization device 11 is assembled, after the membrane 11 has been manufactured separately.

[0076] During dip-coating, the bristles 5 may be generally straight, i.e. not in a U-shape, and positioned along the longitudinal axis A, along the core 22. The bristles 5 may be substantially perpendicular to the stem 22. If not all of the bristles 5 are to be coated, the bristles 5 of one segment 12, 13 may be divided up in a first section 8' and in a second section 9' . For dip-coating, the bristles 5 of some embodiments may be rotated around the core 22 or the longitudinal axis L so that the ends of the bristles 5, later forming the legs 6, and optionally also the intermediate sections 7 of the later U-shape of the bristles 5, are covered with the hydrogel solution 20.

[0077] Fig. 6 reflects the manufacturing process if not all of the first 8' and second 9' sections are to be covered with hydrogel solution 20. In this case, the bristles of the first section 8' may be housed by a housing 21, as shown in Fig. 6b. The bristles in the second section 9' are not housed by the housing 21 but are submerged into the hydrogel solution 20 and are, thus, coated with hydrogel 10.

[0078] Accordingly, when manufacturing the embolization device 1, the following steps may be performed in this order (e.g. defined in claim 13) :

[0079] Firstly, the plurality of flexible bristles 5 are provided along the longitudinal axis A, wherein the bristles 5 extend straight from the core 22, such as perpendicularly. First 8' and second 9' sections of the straight bristles 5 are formed, when separating the first and second sections 8', 9' along the longitudinal axis A. In a second step, the bristles 5 of the first section 8' are covered by the housing 21, i.e. are received within the housing 21, while the bristles 5 in the second section 9' are uncovered. Hence, the bristles 5 in the first section 8' are separated from the bristles 5 in the second section 9' . In the third step, the bristles in the second section 9' are coated with hydrogel 10, while the bristles 5 in the first section 8' are not being coated with hydrogel. In a fourth step, the plurality of bristles 5 is shaped into the U-shape, so that each of the bristles 5 has a general U-shape with two legs 6 connected by an intermediate section 7 in the expanded deployed configuration 4, wherein the legs 6 of the U are substantially parallel to the longitudinal axis A.

[0080] In steps 2 and 3, separating the bristles 5 in the first section 8' may mean that the bristles 5 in the first section 8' are bent towards the longitudinal axis A, so as to extend substantially parallel to the longitudinal axis A. The bristles 5 of the first section 8' may be housed in a housing 21.

[0081] This way of manufacturing may be particularly, suitable for manufacturing the embolization device 1 generally depicted in FIG. 2, wherein the bristles 5 in the first section 8' may correspond to bristles 5 in outer sections 8 of intermediate sections 7, whilst the second section of straight bristles 9' may correspond to bristles 5 of the inner section 9 of intermediate sections 9.

[0082] An embolization device 1 as shown in Fig. 3 may be manufactured as follows. A plurality of flexible bristles 5 may be provided in a U-shape so that the bristles 5 generally have, in the expanded deployed configuration 4, a U-shape with two legs 6 connected by an intermediate section 7, wherein the legs 6 of the U are substantially parallel to the longitudinal direction L. Afterwards, the bristles 5 are at least partially covered at the legs 6 (e.g. within a housing 21) , while the bristles 5 are uncovered at the intermediate sections 7. Hence, coating 10 can is applied to the outside 0 of the intermediate sections 7 of the proximal segment 12. The proximal segment 13 is free of hydrogel 10. The coating may be spray-coated, for example.

[0083] When deploying the embolization device 1 of the disclosure in a patient, the user (medical practitioner or surgeon) may perform the following steps, after having selected the correct size of the embolization device 1 / delivery system 14 for the target site: 1. Flush the delivery system 14 with saline

[0084] 2. Advance the delivery system 14 within the vessel 2 until the embolization device 1 within a sheath (e.g. catheter tube of the delivery system 14) is visible under fluoroscopy at the target site

[0085] 4. Retract the sheath to deploy a distal end (e.g. distal segment 13) of the embolization device 1. The embolization device in the deployed configuration may hold itself within the bodily lumen, e.g. may clamp itself within the bodily lumen .

[0086] 5. Optionally confirm positioning and continue to retract the sheath until a proximal end (e.g. proximal segment 12) of the embolization device 1 is deployed

[0087] 6. Remove the delivery system 14 from the vasculature and accessory devices from the patient and complete the procedure .

[0088] The above method may include a greater or fewer number of steps without departing from the scope of the present disclosure .

[0089] Reference signs

[0090] 1 emboli zation device

[0091] 2 bodily lumen

[0092] 3 collapsed delivery configuration

[0093] 4 expanded deployed configuration

[0094] 5 bristle

[0095] 6 leg

[0096] 7 intermediate section

[0097] 8 outer section of intermediate sections of bristles

[0098] 9 inner section of intermediate sections of bristles

[0099] 10 hydrogel

[0100] 11 membrane

[0101] 12 proximal segment

[0102] 13 distal segment

[0103] 14 delivery system

[0104] 15 hemostasis valve

[0105] 16 loader

[0106] 17 Tuohy borst

[0107] 18 distal end of delivery system

[0108] 19 distal ori fice

[0109] 20 hydrogel -solution

[0110] 21 housing

[0111] 8 ' first section of straight bristles

[0112] 9 ' second section of straight bristles

[0113] 22 core

[0114] L longitudinal direction

[0115] A longitudinal axis

[0116] I inside

[0117] 0 outside

Claims

Claims1. A self-expandable embolization device (1) for promoting clot formation in a bodily lumen (2) , the embolization device (1) configured to have a collapsed delivery configuration (3) and an expanded deployed configuration (4) in which the selfexpandable embolization device is radially expanded relative to a longitudinal axis (A) of the embolization device (1) , the embolization device comprising: a plurality of flexible bristles (5) , each of the bristles (5) generally having, in the expanded deployed configuration (4) , a U-shape with two legs (6) connected by an intermediate section (7) , wherein the legs (6) of the U are substantially parallel to the longitudinal axis (A) ; the bristles define an inside (I) of the bristles (5) directed towards the longitudinal axis (A) and an outside (0) of the bristles (5) configured to be directed towards the bodily lumen ( 2 ) ; and at least in part a hydrogel (10) positioned on the inside (I) , on the outside (0) , and / or between the bristles (5) .

2. The embolization device (1) according to claim 1, wherein the intermediate sections (7) of the bristles (5) are located next to each other along the longitudinal axis (A) so as to form two outer sections (8) and an inner section (9) between the outer sections (8) , when the intermediate sections (7) are viewed along the longitudinal axis (A) ; wherein the hydrogel (10) is provided on the bristles(5) of the inner section (9) , wherein optionally the bristles (5) having the intermediate section in one of the outer sections (8) , and more optionally in both outer sections (8) , are free of hydrogel (10) .

3. The embolization device according to claim 1 or 2, wherein hydrogel (10) is provided on the outside (0) the bristles (5) and at the intermediate sections (7) of thebristles (5) , wherein optionally the legs (6) of the bristles(5) are free of hydrogel (10) .

4. The embolization device according to any of the preceding claims, wherein the embolization device (1) comprises a membrane (11) alongside at least a part of the bristles (5) , optionally the membrane (11) located at least along the intermediate sections (7) and / or on the inside the bristles .

5. The embolization device according to claim 4, wherein the membrane (11) is made of the hydrogel (10) and / or the membrane (11) has a hydrogel coating.

6. The embolization device according to any of the preceding claims, wherein the bristles (5) are arranged in proximal (12) and distal (13) segments opposing each other along the longitudinal axis (A) in that the intermediate sections (7) forming the distal segment (13) are neighboured to the intermediate sections forming the proximal segment (12) and the legs (6) forming the distal segment (13) face away from the legs (6) forming the proximal segment (12) .

7. The embolization device according to claim 6, wherein the hydrogel (10) is provided on the inside (I) , on the outside (0) and / or between the bristles (5) of the proximal segment (12) , optionally wherein the distal segment (13) is free of hydrogel (10) .

8. The embolization device according to any of the preceding claims, wherein the hydrogel (10) is a biocompatible hydrogel, optionally comprising agarose, keratin, PEG and / or polysaccharide .

9. The embolization device according to any of the preceding claims, wherein the hydrogel forms a crosslink structure, optionally by thermal polymerization or light polymerization.

10. A method of manufacturing an embolization device (1) for promoting clot formation in a bodily lumen (2) , optionally the embolization device (1) of any of the preceding claims 1 to 8, wherein the embolization device (1) comprises a plurality of flexible bristles (5) and / or a membrane (11) , wherein at least a part of the plurality of flexible bristles (5) and / or of the membrane (11) is(a) dipped into a solution (20) containing hydrogel (10) dissolved in the solution (20) and / or(b) spray coated with a coating containing hydrogel (10) dissolved in a solution (20) .

11. The method of claim 10 according to (a) , wherein the membrane (11) is at least partially dipped into the solution (20) before the membrane (11) is installed at the bristles (5) .

12. The method of claim 10 or 11 according to (a) , wherein the bristles (5) are generally straight and point in the longitudinal direction (L) so as to form at least a first section (8' ) and a second section (9' ) of bristles, wherein the bristles in the first section (8' ) are housed by a housing (21) , while the bristles in the second section (9' ) are at least partially dipped in the solution (20) while being rotated around the longitudinal axis (A) .

13. A method of manufacturing an embolization device, optionally the embolization device (1) of any of the preceding claims 1 to 8, for promoting clot formation in a bodily lumen, comprising the following steps in this order:

1. providing a plurality of flexible bristles (5) along a longitudinal axis (A) , the bristles (5) being substantially straight and forming at least first (8' ) and second (9' ) sections when viewed along the longitudinal axis (A) ;2. separating the bristles in the first section (8' ) from the bristles (5) in the second section (9' ) ,3. coating the bristles (5) in the second section (8' ) with a hydrogel (10) , while the bristles (5) in the first section (9' ) are not being coated with hydrogel,4. forming the plurality of bristles (5) in a U-shape, so that each of the bristles (5) generally has a U-shape with two legs (6) connected by an intermediate section (7) in the expanded deployed configuration, wherein the legs (6) of the U run substantially parallel to the longitudinal axis (A) .

14. The method of claim 13, wherein, in steps 2 and / or 3, the bristles (5) in the first section (8' ) are bent towards the longitudinal axis (A) and / or are housed in a housing (21) .

15. A method of manufacturing an embolization device (1) for promoting clot formation in a bodily lumen (2) , comprising the following steps in this order:

1. providing a plurality of flexible bristles (5) along a longitudinal direction (L) and in a U-shape, so that the bristles (5) generally have, in an expanded deployed configuration, a U-shape with two legs (6) connected by an intermediate section (7) , wherein the legs (6) of the U are substantially parallel to the longitudinal direction (L) ,2. covering the bristles (5) at least partially at the legs (6) , while the bristles (5) are uncovered at least at the intermediate sections (7) ,3. coating the uncovered intermediate section (7) of the bristles (5) with a hydrogel (10) , while the bristles (5) are not coated with hydrogel at the at least partially covered legs (5) .

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