Mesh occluder for improving exophy

Abstract

A self-expanding occlusive device can both cover the neck of an excrescence and act as a permanent embolization, thereby immediately stabilizing the excrescence. The self-expanding device effectively covers the neck of the excrescence in a desired orientation with, for example, a mesh or other at least partially enclosed component, spanning the neck of the excrescence without protruding into the parent vessel. The device includes elements that immediately stabilize the device in the excrescence, in effect acting as a permanent embolization. The embolic disc is combined with retaining arms of flexible material that expand within the excrescence and provide immediate stabilization, thereby retaining the occlusive assembly or mesh in the neck of the excrescence. In an illustrative embodiment, the arms are in the form of coils configured to expand into a three-dimensional structure.

Description

Technical Field

[0001] The described disclosure relates generally to intravascular devices and, more particularly, to a specially shaped support cap on top of a mesh disk. Background Art

[0002] The present disclosure is applicable to gastrointestinal (GI) organs, vascular aneurysms, and cerebral aneurysms. More specifically, the present disclosure is applicable to the repair of extrusions, including diverticula and aneurysms. In illustrative embodiments, the present disclosure is directed to intravascular devices for filling various vascular malformations or other pathological extrusions. Extrusions may include vascular aneurysms found in intracranial aneurysms, fusiform aneurysms that are extrusions of the arterial wall, and saccular aneurysms consisting of a neck, a stem, and a dome.

[0003] Existing procedures for improving exophyms, including vascular, brain, and intestinal exposures, involve surgical clipping of the exophym, either through an open procedure or through an interventional endovascular procedure. Another conventional procedure involves placement of one or more coils within the exophym sac or aneurysm sac via a microcatheter. The major limitation associated with vascular surgery is that "wide-necked" exophyms (or aneurysms) are generally not amenable to this type of treatment because the implanted device may become dislodged within or from the aneurysm sac. Another limitation associated with procedures using a single-threaded coil device is that the device typically requires the surgeon to insert the coil within the aneurysm, increasing the risk of damaging the vessel and aneurysm wall.

[0004] Other existing procedures include the use of stents, such as intracranial stents, to serve as a support to hold the coil within the aneurysm sac, particularly in exophytic or aneurysmal aneurysms that exhibit wide-necked anatomy. However, this approach may increase the potential for injury to surrounding vessels and / or require antiplatelet therapy to prevent stent thrombosis, thereby increasing the potential for bleeding complications.

[0005] While the prior art discloses the use of self-expanding coils, these devices fail to provide a structure that reduces blood permeability through the neck of the aneurysm, thus resulting in higher coil compaction rates within the aneurysm and recurrence of the aneurysm and the attendant risks. The present disclosure employs a surgical device including a mesh element that is primarily positioned at the neck / aneurysm of the aneurysm to overcome this limitation.

[0006] The prior art also discloses the use of hydrogels and / or combinations of hydrogels, particularly in vascular environments. In some cases, the use of hydrogels may exacerbate medical difficulties due to uneven swelling of the hydrogel, adversely altering the delivery characteristics of the associated mesh occluder, or otherwise causing difficulties in use in certain treatments. Summary of the invention

[0007] The present disclosure eliminates the shortcomings of the prior art by using a mesh or occlusive element and related components that fix the position of the occlusive element relative to the protrusion before separation and before and / or after placement of the appendage to place embolic materials, including embolic coils. More specifically, the present disclosure includes a self-expanding occlusive device that can both cover the neck of the protrusion and serve as a permanent embolism, thereby immediately stabilizing the protrusion. In addition, the self-expanding device effectively covers the neck of the protrusion with, for example, a mesh or other at least partially enclosed component, passing through the neck of the protrusion in a desired direction without protruding into the parent vessel. The device contains elements that immediately stabilize the device in the protrusion, which actually acts as a permanent embolism. In an illustrative embodiment, the present disclosure combines an embolic disc with a retaining arm of a flexible material, such as a wire composed of a shape memory material including metals and polymers, a superelastic material, a spring material, etc., which is deployed within the protrusion and provides immediate stabilization, thereby retaining the occlusive component or mesh in the neck of the protrusion. In an illustrative embodiment, the arm is in the form of a coil configured to be deployed into a three-dimensional structure.

[0008] In an exemplary embodiment, the retaining arms may be in the form of a coil that defines a structure that at least partially follows the contours of the interior region of the external protrusion to stabilize, for example, an occlusive disk immediately adjacent to the neck or a mesh near the external protrusion. The retaining arms in the form of a coil or other configuration may be configured to engage or "grasp" the inner wall of the external protrusion, wherein the mesh or occlusive element is optimally positioned at the neck of the external protrusion. The configuration of the retaining arms may be in the form of one or more coil loops that are connected together to form a dome-shaped structure, or may be independent of each other. It is further contemplated that the retaining arms may not necessarily form a coil shape when deployed, but may be in a slightly curved orientation or even a relatively linear orientation. In other illustrative embodiments, one or more retaining arms may be interengaged with one or more primary embolic coils that were previously or subsequently introduced into the external protrusion to provide further stabilization or retention structure within the external protrusion. In further illustrative embodiments, the retaining arms may be engaged with a hydrogel injected into the external sac or aneurysm and cooperate with the hydrogel to provide further support functions.

[0009] In brief, in summary, the present disclosure provides a mesh occluder for treating an ectropion, and a system and method for deploying the mesh occluder from a parent vessel into an ectropion. On the one hand, the system includes an occlusive component, for example, in the form of a mesh, which can at least partially or completely cover the neck of the ectropion. In certain embodiments, the mesh occluder establishes a permanent embolic plug in the ectropion. The mesh occluder may include one or more self-expanding components that provide a simple or uniform complex matrix that expands and achieves a variety of configurations when deployed, including but not limited to generally hemispherical or semi-oval configurations or other shapes such as cones, kidneys, bilobes or other complex shapes, so that the self-expanding bagging filling device can be quickly fixed in a desired position within the bag. In other illustrative embodiments, the filling device includes slightly curved and / or linear retaining arms.

[0010] The occlusive component of the mesh occluder of the present disclosure, such as an optional configuration of a mesh disc, can have a single layer or multiple layers. Other optional embodiments of the occlusive component or mesh disc include an opening through the occlusive component, for example, usually located in the center to allow the introduction of embolic materials, such as hydrogels, gelatin foams, ethanol, polyvinyl alcohol particles, calibrated microspheres, central vascular plugs, coils, cyanoacrylate n-butyl glue, fibrin glue, polydocanol foam, alcohol alcohol solution and ethylene vinyl alcohol copolymer. The area of ​​the limited opening of the closure element can have its edges gradually tapered or recessed inwardly relative to the protrusion to define a tapered area to promote the entry or re-entry of components, embolic fluids, etc. into or into the protrusion.

[0011] The mesh occluder can be a component of a medical system that includes a microcatheter and a delivery wire to which the mesh occluder is attached. The mesh occluder can be detachably connected to the delivery wire. In some illustrative embodiments, the distal end of the microcatheter can extend through the occluding component, for example, through an opening in the occluding component, thereby providing a catheter for delivering primary and / or supplemental embolic materials into the protrusion. The embolic material can include coils, liquid emboli, hydrogels, combination devices, and other embolic materials known in the art. These can typically be deployed continuously to fill the contour of the protrusion. A non-limiting example of a protrusion is a vascular aneurysm.

[0012] The present disclosure provides a mesh occluder for an excrescence or aneurysm in a blood vessel or intestine that can be at least partially self-expanding and can be immediately stabilized within the moment of deployment. In some iterations, the deployment rate of the retaining arm from a compressed state within a microcatheter to an expanded state within the excrescence is controlled to be slower than the expansion rate of the occluding or mesh element. This can allow the occluding element or disc to be more accurately positioned on the neck of the excrescence while avoiding potential trauma of the retaining arm being dragged across the inner wall of the excrescence. In an illustrative embodiment, the present disclosure includes a self-expanding excrescence filling device having a compressed, unexpanded structure and an expanded, three-dimensional expanded structure, a delivery member (e.g., a wire or a sea wave tube / microcatheter), and a detachable deployment system, the system including a connector capable of releasing the self-expanding excrescence filling device. In a preferred embodiment, the excrescence filling element of the present disclosure is composed of a metal such as platinum or a platinum alloy, nitinol, and / or other biocompatible metals. The severable deployment element may be severed mechanically, electrolytically or thermally, hydrostatically, chemically or otherwise to separate the self-expanding overprotrusion filling device from the delivery member.

[0013] These and other aspects and advantages of the present disclosure will become apparent from the following detailed description and the accompanying drawings, which illustrate, by way of example, the features of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Attached Figure 1 A medical system is illustrated, including a handle or control element, a microcatheter extending from the handle, a delivery assembly at least partially disposed within the microcatheter, and an occlusion assembly of a mesh occluder at a distal end of the delivery assembly in accordance with the principles of the present disclosure;

[0015] Attached Figure 2 Figure shows a side view of a microcatheter of a medical system being passed through a blood vessel into an external protrusion, a mesh occluder being deployed relative to the external protrusion in accordance with the principles of the present disclosure, wherein an occluding element at least partially spans a neck of the external protrusion, and a retaining arm in the form of one or more coils being deployed inside an external bag;

[0016] Figure 3 is similar to Figure 3. Figure 2 , showing control elements of a medical system for delivering an embolic coil within an exoskeleton according to the principles of the present disclosure;

[0017] Attached Figure 3A is similar to Figure 2 -3 is a side view illustrating the occlusion assembly deployed at the base of the target non-spherical exoprotrusion neck;

[0018] Attached Figure 4 is similar to Figure 2 -3, a side view showing the introduction of an embolic agent (e.g., a hydrogel) into the exoprotrusion and the deployment of the retaining arms;

[0019] Attached Figure 5is similar to Figure 2-4 , showing an optional positioning balloon coupled to the outer surface of the microcatheter to position the microcatheter relative to the external protrusion;

[0020] Attached Figure 6 is a side view showing detailed deployment of an optional intervertebral disc balloon;

[0021] Attached Figure 7 is a side view showing deployment of a plurality of independent retaining members within an external protrusion;

[0022] Attached Figure 8 is a side view showing a single retaining arm having a generally linear configuration deployed within an external protrusion;

[0023] Attached Fig. 9 shows a side view of a single retention arm deployed in a generally coiled configuration within an exoprotrusion filled with a hydrogel;

[0024] Attached Fig.10 shows a side view of a plurality of retention arms deployed within a hydrogel-filled exoprotrusion, each retention arm having a generally linear configuration;

[0025] Figures 11-12 show side views of deploying a plurality of coiled retention arms within an external protrusion; and

[0026] 13-14 show side views of multiple coiled retention arms and linear arms deployed within a hydrogel-filled exoprotrusion. DETAILED DESCRIPTION

[0027] In an illustrative embodiment, the present disclosure may be used to retain one or more embolic coils introduced into an excrescence, such as an aneurysm in a blood vessel or gastrointestinal organ, to help retain the embolic coils within the excrescence and also provide immediate support within the excrescence, thereby minimizing the possibility of rupture of the excrescence or aneurysm. More specifically, the present disclosure provides an occlusive device and one or more retaining arms that can be interengaged with one or more embolic coils to prevent the coils from being released through the neck of the excrescence or aneurysm, particularly a large neck aneurysm. It is further contemplated that the mesh occluder can engage any embolic agent, such as a hydrogel introduced into the excrescence, thereby further minimizing the possibility of migration of the embolic coil.

[0028] In other illustrative embodiments, the present disclosure may be used independently of the introduction of embolic coils and / or any other embolic material or element. In this illustrative embodiment, the occlusive member or mesh may define a finer or denser mesh material to function as an occluder and, in conjunction with a retaining arm, secure the occluder element relative to and through the neck as a separate unit. Regardless, it is contemplated that the present disclosure will minimize, if not completely eliminate, the necessity for multiple embolic coils, which provides significant advantages in minimizing aneurysm rupture or other difficulties.

[0029] The present disclosure provides a structure that is immediately stabilized relative to the wall of an excrescence or aneurysm. This immediate stabilization minimizes the possibility of device displacement, thereby eliminating the potential necessity to close, reposition and redeploy the device, thereby minimizing damage to the vessel and reducing surgical time. The present disclosure utilizes an occluding component in the form of a mesh element and a component that secures its position relative to the excrescence prior to detachment and, if necessary, prior to placement of additional embolic material. Thus, in an illustrative embodiment, the present disclosure provides a self-expanding excrescence filling device that can both cover the neck of an excrescence or aneurysm and serve as a permanent embolism in the excrescence, having an element that rapidly stabilizes its position, having a mesh component that passes through the neck of the excrescence at its desired location but does not protrude into the parent container.

[0030] Now refer to the attached Figure 1 , illustrates a medical system according to the principles of the present disclosure. The medical system 1 includes a handle or control element 11 having a housing or frame sized for user operation, a catheter or microcatheter 12 extending from the handle 12, and a microcatheter 12 extending at least partially through the microcatheter 12 and optionally attached to the control element 11. A mesh occluder 14 is connected to the delivery member 13. The mesh occluder 14 can be deployed to improve leakage and will be discussed in more detail below. The mesh occluder 14 is an occluding component and may or may not be a mesh device. However, for simplicity, the mesh occluder 14 will be referred to as a "mesh occluder" hereinafter. However, it will be understood that the occluder may be solid, perforated, contain slits, etc.

[0031] The microcatheter 12 can be operated by the control element 11, and can include, for example, a line embedded in the wall of the microcatheter 12, which can be manipulated to allow the microcatheter to pass through a tortuous blood vessel (e.g., a blood vessel or an intestinal organ). The control element 11 may include one or more controllers that help navigate the microcatheter 12 through the blood vessel. For example, the control element 11 may include circuits, electronic devices, etc. that can send signals to the microcatheter 12 to manipulate the line in the microcatheter 12 to laterally move a portion of the microcatheter 12 and / or send signals to the delivery member 13. The delivery member 13 can be a solid wire, or alternatively, a hypotube. The delivery member 13 can have a separation element 17 at its distal end, and the separation element 17 is used to detachably fix the mesh occluder 14 to the delivery member 13. In an exemplary embodiment, the control element 11 can send an electrical signal, energy, etc. to the separation element 17 to achieve the separation of the mesh occluder 14. In an illustrative embodiment, the control element 11 can be an independent unit (e.g., commercially available) and is coupled to the microcatheter 12 and / or the delivery member 13 before performing a surgical procedure. In other embodiments, the control element 11 is a permanent component of the medical system 1. It is contemplated that the medical system 1 may be completely disposable after a single use or may be partially or fully reusable. If reusable, the components of the medical system may be made of materials that can withstand conventional sterilization procedures. The microcatheter 12 may include one or more externally mounted balloons to facilitate retention of the microcatheter relative to the vessel and the external projections. The microcatheter 12 may have an outer diameter of 0.5 Fr - 20 Fr. In one embodiment, the outer diameter of the microcatheter 12 ranges from 3 Fr to 5 Fr.

[0032] Now refer to the attached Figure 2 , shows a microcatheter 12 introduced into a blood vessel 110 and a mesh occluder 14 deployed relative to a target protrusion (e.g., an aneurysm) 100. As is known in the art, contrast agents can be used to help position the microcatheter 12 and the mesh occluder 14 relative to the protrusion. The deployment of the mesh occluder 14 can be achieved by a variety of mechanisms. In an illustrative embodiment, a mesh occluder 14 including a mesh occlusive component and a retaining arm 200 can be disposed in a compressed state within the microcatheter 12. The control unit 11 can be manipulated to advance the delivery member 13 to eject the mesh occluder 14 from the distal end of the microcatheter 12. Once exposed from the microcatheter 12, the mesh occluder 14 assumes a normal expanded state. In the normal deployed state, the mesh device of the occluding assembly 14 extends at least partially through the neck of the protrusion 100, and the retaining arm 200 is deployed inside the protrusion, such as engaging the inner wall of the protrusion to facilitate the retention of the mesh closure component 14 relative to the neck of the protrusion.

[0033] In the illustrative embodiment, the closure member 14 is a mesh disc, and may optionally be coated with a hydrogel. For treating saccular excrescences (or aneurysms): Intravascularly deployed mesh (metal mesh or other mesh) disc - optionally with two layers, similar to the Anplatz left atrial appendage closure device currently being tested. The disc may be available in a relatively flat version, or with the edges folded up to accommodate different shapes of excrescences (or aneurysms), including very wide neck excrescences (or aneurysms). This deviation from the generally flat plane of the mesh disc 14 of the present disclosure may have an upturned side that conforms to the wall of the target excrescence 100, which is adjacent to the neck of the excrescence 100. This upturned element 14A (sometimes referred to as a "lip") ( Figure 3A ) is optional and is best suited for very wide neck protrusions (or aneurysms) that are less spherical and more cylindrical in shape. For more wide neck protrusions (or aneurysms), the anatomy itself is not suitable for deploying a flat mesh disc 14 because the wide neck protrusions (or aneurysms) lack sufficient overhang area at the neck to support the mesh disc 14. Therefore, in accordance with the present disclosure, a lip 14A is provided on the mesh along with one or more retaining arms 200 to facilitate attachment to wide neck aneurysms. The retaining arm extensions 200 provide supplemental support to be fixed by the protrusion. Unlike the prior art, the fixation device provides a mesh disc with multiple attachment points within the protrusion. More specifically, the mesh disc 14 includes a core 14B, the diameter of which is configured to be smaller than the target protrusion 100. The mesh disc 14B is fixed in place by at least one attached extension arm 200. In an alternative, the occluding component can be a slightly arcuate mesh element.

[0034] In the illustrated embodiment, the retaining arms 200 form a matrix of annular coils, wherein at least portions of the arms engage the inner wall of the protrusion. In one exemplary embodiment, the retaining arms 200 form a dome shape, wherein at least some of the arms are connected at one or more locations. In other embodiments, the retaining arms are independent and may take any configuration, including Figure 2 The dome-shaped matrix shown.

[0035] The advantages of the annular coil matrices are that they will provide a structure by which the currently disclosed mesh disks can achieve more direct and effective stable positioning by the coil loops gripping the outer projection wall, and the mesh portion is optimally positioned in the outer envelope tuning. The coil loops can be spiral or connected in the form of a birdcage (or dome) or similar structure. However, the prior art teaches a substantially spherical or ovoid configuration and lacks the more effective dome-like shape and dense, slightly flattened mesh at the base (neck of the outer projection) near the distal end of the catheter.

[0036] As described above, the occluding device 14 and the retaining arm 200 can be formed of a shape memory material and can optionally or alternatively assume an expanded shape in response to thermal energy, such as when exposed to the thermal environment of blood, or the surgical device can be formed of spring steel or metal. The occluding component 14 and at least one retaining member or arm 200 can be compressed into a shape suitable for delivery through the microcatheter 12. It is also noted that the characteristics of the occluding device 14 and the retaining member 200 can be controlled so that the occluding device retaining arm 200 expands at a faster rate than the retaining arm 200 to minimize the possibility of undesirable "drag" of the retaining arm 200 within the outer protruding wall. Other arrangements can also be envisioned.

[0037] In other illustrative embodiments, the control unit 11 electrically coupled to the separation member 17 can relay a signal to the occluding component 14 to initiate decompression of the occluding component 14 and at least one retaining arm 200 prior to deployment, or to cause the occluding component 14 and the retaining arms to be in their deployed state after deployment from the microcatheter 12. For example, the control element 11 can incorporate mechanical, chemical, hydrostatic, electrical, and / or thermal means to achieve the function of deploying the occluding component 14. For example, an electrical signal and / or thermal energy can be transmitted from the control unit 11, transmitted through the delivery member 14, so that in response to the generated thermal energy, the surgical device 14 assumes its expanded state through shape memory properties and optionally breaks the detachable attachment between the separation element 17 and the surgical device 14. After deployment, the control unit 11 can be influenced to cause retraction of the microcatheter 12 and / or the delivery member 13 relative to the external projection.

[0038] Continue to refer to the attached Figure 2, the mesh disk 14 and at least one retaining arm 200 are deployed through the delivery catheter 12, which passes through the blood vessel 110 to the bottom of the neck of the target capsule protrusion 100. The control unit 11 can optionally send a signal to the delivery member 13 to extend beyond the length of the distal catheter 12 sufficient to enter the target protrusion 100 to allow the mesh disk 14 and at least one retaining arm 200 to be deployed. Once the progress of the delivery member 13 stops, the control element 11 sends a signal to the mesh disk 14 and at least one retaining arm 200 to deploy. The mesh disk 14 and at least one retaining arm 200 enter the target protrusion in a compressed form, and the signal from the control element 11 guides the mesh disk 14 and at least one retaining arm 200 to open like a flower to allow the periphery of the mesh disk 14 and at least one retaining arm 200 to overlap with the bottom of the neck of the outer bag 100. In an illustrative embodiment, the control unit 11 and the microcatheter 12 are manually held in place, while the delivery member 13 is manually pushed forward a length sufficient to enter the target protrusion 100 to allow the mesh disk 14 and at least one retaining arm 200 to be deployed. The mesh disc 14 and at least one retaining arm 200 are introduced into the target exodontia in a compressed form and when it is released from its restraint, the mesh disc 14 and at least one retaining arm 200 open like a flower to allow the perimeter of the disc mesh disc 14 and at least one retaining arm 200 to overlap the base of the neck of the exodontia 100. The disc is then gently pulled back into place manually, as determined preferentially by fluoroscopic and / or angiographic imaging.

[0039] For the treatment of saccular excrescences (or aneurysms), a mesh (metal or other mesh) disc that is deployed intravascularly and incorporates at least two layers may be used. The disc may have a relatively flat version, or some versions where the edges are folded over to accommodate different shapes of excrescences (or aneurysms), including very wide neck excrescences (or aneurysms). This deviation from the generally flat plane of the occluding device, in the form of a mesh disc 14, may have an upturned side that conforms to the wall of the target excrescence 100, which is adjacent to the neck of the excrescence 100. As Figure 3A As shown, the upturned element 14A (sometimes referred to as a "lip") is optional and is best suited for very wide neck protrusions (or aneurysms) that are less spherical and more cylindrical in shape. For wider neck protrusions (or aneurysms), the lip 14A provides sufficient overhang at the neck to support the mesh disc 14 adjacent to the wide neck protrusion (or aneurysm). The present disclosure contemplates the use of a variety of different lip configurations. The lip configurations vary in diameter, shape, and orientation. In a preferred embodiment, the center portion of the mesh disc (i.e., the portion closest to the delivery member, such as a wire or delivery microcatheter) will be oriented parallel to the neck of the target protrusion.

[0040] The diameter of the mesh disk ranges from 0.1 mm to 30 cm. The shape of the mesh disk varies from circular to triangular. The most typical shape is circular or oval. The mesh disk 14 can be coated with a hydrogel. The interstices of the disk 14 can be sized to accommodate the hydrogel.

[0041] In a typical spherical protrusion with a narrow neck, the entire mesh disk 14 and at least one coil arm 200 including the lip 14A should be oriented parallel to the neck of the target protrusion. In this case, the lip overhangs and rests on the base of the target protrusion, completely covering the neck of the target protrusion and extending over a portion of the adjacent base of the target protrusion and forming a base for at least one retaining arm 200.

[0042] In a typical non-spherical protrusion with a wide neck, the entire periphery of the mesh disk 14 should be oriented more perpendicular to the neck of the target protrusion than in the case of a typical spherical protrusion with a narrow neck, so as to lightly grasp the wall near the base of the target protrusion.

[0043] As attached Figure 2 As shown, the medical system 1 may also include or be used with a coil delivery mechanism, which includes a second control unit 20 and a second catheter 22 for delivering one or more embolic coils 24 into the external protrusion before, after, or simultaneously with the deployment of the mesh occluder 14. The embolic coil 24 can be any conventional embolic coil used to treat an aneurysm or any external protrusion within a body vessel. It is contemplated that the mesh occluder 14 including an occlusive or mesh component 14 and a retaining arm 20 will further assist in retaining the embolic coil 24 within the external protrusion. For example, the occlusive component 14 can prevent the release of the microcoil 24 by, for example, interfering with the movement of the microcoil 24 within the external capsule or engaging the microcoil 24, such as at least partially surrounding or wrapping the microcoil 24. It should be noted that the mesh disc or occlusive element 14 of the present disclosure is capable of creating a second "jailed" microcatheter. Figure 4 Depicted is the introduction of one coil 24 within the exosome. As noted, multiple embolic coils 24 may be introduced into the exosome during or even after the initial procedure.

[0044] As described above, after the occluding component 14 and the at least one retaining arm 200 are deployed, the control element 11 can optionally send a signal that causes the coil 24, the hydrogel 16, and / or the lip 14A to deploy. As noted, in one illustrative embodiment, a separate control element 20 controls the separation of the coil 24. After the above elements are deployed, the control element 11 can send a signal to the separation element 17 to separate the transport member 13 from the mesh disk 14 and the at least one retaining arm 200. The control element 11 can then retract the catheter 12 and the transport member 13.

[0045] The present invention can be used with or without the hydrogel 16. One illustrative embodiment is without the hydrogel. However, it should be noted that the present disclosure can be used with the hydrogel, and such use has been disclosed in previous Walzman applications. When using a hydrogel, the hydrogel can optionally expand only to a specific external stimulus, rather than a hydration time. The hydrogel may shrink to an optional external stimulus. This on-demand expansion and contraction helps to reposition medical tools near target areas within veins and arteries. External stimuli include, but are not limited to, thermal, electrical and / or chemical signals. It should also be noted that the hydrogel 16 can optionally be radiopaque, which facilitates remote positioning and location of the hydrogel 16, an embodiment of which has been disclosed in previous applications, such as Walzman'519 and 16 / 024,673.

[0046] Note that the mesh disc 14 and at least one retaining arm 200 will be held in place when deployed by the coils 24 or hydrogel 16, each of which will substantially conform to the interior of the target protrusion 100. The retaining arms can be loops or straight extensions. The extensions can have a variety of widths and shapes. Some embodiments can have rounded atraumatic edges. Alternatively, the mesh disc 14 must have an upward "lip" and can be held in place by friction between the disc and the wall of the target protrusion and the fact that the diameter of the disc 14 is larger than the diameter of the neck of the protrusion 100. Finally, larger discs 14 can be held in place bidirectionally.

[0047] The amount of hydrogel 16 can vary. The specific amount is not important as long as enough hydrogel 16 can be delivered to the protrusion 100 to fill it. Other embodiments may not use hydrogel. In alternative embodiments of the present disclosure, an optional hydrogel coats the mesh disk 14 and at least one attached arm extension 200 so that the hydrogel will expand into and fill the dome of the protrusion 100.

[0048] In a preferred embodiment, the mesh disk 14 and at least one arm extension 200 are radiopaque or have radiopaque markers or other positioning markers, or incorporate the same features into the separation element 17 in conjunction with other techniques for remote visualization and position detection.

[0049] As shown in FIG. 3 , the present disclosure may incorporate elements of the prior art, such as deploying a coil 24 through a microcatheter 13 .

[0050] Refer to the attached Figure 3A , the present disclosure teaches the use of an upturned lip to secure the mesh disk 100 , integrating the coil element 24 of the prior art. Figure 3A Also depicted are embodiments in which the delivery member 13 is a microcatheter capable of acting as a catheter for delivering coils therethrough.

[0051] Reference now Figure 4 , alternative embodiments of the present disclosure combine the mesh disk 14 and at least one retaining arm 200 with a translucent, activated / swollen hydrogel 16. The hydrogel 16 can be deployed on the surface of the mesh disk 14 and at least one retaining arm 200 through a hollow in the delivery member 13, through a second device (not shown), or through a second wire (not shown) deployed by the catheter element 12. Alternatively, the hydrogel 16 can be deployed through the mesh disk 14 and at least one retaining arm 200. Alternatively, a hydrogel embedded coil can be used with the present disclosure.

[0052] Please refer to the attached Figure 5 , which is attached Figure 4 An alternative embodiment of Figure 4 Also included is a centering balloon 303 within the vessel 110. The centering balloon 303 allows for more precise and stable positioning of the catheter element 12 relative to the center of the neck of the target protrusion 100. Prior to deployment, an additional contrast agent or other fluid injection may optionally be used to initiate deployment of the optional balloon 303 or 300 to position the catheter 12 so that the delivery microcatheter 13 is centered to achieve optimal deployment of the mesh disk 14. With more specific reference to the centering balloon 303, the balloon is described in detail in Walzman's application numbered 14 / 482,436 (titled Vascular Access Catheter), which is incorporated herein by reference.

[0053] It should be noted that single balloon and balloon array are described in U.S. Patent No. 14 / 482,436 (titled "Vascular Access Catheter"), which is incorporated herein by reference. The centering balloon 303 of the present disclosure can be a single balloon or a balloon array. A single balloon or a balloon array is designed to help center the end of the catheter element 12 to a position close to the center of the target protrusion. This positioning can be achieved by the expansion of at least one balloon so that the catheter element 12 is deflected in the desired direction.

[0054] Another embodiment of the present disclosure incorporates a Walzman disc balloon 300, as shown in the attached Figure 6 As shown, it is inserted into the catheter element 12. This combination is an alternative embodiment, which is designed to help center the tip of the catheter element 12 to a position close to the center of the target protrusion. It can also serve as a vertical positioning element by abutting the bottom of the mesh plate during the positioning of the target protrusion.

[0055] The two balloon embodiments, either alone or in combination, are also designed to stop flow within a vessel proximal to a target extubation when fully inflated. In the event of a target extubation rupture, inflation will result in controlled unnecessary bleeding.

[0056] Therefore, the present disclosure may have several different embodiments, including:

[0057] First, a separate disc – an appropriately sized disc – can be deployed through the microcatheter into the saccular aneurysm after a second microcatheter is placed in the microcatheter. The disc is gently pulled back into the neck of the ectropion, bridging the neck and stabilizing the disc with a lip over the open portion of the neck. The disc is not initially detached but remains tethered to its delivery system (wire or catheter). If deployed earlier, it may migrate into the ectropion and be ineffective. Through the second microcatheter, now “imprisoned” in the ectropion, appropriately sized coils are sequentially placed and deployed into the ectropion, per current conventional protocols / techniques, until the ectropion is adequately filled with coils. The second microcatheter is removed. At this point, the disc is detached from its delivery wire / catheter and removed.

[0058] Second, a disc mounted on a hypotube or delivery member 13 is introduced into the protrusion through a slightly larger catheter, where the hypotube or delivery member passes through the disc until it just exceeds it. The appropriately sized intervertebral disc can be deployed through a microcatheter in a saccular aneurysm. The intervertebral disc is gently pulled back to the neck of the protrusion, bridging the neck and stabilizing the intervertebral disc with the lip extending beyond the open portion of the neck. The intervertebral disc is not detached at first, but remains tethered to its delivery member / hypotube. If detached prematurely, it is likely to migrate into the protrusion and fail. Through the delivery catheter / microcatheter, a coil of appropriate size is placed and deployed into the protrusion in accordance with current conventional protocols / technical sequences until the protrusion is fully filled with the coil. At this point, the intervertebral disc is detached from its delivery member / hypotube. The delivery member / hypotube is then removed.

[0059] Third, a separate hydrogel-enhanced disc is provided. The disc is an intravascularly deployed mesh composed of a shape memory material (such as Nitinol) or other shape memory material with superelastic properties, such that a compressed mesh disc will return to a flat mesh disc shape when released or activated by an electronic or light pulse. It can optionally have two layers, similar to the inner disc of the Anplatz left atrial appendage closure device currently in trial - the disc can be available in relatively flat versions, or some versions with the edges folded over to accommodate different shapes of ectropions (or aneurysms), including very wide neck ectropions. In this version, however, the outer surface of the disc facing the ectropion is lined with a non-biodegradable hydrogel that, when exposed to blood during deployment, expands over a specified time (10 minutes in the preferred embodiment of the present disclosure) to conform to the size and shape of the outlet pocket and to fill and occlude the outlet pocket. Another layer of the disc near the parent artery may also optionally have a thin layer of hydrogel - but the hydrogel of this layer is designed to expand only to occlude that layer of the disc alone, so it is not possible for the hydrogel of other layers to potentially expand through the mesh into the parent vessel. An appropriately sized disc can be deployed through a microcatheter in a saccular aneurysm. The disc is gently pulled back into the neck of the aneurysm, bridging the neck and stabilizing the disc with a lip extending beyond the open portion of the neck. The disc is not initially detached, but remains tethered to its delivery system (wire or catheter). If detached prematurely, it would likely migrate into the outflow and be ineffective. As the hydrogel expands, the disc is secured to the outflow neck. Once the prescribed time has passed and subsequent angiography confirms outflow occlusion, the disc is detached from its delivery wire / catheter and the delivery wire / catheter and microcatheter deployed through it are removed. Optionally, where appropriate, the hydrogel can be used to fill the outflow sac, which occludes the outflow sac and also stabilizes the disc in place (in Examples 1 and 2, the coil achieves both goals). It should be noted that the previous Walzman publication has claimed such embodiments.

[0060] Fourth, all features of first to third above and optional; in addition, the disc can have a smaller metal core disc 14B that is smaller in size than the diameter of the protrusion and has a hydrogel designed to expand from the edge in a disc shape to make a larger disc that can then be gently dragged into place. It can then be held in place by a coil or optional hydrogel embedded in the top of the disc and then by a layer of the top of the metal disc designed to expand after the side hydrogel and then expand into the dome of the protrusion, or by separately implanted hydrogel beads, etc.

[0061] Smaller discs may also be used in conjunction with other embolic fillers, wherein the disc is secured by at least one arm extension and the disc is used to reduce the effective width of the external projection neck.

[0062] The mesh disc 14 and at least one coil arm 200 may also be optionally delivered via a disc balloon microcatheter (previously described by Walzman 14 / 732,170) or a similar configuration (disc balloon), an intermediate catheter, or another balloon catheter. These may be used as a method of delivering the present disclosure. The method may also be used to deliver any mesh intracapsular device, including other devices taught by the prior art, such as Web and Luna.

[0063] The advantage of delivery via disc balloon microcatheter is twofold. First, the balloon may sometimes help position the mesh disc 14 and at least one coil arm 200, and second, if the rupture occurs during treatment, the balloon can be inflated to stop flow and control active bleeding until more coils can be placed.

[0064] Discs and coil loops vary in size and the time required to fully deploy. More specifically, discs range in diameter from 0.1 mm to 500 mm. Coil loops range in diameter from 0.1 mm-1000 mm. Coil loops can be 0.1 mm-3142 mm long. Coil loops used for coil exposure are typically sized based on the diameter of the target exodontia.

[0065] The time required to fully expand the disc and coil can range from nearly instantaneous [approximately one second or less] to one hour. While in some embodiments, the disc and coil both expand at the same rate, in other embodiments, the disc and coil expand at independent rates. In some embodiments, the coil expands faster than the disc, while in other embodiments, the disc expands faster than the coil.

[0066] In a preferred embodiment, the coil completes its expansion approximately forty-five seconds after the disc completes its expansion. This time offset allows the disclosure to be positioned in an optimal position through the neck (opening) of the target exodontia without dragging metal along the target exodontia or vessel wall under outward tension, thereby eliminating or ameliorating medical difficulties such as damaging the exodontia or vessel wall. Violations may result in injury or death to the patient.

[0067] The present disclosure has at least four structural optional elements. The optional elements are a central annular hole in the disc element of the present disclosure; a single or multiple mesh layers in the disc element of the present disclosure; a hydrogel coating on all or part of the disc element of the present disclosure; and a hydrogel coating on all or part of the retaining arm element of the present disclosure.

[0068] More specifically, the annular hole structure in the disk element of the present disclosure is optional. One embodiment of the present disclosure has a central annular hole structure. Another embodiment of the present disclosure does not have a central annular hole structure.

[0069] More specifically, the single-layer mesh configuration of the present configuration is optional. One embodiment of the present disclosure has a single mesh layer in the disk element of the present disclosure. Another embodiment of the present disclosure has multiple mesh layers in the disk element.

[0070] More specifically, the application of a hydrogel coating to the disc element of the present disclosure is optional. One embodiment of the present disclosure discloses a hydrogel coating on a surface of a disc element of the present disclosure. In another embodiment of the present disclosure, a hydrogel coating is not applied to a surface of a disc element of the present disclosure. In other embodiments, a hydrogel coating is employed on some but not all surfaces of the mesh disc. In some optional embodiments, the hydrogel is chemically optimized to expand significantly and can also be positioned so that it expands into a pathological exocyst to further aid in thrombosis / closure / exocyst of the aneurysm.

[0071] More specifically, the application of the hydrogel coating of the retaining arm element of the present disclosure is optional. One embodiment of the present disclosure discloses a hydrogel coating on the surface of the retaining arm element of the present disclosure. In another embodiment of the present disclosure, the hydrogel coating is not applied to some surfaces of the retaining arm element of the present disclosure. In yet another embodiment of the present disclosure, the hydrogel coating is not applied to any surface of the retaining arm element of the present disclosure.

[0072] Reference now Figure 7 , another embodiment of the present disclosure is shown. At least one or more coil-shaped retaining arms 200 are attached to the mesh component and extend within the exodontia. The retaining arms 200 can engage the inner wall of the exodontia and / or the embolic coil 24 to help keep the coil and mesh occluded relative to the neck of the exodontia.

[0073] Attached Figure 8 An embodiment utilizing a substantially linear retaining arm 200 is shown, which may be advantageous for small protrusions or protrusions having an atypical shape. The ends of the linear retaining arm 200 may be blunt to avoid any potential undesirable engagement with the protrusion wall. In addition, according to this embodiment, the embolic coil is delivered through the microcatheter 12.

[0074] Attached Fig. 9 An embodiment is illustrated in which a single coiled retention arm 200 coupled to a mesh occluder 14 is embedded within an outer protrusion filled with a hydrogel 16. The retention arm 200 engages the hydrogel 16 in a manner that minimizes movement of the retention arm and subsequent movement. The mesh occluder 14 does not use an embolic coil in this embodiment. It is contemplated that the mesh occluder 14 can be used as a stand-alone shunt with the hydrogel 16.

[0075] Attached Fig.10 is with Fig. 9A similar embodiment, but utilizing a plurality of substantially linear retention arms 200 attached to the mesh occluder 14 .

[0076] 11 and 12 are embodiments utilizing multiple coiled retaining arms attached to a mesh occluder 14. According to these embodiments, the retaining arms 200 and the mesh occluder are used as independent shunts. Various configurations of retaining arms can be envisioned, such as FIG. 12A showing a curved peripheral lip 14A of the mesh occluder 14.

[0077] 13 and 14 show various coiled retaining arms 200 and alternative linear retaining arms 200 used with the hydrogel 16 to retain the mesh occluder 14 at the neck of the aneurysm. According to this embodiment, an embolic coil may not be required, wherein the retaining arms and hydrogel are used as independent flow diverters.

[0078] In an illustrative embodiment, a mesh occluder for improving protrusion comprises a control element, a catheter element, a delivery member, a separation element, a mesh disk, a distal opening and at least one attached extension arm, wherein the mesh disk further comprises a proximal face and a distal face, the proximal face being opposite to the distal face; the proximal face and the distal face being substantially flat; wherein the mesh disk further comprises a peripheral lip; wherein the mesh disk comprises a core, the diameter of the core being configured to be smaller than the protrusion, wherein the mesh disk is secured in place by the at least one attached extension arm.

[0079] The mesh tray with at least one attached extension arm includes a matrix adapted to be formed into a shape having a suitable geometry to accommodate the contour of the protrusion.

[0080] The transport member may further include a channel capable of transporting the at least one coil therethrough.

[0081] At least one additional coil may be continuously conveyed by the conveying member.

[0082] A matrix of series-connected delivery coils adapted to form the appropriate geometry can fill the protrusions.

[0083] The mesh disk may be configured to be impregnated with a sufficient amount of the adherent hydrogel to wedge the mesh disk into the target vascular structure.

[0084] The adhered hydrogel may be radiopaque.

[0085] In another illustrative embodiment, an embolic device for improving protrusion includes a control element, a catheter element, a wire, a separation element, a mesh disk, at least one arm extension attached to the mesh disk, and a distal opening, wherein the mesh disk also includes a proximal face and a distal face, the proximal face is opposite to the distal face; the proximal face and the distal face are substantially flat; wherein the mesh disk further includes a peripheral lip and a disk core, the diameter of the disk core is configured to be smaller than the aneurysm, and wherein the mesh disk is fixed in place by at least one arm extension.

[0086] The mesh disk has at least one arm extension including a matrix adapted to be shaped into a suitable geometry to conform to the contour of the protrusion.

[0087] The matrix can be configured to substantially fill the aneurysm.

[0088] The mesh disc and at least one extension arm extension may be configured to be impregnated with a sufficient amount of the adherent hydrogel to wedge the mesh disc into the target vascular structure.

[0089] The mesh disc can be configured to be positioned at the neck of the protrusion.

[0090] The mesh disk can be configured to substantially not fill the protrusions.

[0091] The network disk may also include at least one additional layer.

[0092] At least one of the additional layers may further comprise an adhered hydrogel adapted to modify flow through only the one additional layer.

[0093] The mesh tray having at least one arm extension may be adapted to grip a wall of the protrusion and configured to stabilize the mesh tray in position at the neck of the protrusion.

[0094] The device may include a transport member having a channel capable of transporting at least one coil therethrough.

[0095] At least one additional coil is continuously conveyed through the channel of the conveying member.

[0096] At least one additional coil is delivered serially, comprising a matrix adapted to form a suitable geometry to fill the protrusion.

[0097] Although the present invention has been described in detail in the above embodiments for the purpose of illustration, it should be understood that these details are only for this purpose and can be varied by those skilled in the art without departing from the spirit and scope of the present disclosure.

Claims

1. A mesh occluder for improving protrusion, characterized in that: The invention comprises a control element (11), a catheter element (12), a delivery member (13), a separation element (17), a mesh disk (14), at least one retaining arm (200) attached to the mesh disk (14), and a distal opening, wherein the mesh disk further comprises a proximal face and a distal face, the proximal face being opposite to the distal face; the proximal face and the distal face are substantially flat; wherein the mesh disk further comprises a peripheral lip (14A) and a disk core (14B), the diameter of the disk core (14B) being configured to be smaller than the aneurysm, and wherein the mesh disk is fixed in place by at least one retaining arm (200), At least one retaining arm (200) is connected to the mesh plate (14) on one side of the arm and extends toward the distal end; At least one retaining arm (200) is configured to engage with the outer projection wall and is arranged to facilitate fixing the mesh plate relative to the outer projection, and At least one retaining arm (200) has a proximal end and a distal end, wherein the proximal end is connected to the mesh plate (14), and the mesh plate (14) and the retaining arm (200) are configured to be delivered to the external protrusion together.

2. The occluder according to claim 1, characterized in that: The retaining arm (200) is linear or coiled inside the outer protrusion.

3. The occluder according to claim 1, characterized in that: At least one retaining arm (200) is connected to the peripheral lip.

4. The occluder according to claim 1, characterized in that: The mesh plate (14) having the at least one retaining arm (200) comprises a matrix adapted to be formed into a shape having a suitable geometry to conform to the contour of the protrusion.

5. The occluder according to claim 4, characterized in that: The matrix is ​​configured to substantially fill the aneurysm.

6. The occluder according to claim 1, characterized in that: The mesh disk (14) and the at least one retaining arm (200) are configured to be impregnated with a sufficient amount of adhesive hydrogel to wedge the mesh disk (14) into a target vascular structure.

7. The occluder according to claim 1, characterized in that: The mesh plate (14) is configured to be positioned at the neck of the protrusion.

8. The occluder according to claim 1, characterized in that: The mesh disk (14) is configured to substantially not fill the protrusion.

9. The occluder according to claim 1, characterized in that: The network disk (14) further comprises at least one additional layer.

10. The occluder according to claim 9, characterized in that: The at least one additional layer further comprises an adherent hydrogel adapted to modify flow through only the one additional layer.

11. The occluder according to claim 1, characterized in that: The mesh plate (14) having the at least one retaining arm (200) is adapted to clamp the wall of the protrusion and is configured to stabilize the mesh plate (14) in a suitable position at the neck of the protrusion.

12. The occluder according to claim 1, characterized in that: The delivery member (13) includes a channel through which at least one embolic coil can be delivered.

13. The occluder according to claim 12, characterized in that: Also included is at least one additional embolic coil (24) that is serially delivered via the delivery member.

14. The occluder according to claim 13, characterized in that: The at least one successively delivered additional embolic coil (24) comprises a matrix adapted to be formed into a shape having a suitable geometry to fill the exodontia.

15. The occluder according to any one of claims 1 to 14, characterized in that: The mesh disk (14) used to improve the protrusion is a mesh occluder.

16. The occluder according to any one of claims 1 to 14, characterized in that: The conveying member (13) is a wire.

17. The occluder according to any one of claims 1 to 14, characterized in that: The conveying member (13) is a hypotube.

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