WO2025213237A1

WO2025213237A1 - Highly expansile embolic device and delivery apparatus for endovascular therapies and method of operation thereof

Info

Publication number: WO2025213237A1
Application number: PCT/AU2025/050365
Authority: WO
Inventors: Ashish Mitra
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-04-13
Filing date: 2025-04-13
Publication date: 2025-10-16
Anticipated expiration: 2026-10-13

Abstract

Provided is an embolic device for endovascular therapy by occlusion of a physical anomaly, including a foam structure and at least one embedded radiopaque marker. Further provided is a system for delivering and deploying the embolic device, including an introducer including a tubular body; an introducer sheath including a tubular body; and an embolic device delivery mechanism. The embolic device delivery mechanism includes a tubular body; one or more embolic device in a compressed state positioned within and proximal to a first end of the tubular body of the embolic device delivery mechanism; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the one or more embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on one end.

Description

HIGHLY EXPANSILE EMBOLIC DEVICE AND DELIVERY APPARATUS FOR ENDOVASCULAR THERAPIES AND METHOD OF OPERATION THEREOF

FIELD OF THE DISCLOSURE

[0001] This disclosure relates to endovascular therapies, and more particularly, to expandable embolic devices for endovascular therapies.

BACKGROUND

[0002] Endovascular therapy, a minimally invasive surgical approach, has revolutionized the treatment of various vascular conditions, including aneurysms, arteriovenous malformations (AVMs), aortic dissections, aortic aneurysms, and certain types of tumors. This technique involves navigating through the vascular system using catheters to deliver therapeutic devices directly to the site of pathology. Among the myriad of therapeutic devices used in these procedures, embolic devices have emerged as a critical tool, offering precise and effective vascular occlusion. Embolic devices are compressed for delivery through a catheter and expand into full form after deployment to occlude a targeted site.

[0003] While the evolution of embolic devices has paralleled advancements in imaging and catheter technology, enabling more precise and controlled therapeutic interventions, improvements in embolic devices are still required. For instance, a large number of currently used embolic devices, such as embolic coils and embolic plugs, are often required to achieve complete occlusion, particularly in large vessels such as the aorta, prolonging procedure time and increasing costs. Current embolic devices also rely on thrombosis to block the flow of blood, inherently introducing risks associated with the dislodgement of the blood clot. Further, current embolic devices are fabricated of biodegradable materials, raising concern of degradation of the embolic device over time and the release of materials into the human body. Additionally, the precise placement of current embolic devices can be challenging, particularly in complex vascular anatomies. A need exists for an improved embolic device and delivery method thereof that cures the above-noted deficiencies. SUMMARY

[0004] The following presents a simplified summary of some embodiments of the techniques described herein in order to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented below.

[0005] Some aspects provide is system for endovascular therapy by occlusion of a physical anomaly, including: an introducer including a tubular body; an introducer sheath including a tubular body; and an embolic device delivery mechanism, including: a tubular body; one or more embolic device in a compressed state positioned within and proximal to a first end of the tubular body of the embolic device delivery mechanism; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the one or more embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on one end; wherein: the introducer, the introducer sheath, and the embolic device delivery mechanism are for delivering the one or more embolic device to and deploying the one or more embolic device within the physical anomaly; actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against one of the one or more embolic device and causing translation of the one or more embolic device towards the physical anomaly until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism and into the physical anomaly; and the at least one of the one or more embolic device transitions to an expanded state upon releasing from the tubular body of the embolic device delivery mechanism, thereby at least partially occluding the physical anomaly.

[0006] Some aspects provide is an embolic device for endovascular therapy by at least partial occlusion of a physical anomaly, including: a foam structure; a first set of radiopaque markers embedded within the foam structure; a second set of radiopaque markers embedded within the foam structure; and a set of connection means embedded in the foam structure; wherein: each radiopaque marker of the first set of radiopaque markers is positioned adjacent a peripheral edge or surface of the embolic device on or offset from a first transverse plane proximal to a first end of the embolic device; and each radiopaque marker of the second set of radiopaque markers is positioned adjacent the peripheral edge or surface of the embolic device on or offset from a second transverse plane proximal to a second end of the embolic device; each radiopaque marker of the first set of radiopaque markers is aligned and corresponds with a radiopaque marker of the second set of radiopaque markers; and each pair of aligned and corresponding radiopaque markers are connected with a connection means of the set of connection means, each connection means spanning from the first transverse plane to the second transverse plane.

[0007] Some aspects include a method for occluding a physical anomaly, including: providing the above-described system for endovascular therapy; introducing the introducer and the introducer sheath into a body in which the physical anomaly exists over a guidewire; positioning the introducer and the introducer sheath such that a first end of the tubular body of the introducer is proximal to or within the physical anomaly; once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal or within to the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism, wherein: actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the one of the one or more embolic device and causing translation of the one or more embolic device towards the physical anomaly until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism; and the at least one of the one or more embolic device transitions to an expanded state upon releasing from the tubular body of the embolic device delivery mechanism, thereby at least partially occluding the physical anomaly; retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and retracting the introducer sheath from within the body.

BRIEF DESCRIPTION OF THE FIGURES

[0008] Some embodiments of the present invention are illustrated as an example and are not limited by the figures of the accompanying drawings, in which like references may indicate similar elements.

[0009] FIGS. 1A-1C illustrate examples of embolic devices of different shapes and sizes, according to some embodiments.

[0010] FIGS. 2A and 2B illustrate examples of an embolic device in a compressed state and an expanded state, respectively, according to some embodiments.

[0011] FIGS. 3A and 3B illustrate examples of an embolic device in a compressed state and an expanded state, respectively, according to some embodiments.

[0012] FIGS. 4A-4F illustrate examples of embolic devices of different shapes and sizes in an expanded state occluding physical anomalies of different shapes and sizes, according to some embodiments.

[0013] FIGS. 5A-5E illustrate examples of radiopaque (RO) markers embedded in an embolic device, according to some embodiments.

[0014] FIGS. 6 and 7A-7D illustrate an example of a delivery apparatus for deploying an embolic device, according to some embodiments.

[0015] FIGS. 8A-8G illustrate an example of a method for deploying an embolic device, according to some embodiments.

[0016] FIG. 9 illustrates a flowchart describing an example of a method for deploying an embolic device, according to some embodiments.

[0017] FIG. 10 illustrates a flowchart describing an example of a method for manufacturing an embolic device, according to some embodiments.

DETAILED DESCRIPTION OF SOME EMBODIMENTS [0018] The present inventions will now be described in detail with reference to a few embodiments thereof as illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present inventions. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without some or all of these specific details. In other instances, well known process steps and/or structures have not been described in detail in order to not unnecessarily obscure the present invention. Further, it should be emphasized that several inventive techniques are described, and embodiments are not limited to systems implanting all of those techniques, as various cost and engineering trade-offs may warrant systems that only afford a subset of the benefits described herein or that will be apparent to one of ordinary skill in the art.

[0019] Embolic devices are widely used in vascular interventions to selectively block blood flow in aneurysms, malformations, or bleeding vessels. In cerebral aneurysms, they are deployed to prevent rupture, offering a minimally invasive alternative to open surgical clipping. Peripheral aneurysms — such as in the splenic or internal iliac arteries — can be embolized preemptively or during active bleeding. Arteriovenous malformations (AVMs) and arteriovenous fistulas (AVFs), including those in the brain, lungs, or extremities, are treated by occluding feeding vessels to reduce shunting and hemorrhagic risk. In EndoVascular Aneurysm Repair (EVAR) patients, Type II endoleaks caused by retrograde flow from lumbar or mesenteric branches can be treated with transarterial or translumbar embolization. Embolization also plays a central role in trauma, where coils, gelfoam, or plugs are used to control solid organ hemorrhage (e.g., liver, spleen, kidney), avoiding surgery. Preoperative devascularization of tumors and embolization of the internal iliac artery to extend EVAR grafts are additional vascular applications.

[0020] Embodiments provide an embolic device for immediate occlusion (or embolization or sealing) of a physical anomaly (e.g., aneurysms, lumen, large vessels in aortic dissections and aortic aneurysms, veins, fallopian tubes, arteriovenous malformation, and other vascular abnormalities, such as a vascular tumor). In some embodiments, the physical anomaly includes an interior space. While the embolic device may be used for occlusion of physical anomalies of various shapes and sizes, the embolic device described herein is particularly useful in occluding large endovascular spaces (e.g., large vessels in aortic dissections and aortic aneurysms). In embodiments, the embolic device is delivered to the site of the physical anomaly in a compressed state and upon deployment, the embolic device is actuated to expand, thereby occluding the physical anomaly.

[0021] In some embodiments, the embolic device includes a dense foam structure, wherein occlusion is primarily achieved by the embolic device in the expanded state acting as a physical barrier to blood flow, as opposed to relying primarily on thrombosis to cease blood flow. In some embodiments, the dense foam structure includes a combination of open cell and closed cell structures, resulting in a high compression ratio that allows for delivery of the embolic device in the compressed state and effective occlusion in the expanded state. In some embodiments, the embolic device immediately expands from the compressed state to the expanded state upon deployment into the physical anomaly, the quick expansion of the embolic device being driven by the high radial forces of the dense foam structure acting to expand the embolic device from the compressed state to the expanded state. In some embodiments, the volumetric expansile capacity of the embolic device is up to 6000%, preferably between 1500% to 6000%. In some embodiments, the embolic device further expands an additional 5-20% in volume from the expanded state upon contact with bodily fluids. With instant expansion of the embolic device, means for anchoring the embolic device is unnecessary. In some embodiments, an anchoring means is used for further anchoring the embolic device.

[0022] In some embodiments, a porosity of the embolic device ranges between 0.1mm to 2mm. In some embodiments, a pore size of pores of the embolic device range between 0.18mm to 0.45mm. In some embodiments, the embolic device has largely homogeneous pore distribution. In some embodiments, pores of the embolic device have a largely spherical pore shape.

[0023] A shape of the embolic device may vary in different embodiments (e.g., cylindrical, spherical, bullet, etc.). A diameter of the embolic device may range between 3mm to 48 mm while a length of the embolic device may range between 3mm to 200 mm. The expansive range of diameter and length of the embolic device accommodates a broader range of applications and clinical needs. For instance, a single large embolic device may be used to occlude a physical anomaly that currently requires a plurality of smaller embolic devices for occlusion, reducing procedural time and treatment costs.

[0024] FIGS. 1A-1C illustrate examples of expansile embolic devices 100 including porous structures (e.g., foams or sponges) with various shapes and sizes. In FIG. 1A, diameters of a bottom surface may range between 5mm to 50 mm. In FIG. IB, lengths may vary between 5mm to 300mm. The possibilities in variation in shapes and sizes address a variety of spacefilling applications within the human body. Larger diameter embolic devices may be useful for larger vessels including aneurysms, such as brain aneurysms, popliteal aneurysms, atrial appendages, etc., while smaller diameter embolic devices may be useful for smaller vessels including veins, fallopian tubes, arteriovenous malformations, etc. The embolic devices described herein may also be useful for aortic dissections including false lumen embolization, abdominal and thoracic aortic aneurysms, etc.

[0025] FIG. 2A illustrates an example of an embolic device 200 in a compressed state and FIG. 2B illustrates the embolic device 200 in an expanded state. A change in a size of the embolic device 200 is meant to illustrate a difference between the compressed state and the expanded state and is not indicative of a true change in size of the embolic device 200. FIG. 3 A illustrates an embolic device 300 in a compressed state delivered proximal to a physical anomaly 301 within a body in which the physical anomaly 301 exists using a delivery apparatus 302. FIG. 3B illustrates the embolic device 300 in an expanded state occluding the physical anomaly 301. In some embodiments, the embolic device is oversized to allow conformation to the irregular shape of the physical anomaly 301 to help achieve effective occlusion. A change in a size of the embolic device 300 is meant to illustrate a difference between the compressed state and the expanded state and is not indicative of a true change in size of the embolic device 300. FIGS. 4A-4F illustrate different shapes and sizes of embolic devices 300 in an expanded state occluding different sizes and shapes of physical anomalies 301. In FIGS. 4B and 4C stents 400 are positioned adjacent the embolic device 300.

[0026] In some embodiments, the embolic device includes one or more embedded radiopaque (RO) markers. The RO markers may be in the form of, for example, a wire, a tube, a disc, or another form with an appropriate shape and dimension for the embolic device. The RO markers help in visualizing the embolic device under x-ray guidance during delivery of the embolic device to the physical anomaly. Preferably, a first set of RO markers and a second set of RO markers are embedded on a first end and a second end of the embolic device, respectively. Each of the first set of RO markers and the second set of RO markers may be uniformly distributed and positioned adjacent to peripheral edges of the embolic device and on a same transverse plane such that a diameter (or other geometric measure) of the embolic device may be determined in situ. In some embodiments, the RO markers of first set of RO markers and the RO markers of the second set of RO markers are staggered and slightly offset from a transverse plane proximal to the first end and the second end of the embolic device, respectively. This may allow the embolic device to be further compressed in comparison to when the RO markers of first set of RO markers and the RO markers of the second set of RO markers are positioned on a same transverse plane proximal to the first end and the second end of the embolic device, respectively. In some embodiments, each RO marker embedded proximal to the first end of the embolic device align and correspond with an RO marker embedded proximal to the second end of the embolic device. Each pair of corresponding and aligned RO markers may be connected using a connection means, such as a string or suture wire, for additional safety and integrity of the RO markers, ensuring a more secure means of embedding the RO markers within the embolic device. The connection means may be RO such that a length and/or a placement position of the embolic device post-deployment may be identified in situ. In some embodiments, one or more structural spines are embedded along a longitudinal axis of the embolic device. The structural spine may include a wire, a rod, a tube, etc. and may be fabricated of a rigid material (e.g., nitinol, stainless steel, etc.). The structural spine may provide column strength to the embolic device without substantially compromising the flexibility or conformability of the embolic device. Column strength may help achieve effective crimping or compression of the embolic device within a tubular body (e.g., catheter) and reliable deployment of the embolic device from the tubular body. The structural spine may include RO properties for visualization of the embolic device during delivery and deployment. [0027] FIGS. 5A and 5B illustrate perspective and bottom views, respectively, of an example of an embolic device 500 including a first set of RO markers 501 and a second set of RO markers 502 embedded proximal to a first end and a second end of the embolic device 500. Each of the first set of RO markers 501 and the second set of RO markers 502 are uniformly distributed and positioned in close proximity to peripheral edges and surfaces of the embolic device 500 on a same transverse plane, such that a diameter of the embolic device 500 may be identified in situ. The embolic device 500 further includes a structural spine 503 for providing column strength to the embolic device 500. FIG. 5C illustrates an alternative embodiment of embolic device 500 wherein each RO marker of the first set of RO markers 501 are aligned and correspond with one RO marker of the second set of RO markers 502, whereby a RO string or suture wire 504 connects each pair of corresponding RO markers for additional safety and integrity of the sets of RO markers 501 and 502, providing a more secure means of embedding within the embolic device 500. The RO string or suture wires 504 allow a length and a placement of the embolic device 500 to be identified in situ upon deployment within a human body. FIG. 5D illustrates an alternative embodiment of the embolic device 500 illustrated in FIG. 5C, wherein a third set of RO markers 505 are positioned on a transverse plane midway along a length of the embolic device 500, each RO marker of the third set of RO markers 505 being aligned and corresponding with one RO marker of the first set of RO markers 501 and one RO marker of the second set of RO markers 502. The aligned and corresponding RO markers of the first set of RO markers 501, the second set of RO markers 502, and the third set of RO markers 505 are connected by a RO string or suture wire 504. FIG. 5E illustrates an alternative embodiment of the embolic device 500 illustrated in FIG. 5C, wherein the RO markers of the first set of RO markers 501 and the second set of RO markers 502 are staggered and slightly offset from transverse planes 506 and 507, respectively.

[0028] In some embodiments, the embolic device is impregnated with one or more bioactive or non-bioactive agents to enhance performance, particularly for promoting tissue integration, healing, hemostasis or reducing infection. Examples of bioactive agent include growth factors and proteins for promoting healing and tissue regeneration; drugs (e.g., antibiotics, analgesics, anti-inflammatory drugs) for pain relief, preventing infection, and reducing inflammation; biological agents or cells (e.g., stem cells, osteoblasts) for tissue formation and regeneration and healing; nanoparticles (e.g., silver, hydroxyapatite) for antimicrobial effects, bone bonding/mineralization, and drug delivery; and natural bioactive compounds (e.g., chitosan, hyaluronic acid) for antimicrobial effects, improved biocompatibility, and tissue healing. Examples of non-bioactive agents include crosslinkers for stabilization, porogens for controlling porosity, contract agents for visualization under medical imaging, and pH modifiers or buffers to regulate the local microenvironment.

[0029] Embodiments provide a delivery apparatus for endovascularly delivering the embolic device to a site of a physical anomaly. In some embodiments, the delivery apparatus includes: an introducer; an introducer sheath; and an embolic device delivery mechanism. In some embodiments, the introducer includes a tubular body (i.e., cylindrical), with a first end of the introducer being tapered (i.e., conical). In some embodiments, the introducer further includes a hemostatic valve fixed to a second end of the introducer. In some embodiments, the introducer sheath includes a tubular body. In some embodiments, the introducer sheath further includes a hemostatic valve fixed to an end of the introducer sheath. In some embodiments, when introducing and positioning the introducer and the introducer sheath within the body in which the physical anomaly exists, the introducer is partially housed within the introducer sheath such that the hemostatic valve of the introducer is positioned proximal to and beneath the hemostatic valve of the introducer sheath, with both the tapered first end and the hemostatic valve of the introducer exposed. The introducer may be clearance fit with the introducer sheath. In some embodiments, the embolic device delivery mechanism includes a tubular body; the embolic device in a compressed state positioned within and proximal to a first end of the tubular body; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on an end. In some embodiments, the embolic device delivery mechanism includes two or more embolic devices positioned within the tubular body consecutively, at least one of the two or more embolic devices being positioned proximal to the first end of the tubular body of the embolic device delivery mechanism. In such embodiments the push rod is positioned between one of the two or more embolic devices and the translatory mechanism.

[0030] In some embodiments, the translatory mechanism includes a first housing, a second housing rotationally coupled to and partially positioned within a first portion of the first housing, and a third housing rotationally coupled to and partially positioned within a second portion of the first housing. In such embodiments, an interior surface of the second housing and an interior surface of the third housing are threaded. In some embodiments, the translatory mechanism further includes a first linear guiderail fixed to the first housing and partially housed within the second housing and a second linear guiderail fixed to the first housing and partially housed within the third housing. The translatory mechanism further includes a first nut translationally coupled with the first linear guiderail. Further, threads are disposed on at least a first portion of an exterior surface of the first nut and integrate with threads on the interior surface of the second housing. As the second housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the first nut and the threads on the interior surface of the second housing cause the first nut to translate upwards or downwards depending on a direction of rotation of the second housing. The first linear guiderail to which the first nut is translationally coupled provides guidance and stability as the first nut translate upwards or downwards. An end of the tubular body of the embolic device delivery mechanism or an end of the push rod is fixed to the first nut such that as the first nut moves upwards or downwards, the tubular body of the embolic device delivery mechanism or the push rod is caused to move upwards or downwards. The translatory mechanism further includes a second nut translationally coupled with the second linear guiderail. Further, threads are disposed on at least a first portion of an exterior surface of the second nut and integrate with threads on the interior surface of the third housing. As the third housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the second nut and the threads on the interior surface of the third housing cause the second nut to translate upwards or downwards depending on a direction of rotation of the third housing. The second linear guiderail to which the second nut is translationally coupled provides guidance and stability as the second nut translate upwards or downwards. An end of the tubular body of the embolic device delivery mechanism or an end of the push rod is fixed to the second nut such that as the second nut moves upwards or downwards, the tubular body of the embolic device delivery mechanism or the push rod is caused to move upwards or downwards.

[0031] In an alternative embodiment, the translatory mechanism includes a first housing and a second housing rotationally coupled to the first housing, whereby rotation of the second housing causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the embolic device until the embolic device is released from the tubular body of the embolic device delivery mechanism into the physical anomaly. In some embodiments, the translatory mechanism further includes a linear guiderail disposed on an interior surface of the first housing; a lead screw housed within and rotationally coupled to the first housing; a rotary shaft housed within and fixed to the second housing and fixed to the lead screw; and a lead nut on which a protrusion is disposed, the lead nut screwed onto the lead screw and the protrusion translationally coupled to the linear guiderail disposed on the first housing. In such an embodiments, rotation of the second housing of the translatory mechanism causes the rotary shaft fixed thereto to rotate while rotation of the rotary shaft causes the lead screw fixed thereto to rotate. As the lead screw rotates, the lead nut translates upwards or downwards along the screw and within the first housing, depending on a direction of rotation of the lead screw. The push rod is fixed to the lead nut, therefore, as the lead nut translates upwards along the screw, the push rod translates towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the embolic device until the embolic device is released from the tubular body of the embolic device delivery mechanism into the physical anomaly. The translatory mechanism for causing the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism and push the embolic device out of the tubular body of the embolic device delivery mechanism and into the physical anomaly may vary in other embodiments.

[0032] In some embodiments, a RO band is positioned on an end of at least one of the tubular body of the introducer, the tubular body of the introducer sheath, and the tubular body of the embolic device delivery mechanism to aid with visualization of the respective tubular body during delivery and deployment of the embolic device. In some embodiments, a length of at least one of the tubular body of the introducer, the tubular body of the introducer sheath, and the tubular body of the embolic device delivery mechanism can be up to 1.5m.

[0033] FIG. 6 illustrates an example of an introducer 600 and an introducer sheath 601. The introducer 600 includes a 602 tubular body with a first end 603 of the introducer 600 being tapered and a hemostatic valve 604 fixed to a second end 605 of the introducer 600. The introducer sheath 601 includes a tubular body 606 and a hemostatic valve 607 fixed to an end 608 of the introducer sheath 601. The introducer 600 is initially partially housed within the introducer sheath 601 such that the hemostatic valve 604 of the introducer 600 is positioned proximal to and beneath the hemostatic valve 607 of the introducer sheath 601, with both the tapered first end 603 and the hemostatic valve 604 of the introducer 600 exposed.

[0034] FIGS. 7A illustrates an example of an embolic device delivery mechanism 700 including a tubular body 701, an embolic device 702 in a compressed state positioned within and proximal to a first end 703 of the tubular body 701 ; a translatory mechanism 704 including an end 705 within which the tubular body 701 enters; and a push rod 706 housed within the tubular body 701 and fixed to a component of the translatory mechanism 704. FIG. 7B illustrates an alternative embodiment of the embolic device delivery mechanism 700 includes two embolic devices 702 positioned consecutively within the tubular body 701. FIGS. 7C and 7D illustrate a cross-sectional and assembled view of the translatory mechanism 704. The translatory mechanism 704 includes a first housing 707, a second housing 708 rotationally coupled to and partially positioned within a first portion 709 of the first housing 707, and a third housing 710 rotationally coupled to and partially positioned within a second portion 711 of the first housing 707. An interior surface 712 of the second housing 708 and an interior surface 713 of the third housing 710 are threaded. The translatory mechanism 704 further includes a first linear guiderail 714 fixed to the first housing 707 and partially housed within the second housing 708 and a second linear guiderail 715 fixed to the first housing 707 and partially housed within the third housing 710. The translatory mechanism 704 further includes a first nut 716 translationally coupled with the first linear guiderail 714. Further, threads are disposed on at least a first portion 717 of an exterior surface of the first nut 716 and integrate with threads on the interior surface 712 of the second housing 708. As the second housing 708 rotates relative to the first housing 707, the integration between the threads disposed on the at least the first portion 717 of the exterior surface of the first nut 716 and the threads on the interior surface 712 of the second housing 708 cause the first nut 716 to translate upwards or downwards depending on a direction of rotation of the second housing 708. The first linear guiderail 714 to which the first nut 716 is translationally coupled provides guidance and stability as the first nut 716 translate upwards or downwards. An end of the tubular body 701 of the embolic device delivery mechanism 700 is fixed to the first nut 716 such that as the first nut 716 moves upwards or downwards, the tubular body 701 is caused to move upwards or downwards as well. The translatory mechanism 704 further includes a second nut 718 translationally coupled with the second linear guiderail 715. Further, threads are disposed on at least a first portion 719 of an exterior surface of the second nut 718 and integrate with threads on the interior surface 713 of the third housing 710. As the third housing 710 rotates relative to the first housing 707, the integration between the threads disposed on the at least the first portion 719 of the exterior surface of the second nut 718 and the threads on the interior surface 713 of the third housing 710 cause the second nut 718 to translate upwards or downwards depending on a direction of rotation of the third housing 710. The second linear guiderail 715 to which the second nut 718 is translationally coupled provides guidance and stability as the second nut 718 translate upwards or downwards. An end of the push rod 706 is fixed to the second nut 718 such that as the second nut 718 moves upwards or downwards, the push rod 716 is caused to move upwards or downwards as well. The translatory mechanism 704 further includes an opening 720 through which a guidewire passes such that the tubular body 701 may be introduced into a body over the guidewire.

[0035] Embodiments include a method for deploying the embolic device to occlude a physical anomaly, including: introducing the introducer and the introducer sheath into the body over a guidewire, the tapered end of the introducer entering the body first as the tapered feature eases entry into the body; positioning the introducer and the introducer sheath such that the tapered first end of the tubular body of the introducer is proximal to or within the physical anomaly; once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal to or within the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until the embolic device is fully released from the tubular body of the embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the embolic device and causing translation of the embolic device towards the physical anomaly until the embolic device is fully released from the tubular body of the embolic device delivery mechanism; retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and retracting the introducer sheath from within the body. In some embodiments, actuating the translatory mechanism includes rotating the second housing or third housing of the translatory mechanism of the embolic device delivery mechanism clockwise (or anti-clockwise) while holding the first housing of the translatory mechanism of the embolic device delivery mechanism stationary. In some embodiments, the method further includes rotating the second housing or third housing of the translatory mechanism of the embolic device delivery mechanism clockwise (or anticlockwise) while holding the first housing of the translatory mechanism of the embolic device delivery mechanism stationary to translate the tubular body of the embolic device delivery mechanism towards the physical anomaly. In some embodiments, the embolic device delivery mechanism includes two or more embolic devices positioned consecutively within the tubular body. In such embodiments, the translatory mechanism is actuated until at least one of the two or more embolic devices is fully released from the tubular body of the embolic device delivery mechanism. In some embodiments, the method further includes at least one of: introducing the guidewire into the body such that an end of the guidewire is positioned distal to or within the physical anomaly; and retracting the guidewire from within the body. In some embodiments, the method further includes reintroducing the guidewire into the body before retracting the introducer sheath to perform any ancillary interventions and procedures. Once deployed, the embolic device expands to an expanded state, filling and occluding the physical anomaly. Once expanded, the embolic device preferably remains in position without any additional aid. In some embodiments, additional support or anchoring means is used to maintain the position of the embolic device.

[0036] In some embodiments, a second embolic device delivery mechanism is introduced into the body to deploy a second embolic device within a physical anomaly after a first embolic delivery device deploys a first embolic device within the physical anomaly and the first embolic device delivery mechanism is retracted from within the body, the introducer sheath remaining in place after retracting the first embolic delivery device such that the second embolic delivery device may be introduced into the body for deploying the second embolic device using the same introducer sheath. The introducer sheath remains in place as each of two or more embolic device delivery mechanisms are introduced to deploy an embolic device and are retracted from within the body. A combination of different shapes and sizes of embolic devices may be deployed within a same physical anomaly to achieve optimal performance and efficiency in creating an occlusion.

[0037] FIGS. 8A-8G illustrate an example of a method for deploying the embolic device 702 to occlude a physical anomaly. FIG. 8A illustrates introducing the introducer 600 and the introducer sheath 601 into a body over a guidewire 800 and positioning the introducer 600 and the introducer sheath 601 such that the tapered first end 603 of the tubular body 602 of the introducer 600 is proximal to a physical anomaly 801. FIG. 8B illustrates progressively retracting the introducer 600 from within the body in a direction 802 over the guidewire 800 followed by retracting the guidewire 800, leaving only the introducer sheath 601 within the body. FIG. 8C illustrates progressively introducing the tubular body 701 of the embolic device delivery mechanism 700 into the tubular body 606 of the introducer sheath 601 in a direction 803 such that the first end 703 of the tubular body 701 of the embolic device delivery mechanism 700 is proximal to or within the physical anomaly 801 and outside the tubular body 701 of the embolic device delivery mechanism 700. FIG. 8D illustrates rotating the second housing 708 or the third housing 710 of the translatory mechanism 704 of the embolic device delivery mechanism 700 in an anti-clockwise direction 804 while holding the first housing 707 of the translatory mechanism 704 of the embolic device delivery mechanism 700 stationary, thereby causing the push rod 706 to translate in direction 805 towards the physical anomaly 801 and push against the embolic device 702. Rotation of the second housing 708 of the translatory mechanism 704 continues until the embolic device 702 is fully released from the tubular body 701 of the embolic device delivery mechanism 700, as illustrated in FIG. 8E. FIG. 8F illustrates progressively retracting the embolic device delivery mechanism 700 from within the body in a direction 806, leaving only the introducer sheath 601 within the body, after which the introducer sheath 601 is retracted from within the body. FIG. 8G illustrates the embolic device 702 occluding the physical anomaly 801.

[0038] FIG. 9 illustrates a flowchart describing a method for deploying an embolic device to occlude a physical anomaly including: (900) introducing the introducer and the introducer sheath into a body over a guidewire, the tapered first end of the tubular body of the introducer entering the body first; (901) positioning the introducer and the introducer sheath such that the tapered first end of the tubular body of the introducer is proximal to or within the physical anomaly; (902) once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; (903) introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal to or within the physical anomaly and outside the tubular body of the introducer sheath; (904) rotating the second housing or the third housing of the translatory mechanism of the embolic device delivery mechanism clockwise (or anti-clockwise) while holding the first housing of the translatory mechanism of the embolic device delivery mechanism stationary, thereby causing the push rod to translate towards the physical anomaly and push against the embolic device, the embolic device translating towards the physical anomaly until fully released from the tubular body of the embolic device delivery mechanism; (905) retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and (906) retracting the introducer sheath from within the body.

[0039] In some embodiments, a second embolic device delivery mechanism is introduced into the body to deploy a second embolic device after a first embolic delivery device deploys a first embolic device and the first embolic device delivery mechanism is retracted from the body, the introducer sheath remaining in place as two or more embolic device delivery mechanisms are introduced and retracted from the body to deploy two or more embolic devices. Furthermore, a combination of different shapes and sizes of embolic devices may be used within a same physical anomaly to achieve optimal performance and efficiency in creating an occlusion.

[0040] In a case where the embolic device is misplaced, retrieval of the embolic device is possible. Once the embolic device is retrieved, the embolic device may be repositioned within the physical anomaly. In some embodiments, the embolic device includes features that facilitate recapturing and repositioning or removing of the embolic device from the human body in situ. For example, a specialized tool in combination with the delivery apparatus instantaneously recompresses the embolic device such that it may be repositioned within the human body.

[0041] Embodiments include a method for manufacturing an embolic device, such as the embolic device described herein. In some embodiments, the method for manufacturing an embolic device produces an embolic device with a particular pore structure and geometric shape and size. In some embodiments, the method for manufacturing the embolic device includes: combining dimethyl sulphoxide (DMSO) with polyurethane (PU) (e.g., Carbosil 80A (CS80A) or Carbosil 55D (CS55D) PU pellets from DSM Biomedical) to create a PU solution; combining sodium chloride (NaCl) (or any other salt dissolvable in water and unreactive with DMSO and PU) and the PU solution to create an embolic device mixture; heating the embolic device mixture; pouring the embolic device mixture into an embolic device mold to create a foam structure (i.e., the embolic device) with a shape defined by the embolic device mold; placing the embolic device mold with the embolic device mixture in a water bath; actively washing the embolic device mixture within the embolic device mold, the embolic device mixture forming the foam structure; removing the resulting foam structure from the embolic device mold; drying the foam structure; and storing the foam structure in a container. Parameters of the method for manufacturing the embolic device may vary in different embodiments depending on, for example, a shape and a size of the embolic device. In some embodiments, for every 100ml ofDMSO 10g of CS55D PU pellets in creating the PU solution. In some embodiments, a size of the NaCl ranges between 0.35-0.15mm. The amount of NaCl combined with the PU solution varies depending on an amount of PU solution used. For example, for a cylindrical embolic device with a 24mm diameter and 30mm length, 25g of NaCl is combined with 8mL of PU solution to create the embolic device mixture. In another example, for a cylindrical embolic device with a 24mm diameter and 50mm length, 41g of NaCl is combined with 13mL of PU solution to create the embolic device mixture. In some embodiments, the embolic device mixture is heated at 60°C for between one to three hours before use. In some embodiments, the embolic device mold with the embolic device mixture is placed in the water bath for at least 8 hours, whereby the embolic device mixture forms into the foam structure. In some embodiments, the foam structure undergoes active washing for three days. The amount of active washing depends on a size of the foam structure. In some embodiments, the foam structure is dried at 60°C for between three to eight hours. In some embodiments, the method further includes positioning RO markers and connection means (e.g., RO wires) within the embolic device mold prior to pouring the embolic device mixture within the embolic device mold such that the RO markers and the connection means are embedded within the final foam structure. In different embodiments one or more steps of the method for manufacturing the embolic device may be reordered or omitted and/or additional steps may be added.

[0042] In some embodiments, the embolic device is manufactured from polyurethane pellets. In some embodiments, the manufacturing method preserves the chemistry of the polyurethane pellets, wherein molecular integrity and properties of the polyurethane pellets are maintained.

[0043] The embolic device is preferably fabricated of a biocompatible and biostable (non- biodegradable) polyurethane. The polyurethane is stabilized with silicone and polycarbonate end-groups, preventing degradation and ensuring long-term stability of the embolic device within the human body. The biocompatibility of the polyurethane promotes healthy tissue integration and proliferation, which is further encouraged by the morphology and/or structure of the embolic device. [0044] FIG. 10 illustrates a flowchart describing an example of a method for manufacturing an embolic device, including: (1000) combining dimethyl sulphoxide (DMSO) with polyurethane (PU) to create a PU solution; (1001) combining salt and the PU solution to create an embolic device mixture, wherein the embolic device mixture is created within an embolic device mold or the embolic device mixture is poured into the embolic device mold to create a foam structure with a shape defined by the embolic device mold; (1002) optionally heating the embolic device mold with the embolic device mixture; (1003) placing the embolic device mold with the embolic device mixture in a water bath; (1004) actively washing the embolic device mixture within the embolic device mold; (1005) removing the resulting foam structure from the embolic device mold; and (1006) optionally drying the foam structure.

[0045] It should be understood that the various embodiments described herein are presented by way of example, and that numerous variations, modifications, or combinations of the described embodiments may be made without departing from the scope of the invention. In some instances, certain features of one embodiment may be used in combination with features of another embodiment, or multiple embodiments may be integrated together to achieve a desired result. Additionally, certain elements or steps of the described embodiments may be omitted, substituted, or altered depending on the specific implementation or application.

[0046] In various embodiments, certain components, methods, or functionalities described herein may be modified or adapted to fit specific use cases or design constraints. These modifications may be made in view of particular user requirements, environmental conditions, or regulatory considerations.

[0047] Alternative configurations of the embodiments described herein are also possible. In some cases, a particular feature described with reference to one embodiment may be utilized in other embodiments, even if not explicitly mentioned. Similarly, the order of steps in a process/method or the arrangement of components in a system or apparatus may be altered, provided that the underlying principles of the invention are maintained.

[0048] While particular embodiments have been described, it is to be understood that alternative embodiments may be employed in place of the specifically described forms. In some cases, specific components may be replaced with functionally equivalent alternatives, and in others, operational steps in a process/method or for operating an apparatus may be rearranged or omitted, all without departing from the spirit and scope of the invention.

Claims

1. A system for endovascular therapy by occlusion of a physical anomaly, comprising: an introducer comprising a tubular body; an introducer sheath comprising a tubular body; and an embolic device delivery mechanism, comprising: a tubular body; one or more embolic device in a compressed state positioned within and proximal to a first end of the tubular body of the embolic device delivery mechanism; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the one or more embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on one end; wherein: the introducer, the introducer sheath, and the embolic device delivery mechanism are for delivering the one or more embolic device to and deploying the one or more embolic device within the physical anomaly; actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against one of the one or more embolic device and causing translation of the one or more embolic device towards the physical anomaly until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism and into the physical anomaly; and the at least one of the one or more embolic device transitions to an expanded state upon releasing from the tubular body of the embolic device delivery mechanism, thereby at least partially occluding the physical anomaly.

2. The system of claim 1, wherein each of the one or more embolic device comprises: a foam structure; and at least one radiopaque marker embedded within the respective embolic device.

3. The system of claim 2, wherein: the at least one radiopaque marker comprises: a first set of radiopaque markers embedded within the respective embolic device; and a second set of radiopaque markers embedded within the respective embolic device; each radiopaque marker of the first set of radiopaque markers are positioned adjacent a peripheral edge or surface of the respective embolic device on or offset from a first transverse plane proximal to a first end of the respective embolic device; and each radiopaque marker of the second set of radiopaque markers are positioned adjacent the peripheral edge or surface of the respective embolic device on or offset from a second transverse plane proximal to a second end of the respective embolic device.

4. The system of claim 3, wherein: each of the one or more embolic device further comprises a set of connection means embedded in the respective embolic device; each radiopaque marker of the first set of radiopaque markers embedded in the respective embolic device is aligned and corresponds with a radiopaque marker of the second set of radiopaque markers embedded in the respective embolic device; and each pair of aligned and corresponding radiopaque markers embedded in the respective embolic device are connected with a connection means of the set of connection means embedded in the respective embolic device, each connection means spanning from the first transverse plane to the second transverse plane.

5. The system of claim 4, wherein each connection means of the set of connection means comprises a radiopaque connection means.

6. The system of claim 3, wherein: the at least one radiopaque marker further comprises one or more additional set of radiopaque markers embedded within the respective embolic device; and each radiopaque marker of each of the one or more additional set of radiopaque markers are positioned adjacent a peripheral edge or surface of the respective embolic device on or offset from a respective transverse plane positioned along a longitudinal axis of the respective embolic device.

7. The system of claim 1 , wherein the at least one of the one or more embolic device in the expanded state functions as a physical barrier to blood flow, ceasing blood flow and occluding the physical anomaly without relying on blood clot formation.

8. The system of claim 1, wherein the at least one of the one or more embolic device in the expanded state remains positioned within the physical anomaly without an anchoring means.

9. The system of claim 1, wherein operating the system for endovascular therapy comprises: introducing the introducer and the introducer sheath into a body in which the physical anomaly exists over a guidewire; positioning the introducer and the introducer sheath such that a first end of the tubular body of the introducer is proximal to or within the physical anomaly; once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal or within to the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the one of the one or more embolic device and causing translation of the one or more embolic device towards the physical anomaly until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism; retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and retracting the introducer sheath from within the body.

10. The system of claim 9, wherein operating the system for endovascular therapy further comprises, prior to retracting the introducer sheath from within the body: introducing a tubular body of a second embolic device delivery mechanism into the tubular body of the introducer sheath such that a first end of the tubular body of the second embolic device delivery mechanism is proximal to or within the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until at least one of another one or more embolic device is fully released from the tubular body of the second embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the second embolic device delivery mechanism, pushing against one of the another one or more second embolic device and causing translation of the another one or more embolic device towards the physical anomaly until at least one of the another one or more embolic device is fully released from the tubular body of the second embolic device delivery mechanism; and retracting the second embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body.

11. The system of claim 1 , wherein: the translatory mechanism comprises: a first housing; and a second housing rotationally coupled to the first housing; and actuation of the translatory mechanism comprises rotation of the second housing.

12. The system of claim 1, wherein the translatory mechanism comprises: a first housing; a second housing rotationally coupled to and partially positioned within a first portion of the first housing; a first linear guiderail fixed to the first housing and partially housed within the second housing; and a first nut translationally coupled with the first linear guiderail; wherein: an interior surface of the second housing is threaded; threads are disposed on at least a first portion of an exterior surface of the first nut and integrate with threads on the interior surface of the second housing; as the second housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the first nut and the threads on the interior surface of the second housing cause the first nut to translate upwards or downwards depending on a direction of rotation of the second housing; an end of the tubular body of the embolic device delivery mechanism is fixed to the first nut such that as the first nut moves upwards or downwards, the tubular body is caused to move upwards or downwards as well; and actuation of the translatory mechanism comprises rotation of the second housing.

13. The system of claim 12, wherein the translatory mechanism further comprises: a third housing rotationally coupled to and partially positioned within a second portion of the first housing; a second linear guiderail fixed to the first housing and partially housed within the third housing; and a second nut translationally coupled with the second linear guiderail; wherein: an interior surface of the third housing is threaded; threads are disposed on at least a first portion of an exterior surface of the second nut and integrate with threads on the interior surface of the third housing; as the third housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the second nut and the threads on the interior surface of the third housing cause the second nut to translate upwards or downwards depending on a direction of rotation of the third housing; and an end of the push rod is fixed to the second nut such that as the second nut moves upwards or downwards, the push rod is caused to move upwards or downwards as well.

14. The system of claim 1, wherein manufacturing each of the one or more embolic device comprises: combining dimethyl sulphoxide (DMSO) with polyurethane (PU) to create a PU solution; combining salt and the PU solution to create an embolic device mixture, wherein the embolic device mixture is created within an embolic device mold or the embolic device mixture is poured into the embolic device mold to create a foam structure with a shape defined by the embolic device mold; placing the embolic device mold with the embolic device mixture in a water bath; actively washing the embolic device mixture within the embolic device mold, the embolic device mixture forming the foam structure; and removing the resulting foam structure from the embolic device mold.

15. The system of claim 14, wherein manufacturing each of the one or more embolic device further comprises at least one of: heating the embolic device mold with the embolic device mixture prior to placing the embolic device mold with the embolic device mixture in the water bath; and drying the foam structure after removing the foam structure from the embolic device mold.

16. The system of claim 1 , wherein: each of the one or more embolic device is fabricated from at least polyurethane; each of the one or more embolic device comprises a foam structure; and the polyurethane and a morphology of the foam structure promote healthy tissue integration and proliferation with the foam structure.

17. The system of claim 1 , wherein each of the one or more embolic device comprises a structural spine embedded longitudinally within the respective embolic device.

18. An embolic device for endovascular therapy by at least partial occlusion of a physical anomaly, comprising: a foam structure; a first set of radiopaque markers embedded within the foam structure; a second set of radiopaque markers embedded within the foam structure; and a set of connection means embedded in the foam structure; wherein: each radiopaque marker of the first set of radiopaque markers is positioned adjacent a peripheral edge or surface of the embolic device on or offset from a first transverse plane proximal to a first end of the embolic device; and each radiopaque marker of the second set of radiopaque markers is positioned adjacent the peripheral edge or surface of the embolic device on or offset from a second transverse plane proximal to a second end of the embolic device; each radiopaque marker of the first set of radiopaque markers is aligned and corresponds with a radiopaque marker of the second set of radiopaque markers; and each pair of aligned and corresponding radiopaque markers are connected with a connection means of the set of connection means, each connection means spanning from the first transverse plane to the second transverse plane.

19. The embolic device of claim 18, wherein each connection means of the set of connection means comprises a radiopaque connection means.

20. The embolic device of claim 18, further comprising: one or more additional set of radiopaque markers embedded within the embolic device, wherein each radiopaque marker of each of the one or more additional set of radiopaque markers are positioned adjacent a peripheral edge or surface of the embolic device on or offset from a transverse plane positioned along a longitudinal axis of the embolic device.

21. The embolic device of claim 18, wherein the embolic device in the expanded state functions as a physical barrier to blood flow, ceasing blood flow and occluding the physical anomaly without relying on blood clot formation.

22. The embolic device of claim 18, wherein the embolic device in the expanded state remains positioned within the physical anomaly without an anchoring means.

23. The embolic device of claim 18, wherein the embolic device is deployed using a system, comprising: an introducer comprising a tubular body; an introducer sheath comprising a tubular body; and an embolic device delivery mechanism, comprising: a tubular body; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on one end; wherein: the embolic device is in a compressed state and positioned within and proximal to a first end of the tubular body of the embolic device delivery mechanism; the introducer, the introducer sheath, and the embolic device delivery mechanism are for delivering the embolic device to and deploying the embolic device within the physical anomaly; actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the embolic device and causing translation of the embolic device towards the physical anomaly until the embolic device is fully released from the tubular body of the embolic device delivery mechanism and into the physical anomaly; and the embolic device transitions to an expanded state upon releasing from the tubular body of the embolic device delivery mechanism, thereby at least partially occluding the physical anomaly.

24. The embolic device of claim 23, wherein operating the system comprises: introducing the introducer and the introducer sheath into a body in which the physical anomaly exists over a guidewire; positioning the introducer and the introducer sheath such that a first end of the tubular body of the introducer is proximal to or within the physical anomaly; once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal or within to the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until the embolic device is fully released from the tubular body of the embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the embolic device and causing translation of the embolic device towards the physical anomaly until the embolic device is fully released from the tubular body of the embolic device delivery mechanism; retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and retracting the introducer sheath from within the body.

25. The embolic device of claim 24, wherein operating the system further comprises, prior to retracting the introducer sheath from within the body: introducing a tubular body of a second embolic device delivery mechanism into the tubular body of the introducer sheath such that a first end of the tubular body of the second embolic device delivery mechanism is proximal to or within the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until another embolic device is fully released from the tubular body of the second embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the second embolic device delivery mechanism, pushing against one of the another one or more second embolic device and causing translation of the another embolic device towards the physical anomaly until the another embolic device is fully released from the tubular body of the second embolic device delivery mechanism; and retracting the second embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body.

26. The embolic device of claim 23, wherein: the translatory mechanism comprises: a first housing; and a second housing rotationally coupled to the first housing; and actuation of the translatory mechanism comprises rotation of the second housing.

27. The embolic device of claim 23, wherein the translatory mechanism comprises: a first housing; a second housing rotationally coupled to and partially positioned within a first portion of the first housing; a first linear guiderail fixed to the first housing and partially housed within the second housing; and a first nut translationally coupled with the first linear guiderail; wherein: an interior surface of the second housing is threaded; threads are disposed on at least a first portion of an exterior surface of the first nut and integrate with threads on the interior surface of the second housing; as the second housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the first nut and the threads on the interior surface of the second housing cause the first nut to translate upwards or downwards depending on a direction of rotation of the second housing; an end of the tubular body of the embolic device delivery mechanism is fixed to the first nut such that as the first nut moves upwards or downwards, the tubular body is caused to move upwards or downwards as well; and actuation of the translatory mechanism comprises rotation of the second housing.

28. The embolic device of claim 27, wherein the translatory mechanism further comprises: a third housing rotationally coupled to and partially positioned within a second portion of the first housing; a second linear guiderail fixed to the first housing and partially housed within the third housing; and a second nut translationally coupled with the second linear guiderail; wherein: an interior surface of the third housing is threaded; threads are disposed on at least a first portion of an exterior surface of the second nut and integrate with threads on the interior surface of the third housing; as the third housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the second nut and the threads on the interior surface of the third housing cause the second nut to translate upwards or downwards depending on a direction of rotation of the third housing; and an end of the push rod is fixed to the second nut such that as the second nut moves upwards or downwards, the push rod is caused to move upwards or downwards as well.

29. The embolic device of claim 18, wherein manufacturing the embolic device comprises: combining dimethyl sulphoxide (DMSO) with polyurethane (PU) to create a PU solution; combining salt and the PU solution to create an embolic device mixture, wherein the embolic device mixture is created within an embolic device mold or the embolic device mixture is poured into the embolic device mold to create a foam structure with a shape defined by the embolic device mold; placing the embolic device mold with the embolic device mixture in a water bath; actively washing the embolic device mixture within the embolic device mold, the embolic device mixture forming the foam structure; and removing the resulting foam structure from the embolic device mold.

30. The embolic device of claim 29, wherein manufacturing the embolic device further comprises at least one of: heating the embolic device mold with the embolic device mixture prior to placing the embolic device mold with the embolic device mixture in the water bath; and drying the foam structure after removing the foam structure from the embolic device mold.

31. The embolic device of claim 18, wherein: the embolic device is fabricated from at least polyurethane; the embolic device comprises a foam structure; and the polyurethane and a morphology of the foam structure promote healthy tissue integration and proliferation with the foam structure.

32. The embolic device of claim 18, further comprising a structural spine embedded longitudinally within the embolic device.

33. A method for occluding a physical anomaly, comprising: providing a system for endovascular therapy by occlusion of a physical anomaly, the system comprising: an introducer comprising a tubular body; an introducer sheath comprising a tubular body; and an embolic device delivery mechanism, comprising: a tubular body; one or more embolic device in a compressed state positioned within and proximal to a first end of the tubular body of the embolic device delivery mechanism; a translatory mechanism; and a push rod housed within the tubular body of the embolic device delivery mechanism between the one or more embolic device and the translatory mechanism and fixed to a component of the translatory mechanism on one end; introducing the introducer and the introducer sheath into a body in which the physical anomaly exists over a guidewire; positioning the introducer and the introducer sheath such that a first end of the tubular body of the introducer is proximal to or within the physical anomaly; once the introducer is in position, retracting the introducer from within the body over the guidewire followed by retracting the guidewire, leaving only the introducer sheath within the body; introducing the tubular body of the embolic device delivery mechanism into the tubular body of the introducer sheath such that the first end of the tubular body of the embolic device delivery mechanism is proximal or within to the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism, wherein: actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the embolic device delivery mechanism, pushing against the one of the one or more embolic device and causing translation of the one or more embolic device towards the physical anomaly until at least one of the one or more embolic device is fully released from the tubular body of the embolic device delivery mechanism; and the at least one of the one or more embolic device transitions to an expanded state upon releasing from the tubular body of the embolic device delivery mechanism, thereby at least partially occluding the physical anomaly; retracting the embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body; and retracting the introducer sheath from within the body.

34. The method of claim 33, wherein each of the one or more embolic device comprises: a foam structure; and at least one radiopaque marker embedded within the respective embolic device.

35. The method of claim 34, wherein: the at least one radiopaque marker comprises: a first set of radiopaque markers embedded within the respective embolic device; and a second set of radiopaque markers embedded within the respective embolic device; each radiopaque marker of the first set of radiopaque markers are positioned adjacent a peripheral edge or surface of the respective embolic device on or offset from a first transverse plane proximal to a first end of the respective embolic device; and each radiopaque marker of the second set of radiopaque markers are positioned adjacent the peripheral edge or surface of the respective embolic device on or offset from a second transverse plane proximal to a second end of the respective embolic device.

36. The method of claim 35, wherein: each of the one or more embolic device further comprises a set of connection means embedded in the respective embolic device; each radiopaque marker of the first set of radiopaque markers embedded in the respective embolic device is aligned and corresponds with a radiopaque marker of the second set of radiopaque markers embedded in the respective embolic device; and each pair of aligned and corresponding radiopaque markers embedded in the respective embolic device are connected with a connection means of the set of connection means embedded in the respective embolic device, each connection means spanning from the first transverse plane to the second transverse plane.

37. The method of claim 36, wherein each connection means of the set of connection means comprises a radiopaque connection means.

38. The method of claim 35, wherein: the at least one radiopaque marker further comprises one or more additional set of radiopaque markers embedded within the respective embolic device; and each radiopaque marker of each of the one or more additional set of radiopaque markers are positioned adjacent a peripheral edge or surface of the respective embolic device on or offset from a respective transverse plane positioned along a longitudinal axis of the respective embolic device.

39. The method of claim 33, wherein the at least one of the one or more embolic device in the expanded state functions as a physical barrier to blood flow, ceasing blood flow and occluding the physical anomaly without relying on blood clot formation.

40. The method of claim 33, wherein the at least one of the one or more embolic device in the expanded state remains positioned within the physical anomaly without an anchoring means.

41. The method of claim 33, wherein operating the system for endovascular therapy further comprises, prior to retracting the introducer sheath from within the body: introducing a tubular body of a second embolic device delivery mechanism into the introducing a tubular body of a second embolic device delivery mechanism into the tubular body of the introducer sheath such that a first end of the tubular body of the second embolic device delivery mechanism is proximal to or within the physical anomaly and outside the tubular body of the introducer sheath; actuating the translatory mechanism until at least one of another one or more embolic device is fully released from the tubular body of the second embolic device delivery mechanism, wherein actuation of the translatory mechanism causes the push rod to translate towards the first end of the tubular body of the second embolic device delivery mechanism, pushing against one of the another one or more second embolic device and causing translation of the another one or more embolic device towards the physical anomaly until at least one of the another one or more embolic device is fully released from the tubular body of the second embolic device delivery mechanism; and retracting the second embolic device delivery mechanism from within the body, leaving only the introducer sheath within the body.

42. The method of claim 33, wherein: the translatory mechanism comprises: a first housing; and a second housing rotationally coupled to the first housing; and actuation of the translatory mechanism comprises rotation of the second housing.

43. The method of claim 33, wherein the translatory mechanism comprises: a first housing; a second housing rotationally coupled to and partially positioned within a first portion of the first housing; a first linear guiderail fixed to the first housing and partially housed within the second housing; and a first nut translationally coupled with the first linear guiderail; wherein: an interior surface of the second housing is threaded; threads are disposed on at least a first portion of an exterior surface of the first nut and integrate with threads on the interior surface of the second housing; as the second housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the first nut and the threads on the interior surface of the second housing cause the first nut to translate upwards or downwards depending on a direction of rotation of the second housing; an end of the tubular body of the embolic device delivery mechanism is fixed to the first nut such that as the first nut moves upwards or downwards, the tubular body is caused to move upwards or downwards as well; and actuation of the translatory mechanism comprises rotation of the second housing.

44. The method of claim 43, wherein the translatory mechanism further comprises: a third housing rotationally coupled to and partially positioned within a second portion of the first housing; a second linear guiderail fixed to the first housing and partially housed within the third housing; and a second nut translationally coupled with the second linear guiderail; wherein: an interior surface of the third housing is threaded; threads are disposed on at least a first portion of an exterior surface of the second nut and integrate with threads on the interior surface of the third housing; as the third housing rotates relative to the first housing, the integration between the threads disposed on the at least the first portion of the exterior surface of the second nut and the threads on the interior surface of the third housing cause the second nut to translate upwards or downwards depending on a direction of rotation of the third housing; and an end of the push rod is fixed to the second nut such that as the second nut moves upwards or downwards, the push rod is caused to move upwards or downwards as well.

45. The method of claim 33, wherein manufacturing each of the one or more embolic device comprises: combining dimethyl sulphoxide (DMSO) with polyurethane (PU) to create a PU solution; combining salt and the PU solution to create an embolic device mixture, wherein the embolic device mixture is created within an embolic device mold or the embolic device mixture is poured into the embolic device mold to create a foam structure with a shape defined by the embolic device mold; placing the embolic device mold with the embolic device mixture in a water bath; actively washing the embolic device mixture within the embolic device mold, the embolic device mixture forming the foam structure; and removing the resulting foam structure from the embolic device mold.

46. The method of claim 45, wherein manufacturing each of the one or more embolic device further comprises at least one of: heating the embolic device mold with the embolic device mixture prior to placing the embolic device mold with the embolic device mixture in the water bath; and drying the foam structure after removing the foam structure from the embolic device mold.

47. The method of claim 33, wherein: each of the one or more embolic device is fabricated from at least polyurethane; each of the one or more embolic device comprises a foam structure; and the polyurethane and a morphology of the foam structure promote healthy tissue integration and proliferation with the foam structure.

48. The method of claim 33, wherein each of the one or more embolic device comprises a structural spine embedded longitudinally within the respective embolic device.