Systems for occluding a blood vessel

Abstract

This occlusion plug for occluding a blood vessel comprises a first segment, a second segment mechanically connected to the first segment, each of the first and second segments including a central portion, a distal tip and a proximal tip, the distal tip being configured to be, when the occlusion plug is inserted in a blood vessel, in front of the proximal tip with respect to an insertion direction of the occlusion plug in the blood vessel, the central portion of each of the first and second segments having a radial outer surface and being configured so that the radial outer surface is able, when the occlusion plug is implanted in a blood vessel, to radially contact a wall of the blood vessel, and an interconnect region mechanically connecting the proximal tip of the first segment to the distal tip of the second segment.

Description

TITLE : Systems for occluding a blood vesselTechnical Field

[0001] The present disclosure relates to systems for occluding a blood vessel. More particularly, the present disclosure relates to an occlusion plug or to a microvascular plug for occluding a blood vessel, to a method for manufacturing such a plug, to a method for occluding a blood vessel and to a catheter assembly including such a plug.Background

[0002] For the treatment of various vascular diseases, it is known to deliver plugs in a vasculature of a patient. For example, an embolization plug includes a segment, such as an inflatable balloon, which may be expanded in a blood vessel in order to occlude a blood flow through the vessel.

[0003] Although such medical implants are considered generally satisfactory, it is widely known in the embolization market that there is a demand for longer plugs to treat disease states such as pelvic congestive syndrome.

[0004] In order to solve this problem, a known technique includes using a first plug at the distal end of the vessel and a second plug at the proximal end of the vessel and filling in-between with glue or gel foams. However, such a procedure is expensive, takes a significant amount of time and requires adjunctive devices to perform the treatment.

[0005] Other examples of medical implants to be delivered to a vasculature of a patient are provided in documents US 2022 / 022882 and US 2021 / 282785. However, the devices disclosed in these documents are aneurysm fillers and, therefore, are not occlusion plugs or adapted for occluding a blood vessel.

[0006] There is therefore a need for a device adapted for occluding a blood vessel, which is longer than the known occlusion plugs, without increasing the costs of the treatment procedure and involving a significant time-consuming additional step.Summary of Invention

[0007] According to a first aspect of the present disclosure, there is provided an occlusion plug for occluding a blood vessel, comprising a first segment, a second segmentmechanically connected to the first segment, each of the first and second segments including a central portion, a distal tip and a proximal tip, the distal tip being configured to be, when the occlusion plug is inserted in a blood vessel, in front of the proximal tip with respect to an insertion direction of the occlusion plug in the blood vessel, the central portion of each of the first and second segments having a radial outer surface and being configured so that the radial outer surface is able, when the occlusion plug is implanted in a blood vessel, to radially contact a wall of the blood vessel, and an interconnect region mechanically connecting the proximal tip of the first segment to the distal tip of the second segment.

[0008] According to a second aspect of the present disclosure, there is provided a microvascular plug to occlude a blood flow in a vessel of a vasculature, comprising: a distal segment comprising: a distal front end tip, a distal rear end tip, and a distal embolization body to radially contact a wall of the vessel, the distal embolization body being between the distal front end tip and the distal rear end tip along a direction of delivery of the microvascular plug in the vessel, a first proximal segment comprising: a first proximal front end tip, a first proximal rear end tip, and a first proximal embolization body to radially contact a wall of the vessel, the first proximal embolization body being between the first proximal front end tip and the first proximal rear end tip along a direction of delivery of the microvascular plug in the vessel, and a first joint member mechanically connected to the distal rear end tip and to the first proximal front end tip.

[0009] According to a third aspect of the present disclosure, there is provided a method of manufacturing an occlusion plug for occluding a blood vessel, comprising: obtaining a first segment and a second segment, each of the first and second segments including a central portion, a distal tip and a proximal tip, the distal tip being configured to be, when the occlusion plug is inserted in a blood vessel, in front of the proximal tip with respect to an insertion direction of the occlusion plug in the bloodvessel, the central portion of each of the first and second segments having a radial outer surface and being configured so that the radial outer surface may, when the occlusion plug is implanted in a blood vessel, radially contact a wall of the blood vessel, obtaining an interconnect region, and mechanically connecting, via the interconnect region, the proximal tip of the first segment to the distal tip of the second segment.

[0010] According to a fourth aspect of the present disclosure, there is provided a method of occluding a blood vessel including inserting an occlusion plug as set forth above in the blood vessel, wherein the step of inserting the occlusion plug is implemented in such a way that, for each the first and second segments, the distal tip of said segment is in front of the proximal tip of said segment with respect to an insertion direction of the occlusion plug in the blood vessel.

[0011] According to a fifth aspect of the present disclosure, there is provided a catheter assembly comprising a catheter body, an aperture, a lumen extending within the catheter body and communicating with an exterior of the catheter body via the aperture, and an occlusion plug as set forth above, the occlusion plug being housed in the lumen.Brief Description of Drawings

[0012] To enable better understanding of the present disclosure, and to show how the same may be carried into effect, reference will now be made, by way of examples only, to the accompanying schematic drawings, in whichFig. 1 shows a schematic view of an occlusion plug according to one or more embodiments shown and described herein,Fig. 2 shows a perspective view of the occlusion plug of Fig. 1,Fig. 3 shows a perspective view of an occlusion plug according to one or more embodiments shown and described herein,Fig. 4 is an enlarged view of an interconnect region of an occlusion plug according to one or more embodiments shown and described herein,Fig. 5 is an enlarged view of an interconnect region of an occlusion plug according to one or more embodiments shown and described herein,Fig. 6 is an enlarged view of an interconnect region of an occlusion plug according to one or more embodiments described herein,Fig. 7 is an enlarged view of an interconnect region of an occlusion plug according to one or more embodiments shown and described herein,Fig. 8 is a perspective view of an occlusion plug according to one or more embodiments shown and described herein,Fig. 9 is an enlarged view of an interconnect region of the occlusion plug of Fig. 8,Fig. 10 is an enlarged view of an interconnect region of an occlusion plug according to one or more embodiments shown and described herein,Fig. 11 is a schematic view of an occlusion plug according to one or more embodiments shown and described herein,Fig. 12 is a schematic view of a catheter assembly according to one or more embodiments shown and described herein,Fig. 13 is a flow chart of a method of manufacturing an occlusion plug according to one or more embodiments shown and described herein, andFig. 14 is a flow chart of a method of occluding a blood vessel according to one or more embodiments shown and described herein.Description of Embodiments

[0013] According to the present disclosure, Fig. 1 shows an occlusion plug 2, or a microvascular plug 2. The occlusion plug 2 is configured for occluding a blood vessel. In other words, the occlusion plug 2 is able to occlude a blood flow in such a vessel, in a vasculature of a patient. For example, the vessel wherein a blood flow is occluded by means of the occlusion plug 2 may be a gonadal vein of the vasculature of a patient. For example, the occlusion plug 2 may be used for the treatment of a vascular disease, which may be the pelvic congestive syndrome.

[0014] In order to occlude a blood vessel, the occlusion plug 2 is intended to be inserted in the blood vessel following an insertion direction 5. When the occlusion plug 2 is inserted in a blood vessel, the insertion direction 5 may be parallel to a longitudinal direction of the blood vessel.

[0015] The occlusion plug 2 may include a first segment 4, or a distal segment 4, and a second segment 6, or a proximal segment 6. As it will be explained in more detail below, the first and second segments 4 and 6 are mechanically connected to each other.

[0016] The first segment 4 may include a distal tip 8, or a distal front end tip 8, and a proximal tip 10, or a distal rear end tip 10. The second segment 6 may include a distal tip 12, or a proximal front end tip 12, and a proximal tip 14, or a proximal rear end tip 14.

[0017] The distal tip 8, the proximal tip 10, the distal tip 12 and the proximal tip 14 may be configured so that, when the occlusion plug 2 is inserted in a blood vessel, the distal tip 8 is in front of the proximal tip 10, the proximal tip 10 is in front of the distal tip 12 and the distal tip 12 is in front of the proximal tip 14. In other words, when the occlusion plug 2 is inserted in a blood vessel, the distal tip 8 may be inserted in the blood vessel firstly, the proximal tip 10 may be inserted secondly, the distal tip 12 may be inserted thirdly and the proximal tip 14 may be inserted lastly.

[0018] The first segment 4 may include a central portion 16, or a distal embolization body 16. The central portion 16 may be provided, axially along the insertion direction 5, between the distal and proximal tips 8 and 10. The second segment 6 may include a central portion 18, or a proximal embolization body 18. The central portion 18 may be provided axially along the insertion direction 5 between the distal tip 12 and the proximal tip 14.

[0019] The central portions 16 and 18 may include, with respect to the insertion direction 5, a respective radial outer surface 20 and 22. The respective radial outer surfaces 20 and 22 may radially, outwardly delimit the central portions 16 and 18 with respect to an axis parallel to the insertion direction 5. Therefore, the radial outer surfaces 20 and 22 may, with respect to an axis parallel to the insertion direction 5, radially contact a wall of the blood vessel when the occlusion plug 2 is implanted in the blood vessel.

[0020] The first and second segments 4 and 6 may be expandable and collapsible segments. The first and second segments 4 and 6 may be configured so that the central portions 16 and 18 may radially contact the wall of the vessel when the respective corresponding first and second segments 4 and 6 are in an expanded configuration. For example, the first and second segments 4 and 6 may be an inflatable balloon. In such a case, the first and second segments 4 and 6 may be configured to remain deflated prior toand during delivery of the occlusion plug 2 in a blood vessel, and may be configured to be inflated immediately after delivery of the occlusion plug 2 in a blood vessel.

[0021] As an alternative, it is possible that only one of the first and second segments 4 and 6, or that none of the first and second segments 4 and 6 are expandable and collapsible segments.

[0022] As depicted in Figs. 1 and 2, an external diameter of the first segment 4 may be DI, and an external diameter of the second segment 6 may be D2. In the depicted embodiment, the diameters DI and D2 may be equal to each other. As depicted in Figs. 1 and 2, the diameters DI and D2 may be measured at a position, on the respective radial outer surfaces 20 and 22, wherein the diameter taken in axial cross section perpendicular to the insertion direction 5 is maximum. When at least one of the first and second segments 4 and 6 is an expandable and collapsible segment, the diameter DI or D2 may be measured when the respective segment 4 or 6 is in an expanded configuration.

[0023] The first segment 4 may include a membrane 24. The membrane 24 may include a base 26. The membrane 24 may axially, with respect to the insertion direction 5, extend between the distal tip 8 and the base 26. The second segment 6 may include a membrane 28. The membrane 28 may include a base 30. The membrane 28 may axially, with respect to the insertion direction 5, extend between the distal tip 12 and the base 30.

[0024] The base 26 may be axially, with respect to the insertion direction 5, located between the distal tip 8 and the proximal tip 10. An axial distance 32 with respect to the insertion 5, between the distal tip 8 and the base 26 may be more than 50% and less than 75% of an axial distance 34 with respect to the insertion direction 5, between the distal tip 8 and the proximal tip 10. The base 30 may be axially, with respect to the insertion direction 5, located between the distal tip 12 and the proximal tip 14. An axial distance 36, with respect to the insertion direction 5, between the distal tip 12 and the base 30 may be more than 50% and less than 75% of an axial distance 38, with respect to the insertion direction 5, between the distal tip 12 and the proximal tip 14. The base 26 and the base 30 may then be pressed by the central portions 16 and 18 against the wall of the vessel when the occlusion plug 2 is inserted in the blood vessel.

[0025] As an alternative, it is also possible that only one of the first and second segments 4 and 6 is provided with a membrane, or that none of the segments 4 and 6 are provided with a membrane. Also, it is possible that one of the membranes 24 and 28extends from the respective proximal tip 10 or 14, or that the membranes 24 and 28 only extend on a portion of the axial length, with respect to the insertion direction 5, between the tips 8 and 10 or 12 and 14, without reaching these tips.

[0026] The occlusion plug 2 may further include an interconnect region 40, or a joint member 40. The interconnect region 40 may mechanically connect the first segment 4 to the second segment 6. Therefore, the interconnect region 40 may be axially, with respect to the insertion direction 5, placed between the first and second segments 4 and 6. The interconnect region 40 may be, on one side, mechanically connected to the proximal tip 10 and, on the other side, mechanically connected to the distal tip 12. The interconnect region 40 may include a spring 42. The spring 42 may be a helical spring 42. The spring 42 can be made of a material including stainless steel and / or cobalt chrome.Alternatively, the spring 42 can be made of a material comprising nitinol. The spring 42 may also be made of a polymer. The spring 42 may also be made of a combination of at least one of stainless steel, cobalt chrome, nitinol, and a polymer.

[0027] A distance L between the proximal tip 10 and the distal tip 12 may satisfy a relationship:wherein A may be a coefficient higher than 0.11 and lower than 0.15. In other words, the distance L may be adjusted by modifications of the interconnect region 40 and may modify a degree of freedom of a movement of the segments 4 and 6 relative to each other. The occlusion plug 2 may thus obtain a degree of freedom which is particularly well- adapted for occluding a long vessel, and in particular a vessel in a locomotive joint such as a gonadal vein.

[0028] In the embodiment of Figs. 1 and 2, an external diameter d of the spring 42 may satisfy a relationship:wherein B may be a coefficient higher than 0.14 and lower than 0.20. Therefore, the degree of freedom of the movement of the segments 4 and 6 relative to each other may be adjusted by a design choice on the spring 42, and the occlusion plug 2 may be particularly well-adapted for occluding a long vessel as a vessel in a locomotive joint area, such as a gonadal vein.

[0029] Fig. 3 shows an exemplary occlusion plug 52 according to one or more embodiments described herein. The exemplary occlusion plug 52 may differ from the exemplary occlusion plug 2 of Figs. 1 and 2 in that the first and second segments 4 and 6 may include a collapsible and expandable mesh 54 having a plurality of braided metal strands 56. The strands 56 may have a shape memory. Such a mesh 54 may be provided in a collapsed configuration, in which it may be provided inside a sheath, and an expanded configuration. For example, the plurality of braided metal strands 56 having a shape memory may expand, by shape memory, when the mesh 54 is unsheathed. As an example, the first and second segments 4 and 6 may each be an Amplatzer vascular plug, also known under the acronym A VP.

[0030] Fig. 4 shows an exemplary interconnect region 58 of an occlusion plug according to one or embodiments described herein. As visible in Fig. 4, the spring 42 of the interconnect region 58 may include a distal end 60 and a proximal end 62. The interconnect region 58 may include a first welded portion 64, in which the distal end 60 is welded to the proximal tip 10 of the first segment 4. The interconnect region 58 may include a second welded region 66, in which the proximal end 62 is welded to the distal tip 12 of the second segment 6.

[0031] Fig. 5 shows an interconnect region 68 of an occlusion plug according to one or more embodiments described herein. The interconnect region 68 may differ from the interconnect region 58 by adhesive members 70 and 72. The adhesive member 70 may be in contact with the proximal tip 10 of the first segment 4 and with the distal end 60 of the spring 42. The adhesive member 72 may be in contact with the distal tip 12 of the second segment 6, and with the proximal end 62 of the spring 42. Hence, the interconnect region 68 may be adhesive-bonded to the proximal tip 10 of the first segment 4, and may be adhesive-bonded to the distal tip 12 of the second segment 6.

[0032] Fig. 6 shows an interconnect region 74 of an occlusion plug according to one or more embodiments described herein. The interconnect region 74 may differ from the interconnect region 58 by two crimped regions 76 and 78. The crimped regions 76 and 78 may be at the same location as, respectively, the welded regions 64 and 66 in the embodiment of Fig. 4. In detail, the proximal tip 10 of the first segment 4 may be hollow and may be crimped around the distal end 60 of the spring 42. Similarly, the distal tip 12 of the second segment 6 may be hollow and may be crimped around the proximal end 62of the spring 42. Therefore, the interconnect region 74 may be crimped to the proximal tip 10 and the distal tip 12.

[0033] Although three main embodiments are described herein corresponding respectively to welding, adhesive bonding and crimping, any other bonding technique may be employed in order to attach the ends of the spring 42 to the tips of the segments. In particular, a first bonding technique among the above-described bonding techniques may be employed for attaching to the proximal tip 10 and a second bonding technique among the above-described bonding techniques, different from the first bonding technique, may be used for attaching to the distal tip 12. Additionally or alternatively, a combination of at least one of the above-described bonding techniques may be employed such as, for example, welding and crimping to at least one of the proximal tip 10 and the distal tip 12.

[0034] Fig. 7 shows an interconnect region 80 of an occlusion plug according to one or more embodiments described herein. The interconnect region 80 may differ from the interconnect region 58 by a coil interconnect 82. The coil interconnect 82 may include a first coil 84 and a second coil 86. The coils 84 and 86 may be respectively attached to the proximal tip 10 and the distal tip 12. The coils 84 and 86 may be interconnected to each other. For example, one of the coils 84, 86 may pass inside the loop formed by the other of the coils 84, 86.

[0035] Figs. 8 and 9 show an occlusion plug 88 according to one or more embodiments described herein. The occlusion plug 88 may differ from the occlusion plug 2 by an interconnect region 90 including a hook interconnect 92. The hook interconnect 92 may include a hook 94 and a buckle 96. The hook 94 may be mechanically connected to the distal tip 12, whereas the buckle 96 may be mechanically connected to the proximal tip 10. Naturally, in an alternative embodiment, the hook 94 may be mechanically connected to the proximal tip 10, whereas the buckle 96 may be mechanically connected to the distal tip 12.

[0036] In an alternative embodiment, the buckle 96 may be replaced with a supplementary hook, and the hook 94 and the supplementary hook may have such dimensions that it is impossible to disengage them from each other without using a specific tool.

[0037] Fig. 10 shows an interconnect region 98 of an occlusion plug according to one or more embodiments described herein. The interconnect region 98 may include a distalregion 100, a proximal region 102 and an intermediate region 104. The regions 102, 104 and 100 may be provided in this order along the insertion direction 5. The proximal region 102 may be mechanically connected to the distal tip 12 of the second segment 6, whereas the distal region 100 may be mechanically connected to the proximal tip 10 of the first segment 4. The distal and proximal regions 100 and 102 may have the same thickness El. The intermediate region 104 may have a thickness E2 smaller than the thickness El. Therefore, the intermediate region 104 may form a thin region of the interconnect region 98. The thickness E2 may be more than 0,2 mm and / or lower than 0,5 mm.

[0038] In a further alternative embodiment, the distal and proximal regions 100 and 102 may have respective thicknesses El and EE, and the thicknesses El and El’ may be different. Preferably, E2 is smaller than both El and El’.

[0039] Fig. 11 shows an occlusion plug 106 according to one or more embodiments described herein. As well as the occlusion plug 2, the occlusion plug 106 may include the segment 4 axially extending, with respect to the insertion direction 5, between the distal tip 8 and the proximal tip 10, and provided with the central portion 16, the segment 6 axially extending, with respect to the insertion direction 5, between the distal tip 12 and the proximal tip 14, and provided with the central portion 18, and the interconnect region 40.

[0040] The occlusion plug 106 may further include three additional segments 108, 110 and 112. The additional segments 112, 110 and 108 may be provided in this order along the insertion direction 5. In other words, the occlusion plug 106 may include, further to the proximal segment 18, a second proximal segment 108, a third proximal segment 110 and a fourth proximal segment 112. Therefore, the occlusion plug 106 may include five segments 4, 6, 108, 110 and 112.

[0041] The additional segment 108 may include a distal tip 114, or a second proximal front end tip 114, and a proximal tip 116, or a second proximal rear end tip 116. The additional segment 110 may include a distal tip 118, or a third proximal front end tip 118, and a proximal tip 120, or a third proximal rear end tip 120. The additional segment 112 may include a distal tip 122, or a fourth proximal front end tip 122, and a proximal tip 124, or a fourth proximal rear end tip 124. Therefore, with respect to the insertion direction 5, the proximal tip 14 may be in front of the distal tip 114, which may be in front of theproximal tip 116, which may be in front of the distal tip 118, which may be in front of the proximal tip 120, which may be in front of the distal tip 122, which may be in front of the proximal tip 124. Furthermore, the distal tip 8, which may be axially in front, with respect to the insertion direction 5, of the entire occlusion plug 106, may be a distal end 126 of the occlusion plug 106. The proximal tip 124, which may be axially to the rear, with respect to the insertion direction 5, of the entire occlusion plug 106, may be a proximal end 128 of the occlusion plug 106.

[0042] The occlusion plug 106 may include an additional interconnect region 130, or a second joint member 130. The additional interconnect region 130 may be associated with the additional segment 108. The additional interconnect region 130 may be mechanically connected to the distal tip 114 of the associated additional segment 108, and to the proximal tip 14 of the second segment 6. The occlusion plug 106 may include an additional interconnect region 132, or a third joint member 132. The additional interconnect region 132 may be associated with the additional segment 110. The additional interconnect region 132 may be mechanically connected to the distal tip 118 of the associated additional segment 110, and to the proximal tip 116 of the additional segment 108. The occlusion plug 106 may include an additional interconnect region 134, or a fourth joint member 134. The additional interconnect region 134 may be associated with the additional segment 112. The additional interconnect region 134 may be mechanically connected to the distal tip 122 of the associated additional segment 112 and to the proximal tip 120 of the additional segment 110.

[0043] As depicted in Fig. 11, an axial length of the occlusion plug 106 may be defined as the axial distance 136, along the insertion direction 5, between the distal end 126 and the proximal end 128. The distance 136 may be more than 5 cm and less than 20 cm. Therefore, the occlusion plug 106 may have an increased length while maintaining a degree of freedom which allows the plug to bend and deform with natural vessel movement. Furthermore, the occlusion plug 106 allows for treatment of longer vessels using a single device. Also, the procedure of treating a vascular disease by means of an occlusion plug such as the one described herein is rendered less expensive and take less time, and does not need any adjunctive device.

[0044] Fig. 12 shows a catheter assembly 137 according to one or more embodiments described herein.

[0045] The catheter assembly 137 may include a catheter body 138. The catheter body 138 may include a catheter hub 140 and a needle 142. The needle 142 may include a distal end 144 axially opposed to the catheter hub 140.

[0046] The catheter body 138 may include a lumen 146. The needle 142 may include, as the distal end 144, an aperture 148. The lumen 146 may be within the catheter body 138 and may communicate with an exterior of the catheter body 138 via the aperture 148.

[0047] The catheter assembly 137 may include an occlusion plug such as, as depicted in Fig. 12, the occlusion plug 106. The occlusion plug 106 may be housed in the lumen 146 in a state wherein the catheter assembly 137 is ready for use, before occlusion of a blood vessel.

[0048] When the segments 4, 6, 108, 110 and 112 are expandable and collapsible segments, they may be in a collapsed configuration when they are housed in the lumen 146. When the segments 4, 6, 108, 110 and 112 include a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory, the segments may be in a collapsed configuration when they are sheathed inside the lumen 146, and may, by shape memory, automatically expand when passing via the aperture 148 into an exterior of the lumen 146. Also, in such a case, the segments 4, 6, 108, 110 and 112 may automatically contract when they are retracted, via the aperture 148 towards the lumen 146.

[0049] Fig. 13 shows a method of manufacturing the occlusion plug 106 according to one or more embodiments described herein.

[0050] The exemplary method of Fig. 13 may include a first step E01 of obtaining at least two segments 4, 6, 108, 110 and 112. In the step E01, the segments 4, 6, 108, 110 and 112 may be provided in a collapsed configuration if the segments are expandable and collapsible segments.

[0051] The exemplary method of Fig. 13 may include a second step E02 of obtaining an interconnect region, such as the interconnect region 40.

[0052] The exemplary method of Fig. 13 may include a third step E03, which may be implemented after the steps E01 and E02, of mechanically connecting, via the interconnect region 40 obtained in the step E02, the proximal tip of the segment 4 with the distal tip of the segment 6 obtained in the step E01.

[0053] In more detail, the step E03 of the exemplary method of Fig. 13 may include a sub-step E031 of welding the spring 42 of the interconnect region 40 to the distal tip 12, and of welding the spring 42 to the proximal tip 10 or 16.

[0054] Alternatively, the exemplary method of Fig. 13 may include a step of adhesivebonding the spring 42 to the tip 10 or 12. As a further alternative, the exemplary method of Fig. 12 may include a step of crimping the spring 42 to the tips 10 or 12.

[0055] The exemplary method of Fig. 13 may include a step E04 of obtaining at least one additional segment. For example, the step E04 may include obtaining the additional segments 108, 110 and 112 in the same way as the segments 4 and 6 were obtained in the step E01.

[0056] The exemplary method of Fig. 13 may include a step E05 of obtaining, for each additional segment obtained during the step E04, an additional interconnect region 130, 132 and 134 associated to said additional segment. The additional interconnect regions 130, 132 and 134 may be obtained, during the step E05, in the same way as the interconnect region 40 during the step E02.

[0057] In the steps E02 or E05 of the exemplary method of Fig. 13, an alternative interconnect region such as the interconnect region 58, 68, 74, 80 or 88 may be obtained.

[0058] The exemplary method of Fig. 13 may include a step E06 of mechanically connecting the distal tips 114, 118 and 122 of the additional segments 108, 110 and 112 obtained during the step E04, to a proximal tip 14, 116, 120 of the second segment 6 or of the additional segments 108, 110 using the respective additional interconnect regions 130, 132 and 134. The mechanical connection may be implemented, in the step E06, in the same way as the mechanical connection implemented during the step E03. In particular, a welding step, an adhesive-bonding step and / or a crimping step may be implemented during the step E06.

[0059] As an alternative, the segments 4 and 6, and the additional segments 108, 110 and / or 112 may be obtained in a same step, which may be the step E01, and the interconnect region 40, and the additional interconnect regions 130, 132 and / or 134 may be obtained in a single step, which may be the step E02.

[0060] The exemplary method of Fig. 13 may include a step E07 of inserting the occlusion plug 106 obtained after the step E06 in a lumen such as the lumen 146 of the catheter assembly 137. During the step E07, if the segments 4, 6, 108, 110 and 112 areexpandable and collapsible segments, these segments may be housed in the lumen in a collapsed configuration. If the segments 4, 6, 108, 110 and 112 include a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory, it may be that the segments 4, 6, 108, 110 and 112 are in an expanded configuration in the steps E01 to E06, and may automatically be contracted during implementation of the step E07, in which the segments are sheathed in the catheter assembly 137.

[0061] Fig. 14 shows a method of occluding a blood vessel according to one or more embodiments described herein. The method of occluding a blood vessel may be for treating the pelvic congestive syndrome.

[0062] The exemplary method of Fig. 13 may include a first step El l of inserting an occlusion plug such as the occlusion plug 106 in a blood vessel. The blood vessel may be a gonadal vein.

[0063] In the exemplary method of Fig. 14, the step El l may include a first substep El 11 of obtaining a catheter accommodating, in a lumen, the occlusion plug in a collapsed configuration. For example, during the step El 11, the catheter assembly 137 may be obtained.

[0064] The step El l may include a second sub-step El 12 of inserting, after the substep El 11, the catheter assembly 137 in the blood vessel at a point of delivery.

[0065] The step El l may include a third sub-step El 13 of causing, after the substep El 12, the occlusion plug 106 to move out of the lumen 146 of the catheter assembly 137. In other words, during the sub-step El 13, the occlusion plug 106 may pass through the aperture 108 and may be unsheathed.

[0066] After the sub-step El 13, the occlusion plug 106 may be placed inside the blood vessel, with, for each of the segments 4, 6, 108, 110 and 112, the distal tip placed in front, with respect to the insertion direction 5, of the proximal tip.

[0067] In case that the segments 4, 6, 108, 110 and 112 are expandable and collapsible segments, the exemplary method of Fig. 13 may include a step E12 of expanding, after the step El l, the segments 4, 6, 108, 110 and 112. For example, in case that the segments 4, 6, 108, 110 and / or 112 are inflatable balloons, the step E12 may be a step of inflating the segments. After the step El 2, the radial outer surface of the central portions of the respective segments 4, 6, 108, 110 and 112 may radially contact a wall of the blood vessel and may occlude a blood flow inside the blood vessel.

[0068] If the segments 4, 6, 108, 110 and 112 include a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory, the step of expanding the segments may be automatically caused by the sub-step El 13 in which the segments 4, 6, 108, 110 and 112 are unsheathed from the catheter assembly 137.

[0069] All of the above are fully within the scope of the present disclosure and are considered to form the basis for alternative embodiments in which one or more combinations of the above-described features are applied, without limitation to the specific combination disclosed above.

[0070] In light of this, there will be many alternatives which implement the teaching of the present disclosure. It is expected that one skilled in the art will be able to modify and adapt the above disclosure to suit his or her own circumstances and requirements within the scope of the present disclosure, while retaining some or all technical effects of the same, either disclosed or derivable from the above, in light of his or her common general knowledge in this art. All such equivalence, modifications or adaptations fall within the scope of the present disclosure.

Claims

Claims1. An occlusion plug for occluding a blood vessel, comprising a first segment, a second segment mechanically connected to the first segment, each of the first and second segments including a central portion, a distal tip and a proximal tip, the distal tip being configured to be, when the occlusion plug is inserted in a blood vessel, in front of the proximal tip with respect to an insertion direction of the occlusion plug in the blood vessel, the central portion of each of the first and second segments having a radial outer surface and being configured so that the radial outer surface is able, when the occlusion plug is implanted in a blood vessel, to radially contact a wall of the blood vessel, and an interconnect region mechanically connecting the proximal tip of the first segment to the distal tip of the second segment.

2. The occlusion plug according to claim 1, wherein at least one of the first and second segments is an expandable and collapsible segment, said at least one of the first and second segments being configured so that the radial outer surface is able to radially contact the wall of the blood vessel when said at least one of the first and second segments is in an expanded configuration.

3. The occlusion plug according to claim 1 or 2, wherein at least one of the first and second segments includes a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory.

4. The occlusion plug according to any of claim 1 to 3, wherein a distance L between the distal tip of the second segment and the proximal tip of the first segment satisfies a relationshipD1 + D2L = A x - - - wherein DI is a diameter of the first segment in an expanded configuration, D2 is a diameter of the second segment in an expanded configuration, and A is a coefficient higher than 0.11 and lower than 0.15.

5. The occlusion plug according to any of claim 1 to 4, wherein at least one of the first and second segments includes a membrane.

6. The occlusion plug according to claim 5, wherein the membrane includes a base provided on the radial outer surface of said at least one of the first and second segments.

7. The occlusion plug according to claim 5 or 6, wherein the membrane is provided on more than 50 %, and / or on less than 75 % of the distance between the distal tip and the proximal tip of said at least one of the first and second segments.

8. The occlusion plug according to any of claim 1 to 7, further including at least one additional segment and, for each of said at least one additional segment, an additional interconnect region associated to said additional segment and mechanically connecting the distal tip of said additional segment to a proximal tip of the second segment or of another additional segment, a proximal tip of the last of said at least one additional segment being a proximal end of the occlusion plug.

9. The occlusion plug according to claim 8, wherein the distal tip of the first segment is a distal end of the occlusion plug, a distance between the distal end and the proximal end being more than 5 cm and less than 20 cm.

10. The occlusion plug according to any of claim 1 to 9, wherein the interconnect region includes a part made of a material including at least one among stainless steel, cobalt chrome, nitinol, and a polymer.

11. The occlusion plug according to any of claim 1 to 10, wherein the interconnect region is welded to at least one of the distal tip of the second segment and the proximal tip of the first segment.

12. The occlusion plug according to any of claim 1 to 11, wherein the interconnect region is adhesive bonded to at least one of the distal tip of the second segment and the proximal tip of the first segment.

13. The occlusion plug according to any of claim 1 to 12, wherein the interconnect region is crimped to at least one of the distal tip of the second segment and the proximal tip of the first segment.

14. The occlusion plug according to any of claim 1 to 13, wherein the interconnect region comprises a spring.

15. The occlusion plug according to claim 14, wherein the spring is a helical spring.

16. The occlusion plug according to claim 15, wherein an external diameter d of the helical spring satisfies a relationship:wherein DI is an external diameter of the first segment in an expanded configuration, D2 is an external diameter of the second segment in an expanded configuration, and B is a coefficient higher than 0.14 and lower than 0.20.

17. The occlusion plug according to any of claim 1 to 16, wherein the interconnect region comprises a coil interconnect.

18. The occlusion plug according to any of claim 1 to 17, wherein the interconnect region comprises a thin region.

19. The occlusion plug according to claim 18, wherein a thickness of the thin region is more than 0,2 mm and / or lower than 0,5 mm.

20. The occlusion plug according to any of claim 1 to 19, wherein the interconnect region comprises a hook interconnect.

21. A microvascular plug to occlude a blood flow in a vessel of a vasculature, comprising: a distal segment comprising: a distal front end tip, a distal rear end tip, and a distal embolization body to radially contact a wall of the vessel, the distal embolization body being between the distal front end tip and the distal rear end tip along a direction of delivery of the microvascular plug in the vessel, a first proximal segment comprising: a first proximal front end tip, a first proximal rear end tip, and a first proximal embolization body to radially contact a wall of the vessel, the first proximal embolization body being between the first proximal front end tip and the first proximal rear end tip along a direction of delivery of the microvascular plug in the vessel, and a first joint member mechanically connected to the distal rear end tip and to the first proximal front end tip.

22. The microvascular plug according to claim 21, wherein the distal segment is an expandable and collapsible segment, the distal embolization body being able to radially contact the wall of the vessel when the distal segment is in an expanded configuration.

23. The microvascular plug according to claim 21 or 22, wherein the first proximal segment is an expandable and collapsible segment, the first proximal embolization body being able to radially contact the wall of the vessel when the first proximal segment is in an expanded configuration.

24. The microvascular plug according to any of claim 21 to 23, wherein at least one of the distal and first proximal segments includes a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory.

25. The microvascular plug according to any of claim 21 to 24, wherein a distance L between the distal rear end tip and the first proximal front end tip satisfies a relationshipD1 + D2L = A x - - - wherein DI is a diameter of the distal segment in an expanded configuration, D2 is a diameter of the first proximal segment in an expanded configuration, and A is a coefficient higher than 0.11 and lower than 0.15.

26. The microvascular plug according to any of claim 21 to 25, wherein at least one of the distal and first proximal embolization body includes a membrane.

27. The microvascular plug according to claim 26, wherein the membrane includes a base to be pressed by said at least one of the distal and first proximal embolization body against the wall of the vessel.

28. The microvascular plug according to claim 26 or 27, wherein the membrane is provided on more than 50 %, and / or on less than 75 % of a length of the distal or first proximal segment corresponding to said at least one of the distal and first proximal embolization body.

29. The microvascular plug according to any of claim 21 to 28, further including a second proximal segment and a second joint member associated to the second proximal segment, the second proximal segment comprising a second proximal front end tip, a second proximal rear end tip, and a second proximal embolization body to radially contact a wall of the vessel, the second proximal embolization body being between the second proximal front end tip and the second proximal rear end tip along a direction of delivery of the microvascular plug in the vessel, the second joint member mechanically connecting the second proximal front end tip to the first proximal rear end tip.

30. The microvascular plug according to claim 29, wherein a distance between a rear end tip of the most proximal of the proximal segments and the distal front end tip is more than 5 cm and less than 20 cm.

31. The microvascular plug according to any of claim 21 to 30, wherein the first joint member includes a part made of a material including at least one among stainless steel, cobalt chrome, nitinol, and a polymer.

32. The microvascular plug according to any of claim 21 to 31, wherein the first joint member is welded to at least one of the first proximal front end tip and the distal rear end tip.

33. The microvascular plug according to any of claim 21 to 32, wherein the first joint member is adhesive bonded to at least one of the first proximal front end tip and the distal rear end tip.

34. The microvascular plug according to any of claim 21 to 32, wherein the first joint member is crimped to at least one of the first proximal front end tip and the distal rear end tip.

35. The microvascular plug according to any of claim 21 to 34, wherein the first joint member comprises a spring.

36. The microvascular plug according to claim 35, wherein the spring is a helical spring.

37. The microvascular plug according to claim 36, wherein an external diameter d of the helical spring satisfies a relationship:wherein DI is an external diameter of the distal segment in an expanded configuration, D2 is an external diameter of the first proximal segment in an expanded configuration, and B is a coefficient higher than 0.14 and lower than 0.20.

38. The microvascular plug according to any of claim 21 to 37, wherein the first joint member comprises a coil interconnect.

39. The microvascular plug according to any of claim 21 to 38, wherein the first joint member comprises a thin region.

40. The microvascular plug according to claim 39, wherein a thickness of the thin region is more than 0,2 mm and / or lower than 0,5 mm.

41. The microvascular plug according to any of claim 21 to 40, wherein the interconnect region comprises a hook interconnect.

42. A method of manufacturing an occlusion plug for occluding a blood vessel, comprising: obtaining a first segment and a second segment, each of the first and second segments including a central portion, a distal tip and a proximal tip, the distal tip being configured to be, when the occlusion plug is inserted in a blood vessel, in front of the proximal tip with respect to an insertion direction of the occlusion plug in the blood vessel, the central portion of each of the first and second segments having a radial outer surface and being configured so that the radial outer surface may, when the occlusion plug is implanted in a blood vessel, radially contact a wall of the blood vessel, obtaining an interconnect region, and mechanically connecting, via the interconnect region, the proximal tip of the first segment to the distal tip of the second segment.

43. The method of manufacturing an occlusion plug according to claim 42, wherein at least one of the first and second segments is an expandable and collapsible segment, said at least one of the first and second segments being configured so that the radial outer surface may radially contact the wall of the blood vessel when said at least one of the first and second segments is in an expanded configuration.

44. The method of manufacturing an occlusion plug according to claim 42 or 43, wherein at least one of the first and second segments includes a collapsible and expandable mesh having a plurality of braided metal strands.

45. The method of manufacturing an occlusion plug according to any one of claims 42 to 44, further including: obtaining at least one additional segment, obtaining, for each of said at least one additional segment, an additional interconnect region associated to said additional segment, and mechanically connecting the distal tip of said at least one additional segment to a proximal tip of the second segment or of another additional segment.

46. The method of manufacturing an occlusion plug according to any one of claims 42 to 45, wherein the step of mechanically connecting includes a step of welding theinterconnect region to at least one of the distal tip of the second segment and the proximal tip of the first segment.

47. The method of manufacturing an occlusion plug according to any one of claim 42 to 46, wherein the step of mechanically connecting includes a step of adhesive bonding the interconnect region to at least one of the distal tip of the second segment and the proximal tip of the first segment.

48. The method of manufacturing an occlusion plug according to any one of claims 42 to 47, wherein the step of mechanically connecting includes a step of crimping the interconnect region to at least one of the distal tip of the second segment and the proximal tip of the first segment.

49. A method of occluding a blood vessel, including inserting an occlusion plug according to any one of claims 1 to 20 in the blood vessel, wherein the step of inserting the occlusion plug is implemented in such a way that, for each the first and second segments, the distal tip of said segment is in front of the proximal tip of said segment with respect to an insertion direction of the occlusion plug in the blood vessel.

50. The method of occluding a blood vessel according to claim 49, wherein at least one of the first and second segments is an expandable and collapsible segment, the method further including, after the step of inserting, expanding the first and second segments so that the radial outer surfaces of said respective first and second segments radially contact a wall of the blood vessel.

51. The method of occluding a blood vessel according to claim 49 or 50, wherein the step of inserting includes a first sub-step of preparing a catheter assembly accommodating, in a lumen, the occlusion plug in a collapsed configuration, a second sub-step, after the first sub-step, of inserting the catheter assembly in the blood vessel at a point of delivery and a third sub-step of causing the occlusion plug to move out of the lumen.

52. The method of occluding a blood vessel according to claim 51, wherein at least one of the first and second segments includes a collapsible and expandable mesh having a plurality of braided metal strands having a shape memory, the third sub-step automatically causing the first and second segments to expand.

53. The method of occluding a blood vessel according to any one of claims 49 to 52, in the treatment of the pelvic congestive syndrome.

54. The method of occluding a blood vessel according to any one of claims 49 to 53, wherein the step of inserting includes inserting the occlusion plug in a gonadal vein.

55. A catheter assembly, comprising a catheter body, an aperture, a lumen extending within the catheter body and communicating with an exterior of the catheter body via the aperture, and an occlusion plug according to any of claim 1 to 20, the occlusion plug being housed in the lumen.

56. The catheter assembly of claim 55, wherein at least one of the first and second segments is an expandable and collapsible segment, said at least one of the first and second segments being configured so that the radial outer surface may radially contact the wall of the blood vessel when said at least one of the first and second segments is in an expanded configuration, the first and second segments being in a collapsed configuration.

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