System for treating protrusions

Abstract

The present application provides a system for treating a protrusion, comprising: a control element coupleable to a catheter element; a delivery member extending at least partially through the catheter element; and an occluder disc detachably coupled to the delivery member using a separating element. The occluder disc defines an opening and includes: a disc core having a diameter configured to be smaller than the protrusion; and at least one retaining arm configured to extend from the opening toward the outwardly projecting distal end, engage the outwardly projecting wall, and secure the occluder disc in place, where the at least one retaining arm has a proximal end connected to the occluder disc. The delivery member is configured to deliver the occluder disc and the at least one retention arm to the protrusion.

Description

This application is a divisional application of a Chinese patent application with an application date of September 14, 2020, an application number of 202080064532.5, and an invention title of "Retrievable Mesh Occluder for Improving Protrusions". Technical Field

[0001] The disclosed subject matter generally relates to intravascular devices and, more particularly, to a specially shaped support cap at the top of a mesh disk. Background Art

[0002] The present disclosure is applicable to gastrointestinal (GI) organs, vascular aneurysms, and brain aneurysms. More specifically, the present disclosure is applicable to the repair of protrusions, including diverticula and aneurysms. In an illustrative embodiment, the present disclosure relates to intravascular devices for filling various vascular malformations or other pathological protrusions. Protrusions may include vascular aneurysms found in intracranial aneurysms, fusiform aneurysms that protrude outside the arterial wall, and saccular aneurysms composed of a neck, a stem, and a dome.

[0003] Existing procedures for improving protrusions, including vascular, brain, and intestinal exposures, involve surgically clipping the protrusion either through an open procedure or through an interventional intravascular procedure. Another conventional procedure involves placing one or more coils into the protrusion sac or aneurysm sac through a microcatheter. The main limitation associated with vascular surgery is that "wide-neck" protrusions (or aneurysms) are generally not suitable for this type of treatment because the implanted device may displace within or from the aneurysm sac. Another limitation associated with procedures using single-threaded coil devices is that the device typically requires the surgeon to stuff the coil into the aneurysm, thereby increasing the risk of damaging the blood vessel and the aneurysm wall.

[0004] Other existing procedures also include using stents, such as intracranial stents, as supports for holding coils within the aneurysm sac, particularly in protrusions or aneurysms exhibiting a wide-neck anatomy. However, this method may increase the likelihood of damage to surrounding blood vessels, and / or require antiplatelet therapy to prevent thrombus formation within the stent, thereby increasing the likelihood of bleeding complications.

[0005] Although 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 protrusion, thus resulting in a higher coil compaction rate within the protrusion, as well as recurrence of the protrusion and the attendant risks. The present disclosure employs a surgical device that includes a mesh element that is primarily positioned at the neck of the aneurysm / protrusion to overcome this limitation.

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

[0007] The present disclosure overcomes the disadvantages of the prior art by using a mesh or occluding element and associated components that position an embolization material, including an embolization coil, relative to the protrusion before separation and before and / or after placement of an adjunct, to fix the position of the occluding element relative to the protrusion. More specifically, the present disclosure includes a self-expanding occluding device that can both cover the neck of the protrusion and serve as a permanent embolization, 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 within the protrusion, effectively acting as a permanent embolization. In an illustrative embodiment, the present disclosure combines an embolization disk with a retaining arm of a flexible material, such as a wire formed of a shape memory material including metal and polymer, a superelastic material, a spring material, etc., which unfolds within the protrusion and provides immediate stabilization, thereby holding the occluding component or mesh at the neck of the protrusion. In an illustrative embodiment, the arm is in the form of a coil configured to unfold into a three-dimensional structure.

[0008] In an exemplary embodiment, the retaining arm can be in the shape of a coil that defines a structure that at least partially follows the contour of the internal region of the protrusion to stabilize, for example, an occlusion disk near the neck or a mesh near the protrusion. The retaining arm in the form of a coil or other configuration can be constructed to engage or "grab" the inner wall of the protrusion, where the mesh or occluding element is optimally positioned at the neck of the protrusion. The configuration of the retaining arm can be in the form of one or more coil loops that are connected together to form a dome-shaped structure or can be independent of each other. Further contemplated is that the retaining arm need not form a coil shape when deployed, but can be in a slightly curved orientation or even a relatively linear orientation. In other illustrative embodiments, one or more retaining arms can be engaged with one or more primary embolization coils that are introduced into the protrusion either before or after, to provide further stabilization or a retaining structure within the protrusion. In still further illustrative embodiments, the retaining arm can be engaged with a hydrogel injected into the outer sac or aneurysm and cooperate with the hydrogel to provide a further support function.

[0009] Briefly stated, generally speaking, the present disclosure provides a reticulated occluder for treating an extruding, and a system and method for deploying the reticulated occluder from a parent vessel into the extruding. On the one hand, the system includes an occluding member, e.g., in the form of a reticulum, which can at least partially or completely cover the neck of the extruding. In certain embodiments, the reticulated occluder creates a permanent embolization plug in the extruding. The reticulated occluder can include one or more self-expanding components that provide a simple or uniform complex matrix that expands and assumes a variety of configurations when deployed, including but not limited to generally hemispherical or semi-ovoid configurations or other shapes such as conical, kidney-shaped, bi-lobed, or other complex shapes, enabling the self-expanding bag filling device to be quickly fixed in the desired position within the bag. In other illustrative embodiments, the filling device includes slightly curved and / or linear retaining arms.

[0010] An alternative configuration of the occluding member of the reticulated occluder of the present disclosure, e.g., a reticulated disk, can have a single layer or multiple layers. Other alternative embodiments of the occluding assembly or the mesh disk include openings through the occluding assembly, e.g., generally located centrally, to allow the introduction of embolization materials such as hydrogels, gelatin foams, ethanol, polyvinyl alcohol particles, calibrated microspheres, central vascular plugs, coils, n-butyl cyanoacrylate glue, fibrin glue, polidocanol foam, alcohol-soluble protein solution, and ethylene vinyl alcohol copolymer. The region of the defined opening of the closure element can have its edges tapered or recessed inwardly relative to the extruding to define a conical region to facilitate the entry or re-entry of components, embolization fluids, etc. into the extruding.

[0011] The reticulated occluder can be a component of a medical system that includes a microcatheter and a delivery line to which the reticulated occluder is attached. The reticulated occluder can be detachably connected to the delivery line. In some illustrative embodiments, the distal end of the microcatheter can extend through the occluding member, e.g., through an opening in the occluding member, thereby providing a catheter for delivering primary and / or supplementary embolization materials into the extruding. The embolization materials can include coils, liquid embolics, hydrogels, combination devices, and other embolization materials known in the art. These can generally be deployed continuously to fill the profile of the extruding. A non-limiting example of an extruding is a vascular aneurysm.

[0012] The present disclosure provides a mesh occluder for an outpouching or aneurysm in a blood vessel or intestine, which can be at least partially self-expanding and capable of stabilizing immediately upon deployment. In some iterations, the deployment rate of the retention arm from a compressed state within a microcatheter to a deployed state within the outpouching is controlled to be slower than the expansion rate of the occlusion or mesh element. This can allow the occlusion element or disk to be more precisely positioned on the neck of the outpouching while avoiding potential trauma to the inner wall of the outpouching by the retention arm being dragged across it. In an illustrative embodiment, the present disclosure includes a self-expanding outpouching filling device having a compressed undeployed configuration and a deployed three-dimensional deployed configuration, a delivery member (such as a wire or hypotube / microcatheter), and a separable deployment system that includes a connector capable of releasing the self-expanding outpouching filling device. In a preferred embodiment, the outpouching filling element of the present disclosure is constructed of a metal such as platinum or a platinum alloy, nitinol, and / or other biocompatible metals. The severable deployment element can be severed mechanically, electrolytically, thermally, hydrostatically, chemically, or otherwise to separate the self-expanding outpouching 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 the features of the present disclosure by way of example. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG Figure 1 illustrates a medical system, 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 the distal end of the delivery assembly in accordance with the principles of the present disclosure;

[0015] FIG Figure 2 shows a side view of a microcatheter of a medical system entering an outpouching through a blood vessel, where, in accordance with the principles of the present disclosure, the mesh occluder is deployed relative to the outpouching, with the occlusion element at least partially spanning the neck of the outpouching and the retention arm being deployed in the form of one or more coils inside the outer sac;

[0016] FIG Figure 3A is a side view similar to FIG Figure 2 showing a control element of a medical system for delivering an embolization coil within an outpouching in accordance with the principles of the present disclosure;

[0017] FIG Figure 3B is a side view similar to FIG Figure 2 -3, illustrating an occlusion assembly deployed at the bottom of the neck of a target non-spherical outpouching;

[0018] FIG Figure 4 is a side view similar to FIG Figure 2 -3, showing the introduction of an embolic agent (such as a hydrogel) within the outpouching and the deployment of the retention arm;

[0019] FIGFigure 5 is similar to attachment Figures 2-4 side view, showing an optional positioning balloon connected to the outer surface of the microcatheter to position the microcatheter relative to the protrusion;

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

[0021] attachment Figure 7 is a side view showing the deployment of multiple independent retention members inside the protrusion;

[0022] attachment Figure 8 is a side view showing the deployment of a single retention arm having a generally linear configuration inside the protrusion;

[0023] attachment Figure 9 shows a side view of the deployment of a single retention arm having a generally coiled configuration inside the hydrogel-filled protrusion;

[0024] attachment Figure 10 shows a side view of the deployment of multiple retention arms inside the hydrogel-filled protrusion, each retention arm having a generally linear configuration. DETAILED DESCRIPTION

[0025] In an illustrative embodiment, the present disclosure can be used to hold one or more embolization coils introduced into a protrusion, such as an aneurysm in a blood vessel or gastrointestinal organ, to help retain the embolization coils within the protrusion and also provide immediate support within the protrusion, thereby minimizing the likelihood of rupture of the protrusion or aneurysm. More specifically, the present disclosure provides an occlusion device and one or more retention arms that can engage with one or more embolization coils to prevent the coils from being released through the neck of the protrusion or aneurysm, particularly a wide-neck aneurysm. It is further contemplated that a mesh occluder can engage any embolizing agent, such as a hydrogel introduced into the protrusion, thereby further minimizing the likelihood of embolization coil migration.

[0026] In other illustrative embodiments, the present disclosure can be used independently of the introduction of embolization coils and / or any other embolizing substance or element. In this illustrative embodiment, the occlusion member or mesh can define a finer or denser mesh material to act as an occluder and, in combination with the retention arms, fix the occluder element as an independent unit relative to and across the neck. In any case, it is contemplated that the present disclosure will minimize (if not completely eliminate) the need for multiple embolization coils, which provides a significant advantage in minimizing aneurysm rupture or other difficulties.

[0027] The present disclosure provides a structure that is immediately stable relative to the wall of an outpouching or aneurysm. This immediate stability minimizes the likelihood of device displacement, thereby eliminating the potential need to close, reposition, and redeploy the device, thus minimizing damage to the blood vessel and reducing the operative time. The present disclosure employs an occluding member in the form of a reticular element and a member that secures its position relative to the outpouching prior to detachment and, if desired, prior to placement of additional embolization material. Thus, in an illustrative embodiment, the present disclosure provides a self-expanding outpouching filling device that both covers the neck of the outpouching or aneurysm and serves as a permanent embolization within the outpouching, having elements that rapidly stabilize its position, having a reticular assembly that passes through the neck of the outpouching at its desired location but does not protrude into the parent vessel.

[0028] Reference is now made to the attached Figure 1 , which illustrates a medical system in accordance with 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 delivery member 13 that extends at least partially through the microcatheter 12 and is optionally attached to the control element 11. A reticular occluder 14 is attached to the delivery member 13. The reticular occluder 14 is deployable to improve leakage and will be discussed in more detail below. The reticular occluder 14 is an occluding member and may or may not be a reticular device. However, for simplicity, the mesh occluder 14 will be referred to hereinafter as the "mesh occluder". However, it will be understood that the occluder may be solid, perforated, include slits, etc.

[0029] The microcatheter 12 can be operated via a control element 11 and can include, for example, a wire embedded within the wall of the microcatheter 12 that can be manipulated to navigate the microcatheter through tortuous blood vessels (e.g., blood vessels or intestinal organs). The control element 11 can include one or more controllers that assist in navigating the microcatheter 12 through the blood vessel. For example, the control element 11 can include circuitry, electronics, etc. capable of sending signals to the microcatheter 12 to manipulate the wire within the microcatheter 12 to laterally move portions 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 for removably securing 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 effect separation of the mesh occluder 14. In one illustrative embodiment, the control element 11 can be a stand-alone unit (e.g., commercially available) and can be coupled to the microcatheter 12 and / or the delivery member 13 prior to 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 can be entirely disposable after a single use or can be partially or fully reusable. If reusable, the components of the medical system can be made of materials capable of withstanding conventional sterilization procedures. The microcatheter 12 can include one or more externally mounted balloons to facilitate retention of the microcatheter relative to the blood vessel and the protrusion. The microcatheter 12 can have an outer diameter in the range of 0.5Fr - 20Fr. In one embodiment, the outer diameter of the microcatheter 12 ranges from 3Fr to 5Fr.

[0030] Now referring to the attached Figure 2 , there is shown 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 assist in positioning the microcatheter 12 and the mesh occluder 14 relative to the protrusion. Deployment of the mesh occluder 14 can be achieved by a variety of mechanisms. In one illustrative embodiment, a mesh occluder 14 including a mesh occlusion member and retention arms 200 can be disposed within the microcatheter 12 in a compressed state. 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 its normal expanded state. In the normal deployed state, the mesh device of the occlusion assembly 14 at least partially extends through the neck of the protrusion 100, and the retention arms 200 deploy within the interior of the protrusion, e.g., engaging the inner wall of the protrusion to facilitate retention of the mesh occlusion member 14 relative to the neck of the protrusion.

[0031] In an illustrative embodiment, the occluding member 14 is a mesh disk and may optionally be coated with a hydrogel. For treating a saccular protrusion (or aneurysm): a mesh deployed inside a blood vessel (metal mesh or other mesh) Intervertebral disk - optionally having two layers, similar to the Anplatz left atrial appendage closure device currently being tested. The intervertebral disk may have a relatively flat version, or a version with edges folded up to accommodate different shaped protrusions (or aneurysms), including very wide neck protrusions (or aneurysms). This deviation from the generally flat plane of the mesh disk 14 of the present disclosure may have an upturned side that conforms to the wall of the target protrusion 100, which is close to the neck of the protrusion 100. This upturned element 14A (sometimes referred to as a "lip") ( Figure 3B ) is optional and is most suitable 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 the flat mesh intervertebral disk 14 because the wide-neck extension (or aneurysm) lacks sufficient overhanging area at the neck to support the mesh intervertebral disk 14. Thus, in accordance with the present disclosure, the lip 14A is provided on the mesh together with one or more retention arms 200 to facilitate attachment to a wide-neck aneurysm. The retention arm extensions 200 provide supplementary support for fixation through the protrusion. Different from the prior art, this fixation device provides a mesh disk with multiple attachment points inside the protrusion. More specifically, the mesh disk 14 includes a core 14B, the diameter of which is configured to be smaller than the target protrusion 100. The mesh disk 14B is fixed in place by at least one attached extension arm 200. In an alternative, the occluding member may be a slightly arcuate grid element.

[0032] In an illustrative embodiment, the retention arms 200 form an annular coil matrix, wherein at least a portion of the arms engages the inner wall of the protrusion. In one exemplary embodiment, the retention arms 200 form a dome shape, wherein at least some of the arms are connected at one or more locations. In other embodiments, the retention arms are independent and may adopt any configuration, including Figure 2 the dome-shaped matrix shown.

[0033] The advantage of the annular coil matrix is that they will provide a structure through which the currently disclosed mesh disk can achieve a more direct and effective stable positioning by gripping the protrusion wall with the coil rings, and the mesh portion is optimally positioned in the outer tuning. The coil rings may be helical or connected in the form of a birdcage (or dome-shaped) or similar structure. However, the prior art teaches a generally spherical or oval configuration and lacks a more effective dome-shaped configuration and a dense, slightly flat mesh at the bottom (neck of the protrusion) near the distal end of the catheter.

[0034] As described above, the occlusion device 14 and the retention arm 200 can be formed from 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 the blood, or, the surgical device can be formed from spring steel or metal. The occlusion member 14 and at least one retention member or arm 200 can be compressed into a shape suitable for delivery through the microcatheter 12. It has also been noted that the properties of the occlusion device 14 and the retention member 200 can be controlled such that the occlusion device retention arm 200 expands at a faster rate than the retention arm 200 to minimize the likelihood of an undesired "drag" of the retention arm 200 within the protruding wall. Other arrangements are also contemplated.

[0035] In other illustrative embodiments, a control unit 11 electrically coupled to the separation member 17 can relay a signal to the occlusion member 14 to initiate decompression of the occlusion member 14 and at least one retention arm 200 prior to deployment, or cause the occlusion member 14 and the retention arm to assume 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 effect the deployment of the occlusion member 14. For example, an electrical signal and / or thermal energy can be transmitted from the control unit 11, through the delivery member 14, in response to the generated thermal energy, the surgical device 14 assumes its expanded state through shape memory properties, and optionally disrupts the detachable attachment between the separation element 17 and the surgical device 14. After deployment, the control unit 11 can be actuated to cause retraction of the microcatheter 12 and / or the delivery member 13 relative to the protrusion.

[0036] Continuing reference to the attached Figure 2, the mesh disk 14 and at least one retention arm 200 are deployed through a delivery catheter 12 that passes through a blood vessel 110 to the base of the neck of the target outpouch 100. The control device 11 can optionally signal the delivery member 13 to extend beyond the length of the distal catheter 12 sufficient to enter the target outpouch 100 to allow deployment of the mesh disk 14 and at least one retention arm 200. Once the advancement of the delivery member 13 stops, the control element 11 signals the deployment of the mesh disk 14 and at least one retention arm 200. The mesh disk 14 and at least one retention arm 200 enter the target outpouch in a compressed form, and a signal from the control element 11 guides the mesh disk 14 and at least one retention arm 200 to open like a flower to allow the perimeter of the mesh disk 14 and at least one retention arm 200 to overlap the base of the neck of the outpouch 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 advanced forward a length sufficient to enter the target outpouch 100 to allow deployment of the mesh disk 14 and at least one retention arm 200. The mesh disk 14 and at least one retention arm 200 enter the target outpouch in a compressed form, and when it is released from its restraint, the mesh disk 14 and at least one retention arm 200 open like a flower to allow the perimeter of the disk-shaped mesh disk 14 and at least one retention arm 200 to overlap the base of the neck of the outpouch 100. The disk is then gently pulled back into place manually, preferably determined by fluoroscopy and / or angiographic images.

[0037] For the treatment of saccular outpouches (or aneurysms), an endovascularly deployable mesh (wire mesh or other mesh) disk can be used in combination with at least two layers. The disk can have a relatively flat version, or some versions with edges folded up to accommodate different shaped outpouches (or aneurysms), including very wide neck outpouches (or aneurysms). This deviation from the generally flat plane of the occluding device, in the form of the mesh disk 14, can have an upturned side that conforms to the wall of the target outpouch 100, which is near the neck of the outpouch 100. As Figure 3B shown, the upturned element 14A (sometimes referred to as a "lip") is optional and most suitable for very wide neck outpouches (or aneurysms) that are less spherical in shape and more cylindrical in shape. For wider neck outpouches (or aneurysms), the lip 14A provides sufficient overhang at the neck to support the mesh disk 14 adjacent to the wide neck outpouch (or aneurysm). The present disclosure contemplates the use of a variety of different lip configurations. The lip configurations differ in diameter, shape, and orientation. In a preferred embodiment, the central portion of the mesh disk (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 outpouch.

[0038] The diameter of the mesh disk ranges from 0.1 millimeter to 30 centimeters. The shape of the mesh disk varies from circular to triangular. The most typical shapes are circular or oval. The mesh disk 14 can be coated with a hydrogel. The voids of the disk 14 can be sized to accommodate the hydrogel.

[0039] In a typical spherical protrusion with a narrow neck, the entire mesh disk 14 and at least one coil arm 200 include a lip 14A and 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 retention arm 200.

[0040] In a typical non-spherical protrusion with a wide neck, the entire outer perimeter 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 gently grip the wall near the bottom of the target protrusion.

[0041] As attached Figure 2 As shown, the medical system 1 can also include or be used in conjunction with a coil delivery mechanism that includes a second control unit 20 and a second catheter 22 for delivering one or more embolization coils 24 into the protrusion before, after, or simultaneously with the deployment of the mesh occluder 14. The embolization coils 24 can be any conventional embolization coils for treating aneurysms or any protrusions within the body's blood vessels. It is contemplated that the mesh occluder 14 including the occluding or mesh member 14 and the retention arms 20 will further assist in retaining the embolization coils 24 within the protrusion. For example, the occluding member 14 can prevent the release of the micro-coils 24 by, for example, interfering with the movement of the micro-coils 24 within the outer sac or engaging the micro-coils 24, such as by at least partially surrounding or winding the micro-coils 24. It should be noted that the mesh disk or occluding element 14 of the present disclosure is capable of creating a second "jailing" microcatheter. Figure 4 Depicts the introduction of one coil 24 into the protrusion. As noted, multiple embolization coils 24 can be introduced into the protrusion during or even after the initial procedure.

[0042] As described above, after the deployment of the occluding member 14 and at least one retention arm 200, the control element 11 is optionally capable of sending signals that cause the deployment of the coils 24, the hydrogel 16, and / or the lip 14A. As noted, in one illustrative embodiment, a separate control element 20 controls the separation of the coils 24. After the deployment of the above elements, the control element 11 is capable of sending a signal to the separation element 17 to separate the delivery member 13 from the mesh disk 14 and at least one retention arm 200. Then the control element 11 is capable of retracting the catheter 12 and the delivery member 13.

[0043] The present invention can be used with or without the hydrogel 16. One illustrative embodiment does not have a hydrogel. However, it should be noted that the present disclosure can be used with a hydrogel, and such use has been disclosed in the previous Walzman application. When a hydrogel is used, the hydrogel can optionally expand only in response to a specific external stimulus rather than the hydration time. The hydrogel may contract in response to an optional external stimulus. This on-demand expansion and contraction helps to reposition the medical tool near the target area within veins and arteries. External stimuli include, but are not limited to, heat, electricity, and / or chemical signals. It should also be noted that the hydrogel 16 can optionally be radiopaque, which facilitates the remote positioning and localization of the hydrogel 16. This embodiment has been disclosed in previous applications, such as Walzman'519 and 16 / 024,673.

[0044] Note that the mesh disk 14 and at least one retaining arm 200 will be held in place by the coil 24 or the hydrogel 16 when deployed. Each coil will generally conform to the interior of the target protrusion 100. The retaining arm can be a loop or a straight extension. The extension can have various widths and shapes. Some embodiments can have a rounded atraumatic edge. Alternatively, the mesh disk 14 must have an upward "lip" and can be held in place by the friction between the disk and the target protrusion wall and the fact that the diameter of the disk 14 is greater than the neck diameter of the protrusion 100. Finally, the larger disk 14 can be held in place bidirectionally.

[0045] The amount of the hydrogel 16 can vary. As long as sufficient hydrogel 16 can be delivered to the protrusion 100 to fill it, the specific amount is not important. Other embodiments may not use a hydrogel. In an alternative embodiment of the present disclosure, an optional hydrogel coats the mesh disk 14 and at least one attached arm extension 200 such that the hydrogel will expand into and fill the dome of the protrusion 100.

[0046] 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 other techniques for remote visualization and position detection. The same characteristics are included in the separation element 17.

[0047] As shown in the attached Figure 3A figures, the present disclosure can incorporate elements of the prior art, such as deploying the coil 24 through the microcatheter 13.

[0048] Referring to the attached Figure 3B figures, the present disclosure teaches the use of an upturned lip to secure the mesh disk 100 and integrate the prior art coil element 24. Figure 3B An embodiment is also depicted in which the delivery member 13 is a microcatheter capable of serving as a conduit for delivering the coil through it.

[0049] Now referring to Figure 4 ,alternative embodiments of the present disclosure combine the mesh disk 14 and at least one retention 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 retention arm 200 through the 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 retention arm 200. Alternatively, a hydrogel-embedded coil can be used with the present disclosure.

[0050] Now referring to the appended Figure 5 ,which is an alternative embodiment of the appended Figure 4 . The appended Figure 4 also includes a centering balloon 303 within the blood vessel 110. The centering balloon 303 allows the catheter element 12 to be positioned more precisely and stably relative to the center of the neck of the target protrusion 100. Prior to deployment, additional contrast agent or other fluid injection can be optionally performed to initiate the deployment of the optional balloon 303 or 300 to position the catheter 12, thereby centering the delivery microcatheter 13 to achieve optimal deployment of the mesh disk 14. More specifically referring to the centering balloon 303, the balloon is described in detail in Walzman's application No. 14 / 482,436 (titled "Vascular Access Catheter"), which is incorporated herein by reference.

[0051] It should be noted that a single balloon and balloon arrays are described in U.S. Patent 14 / 482,436 (titled "Vascular Access Catheter") incorporated herein by reference. The centering balloon 303 of the present disclosure can be a single balloon or a balloon array. The single balloon or balloon array is designed to help center the distal end of the catheter element 12 to a position near the center of the target protrusion. This positioning can be achieved by inflating at least one balloon so as to deflect the catheter element 12 in a desired direction.

[0052] Another embodiment of the present disclosure incorporates the Walzman disk balloon 300, as shown in the appended Figure 6 , inserted into the catheter element 12. This combination is an alternative embodiment that is designed to help center the tip of the catheter element 12 to a position near the center of the target protrusion. It can also serve as a vertical positioning element by abutting the bottom of the mesh disk during target protrusion positioning.

[0053] The two separate or combined balloon embodiments are also designed to block the flow within the container approaching the target leakage when fully inflated. In the case of rupture of the target protrusion, inflation will result in controlling unnecessary bleeding.

[0054] Thus, the present disclosure can have several different embodiments, including:

[0055] 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 outpouring, 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 outpouring and be ineffective. Through the second microcatheter, now “imprisoned” in the outpouring, appropriately sized coils are sequentially placed and deployed into the outpouring, per current conventional protocols / techniques, until the outpouring is adequately filled with coils. The second microcatheter is removed. At this point, the disc is detached from its delivery wire / catheter and removed.

[0056] 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.

[0057] Third, provide a separate hydrogel-enhanced intervertebral disc. The intervertebral disc is a network deployed inside blood vessels and is composed of shape memory materials (such as nitinol) or other memory shape materials with superelastic properties, so that the compressed network disc will return to a flat network disc shape when released or be 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 being tested - the disc can have a relatively flat version, or some versions with the edges folded up to fit different shaped outpouchings (or aneurysms), including very wide neck outpouchings. However, in this version, the outer surface of the disc facing the outpouching is lined with a non-biodegradable hydrogel that will expand when exposed to blood during deployment to conform to the size and shape of the outpouching and fill and occlude the outpouching within a specified time (10 minutes in the preferred embodiment of the present disclosure). Another layer of the intervertebral disc near the aneurysm-bearing artery can also optionally have a thin layer of hydrogel - but the hydrogel of this layer is designed to only expand to separately seal this layer of the intervertebral disc, so it is impossible for the hydrogel of other layers to potentially expand through the grid into the parent blood vessel. An appropriately sized intervertebral disc can be deployed through a microcatheter in a saccular aneurysm. Gently pull the intervertebral disc back to the neck of the aneurysm, bridge the neck, and have the lip extend beyond the opening part of the neck to stabilize the intervertebral disc. The intervertebral disc is not initially detached but is still tethered to its delivery system (wire or catheter). If detached prematurely, it is likely to migrate into the outer package and be ineffective. When the hydrogel expands, the disc is fixed at the outflow neck. Once the specified time has passed and subsequent angiography confirms the occlusion of the outpouching, the intervertebral disc is detached from its delivery line / catheter, and the delivery line / catheter and the microcatheter through which it was deployed are removed. Optionally, in appropriate cases, the hydrogel can be used to fill the outer sac, which seals the outer sac and also stabilizes the intervertebral disc in place (in Examples 1 and 2, the coil achieves these two goals). It should be noted that the previous Walzman disclosure has claimed protection for such embodiments.

[0058] Fourth, all of the features of the first to third above and optionally; in addition, the disc can have a smaller metal core disc 14B with a size smaller than the diameter of the outpouching, and have a hydrogel designed to unfold in a disc shape from the edge to form a larger disc, which can then be gently dragged into place. Then it can be fixed in place by a coil embedded in the top of the disc or an optional hydrogel, and then a layer on top of the metal disc is designed to expand after the side hydrogel and then expand into the dome of the outpouching, or by separately implanted hydrogel beads, etc.

[0059] The smaller disc can also be used in combination with other embolization fillers, where the disc is fixed by at least one arm extension, and the disc is used to reduce the effective width of the aneurysm neck.

[0060] The reticulated disk 14 and at least one coil arm 200 may also optionally be delivered via a disk balloon microcatheter (previously described by Walzman 14 / 732,170) or a similar configuration (disk balloon), an intermediate catheter, or another balloon catheter. These may be used as a delivery method of the present disclosure. The method may also be used to deliver any reticulated sac device, including other devices taught by the prior art, such as Web and Luna.

[0061] The advantages of delivery via a disk balloon microcatheter are twofold. First, the balloon may sometimes assist in positioning the reticulated disk 14 and at least one coil arm 200. Second, if a rupture occurs outside during treatment, the balloon can be inflated to stop the flow and control active bleeding until more coils can be placed.

[0062] The sizes of the disk and the coil ring and the time required for full deployment vary. More specifically, the diameter of the disk ranges from 0.1 mm to 500 mm. The diameter of the coil ring ranges from 0.1 mm to 1000 mm. The length of the coil ring can be 0.1 mm to 3142 mm long. The coil ring for coil exposure is typically sized according to the diameter of the target outpouching.

[0063] Regarding the time required for full deployment of the disk and the coil, it ranges from almost instantaneous [about one second or less] to one hour. Although in some embodiments, both the disk and the coil expand at the same rate, in other embodiments, the disk and the coil expand at independent rates. In some embodiments, the coil expands faster than the disk, while in other embodiments, the disk expands faster than the coil.

[0064] In a preferred embodiment, the coil completes its expansion approximately forty-five seconds after the disk finishes its expansion. This time offset allows the present disclosure to be positioned at the optimal location through the neck (opening) of the target outpouching without dragging the metal along the target outpouching or the vessel wall under outward tension, thereby eliminating or improving medical difficulties, such as damaging the outpouching or the vessel wall. Violations may result in patient injury or death.

[0065] The present disclosure has at least four structural optional elements. The optional elements are the central annular hole in the disk element of the present disclosure; the single or multiple grid layers in the disk element of the present disclosure; the hydrogel coating on all or part of the disk element of the present disclosure; the hydrogel coating on all or part of the holding arm element of the present invention.

[0066] 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.

[0067] 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 disc element of the present disclosure. Another embodiment of the present disclosure has multiple mesh layers in the disc element.

[0068] More specifically, the application of the hydrogel coating to the disc element of the present disclosure is optional. One embodiment of the present disclosure discloses a hydrogel coating on the surface of the disc element of the present disclosure. In another embodiment of the present disclosure, the hydrogel coating is not applied to the surface of the disc element of the present disclosure. In other embodiments, the hydrogel coating is employed on some but not all surfaces of the mesh disc. In some optional embodiments, the hydrogel is chemically optimized to significantly swell and can also be positioned such that it swells into the pathological extracapsule to further assist in aneurysm thrombosis / closure / extracapsule.

[0069] More particularly, the application of the hydrogel coating to 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.

[0070] Now referring Figure 7 , another embodiment of the present disclosure is shown. At least one or more retaining arms 200 in the shape of coils are attached to the mesh member and extend within the outpouching. The retaining arms 200 can engage the inner wall of the outpouching and / or the embolization coil 24 to help hold the coil and the mesh relative to the occluding wall at the neck of the outpouching.

[0071] Attached Figure 8 shows an embodiment utilizing a substantially linear retaining arm 200, which may be advantageous for small outpouchings or outpouchings with atypical shapes. The ends of the linear retaining arm 200 can be blunt to avoid any potential unwanted engagement with the outpouching wall. Additionally, according to this embodiment, the embolization coil is delivered through the microcatheter 12.

[0072] Attached Figure 9 illustrates an embodiment in which a single coiled retaining arm 200 coupled to the mesh occluder 14 is embedded within an outpouching filled with hydrogel 16. The retaining arm 200 engages the hydrogel 16 in a manner that minimizes movement of the retaining arm and subsequent movement. The mesh occluder 14 does not use an embolization coil in this embodiment. It is envisioned that the mesh occluder 14 can be used as an independent shunt together with the hydrogel 16.

[0073] Attached Figure 10 is a similar embodiment to Figure 9 but utilizes multiple substantially linear retaining arms 200 attached to the mesh occluder 14.

[0074] In an illustrative embodiment, a mesh occluder for improving an aneurysm includes a control element, a catheter element, a delivery member, a separating element, a mesh disk, a distal opening, and at least one attached extension arm, wherein the mesh disk further includes a proximal face and a distal face, the proximal face being opposite the distal face; the proximal face and the distal face are substantially flat; wherein the mesh disk further includes a peripheral lip; wherein, the mesh disk includes a core, the diameter of the core being configured to be less than the aneurysm, and wherein, the mesh disk is secured in place by the at least one attached extension arm.

[0075] A mesh disk having at least one attached extension arm includes a matrix adapted to form a shape having a suitable geometry to conform to the profile of the aneurysm.

[0076] The delivery member may further include a channel capable of delivering at least one coil therethrough.

[0077] At least one additional coil may be delivered continuously through the delivery member.

[0078] A matrix of serially delivered coils adapted to form a suitable geometry may fill the aneurysm.

[0079] The mesh disk may be configured to be impregnated with a sufficient amount of adherent hydrogel to wedge the mesh disk into the target vascular structure.

[0080] The adherent hydrogel may be radiopaque.

[0081] In another illustrative embodiment, an embolization device for improving an aneurysm includes a control element, a catheter element, a wire, a separating element, a mesh disk, at least one arm extension attached to the mesh disk, and a distal opening, wherein the mesh disk further includes a proximal face and a distal face, the proximal face being opposite 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 being configured to be less than the aneurysm, and wherein the mesh disk is secured in place by at least one arm extension.

[0082] The mesh disk has at least one arm extension including a matrix adapted to form a shape having a suitable geometry to conform to the profile of the aneurysm.

[0083] The matrix may be configured to substantially fill the aneurysm.

[0084] The mesh disk and at least one extension arm extension may be configured to be impregnated with a sufficient amount of adherent hydrogel to wedge the mesh disk into the target vascular structure.

[0085] The mesh disk may be configured to be positioned at the neck of the aneurysm.

[0086] The mesh disk may be configured to substantially not fill the aneurysm.

[0087] The mesh disk may further include at least one additional layer.

[0088] The at least one additional layer may further include an adhered hydrogel that is adapted to alter the flow through only one additional layer.

[0089] The mesh disk having at least one arm extension may be adapted to grip a protruding wall and configured to stabilize the mesh disk in place at the protruding neck.

[0090] The device may include a delivery member having a channel that is capable of delivering at least one coil therethrough.

[0091] At least one additional coil is continuously delivered through the channel of the delivery member.

[0092] At least one additional coil is serially delivered and includes a matrix that is adapted to form a suitable geometry to fill the protrusion.

[0093] Although the present invention has been described in detail in the above embodiments for purposes of illustration, it should be understood that these details are for that purpose only and that those skilled in the art may make variations thereto without departing from the spirit and scope of the present disclosure.

Claims

1. A system for treating an outpouching, characterized in that, comprising: a control element (11) that can be coupled to a catheter element (12); a delivery member (13) that at least partially extends through the catheter element (12); and an occluder disk (14) that is detachably coupled to the delivery member (13) using a separation element (17); wherein the occluder disk (14) defines an opening and comprises: a disk core (14B) whose diameter is configured to be smaller than the outpouching; and at least one retaining arm (200) that is configured to extend from the opening towards the distal end of the outpouching, engage the wall of the outpouching, and fix the occluder disk (14) in place, wherein the at least one retaining arm (200) has a proximal end connected to the occluder disk (14), wherein the delivery member (13) is configured to deliver the occluder disk (14) and the at least one retaining arm (200) to the outpouching.

2. The system according to claim 1, characterized in that, the occluder disk further comprises a peripheral lip (14A).

3. The system according to claim 1, characterized in that, the occluder disk (14) comprises a proximal face and a distal face, and the proximal face and the distal face are substantially flat.

4. The system according to claim 1, characterized in that, the at least one retaining arm (200) is linear or coiled within the outpouching.

5. The system according to claim 2, characterized in that, the at least one retaining arm (200) is connected to the peripheral lip (14A).

6. The system according to claim 1, characterized in that, the occluder disk (14) comprises a matrix that is adapted to form a shape with a suitable geometry to conform to the contour of the outpouching.

7. The system according to claim 6, characterized in that, the matrix is configured to substantially fill the outpouching.

8. The system according to claim 1, characterized in that, the occluder 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 occluder disk (14) into the target vascular structure.

9. The system according to claim 1, characterized in that, the occluder disk (14) is configured to be positioned at the neck of the outpouching.

10. The system according to claim 1, characterized in that, the occluder disk (14) is configured to substantially not fill the outpouching.

11. The system according to claim 1, characterized in that, the occluder disk (14) further comprises at least one additional layer.

12. The system according to claim 11, characterized in that, the at least one additional layer further comprises an adhesive hydrogel adapted to alter the flow through only one additional layer.

13. The system according to claim 1, characterized in that, The occluder disk (14) having the at least one retention arm (200) is adapted to grip the protruding wall and is configured to stabilize the occluder disk (14) at a position at the neck of the protrusion.

14. The system according to claim 1, wherein, the delivery member (13) includes a passage through which at least one embolization coil can be delivered.

15. The system according to claim 14, wherein, it further includes at least one additional embolization coil (24) that is continuously delivered through the delivery member.

16. The system according to claim 15, wherein, the at least one additional embolization coil (24) delivered continuously includes a matrix that is adapted to form a shape with a suitable geometry to fill the protrusion.

17. The system according to any one of claims 1-16, wherein, the occluder disk (14) for treating the protrusion is a mesh occluder.

18. The system according to any one of claims 1-17, wherein, the delivery member (13) is a wire.

19. The system according to any one of claims 1-17, wherein, the delivery member (13) is a hypotube.

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