Device for vascular occlusion and method of using the same

Abstract

This disclosure features devices, systems, and kits for vascular occlusion, as well as methods for using them.

Description

Background Art

[0001] Embolization procedures temporarily or permanently occlude blood flow to one or more predetermined blood vessels. Endovascular embolization is a minimally invasive method for treating a wide range of medical conditions, including, but not limited to, traumatic and non-traumatic bleeding, preoperative vascular occlusion of organs and tumors, preoperative liver growth promotion, congenital or acquired vascular malformations, pelvic venous congestion syndrome, and varicoceles.

[0002] Vascular coils and plugs are the most commonly used devices for mechanical vascular embolization. In some clinical situations, vascular plugs may be more advantageous than coils. For example, vascular plugs can have a low risk of migration in high-flow vascular zones or short landing zones, occlusion of larger blood vessels can be achieved with a single plug rather than multiple coils, and repositioning and accurate placement are enabled by the delivery mechanism. In addition, vascular plugs can shorten the treatment time because they achieve occlusion faster compared to vascular coils. Finally, vascular plugs are considered a more cost-effective intervention because they can result in complete vascular occlusion in a shorter time and with fewer devices.

[0003] Currently available vascular plugs have certain limitations. Firstly, because such plugs are relatively large, they are more difficult to navigate through winding vessels. Secondly, when embolization of longer vascular segments is desired (e.g., when treating pelvic congestion syndrome and varicocele), multiple vascular plugs are required, making the procedure time and cost comparable to that of vascular coils. Thirdly, these vascular plugs are not well-suited for embolization across sharp angles, which increases the embolization time and the risk of recanalization. Fourthly, these vascular plugs require 20-30% oversizing to ensure proper adhesion to the vessel wall. However, oversizing often leads to plug elongation and accidental occlusion of other vessels after deployment. Accidental occlusion of other vessels is a significant consideration when embolizing short vessels (e.g., gastroduodenal arteries). Fifthly, most commercially available vascular plugs cannot be deployed on wire. Sixth, these vascular plugs are suitable for repositioning before full deployment, but cannot be repositioned after installation or release.

[0004] Therefore, there is a need for improved vascular plugs to address these challenges. [Overview of the project]

[0005] This disclosure features a device for vascular occlusion and a method of using the same.

[0006] In one embodiment, the disclosure features a vascular occlusion device having a proximal end and a distal end defining a first axis, with a length between the proximal and distal ends. The vascular occlusion device includes a helical grid along the first axis, the helical grid having a width extending along a second axis perpendicular to the first axis, and one or more connectors located at the proximal end, the distal end, or both. The helical grid includes a network of grid cells. The helical grid is configured to transform between a compressed state (e.g., a deformed shape) and an uncompressed state (e.g., a non-deformed shape) about the second axis.

[0007] In some embodiments, the vascular occlusion device is sized to occlude blood vessels (e.g., veins, arteries, grafts, stents, arterioles, capillaries, splenic arteries, gastroduodenal arteries, and fistulas). In some embodiments, the helical grid includes about 1 to about 25 turns (e.g., about 1 to about 10 turns, about 1 to about 5 turns, or about 3 turns). In some embodiments, each turn includes a pitch of about 1 mm to about 30 mm (e.g., about 1 to 20 mm, about 5 to 20 mm, or about 5 to 15 mm). In some embodiments, the grid cells are compressible (e.g., deformable). In some embodiments, the grid cells include polygonal, square, rectangular, triangular, rhombic, circular, elliptical, egg-shaped, oblong, lens-shaped, star-shaped, delta-shaped, slit-shaped, or amorphous shapes.

[0008] In some embodiments, when the vascular occlusion device is in an uncompressed state (e.g., in an undeformed or uncompacted shape), the width of the vascular occlusion device is about 1 mm to about 30 mm (e.g., about 1 to 20 mm, about 5 to 20 mm, or about 5 to 15 mm). In some embodiments, the width of the vascular occlusion device is periodic along its length. In some embodiments, the width of the helical grid is wider than the width of the vascular occlusion device at the proximal end, the distal end, or both. In some embodiments, the helical grid includes a thickness of about 0.01 mm to about 1 mm (e.g., about 0.03 mm to about 0.8 mm, about 0.05 mm to about 0.6 mm, about 0.1 mm to about 0.4 mm, or about 0.2 mm to about 0.3 mm). In some embodiments, the length of the vascular occlusion device is approximately 10 mm to approximately 600 mm (for example, approximately 20 mm to approximately 500 mm, approximately 30 mm to approximately 400 mm, approximately 40 mm to approximately 300 mm, approximately 50 mm to approximately 200 mm, approximately 60 mm to approximately 100 mm, or approximately 80 mm).

[0009] In some embodiments, the helical grid self-expands from a compressed state to an uncompressed state (for example, the helical grid can return to its pre-deformed or non-compacted shape when the compressive force is removed). In some embodiments, the helical grid is flexible. In some embodiments, the helical grid includes two outer edges, with grid cells disposed between the two outer edges. In some embodiments, one or more connectors are configured to reversibly engage with a pusher (for example, a pusher including an unfolding hook). In some embodiments, one or more connectors include one or more loops or fasteners. In some embodiments, the connector includes a lumen configured to accommodate a guidewire, such as a guidewire having a diameter of about 0.2 mm to about 1 mm.

[0010] In some embodiments, the vascular occlusion device includes a radiopaque marker. In some embodiments, the radiopaque marker is located on the distal end, the proximal end, a helical grid, or a combination thereof.

[0011] In some embodiments, the helical lattice is made of or includes a shape memory material. In some embodiments, the shape memory material includes nitinol. In some embodiments, the vascular occlusion device further includes a coating. In some embodiments, the coating includes a thrombogenic agent. In some embodiments, the coating includes thrombin. In some embodiments, the coating includes a hydrogel. In some embodiments, the hydrogel includes polysaccharides, mucopolysaccharides, carboxyalkylcellulose, synthetic polymers, or proteins.

[0012] In some embodiments, the vascular occlusion device further includes a plurality of filaments attached to a helical grid, at least a portion of which extends radially from the helical grid. In some embodiments, the filaments contain a thrombus-forming agent. In some embodiments, the filaments contain a synthetic polymer. In some embodiments, the synthetic polymer contains polyester.

[0013] In a second embodiment, the disclosure features a delivery system comprising: a vascular occlusion device of the first embodiment; a catheter having a proximal and distal end and having a length between the proximal and distal ends; a pusher having a proximal and distal end, the distal end configured to reversibly attach to the proximal end of a connector; and a cartridge. In some embodiments, the reversible attachment between the pusher and the proximal connector of the vascular occlusion device is a rotational engagement. In some embodiments, the pusher comprises a deployment shaft having a proximal and distal end, and a deployment hook at the distal end, the deployment hook engaging with the proximal connector of the vascular occlusion device. In some embodiments, the deployment shaft is a wire or a rod, optionally, the wire is configured to slidably translate the vascular occlusion device through the catheter when force is applied, thereby moving the vascular occlusion device through the catheter to a target site in the vessel for occlusion.

[0014] In some embodiments, the cartridge includes a proximal opening and a distal opening, with either the proximal or distal opening, or both, having a lumen extending along the length of the cartridge from the proximal opening to the distal opening. In some embodiments, the lumen of the cartridge is sized to receive a vascular occlusion device, which can be inserted into the cartridge or compressed (e.g., deformed or compacted) within the cartridge. In some embodiments, the catheter includes a proximal end and a distal end, and optionally, the proximal end of the catheter is configured to receive the distal end of the cartridge. In some embodiments, the proximal end of the catheter is configured to be reversibly attached to the cartridge. In some embodiments, the reversible attachment is performed by pressure fitting. In some embodiments, the proximal end of the catheter is attached to the distal opening of the cartridge. In some embodiments, attaching the cartridge to the catheter creates a fluid communication between them, thereby allowing the vascular occlusion device residing in the cartridge to slide gliding from the cartridge to the catheter via the attachment. In some embodiments, the proximal opening, distal opening, and / or lumen of the cartridge have lumens configured to receive a guidewire, which optionally has a diameter of about 0.2 mm to about 1 mm. In some embodiments, the guidewire is configured to direct the vascular occlusion device through the catheter to a target site in the blood vessel for occlusion.

[0015] In some embodiments, the delivery system further includes a deployment device comprising a deployment device body, the deployment device being configured to connect to the proximal end of the catheter and the proximal end of a pusher. In some embodiments, the pusher is advanced along the length of the catheter by applying force to the deployment device.

[0016] In some embodiments, the delivery system includes an actuator, which is configured such that the operation of the actuator causes the catheter to be retracted into the deployment device body or to extend the catheter from the deployment device body. In some embodiments, the actuator is a rotary actuator.

[0017] In some embodiments, the deployment device further comprises an inlet port that communicates fluid with the proximal end of the catheter. In some embodiments, the inlet port is configured to connect to a fluid source, thereby allowing the fluid source to flow through the inlet port into the lumen of the catheter and deliver the fluid contained in the fluid source to the target blood vessel.

[0018] In some embodiments, the deployment device further comprises a deployment release, which is configured to manipulate the position of the deployment hook during operation. In some embodiments, the operation of the deployment release can raise the deployment hook to disengage it from the proximal connector, or lower the deployment hook to engage the deployment hook and the proximal connector. In some embodiments, the deployment release is mechanically or electronically coupled to the deployment hook. In some embodiments, the operation of the deployment release includes pushing down the deployment release, rotating the deployment release, or sliding the deployment release.

[0019] In a third aspect, the Disclosure provides a method for occluding a blood vessel (e.g., a vein, artery, graft, stent, arteriole, capillary, splenic artery, gastroduodenal artery, and fistula), characterized by a) inserting a blood vessel occlusion device of the first and / or second aspect into the blood vessel in a compressed state (e.g., deformed or compacted shape), and b) deploying the blood vessel occlusion device at a target site within the blood vessel, thereby converting the blood vessel occlusion device to an uncompressed state (e.g., the undeformed or uncompacted shape the device had before the compressive force was applied), thereby occluding blood flow within the blood vessel.

[0020] In some embodiments, the method further includes advancing the vascular occlusive device through the blood vessel after the insertion step a) (for example, by using a pusher, for example, by moving the vascular occlusive device along a catheter present in the blood vessel). In some embodiments, the traverse of the vascular occlusive device through the blood vessel is achieved by using one or more components of the delivery system of the second embodiment (e.g., one or more of a catheter, a guidewire, and a pusher).

[0021] In some embodiments, the delivery system includes a catheter, a guidewire, and / or a pusher, each of which is used to translate the occlusive device through the blood vessel to the target site to be occluded. In some embodiments, the occlusive device is located in a cartridge of the delivery system prior to step a). In some embodiments, the occlusive device is housed within the lumen of the cartridge. In some embodiments, the method further includes attaching the cartridge to the proximal end of the catheter prior to step a).

[0022] In some embodiments, inserting the occlusive device in step a) further includes using a pusher to transfer the occlusive device from the cartridge to the catheter. In some embodiments, the occlusive device is reversibly attached to the pusher. In some embodiments, the reversible attachment is by rotational engagement (e.g., hook and loop engagement). In some embodiments, the pusher is removed from the occlusive device after the occlusive device has been deployed into the blood vessel and converted to an uncompressible state (e.g., an undeformable or uncompacted shape).

[0023] In some embodiments, the method further includes advancing the vascular occlusion device through a blood vessel while the vascular occlusion device is inside a catheter. In some embodiments, advancing the vascular occlusion device within a target blood vessel includes pushing the vascular occlusion device through the blood vessel (e.g., inside a catheter inserted into the blood vessel) by, for example, using a pusher. In some embodiments, the vascular occlusion device may be reversibly engaged with a pusher, for example, through a proximal connector of the vascular occlusion device and the pusher's deployment hook.

[0024] After the vascular occlusion device has been advanced to a desired location within the blood vessel inside the catheter, the pusher can be disengaged from the vascular occlusion device, the catheter can be retracted, and the vascular occlusion device can be converted to an uncompressible state. In some embodiments, disengaging the pusher from the vascular occlusion device includes disengaging the deployment hook from the proximal connector after the vascular occlusion device has been converted to an uncompressible state.

[0025] The vascular occlusion device can be re-engaged with the pusher after deployment by re-engaging the deployment hook and proximal connector. The catheter can then be extended along the length of the vascular occlusion device, converting the vascular occlusion device to at least partially compressed. The vascular occlusion device can then be repositioned and / or redeployed within the target vessel. In some embodiments, repositioning includes fully extending the catheter along the length of the vascular occlusion device, converting the entire vascular occlusion device to compressed, and withdrawing the vascular occlusion device from the target body. In some embodiments, the catheter is connected to an actuator, the operation of which causes the catheter to be retracted or extended. In some embodiments, the actuator is a rotary actuator.

[0026] The deployment hook can be mechanically or electronically coupled to the deployment release. By operating the deployment release, the deployment hook rises or falls, thereby engaging and / or disengaging the deployment hook and the proximal connector. Both the deployment hook and the deployment release can be located on the deployment device. In one embodiment, the deployment device is a handheld device.

[0027] In some embodiments, advancing the vascular occlusion device within the target vessel includes advancing the vascular occlusion device over a guide wire that is positioned to direct the vascular occlusion device to the target site within the vessel.

[0028] In some embodiments, the method includes administering a therapeutic agent via a catheter. In some embodiments, the therapeutic agent is a thrombogenic agent or an anti-tumor agent.

[0029] In a fourth aspect, the present disclosure features a kit that includes the vascular occlusion device of the first aspect or the delivery system of the second aspect and one or more additional components. In some embodiments, the one or more additional components include one or more cartridges, catheters, guide wires, deployment devices, and / or pushers (e.g., rods or wires).

[0030] Other features and advantages of the present disclosure will become apparent from the following description of its preferred embodiments and from the claims.

[0031] Definitions For ease of understanding the present disclosure, some terms are defined below. The terms defined herein have meanings commonly understood by those of ordinary skill in the art relevant to the present disclosure. Terms such as "a," "an," and "the" are not intended to refer only to singular entities (unless the context clearly indicates otherwise) and include the general class of specific examples used for illustration.

[0032] As used herein, the term “approximately” means a value that is 10% above or below the stated value.

[0033] "To treat" or "treatment" means the medical management of an object intended to result in the improvement, restoration, or prevention of injury, disease, pathological condition, or impairment. Exemplary injuries, diseases, pathological conditions, or impairments that can be treated by the compositions and methods described herein include bleeding, preoperative vascular occlusion of organs and tumors, aortic aneurysm rupture, arteriovenous malformations, neurovascular abnormalities, arteriovenous fistulas, intracranial aneurysms, improvement of bleeding from blood vessels occurring during treatment of any disease or disease, promotion of liver growth, pelvic venous congestion syndrome, congenital or acquired vascular malformations, varicocele, and restriction of blood flow to an object undergoing surgical or imaging procedures (e.g., angiography). Treatment may include reducing blood flow in the subject to, for example, less than approximately 60 mL / s, less than approximately 50 mL / s, less than approximately 40 mL / s, less than approximately 30 mL / s, less than approximately 20 mL / s, less than approximately 10 mL / s, less than approximately 5 mL / s, less than approximately 4 mL / s, less than approximately 3 mL / s, less than approximately 2 mL / s, less than approximately 1 mL / s, or less than 0 mL / s. "To treat" or "treatment" includes active treatment, i.e., treatment directed in particular to the improvement of injury or disease, pathological condition or disability, and also includes causal treatment, i.e., treatment directed to the removal of the cause of injury or disease, pathological condition or disability. In addition, “treating” or “treatment” also includes elective treatment, i.e., treatment designed to alleviate symptoms rather than cure an injury or disease, pathological condition or disability; preventive treatment, i.e., treatment aimed at preventing an injury or disease, pathological condition or disability; and adjunct treatment, i.e., treatment used to complement another specific therapy aimed at improving an injury or disease, pathological condition or disability.

[0034] When used herein, any value provided in a range of values ​​includes both the upper and lower limits, as well as any value that falls within the upper and lower limits. [Brief explanation of the drawing]

[0035] The following detailed description of embodiments of this disclosure can be better understood in conjunction with the accompanying drawings. However, it should be understood that this disclosure is not limited to the exact arrangement and means of embodiments shown in the drawings.

[0036] [Figure 1] This is an image of a vascular occlusion device 100, labeled to define the length (L), width (W), and thickness (T) of the vascular occlusion device, as well as the pitch (P) of one turn of the helical grid. [Figure 2A-F] This image shows a vascular occlusion device 100, which includes a proximal end 110, a distal end 120, a helical grid 130 containing grid cells 140 between the ends, and connectors for the proximal end 110 and the distal end 120 (proximal connector 170 and distal connector 180, respectively). The vascular occlusion device 100 may include a coating 190. Each of Figures 2A to 2F includes a common axial system that highlights the relative orientation of the vascular occlusion device 100 in each figure. Figure 2A shows a side view of the vascular occlusion device 100 (a view along the first axis of the device), highlighting the proximal end 110 and the distal end 120 of the vascular occlusion device 100. Figures 2B to 2F show the rotation of the vascular occlusion device 100 around the z-axis assigned to Figure 2A. [Figure 3] This is an image of a vascular occlusion device 100 partially inserted into a delivery system 200, including a catheter 210 having a proximal end 211 and a distal end 212. The proximal end 110, proximal connector 170, and a portion of the helical grid 130 of the vascular occlusion device 100 are compressed inside the catheter 210. The distal end 120, distal connector 180, and a portion of the helical grid 130 are not compressed outside the catheter 210. [Figure 4A-B] This image shows three different orientations of spikes that can be incorporated into a vascular occlusion device. Figure 4A shows one embodiment of a spike in an uncompressed state. Figure 4B shows one embodiment of a spike in a compressed state. The spikes may be included along the helical grid 130 (for example, at the first outer edge 150 or the second outer edge 160). [Figure 5A-B]These are photographs of prior art vascular devices showing filament 1200. The vascular occlusion devices 100 in Figures 1-4 can be improved to include a surrounding layer of fibrous material such as filament 1200, or a similar type of material (e.g.). The image in Figure 5A is copied from Trerotola et al. (J. Vasc. Interv. Radiol. 30(6):949-955, 2019). The images from Figure 5B onwards are copied from Kim (J. Cerebrovasc. Endovasc. Neurosurg. 15(2)(2013)). [Figure 6] Figures 5A and 5B depict a vascular occlusion device 100 including filaments 1200 as shown. In such embodiments, the coating 190 may be applied to the filaments 1200, the helical grid 130, or both. [Figure 7] This is an image of a vascular occlusion device 100 partially inserted into a delivery system 200, which includes a catheter 210. [Figure 8] This is an image of a cartridge 220 including a proximal end 221, a distal end 222, and a lumen 223 between them. The distal end 222 may include a structure designed to connect to the proximal end 211 of the catheter 210. The vascular occlusion device 100 may be pre-loaded inside the lumen 223. [Figure 9A-F] The cartridge 220 is shown in front view (Figure 9A), top view (Figure 9B), side view (Figure 9C), and perspective view (Figure 9D). Figures 9E to 9F show perspective views of the cartridge 220, in which the cartridge 220 is asymmetrical and may require deployment through different vascular access points such as the femoral artery (Figure 9E) or the jugular vein (Figure 9F). The cartridge 220 may be designed with markings to communicate the directionality of the device, for example, with respect to the deployment of the blood flow and / or vascular occlusion device 100. [Figure 10A-C]The deployment of the vascular occlusion device 100 into the target blood vessel is illustrated. Figure 10A shows the vascular occlusion device 100 in a compressed state within the catheter 210. The proximal connector 170 at the proximal end 110 is connected to a pusher 230, which includes a deployment shaft 231 and a deployment hook 232. Figure 10B shows a magnified view of the distal end of the vascular occlusion device 100 within the catheter 210. Figure 10C shows a magnified view of the connection between the pusher 230 and the proximal connector 170. [Figure 11] An exemplary method for deploying the vascular occlusion device 100 is shown. [Figure 12A-D] Figure 12D shows the deployment device 240, which includes an inlet port 241, a rotary actuator 242, and a deployment release 243. Figures 12A and 12B show a top view of the deployment device 240. Figure 12C shows a side view of the deployment device 240. Figure 12B shows an arrow indicating the direction of rotation of the rotary actuator 242. Figure 12C further shows the operation of the deployment release 243. Figure 12D shows the deployment device 240, which includes the inlet port 241, the rotary actuator 242, and the deployment release 243 connected to the catheter 210. The vascular occlusion device 100 is shown constrained at the distal end of the catheter 210. [Modes for carrying out the invention]

[0037] This disclosure features devices, systems, methods, and kits for vascular occlusion. In particular, this disclosure features a compressible (e.g., deformable or compactible) vascular occlusion device including a helical grid.

[0038] The vascular occlusion device 100 may include a proximal portion, a distal portion, and an intermediate portion between them, the proximal portion, distal portion, and intermediate portion being positioned between the proximal end 110 and the distal end 120. The vascular occlusion device includes a width defined along a second axis perpendicular to a first axis. The vascular occlusion device 100 is defined by its length (L) and width (W) (Figure 1). The length of the vascular occlusion device 100 is the distance along the first axis and is defined as the distance between the proximal end 110 and the distal end 120. The length of the vascular occlusion device 100 may range from approximately 10 mm to approximately 600 mm (for example, approximately 20 mm to approximately 500 mm, approximately 30 mm to approximately 400 mm, approximately 40 mm to approximately 300 mm, approximately 50 mm to approximately 200 mm, approximately 60 mm to approximately 100 mm, or approximately 80 mm). The width of the vascular occlusion device is the distance between two points on the vascular occlusion device along a second axis perpendicular to a first axis. The width or thickness of the device may be constant along the length of the device or may vary. The width of the vascular occlusion device 100 may be about 1 mm to about 30 mm (e.g., about 1 to 20 mm, about 5 to 20 mm, or about 5 to 15 mm) when in an uncompressed state (e.g., an undeformable or uncompacted shape). The width of the vascular occlusion device 100 may be periodic along its length. The proximal and distal portions of the vascular occlusion device 100 may have the same width or different widths. In embodiments where the proximal and distal portions have different lengths, the vascular occlusion device 100 may be described as "asymmetrical". The intermediate portion of the vascular occlusion device 100 may include a width wider than the width of the proximal and / or distal portions.

[0039] Figure 2A shows a side view (i.e., a view along the second axis) of the vascular occlusion device 100. Figures 2B to 2F show different orientations of the vascular occlusion device 100 after rotation around the axis. The vascular occlusion device 100 includes a proximal portion, a distal portion, and an intermediate portion, all of which are located between the proximal end 110 and the distal end 120. The intermediate portion of the device comprises a helical grid 130, which is made up of a network of grid cells 140 between them. The helical grid 130 may include a first outer edge 150 and a second outer edge 160, with a network of grid cells 40 located between these edges. The proximal end 110 may include a proximal connector 170, and the distal end 120 may include a distal connector 180. Either the proximal connector 170 or the distal connector 180 connects to an external component (e.g., a guidewire or a pusher (e.g., a pusher 230)) to facilitate the movement of the vascular occlusion device 100 through the target blood vessel.

[0040] The proximal portion of the vascular occlusion device 100 includes a proximal end 110 and may further include a proximal connector 170. The intermediate portion of the vascular occlusion device 100, including the helical grid 130, may have a length of approximately 10 mm to approximately 600 mm and a width of approximately 1 mm to approximately 30 mm. The width of the intermediate portion may be periodic along its length. The distal portion of the vascular occlusion device 100 includes a distal end 120 and may further include a distal connector 180. The intermediate portion may have a width wider than the width of the proximal and / or distal portions.

[0041] All or part of the vascular occlusion device 100, including a portion containing the helical grid 130, can be fabricated using a shape memory material. The shape memory material may be or may include nitinol or stainless steel. The vascular occlusion device 100 may contain one or more bioabsorbable materials such as collagen, PLGA, and PLLA. The vascular occlusion device 100 can be fabricated using two or more materials. The proximal end 110 and the distal end 120 may be fabricated independently from a material having a Young's modulus of at least about 10 GPa (for example, a Young's modulus in the range of about 10 to about 50 GPa, such as about 28 GPa). Any part of the vascular occlusion device 100 may be reinforced with a reinforcing material. The reinforcing material may be a wire, braided wire, or coil that passes through or is present within the lumen contained in the proximal end 110, the distal end 120, and / or the helical grid 130. The reinforcing material may be a continuous layer on the surface of the vascular occlusion device 100. The proximal end 110, the distal end 120, and the helical lattice 130 may be independently made from or include a flexible material (e.g., silicone rubber). For example, the proximal end 110, the distal end 120, and the helical lattice 130 may be coated with a flexible material (e.g., silicone rubber).

[0042] The helical grid 130 includes one or more turns along the first axis of the vascular occlusion device 100. Each turn is defined by a pitch (P). The pitch of the helical grid may be 1 mm to 200 mm (e.g., about 1 to 100 mm, about 1 to 30 mm, about 1 to 20 mm, about 5 to 20 mm, or about 5 to 15 mm). The helical grid 130 may have about 1 to about 25 turns (e.g., about 1 to 10 turns, about 1 to 5 turns, or about 3 turns). The pitch of each turn may be the same or different. The helical grid 130 further includes several grid cells 140, each of which is defined by shape and region. The shapes and / or regions of all grid cells 140 of the helical grid 130 may be identical. The shapes and / or regions of one or more grid cells 140 may differ from one or more other grid cells 140 of the helical grid 130. The helical grid 130 may include more than one, for example, more than two, more than three, more than four, more than five, more than six, more than seven, more than eight, more than nine, or more than ten grid cells 140 of different shapes and / or regions.

[0043] The vascular occlusion device 100 may include one or more lumens, for example, in or through the proximal end 110, in or through the proximal connector 170, in or through the distal end 120, in or through the distal connector 180, and / or in or through the helical grid 130. A guidewire may pass through one or more of these lumens, thereby slidably attaching the vascular occlusion device 100 to the guidewire. The guidewire may be included as part of the delivery system 200.

[0044] Those skilled in the art may select a vascular occlusion device with an appropriate length, width, thickness, number of turns, pitch of one or more turns, shape of one or more grid cells, and / or region of one or more grid cells to reduce blood flow. Those skilled in the art may select the dimensions of the vascular occlusion device based, for example, the size of the vessel to be occluded (see Table 1), and / or the desired blood flow through and around the vessel after occlusion.

[0045] The vascular occlusion device 100 is sized to fit inside a blood vessel. The diameter of the vascular occlusion device 100 and / or the diameter of the helical grid 130 may be selected to be slightly smaller than, approximately equal to, or slightly larger than the overall diameter of the blood vessel to be occluded using the vascular occlusion device 100 (for example, the width may be about 1% to about 10% narrower than the width of the blood vessel). For example, the width of the vascular occlusion device 100 may be, for example, about 1% to about 10% wider than the width of the blood vessel, or about 1% to about 10% narrower than the width of the blood vessel. If the vascular occlusion device 100 is sized to be slightly larger than the blood vessel and is used to occlude the blood vessel, the vascular occlusion device 100 may be able to partially return to its uncompressible state when the compressive force is released (for example, when the vascular occlusion device 100 has exited the catheter and been deployed into the blood vessel). In such embodiments, the vascular occlusion device 100 is partially constrained by the blood vessel. This also facilitates holding the vascular occlusion device 100 at the target site within the blood vessel, which can further improve occlusion.

[0046] For example, the vascular occlusion device 100 can be provided in one of a number of different sizes configured to fit into a target vessel. Exemplary vessels and vessel sizes are provided in Table 1. Table 1. Exemplary blood vessels [Table 1]

[0047] The vascular occlusion device 100 can be sized to fit into, for example, the aorta (diameter approximately 2 cm to 3 cm), arteries (diameter approximately 3 mm to 25 mm), veins (diameter approximately 0.6 cm to 2 cm), fistulas (diameter approximately 0.5 cm to 2.5 cm), grafts (approximately 6 mm to 14 mm), and stents (approximately 2.5 mm to 14 mm). The width of the vascular occlusion device 100 (for example, at least within the middle portion) can be selected to match the maximum size of the vessel in which the vascular occlusion device 100 is placed, or to slightly exceed it (for example, approximately 1% to 10%).

[0048] Further examples of blood vessels that can be occluded using the vascular occlusion device 100 include veins, arteries, stents, arterioles, capillaries, splenic arteries, gastroduodenal arteries, fistulas, and grafts.

[0049] The vascular occlusion device 100 can be in a first state (uncompressed state (e.g., non-deformable or non-compacted shape)) and can be deformed or compacted to a second state (compressed state). In the uncompressed state, the vascular occlusion device 100 can have a width of approximately 1 mm to approximately 30 mm (e.g., approximately 1 to 20 mm, approximately 5 to 20 mm, or approximately 5 to 15 mm). In the compressed state, the vascular occlusion device 100 can have a width of approximately 0.5 mm to approximately 6 mm (see Figure 3). The width of the vascular occlusion device 100 in the compressed state, the uncompressed state, or both may vary along its length.

[0050] The vascular occlusion device 100 can be inserted directly into the target blood vessel or with the assistance of a delivery system 200 (see, for example, Figure 3). For example, the vascular occlusion device 100 can be inserted into the blood vessel in a compressed state (e.g., deformed or compacted shape) using components of the delivery system 200, such as a catheter 210, delivered to a target blood vessel site, and deployed within the blood vessel. The delivery system 200 may include, for example, one or more of the following: a catheter 210 (having a proximal end 211 and a distal end 212), a cartridge (having a proximal opening 221, a distal opening 222 and a lumen 223), a guidewire, and a pusher (e.g., a pusher 230). Components of the delivery system 200 may be used to guide the vascular occlusion device 100 to a target site within the target blood vessel and deploy the vascular occlusion device 100 within the blood vessel, thereby enabling the vascular occlusion device to occlude blood flow at the target site.

[0051] In some embodiments, the pusher may be a pusher 230. The pusher 230 includes the deployment shaft 231 and a deployment hook 232 at the distal end of the deployment shaft 231. The deployment hook 232 is configured to be reversibly attached to the proximal connector 170. For example, the deployment hook 232 may be mated into the proximal connector 170, creating a reversible interlock.

[0052] The vascular occlusion device 100 may be supplied in a compressed state inside a cartridge 220. The cartridge 220 is designed to accommodate the vascular occlusion device 100, particularly in a compressed state. During the vascular occlusion procedure, the distal end of the cartridge 220 can be attached to the proximal end of the catheter 210 (e.g., by pressure fitting), thereby establishing fluid communication between the cartridge 220 and the catheter 210. The vascular occlusion device 100 can then be transferred from the cartridge 220 to the catheter 210 (e.g., using a pusher (e.g., a rod or wire)). Once transferred inside the catheter 210, the vascular occlusion device 100 can be navigated through the catheter 210 by the pusher to the target site in the vessel where the occlusion is to be formed. At the target site, the vascular occlusion device 100 can be released from the catheter 210 by using the pusher, and the vascular occlusion device 100 can be deployed into the vessel. When released from the catheter 210, the compressive force on the vascular occlusion device 100 is released, allowing the vascular occlusion device 100 to return to an uncompressible state (for example, the vascular occlusion device 100 can assume its non-deformable or non-compacted shape). By assuming an uncompressible state, the vascular occlusion device 100 can come into contact with the blood vessel wall, thereby allowing the vascular occlusion device 100 to be attached to the appropriate location within the blood vessel and cause occlusion.

[0053] Alternatively, once the vascular occlusion device 100 has been navigated by the pusher through the catheter 210 to the target site in the blood vessel where the occlusion is to be formed, the operator can use the pusher to hold the vascular occlusion device 100 in place while gently withdrawing the catheter 210, thereby releasing the vascular occlusion device 100 from the catheter and deploying the catheter 210 into the blood vessel at the target site. Upon release from the catheter 210, the compressive force on the vascular occlusion device 100 is released, allowing it to return to an uncompressible state (for example, the vascular occlusion device 100 can assume its non-deformable or non-compacted shape). By assuming an uncompressible state, the vascular occlusion device 100 can contact the blood vessel wall, thereby attaching the vascular occlusion device 100 to the appropriate location in the blood vessel and causing occlusion.

[0054] spiral lattice As shown in Figures 2A to 2F, the vascular occlusion device 100 includes an intermediate section having a helical grid 130. The helical grid 130 includes a network of helical cells 140. The helical grid 130 of the vascular occlusion device 100 may include approximately 1 to approximately 25 turns (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 turns). Each turn is defined by a pitch P, which is the length along the first axis of the vascular occlusion device 100 for the helical grid 130 to complete a single 360° rotation. Each turn may have the same pitch or may have different pitches. For example, each turn may have the same pitch, such as approximately 1 mm to 200 mm, 2 mm to 190 mm, 3 mm to 180 mm, 4 mm to 170 mm, 5 mm to 160 mm, 6 mm to 150 mm, 7 mm to 140 mm, 8 mm to 130 mm, 9 mm to 120 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, 100 mm, 105 mm, 110 mm, 115 mm, etc. (See Figure 1).

[0055] The helical lattice cells 140 are compressible (e.g., compactible or deformable). The helical lattice cells 140 may have any of a number of different shapes, such as polygonal, square, rectangular, triangular, rhombic, circular, elliptical, egg-shaped, oval, lens-shaped, star-shaped, delta-shaped, slit-shaped, or amorphous. Each shape and / or region of the lattice cells 140 of the helical lattice 130 may be identical, or all or a subset of the lattice cells 140 may have different shapes. The helical lattice 130 may include lattice cells 140 with one or more different shapes and / or regions, for example, lattice cells 140 with two or more different shapes and / or regions, lattice cells 140 with three or more different shapes and / or regions, lattice cells 140 with four or more different shapes and / or regions, lattice cells 140 with five or more different shapes and / or regions, and so on.

[0056] The helical grid 130 may include a first outer edge 150 and a second outer edge 160, with a network of grid cells 140 arranged between these edges. The first outer edge 150 and the second outer edge 160 may be joined at a proximal end 110 and a distal end 120, respectively, to form a structure. This structure may be a connector, for example, a proximal connector 170 at the proximal end 110 and / or a distal connector 180 at the distal end 120. The connector may be, for example, a loop, a hook, or a fastener.

[0057] The helical grid 130 can be installed in a compressed state (e.g., deformed or compacted shape) inside a component of the delivery system 200, such as a cartridge 220 or a catheter 210. The helical grid 130 can be compressed by a force that is installed inside or drawn into the component of the delivery system 200. The helical grid 130 can then be guided to the site of occlusion by a component of the delivery system 200 (e.g., a pusher (e.g., a rod or wire)). The helical grid 130 may be able to return to an uncompressed state upon removal from the component of the delivery system 200 (e.g., after being deployed from the catheter 210 into a blood vessel (see, for example, Figure 3)).

[0058] The helical grid 130 includes a length defined along a first axis. The length of the helical grid 130 may range from about 10 mm to about 600 mm (e.g., about 20 mm to about 500 mm, about 30 mm to about 400 mm, about 40 mm to about 300 mm, about 50 mm to about 200 mm, about 60 mm to about 100 mm, or about 80 mm; Figure 1). The helical grid 130 includes a width defined along a second axis of about 1 mm to about 30 mm (e.g., about 1 to 20 mm, about 5 to 20 mm, or about 5 to 15 mm) when the vascular occlusion device 100 is in an uncompressed state. The proximal and distal portions of the helical grid 130 may have the same width or different widths. In embodiments where the proximal and distal portions have different lengths, the vascular occlusion device 130 may be referred to as "asymmetrical".

[0059] The width of the helical grid 130 may be periodic along its length. The helical grid 130 includes thicknesses of approximately 0.01 mm to 1 mm (for example, approximately 0.3 mm to 0.8 mm, approximately 0.05 mm to 0.6 mm, approximately 0.1 mm to 0.4 mm, or approximately 0.2 mm to 0.03 mm) (see Figure 2).

[0060] The helical grid 130 may include one or more spikes 1100 (see Figures 4A to 4B). The spikes 1100 may project outward from a first outer edge 150, a second outer edge 160, or both. The spikes 1100 may project outward only when the helical grid 130 is in an uncompressed state. The spikes 1100 may be compressible about a second axis. When compressed, the spikes 1100 may not project significantly from the helical grid 130. The helical grid 130 and / or the spikes 1100 may include textures (e.g., bumps, depressions, ridges, etc.). The textures may be located on the inner or outer surface of the helical grid 130.

[0061] connector The vascular occlusion device 100 may include one or more connectors that can be used to connect to (e.g., attach to) components of the delivery system 200 (e.g., pushers). The connectors may be, for example, loops, fasteners, hooks, traction devices (e.g., magnets), etc. The vascular occlusion device 100 may include connectors at the distal end 120 (i.e., distal connector 180) and / or the proximal end 110 (i.e., proximal connector 170). The vascular occlusion device 100 may include one or more proximal connectors 170 and / or one or more distal connectors 180. The proximal connectors 170 and / or distal connectors 180 may have a circular, semicircular, oval, or cylindrical shape. The connectors may have a thickness of 0.01 mm to 1 mm. The vascular occlusion device 100 may interact with the delivery system 200 through either the proximal connector 170 or the distal connector 180, or both. The proximal connector 170 may be further configured to be reversibly attached to the snare, allowing for removal and / or repositioning of the vascular occlusion device 100. The proximal connector 170, the distal connector 180, or both may interact with, for example, the guidewire of the delivery system 200, the pusher of the delivery system 200, or a connector (e.g., a connector included in the delivery system 200). The proximal connector 170 or the distal connector 180 may be reversibly attached to the delivery system 200, the guidewire of the delivery system 200, the pusher of the delivery system 200, or a connector (e.g., a connector included in the delivery system 200). The guidewire may be screwed into the lumen of either the proximal connector 170 or the distal connector 180.

[0062] In the vascular occlusion device 100, tension (e.g., mechanical pressure by compression, torsion, or rotation) may be applied to the connector to induce a change from an uncompressible state to a compressed state of the vascular occlusion device 100. Removal of tension (e.g., removal of compression) may induce a change from a compressed state to an uncompressible state. The connector of the vascular occlusion device 100 may include a lumen configured to accommodate a guidewire having an inner diameter of about 0.2 mm to about 1 mm.

[0063] filament The vascular occlusion device 100 may include a plurality of filaments 1200. The filaments 1200 incorporated inside or outside the vascular occlusion device 100 may be the same as or similar to filaments known in the art that are used with other types of vascular devices (e.g., U.S. Patents 8,535,700, 5,658,308, 5,792,154, 5,935,145, 6,001,092, 6,033,423, 6,280,457, and 6,299,627, as well as Trerotola et al. (J. Vasc. Interv. Radiol. 30(6):949-955, 2019) and Kim (J. Cerebrovasc. Endovasc. Neurosurg. 15(2), 2013), each of which is incorporated herein by reference). Filaments as shown in Figures 5A and 5B can be incorporated into a vascular occlusion device 100 as shown in Figure 6. Similar or identical filaments may be included in the vascular occlusion device 100 described herein.

[0064] Filament 1200 may be or contain natural or synthetic polymers. Examples of natural or synthetic polymers include polyesters, polyurethanes, polyethers, polyamides (e.g., nylon polymers and their derivatives), polyimides, polyacrylates, epoxy, olefins (e.g., polyethylene, polypropylene, polybutadiene, polystyrene, etc.) and their copolymers (fluorinated polymers (e.g., polytetrafluoroethylene), siloxane-based polymers, cellulose, rayon, rubber, polyester, glycosides, caprolactone polymers, hydroxybutyrates, and polyhydroxyvalerates).

[0065] The filament 1200 can be attached to the vascular occlusion device 100, for example, by adhesive or heat treatment. The filament 1200 can be attached to the helical grid 130, with at least a portion of the filament 1200 extending radially from the helical grid 130. The filament 1200 may include a coating 190.

[0066] coating In some embodiments, all or part of the vascular occlusion device 100 may include a coating 190. The coating 190 may be, for example, an agent (e.g., a therapeutic agent) that promotes blood coagulation, stimulates the repair of the target blood vessel, reduces the risk of secondary infection of the target, lubricates the vascular occlusion device 100, or extends the operating life of the vascular occlusion device 100. The coating 190 may be included in the helical grid 130 or the filaments 1200. The helical grid 130 and / or the filaments 1200 may include coated portions, uncoated portions, or both. The helical grid 130 and / or the filaments 1200 may include only coated portions.

[0067] The agent of coating 190 may be or may contain a thrombogenic agent or a fibrosis-promoting material (e.g., a thrombin-containing composition or a fibrinogen-containing composition). Exemplary coatings are known in the art (e.g., U.S. Patent No. 8,535,700, which is incorporated herein by reference in its entirety).

[0068] Coating 190 may also include a hydrogel. The hydrogel may be capable of expanding upon exposure to an aqueous medium and / or physiological fluid (e.g., blood or its components). In some embodiments, the hydrogel may include polysaccharides, mucopolysaccharides, carboxyalkylcellulose, synthetic polymers, or proteins. Other exemplary hydrogels are known in the art (see, for example, U.S. Patents 11,090,078, 7,220,270, 8,535,700, and 8,163,362, each of which is incorporated herein by reference).

[0069] Radiopaque markers In some embodiments, the vascular occlusion device 100 may include a radiopaque marker. Radiopaque markers and their inclusion in vascular devices are known in the Art (see, for example, U.S. Patent Applications No. 13 / 793,474, No. 17 / 152,581, and No. 15 / 183,468, and U.S. Patents No. 8,123,777, No. 10,517,605, No. 7,938,820, and No. 9,060,802, each of which is incorporated herein by reference).

[0070] The radiopaque marker may be included along the entire length of the vascular occlusion device 100 or only along a portion thereof. For example, the radiopaque marker may be included at the proximal end 110, the distal end 120, or both.

[0071] Delivery system The vascular occlusion device 100 may be included in one or more components of a delivery system (e.g., as part of a kit) or may be used in conjunction with components (e.g., during a vascular occlusion procedure). Components of the delivery system 200 may be used to deploy the vascular occlusion device 100 at a desired site within the target vessel. The delivery system 200 may include the vascular occlusion device 100 and one or more additional components such as a catheter 210, a cartridge 220, a guidewire, a pusher (e.g., a rod or wire), or a snare.

[0072] The catheter 210 of the delivery system 200 has a proximal end 211 and a distal end 212, and a length between the proximal end 211 and the distal end 212, including a lumen over the length of the catheter 210. The length of the catheter 210 is sufficient to navigate the target vessel. The catheter 210 may include an inner diameter of up to 30 mm and an outer diameter smaller than the diameter of the vessel into which the occlusive vessel 100 is deployed. The catheter 210 may be sized to maintain the occlusive vessel 100 in a compressed state (e.g., deformed or compacted) when the occlusive vessel 100 is inserted into the catheter 210. The catheter 210 may also be used during occlusive procedures to deliver a therapeutic agent to a desired site within the target vessel (e.g., as an injector). In such embodiments, the therapeutic agent may be administered via the proximal end 211 of the catheter 210 (e.g., via a syringe through an infusion port). Figure 7 shows an image of the vascular occlusion device 100 partially deployed from the catheter 210.

[0073] The cartridge 220 shown in Figures 8 and 9 includes a proximal opening 221, a distal opening 222, and a lumen 223 between the openings, the lumen providing fluid communication between the proximal opening 221 and the distal opening 222. The proximal opening 221 may include a lumen having a diameter of at least the diameter of the pusher. The distal opening 222 may include a connector designed to be attached to the proximal end 211 of the catheter 210 (for example, the distal opening 222 may include a structure designed to pressure-fit with the proximal end 211). The connector may have an outer diameter smaller than the inner diameter of the catheter 210. The distal opening 222 may further include a lumen (for example, a lumen within a structure designed to provide fluid communication with the proximal end 211 of the catheter 210). The lumen 223, extending along the length of the cartridge 220 from the proximal opening 221 to the distal opening 222, can be sized to accommodate the vascular occlusion device 100 in a compressed state (i.e., the vascular occlusion device 100 can be pre-loaded inside the lumen 223 of the cartridge 220). The vascular occlusion device 100 can be stored inside the cartridge 220, for example, within the lumen 223, before the device is deployed.

[0074] The pusher of the delivery system 200 (e.g., a rod or wire, e.g., pusher 230) may include a structure designed to engage with the proximal connector 170 of the vascular occlusion device 100. In some embodiments, the structure is a deployment hook 232. The pusher (e.g., pusher 230) can be used to apply a biasing force to the vascular occlusion device 100 to deploy the vascular occlusion device from the cartridge 220 into the catheter 210, and from the catheter 210 into the blood vessel of the target site for vascular occlusion. The pusher may be or include a rod or wire. In some embodiments, the pusher is pusher 230. The pusher 230 has a diameter equal to the inner diameter of the catheter 210 at most. Engagement of the pusher with the proximal connector 170 may be by a hook-and-loop configuration (e.g., a deployment hook 232 configured to engage with a structure (e.g., a loop) at the proximal connector 170), or by other preferred mechanical connection. The pusher can be used to guide the vascular occlusion device 100 through the cartridge 220 and / or catheter 210 by applying a gentle but reliable mechanical force to the proximal connector 170 that moves the vascular occlusion device 100 forward. The attachment between the pusher 230 and the proximal connector 170 may be reversible. For example, the pusher 230 and the proximal connector 170 may be rotationally engaged (for example, the pusher may have a hook structure at its distal end configured to engage with the loop structure of the proximal connection 170). Figures 10A to 10C show an example of rotational engagement between the deployment hook 232 of the pusher 230 and the proximal connector 170. Alternatively, the pusher and the proximal connector 170 may be reversibly attached via screws or snaps, or by traction (for example, by using magnetized components). It is also conceivable that the proximal connector 170 and the pusher may be permanently joined. If desired, the pusher may be used not only to deploy the vascular occlusion device 100 during the vascular occlusion procedure, but also to remove the vascular occlusion device 100 after the completion of the procedure or treatment. For example, the deployment hook 232 may be configured to re-engage with the proximal connector 170.After re-engagement, the deployment shaft 231 may be retracted along the length of the catheter 210, thereby drawing the vascular occlusion device 100 into the lumen of the catheter 210, for example, by compressing the vascular occlusion device 100 into a compressed state.

[0075] The delivery system 200 may include a deployment device 240 designed to be held by an operator, which is configured to advance the vascular occlusion device 100 along the length of the catheter 210 by applying force (e.g., to the proximal end of the pusher 230). The deployment device 240 includes a proximal end configured to connect to the proximal end of the deployment shaft 231, the proximal end 211 of the catheter 210, and / or the proximal end of the guidewire. The deployment device 240 may further include an inlet port 241. The inlet port 241 is configured to be in fluid communication with a fluid (e.g., saline solution with or without the drug (e.g., an IV bag)). When the deployment device 240 is connected to the proximal end 211 of the catheter 210, the inlet port 241 may be in fluid communication with the lumen of the catheter 210. The drug applied through the inlet port 241 may then flow through the lumen of the catheter 210 to the target site in the target blood vessel.

[0076] The deployment device 240 may further include an actuator. The actuator engages with the proximal end 211 of the catheter 210. The catheter 210 may extend from the body of the deployment device 240 or be retracted into the body of the deployment device 210 by operating the actuator or a secondary component coupled thereto. The actuator may function by rotation (e.g., rotation of the actuator causes the catheter 210 to be retracted from the body of the deployment device 240, e.g., a rotary actuator 242, or to be deployed) or by sliding (e.g., movement of the actuator along the length of the deployment device 240 causes the catheter 210 to be retracted from the body of the deployment device 240 or to be deployed). Figures 12A to 12D show an example of a rotary actuator 242. The deployment device 240 may further include a deployment release 243. The deployment release 243 may be mechanically or electronically coupled to the deployment hook 232 via mechanical or electrical components contained in the deployment shaft 231. The deployment hook 232 is operated by operating the deployment release 243 (for example, by pushing down, rotating, or sliding the deployment release 243). For example, when the deployment hook 232 is engaged with the vascular occlusion device 100 via the proximal connector 170, the operational deployment release 243 may raise the deployment hook 232, disengaging the pusher 230 from the proximal connector 170, thereby releasing the vascular occlusion device 100. Alternatively, when the deployment hook is not engaged with the vascular occlusion device 100 via the proximal connector 170, the operational deployment release 243 may lower the deployment hook 232, rotatably engaging the deployment hook 232 with the proximal connector 170, thereby engaging the pusher 230 with the vascular occlusion device 100. An example of the deployment release 243 is shown in Figure 12C.

[0077] The delivery system 200 may include a snare. The snare is configured to be reversibly attached to the proximal connector 170 (for example, using the method described herein). If the position of the vascular occlusion device 100 is unsatisfactory, the snare can be advanced through the catheter 210 and reversibly attached to the vascular occlusion device 100. The snare and the vascular occlusion device 210 can then be retracted into the lumen of the catheter 210, converting the vascular occlusion device 100 into a compressed state. The vascular occlusion device 100 can then be repositioned. Once the vascular occlusion device 100 reaches the desired position, it can be redeployed from the lumen of the catheter 210 into the target vessel and expanded into an uncompressed state.

[0078] The vascular occlusion device 100 can be compressed within a catheter 210 or a cartridge 220. The vascular occlusion device 100 can be delivered to a target vascular site using methods developed for different types of vascular devices (see, for example, U.S. Patents 10,695,159, 10,786,268, 8,734,374, 5,702,413, and U.S. Patent Application No. 2010 / 0204712, the entirety of which is incorporated by reference). Such methods may also be applied to the systems and devices of this specification.

[0079] Exemplary guidewires that can be used as part of the delivery system 200 are known in the art (see, for example, U.S. Patent Applications No. 11 / 314924 and No. 17 / 240,591, which are incorporated herein by reference in their entirety). The guidewire may be contained within the lumen of the catheter 210 or may be sized to fit therein.

[0080] How to use The vascular occlusion device 100 and delivery system 200 can be used during vascular occlusion procedures to occlude blood flow in a target vessel. Specifically, the vascular occlusion device 100 can be used to occlude a vessel by, for example, a) inserting the vascular occlusion device 100 into a vessel in a compressed state (e.g., deformed or compacted shape), and b) unfolding the vascular occlusion device 100 at a target site in the vessel, thereby converting the vascular occlusion device 100 to an uncompressed state (e.g., non-deformed or non-compacted shape). The vascular occlusion device 100 can be supplied in a compressed state inside the catheter 210 or cartridge 220 of the delivery system 200.

[0081] The vascular occlusion device 100 may be provided pre-loaded in a cartridge 220. In this case, the procedure includes attaching the distal end 222 of the cartridge 220 to the proximal end 211 of the catheter 210 to establish fluid communication between them, and then pushing the vascular occlusion device 100 from the cartridge 220 into the catheter 210, for example, by using a pusher. The distal end 212 of the catheter 210 can then be moved to the site of the blood vessel requiring occlusion. Subsequently, the vascular occlusion device 100 can be navigated to the distal end 212 of the catheter 210, for example, by using a pusher (e.g., a rod or wire (e.g., pusher 230)). The pusher may be reversibly attached to the vascular occlusion device 100 (e.g., through a rotational engagement between a connector included in the pusher and the proximal connector 170). When the vascular occlusion device 100 has reached the site of occlusion of the blood vessel, the pusher can be used to deploy the vascular occlusion device 100 from the catheter 210 into the blood vessel. When deployed, the vascular occlusion device 100 assumes an uncompressible state (to the extent permissible based on the size of the blood vessel), thereby adhering to the target site. Subsequently, the deployment of the vascular occlusion device 100 facilitates the occlusion of the blood vessel. Once the vascular occlusion device 100 is contained within the blood vessel, the catheter 210 can be removed from the blood vessel, and the insertion site can be closed.

[0082] The distal end 212 of the catheter 210 can be positioned at the desired occlusion site or an adjacent site. The distal opening 222 of the cartridge 220 can then be fitted into the proximal end 211 of the catheter 210 (for example, via a connector designed to attach to the proximal end 211 of the catheter 210) by optionally passing a guidewire through the lumen of the proximal connector 170 or the distal connector 180. The pusher 230 of the delivery system 200 can then be fed into the proximal opening of the cartridge 220. The deployment hook 232 at the distal end of the pusher 230 can then engage with the proximal connector 170 at the proximal end 110 of the vascular occlusion device 100. Force can then be applied to the vascular occlusion device 100 (for example, through the proximal connector 170) using the pusher 230, and the vascular occlusion device 100 can then be pushed from the lumen 223 of the cartridge 220 into the lumen of the catheter 210. The vascular occlusion device 100 can be pushed along the length of the catheter 210 by continuously applying force using the pusher 230. The vascular occlusion device 100 can then be pushed out from the distal end 212 of the catheter 210. The vascular occlusion device 100 can then self-inflate and occlude the vessel once it has been deployed from the catheter 210.

[0083] Alternatively, the delivery system 200 may include a guidewire. The guidewire may be inserted into the lumen of the catheter 210. The guidewire may enter the target blood vessel and be navigated to a desired location within the vessel. Positioning the guidewire and catheter 210 may include making an incision in the target blood vessel (e.g., in the target femoral artery) and feeding the guidewire and catheter 210 into the incision to access the target blood vessel. A pusher may be used to move the vascular occlusion device 100 along the length of the guidewire until it reaches a desired location within the target blood vessel. Once the vascular occlusion device 100 is positioned, the guidewire may be removed from the blood vessel.

[0084] A snare may be used to reposition the vascular occlusion device 100. The snare can be advanced through the catheter 210 (e.g., using a pusher of a delivery system 200 or a similar mechanism) and reversibly attached to the vascular occlusion device 100. The snare and the vascular occlusion device 100 can then be retracted into the lumen of the catheter 210, converting the vascular occlusion device 100 into a compressed state. The vascular occlusion device 100 can then be repositioned by moving the catheter 210 to a desired position. Once the desired position is reached, the vascular occlusion device 100 can be redeployed from the lumen of the catheter 210 into the target vessel (e.g., using a pusher), resulting in a conversion that returns the vascular occlusion device to an uncompressed state.

[0085] Figure 11 shows an exemplary deployment method. The vascular occlusion device 100 is reversibly attached to the pusher 230 via a deployment hook 232. In this exemplary method, the vascular occlusion device 100 is advanced to the distal end of the catheter 210 (step (1)). Advancement of the vascular occlusion device 100 may include advancing the vascular occlusion device 100 along a guidewire. The catheter is retracted when it is positioned at the desired site, allowing the vascular occlusion device 100 to expand into an uncompressible state (steps (1)-(2)). Finally, the deployment hook 232 is disengaged from the vascular occlusion device 100, thereby deploying the vascular occlusion device 100 into the target vessel (step (4)).

[0086] The pusher 230 and / or catheter 210 may be connected to a deployment device 240. The deployment device 240 allows the pusher 230 to be manipulated (for example, by applying pressure to the proximal end of the pusher 230 through the deployment device 240) to position the pusher 230, attached to the vascular occlusion device 100, at a target site within the target vessel. The deployment device 240 further includes an actuator connected to the catheter 210. The operation of the rotary actuator 242 allows the catheter 210 to be extended or retracted (for example, along a guidewire). For example, the catheter 210 may be retracted, thereby releasing the vascular occlusion device 100 from the catheter 210 and converting the vascular occlusion device 100 from a compressed state to an uncompressed state. Alternatively, the catheter 210 may be extended, thereby recapturing the vascular occlusion device 100 within the catheter 210 and converting the vascular occlusion device 100 back to a compressed state.

[0087] The deployment device 240 may further include an inlet port 241. The inlet port 241 is configured to be in fluid communication with a solution (e.g., saline solution that may contain a drug, in the form of an IV bag). When the deployment device 240 is connected to the proximal end 211 of the catheter 210, the inlet port 241 may be configured to be in fluid communication with the lumen of the catheter 210. The solution applied through the inlet port 241 can then flow through the lumen of the catheter 210 to a target site in the target blood vessel. The vascular occlusion device 100 may be used to partially or completely restrict blood flow in the target. The target blood flow may be reduced to, for example, less than approximately 60 mL / s, less than approximately 50 mL / s, less than approximately 40 mL / s, less than approximately 30 mL / s, less than approximately 20 mL / s, less than approximately 10 mL / s, less than approximately 5 mL / s, less than approximately 4 mL / s, less than approximately 3 mL / s, less than approximately 2 mL / s, less than approximately 1 mL / s, or less than 0 mL / s. If the vascular occlusion device 100 is not intended to be permanently implanted in the target body, the vascular occlusion device 100 may be used to restrict the target blood flow for a predetermined period of time, for example, less than 1 hour, for example, less than 30 minutes, less than 20 minutes, less than 15 minutes, less than 10 minutes, or less than 5 minutes. Alternatively, blood flow may be restricted by the vascular occlusion device 100 for a period of time exceeding 1 hour (for example, permanently).

[0088] In embodiments where it is desired to apply a therapeutic or diagnostic agent during treatment, the cartridge 220 may be removed from the proximal end 211 of the catheter 210 (for example, after deploying the vascular occlusion device 100 and removing the pusher from the catheter 210). The therapeutic or diagnostic agent may then be delivered (e.g., injected) through the proximal end 211. In such embodiments, the catheter 210 may be used (e.g., as an injector) to deliver the therapeutic or diagnostic agent to a target site in the blood vessel.

[0089] Vascular occlusion devices 100 or delivery systems, including the vascular occlusion device 100 described herein, can be used to treat a number of injuries, diseases, disorders, and pathological conditions. Examples include bleeding, preoperative vascular occlusion of organs and tumors, aortic aneurysm rupture, arteriovenous malformations, neurovascular anomalies, arteriovenous fistulas, intracranial aneurysms, improvement of bleeding from blood vessels occurring during any disease or treatment of a disease, promotion of liver growth, pelvic venous congestion syndrome, congenital or acquired vascular malformations, varicocele, and restriction of blood flow to subjects undergoing surgical or imaging procedures (e.g., angiography). Vascular occlusion devices 100 can be used to improve bleeding from blood vessels occurring during any disease or treatment of a disease. Vascular occlusion devices 100 can be used to treat any pathological condition known in the art to be treatable by occlusion.

[0090] The vascular occlusion device 100 can be used to treat cancer, for example, by occluding a blood vessel near a tumor to block blood flow to the tumor. An antitumor agent can then be injected via a catheter 210, if desired. In addition, either the same or a different antitumor agent may be included as a coating 190.

[0091] The vascular occlusion device 100 may engage with a blood vessel throughout the entire medical procedure or only for a portion of the procedure time, i.e., to occlude the flow through the blood vessel. The duration for which the vascular occlusion device 100 is used may depend on the need to restrict the blood flow of the subject during the medical procedure.

[0092] kit This disclosure features a kit comprising a vascular occlusion device 100 and one or more additional components, such as one or more components of a delivery system 200. The one or more components may include one or more of a catheter (e.g., catheter 210), a guidewire, a pusher (e.g., pusher 230), and a cartridge (e.g., cartridge 220). The cartridge may be supplied into the kit with the vascular occlusion device 100 pre-loaded inside its lumen. The kit and its components can be used in a vascular occlusion procedure, during which the vascular occlusion device 100 is deployed to a target site in a vessel where blood flow occlusion is required, using the components of the kit.

[0093] Manufacturing method The vascular occlusion device 100 and other components disclosed herein can be manufactured using methods known in the art, including, for example, machining, injection molding, additive manufacturing (3D printing), laser cutting, shaping, or a combination thereof. The vascular occlusion device 100 can then be loaded into the cartridge 220. This may include compressing the vascular occlusion device 100 inside the cartridge 220, or fabricating the cartridge 220 (for example, through the methods described herein) and then fitting the cartridge 220 around the vascular occlusion device 100. [Examples]

[0094] The following examples are provided to those skilled in the art to explain how the compositions and methods described herein may be used, prepared, and evaluated, and are intended to be purely illustrative of the invention and not intended to limit the scope of the invention.

[0095] Example 1: Use of a vascular occlusion device This embodiment demonstrates the use of the vascular occlusion device 100 in the treatment of trauma, such as traumatic splenic injury.

[0096] Using prior art, an incision is made in the right common femoral artery. A 6Fr sheath is then placed in the artery. Next, the celiac artery is catheterized through the sheath using a guidewire and a curved catheter (e.g., SosOmni). The location of the vascular injury (e.g., bleeding from the vessel) is monitored via angiography. The curved catheter is then replaced with a 4Fr straight glide catheter and advanced to the appropriate position in the splenic artery. A cartridge containing the occlusive device 100 is attached to the proximal hub of the 4Fr catheter. Using a pusher rod, the occlusive device 100 is pushed into the catheter and toward the intended deployment position. The advancement of the occlusive device 100 within the catheter is monitored in real time under fluoroscopy using radiopaque markers on the device. When the occlusive device 100 is in the correct position, the occlusive device 100 is held in place by the pusher rod, and the 4Fr catheter is slowly withdrawn to deploy the occlusive device 100 (e.g., desheath it).

[0097] If the position of the vascular occlusion device 100 is unsatisfactory, the snare can be advanced through the 4Fr catheter, and the neck of the vascular occlusion device 100 (e.g., the segment between the proximal connector and the body of the vascular occlusion device 100) can be captured by the snare. The vascular occlusion device 100 can then be withdrawn (e.g., "sheathed") into the 4Fr catheter. The sheathed vascular occlusion device 100 is then properly positioned and deployed again.

[0098] Example 2: Deployment of a vascular occlusion device This embodiment demonstrates the deployment of a vascular occlusion device 100 using a delivery system 200 in the treatment of trauma, such as traumatic splenic injury.

[0099] Using prior art, an incision is made in the right common femoral artery. A 6Fr sheath is then placed in the artery. Next, the celiac artery is catheterized through the sheath using a guidewire and a curved catheter (e.g., SosOmni). The location of the vascular injury (e.g., bleeding from the vessel) is monitored via angiography. Next, the curved catheter is replaced with catheter 210. Next, the catheter is advanced to the appropriate position in the target vessel. A cartridge 220 containing the vascular occlusion device 100 is attached to the proximal end 211 of catheter 210. The deployment hook 232 of the pusher 230 is attached to the proximal connector 170 at the proximal end 110 of the vascular occlusion device 100. The proximal end of the deployment shaft 231 of the pusher 230 is attached to the deployment device 240. A biasing force is applied to the pusher 230 through the deployment device 240 to transfer the vascular occlusion device 100 from cartridge 220 to catheter 210. Next, a biasing force is continuously applied to advance the vascular occlusion device 100 to the appropriate position within the target blood vessel. The advancement of the vascular occlusion device 100 within the catheter is monitored in real time under fluoroscopy using radiopaque markers on the device.

[0100] Once the vascular occlusion device 100 is positioned correctly, the rotary actuator 242 is activated to retract the catheter, allowing the vascular occlusion device 100 to expand into an uncompressed state. The deployment release 243 is then activated to raise the deployment hook 232, thereby separating the deployment hook 232 from the proximal connector 170.

[0101] During deployment, the drug may be applied through the inlet port 241 of the deployment device 240. The drug flows through the inlet port 241 to the catheter 210 and is released at the appropriate location within the target blood vessel.

[0102] To reposition the vascular occlusion device 100, the deployment release 243 is operated to lower the deployment hook 232 and reconnect the deployment hook 232 to the proximal connector 170. Then, the rotary actuator 242 is operated to extend the catheter 210 and compress the vascular occlusion device 100 within the catheter 210. Then, the vascular occlusion device 100 is repositioned and redeployed as described above.

[0103] Other embodiments Those skilled in the art will see various modifications and variations of the invention described without departing from the scope and spirit of the invention. Although the invention has been described in relation to specific embodiments, it should be understood that the claimed invention should not be excessively limited to such specific embodiments. In fact, various modifications of the described modes for carrying out the invention, which will be obvious to those skilled in the art, are intended to be within the scope of the invention.

[0104] Other embodiments are described in the claims.

Claims

1. A vascular occlusion device comprising a proximal end and a distal end defining a first axis, with a length between the proximal end and the distal end, a) The vascular occlusion device comprises a helical grid along the first axis, the helical grid having a width extending along a second axis perpendicular to the first axis, and one or more connectors at the proximal end, the distal end, or both, b) The helical grid comprises a network of grid cells, c) A vascular occlusion device in which the helical grid is configured to convert between a compressed state and an uncompressed state about the second axis.

2. The vascular occlusion device according to claim 1, wherein the vascular occlusion device is sized to occlude a blood vessel.

3. The vascular occlusion device according to claim 1 or 2, wherein the helical grid comprises about 1 to about 25 turns.

4. The vascular occlusion device according to claim 3, wherein the helical grid comprises approximately 1 to 10 turns.

5. The vascular occlusion device according to claim 3 or 4, wherein the helical grid comprises approximately 1 to 5 turns.

6. The vascular occlusion device according to any one of claims 3 to 5, wherein the helical grid includes approximately 3 turns.

7. A vascular occlusion device according to any one of claims 3 to 6, wherein each turn includes a pitch of approximately 1 mm to approximately 30 mm.

8. The vascular occlusion device according to any one of claims 1 to 7, wherein the grid cell is compressible.

9. The vascular occlusion device according to any one of claims 1 to 8, wherein the grid cells include polygonal, square, rectangular, triangular, rhombus, circular, elliptical, egg-shaped, oblong, lens-shaped, star-shaped, delta-shaped, slit-shaped, or amorphous shapes.

10. The vascular occlusion device according to any one of claims 1 to 9, wherein when the vascular occlusion device is in the uncompressed state, the width is approximately 1 mm to approximately 30 mm.

11. The vascular occlusion device according to any one of claims 1 to 10, wherein the width is approximately 5 mm to approximately 20 mm.

12. The vascular occlusion device according to any one of claims 1 to 11, wherein the width is approximately 5 mm to approximately 15 mm.

13. The vascular occlusion device according to any one of claims 1 to 12, wherein the width of the vascular occlusion device is periodic along the length.

14. The vascular occlusion device according to any one of claims 1 to 13, wherein the width of the helical grid is wider than the width of the vascular occlusion device at the proximal end, the distal end, or both.

15. The vascular occlusion device according to any one of claims 1 to 14, wherein the helical grid includes a thickness of about 0.01 mm to about 1 mm.

16. The vascular occlusion device according to any one of claims 1 to 15, wherein the helical grid includes a thickness of about 0.03 mm to about 0.8 mm.

17. The vascular occlusion device according to any one of claims 1 to 16, wherein the helical grid includes a thickness of about 0.05 mm to about 0.6 mm.

18. The vascular occlusion device according to any one of claims 1 to 17, wherein the helical grid includes a thickness of about 0.1 mm to about 0.4 mm.

19. The vascular occlusion device according to any one of claims 1 to 18, wherein the helical grid includes a thickness of about 0.2 mm to about 0.3 mm.

20. The vascular occlusion device according to any one of claims 1 to 19, wherein the length of the vascular occlusion device is approximately 10 mm to approximately 600 mm.

21. The vascular occlusion device according to any one of claims 1 to 20, wherein the length of the vascular occlusion device is approximately 20 mm to approximately 500 mm.

22. The vascular occlusion device according to any one of claims 1 to 21, wherein the length of the vascular occlusion device is approximately 30 mm to approximately 400 mm.

23. The vascular occlusion device according to any one of claims 1 to 22, wherein the length of the vascular occlusion device is approximately 40 mm to approximately 300 mm.

24. The vascular occlusion device according to any one of claims 1 to 23, wherein the length of the vascular occlusion device is approximately 50 mm to approximately 200 mm.

25. The vascular occlusion device according to any one of claims 1 to 24, wherein the length of the vascular occlusion device is approximately 60 mm to approximately 100 mm.

26. The vascular occlusion device according to any one of claims 1 to 25, wherein the length of the vascular occlusion device is approximately 80 mm.

27. The vascular occlusion device according to any one of claims 1 to 26, wherein the helical grid self-expands from the compressed state to the uncompressed state.

28. The vascular occlusion device according to any one of claims 1 to 27, wherein the helical grid is flexible.

29. The vascular occlusion device according to any one of claims 1 to 28, wherein the helical grid comprises two outer edges, and the grid cells are disposed between the two outer edges.

30. The vascular occlusion device according to any one of claims 1 to 29, wherein one or more connectors are configured to reversibly engage with a pusher.

31. The vascular occlusion device according to claims 1 to 30, wherein the one or more connectors include one or more loops or fasteners.

32. The vascular occlusion device according to any one of claims 1 to 31, wherein the connector has a lumen configured to accommodate a guidewire having a diameter of about 0.2 mm to about 1 mm.

33. A vascular occlusion device according to any one of claims 1 to 32, further comprising a radiopaque marker.

34. The vascular occlusion device according to claim 33, wherein the radiopaque marker is located on the distal end, the proximal end, the helical grid, or a combination thereof.

35. The vascular occlusion device according to any one of claims 1 to 34, wherein the helical grid comprises a shape memory material.

36. The vascular occlusion device according to claim 35, wherein the shape memory material comprises nitinol.

37. A vascular occlusion device according to any one of claims 1 to 36, further comprising a coating.

38. The vascular occlusion device according to claim 37, wherein the coating comprises a thrombus-forming agent.

39. The vascular occlusion device according to claim 37 or 38, wherein the coating comprises thrombin.

40. The vascular occlusion device according to any one of claims 37 to 39, wherein the coating comprises a hydrogel.

41. The vascular occlusion device according to claim 40, wherein the hydrogel comprises a polysaccharide, a mucopolysaccharide, a carboxyalkylcellulose, a synthetic polymer, or a protein.

42. The vascular occlusion device according to any one of claims 1 to 41, further comprising a plurality of filaments attached to the helical grid, wherein at least a portion of the filaments extends radially from the helical grid.

43. The vascular occlusion device according to claim 42, wherein the filament contains a thrombus-forming agent.

44. The vascular occlusion device according to claim 42 or 43, wherein the filament comprises a synthetic polymer.

45. The vascular occlusion device according to claim 44, wherein the synthetic polymer includes polyester.

46. A delivery system, (a) A vascular occlusion device according to any one of claims 1 to 45, (b) A catheter having a proximal end and a distal end, with a length between the proximal end and the distal end, (c) A pusher comprising a deployment shaft having a proximal end and a distal end, wherein the distal end is configured to be reversibly attached to the proximal connector of the vascular occlusion device, and (d) A delivery system comprising one or more cartridges.

47. The delivery system according to claim 46, wherein the reversible attachment between the pusher and the proximal connector of the vascular occlusion device is by rotational engagement.

48. The delivery system according to claim 46 or 47, wherein the deployment shaft comprises a deployment hook at the distal end of the deployment shaft, and the deployment hook engages with the proximal connector of the vascular occlusion device.

49. The delivery system according to any one of claims 46 to 48, wherein the deployment shaft is a rod or a wire.

50. The delivery system according to any one of claims 46 to 49, wherein the pusher is configured to, when force is applied, slidably translate the vascular occlusion device along the length of the catheter, thereby moving the vascular occlusion device to a target site in the blood vessel for vascular occlusion.

51. The delivery system according to any one of claims 46 to 50, wherein the cartridge comprises a proximal opening and a distal opening, and a lumen extending the length of the cartridge from the proximal opening to the distal opening.

52. The delivery system according to claim 51, wherein the lumen is sized to accommodate the vascular occlusion device.

53. The delivery system according to claim 52, wherein the cartridge comprises a vascular occlusion device inside its lumen.

54. The delivery system according to claim 53, wherein the cartridge and the catheter are configured to be joined together to establish fluid communication.

55. The delivery system according to any one of claims 46 to 54, wherein the proximal end of the catheter is configured to be reversibly attached to the cartridge.

56. The delivery system according to claim 55, wherein the reversible attachment between the catheter and the cartridge is a pressure fit.

57. The delivery system according to claim 55 or 56, wherein the proximal end of the catheter is configured to be attached to the distal opening of the cartridge.

58. The delivery system according to any one of claims 55 to 57, wherein the lumen of the cartridge comprises the vascular occlusion device, and the vascular occlusion device is configured to slidably translate from the cartridge to the catheter in response to the attachment of the cartridge to the catheter.

59. The delivery system according to any one of claims 51 to 58, wherein the proximal opening, the distal opening, and / or the lumen of the cartridge are configured to host a guidewire having a diameter of about 0.2 mm to about 1 mm.

60. The delivery system according to claim 59, wherein the guidewire is configured to direct the vascular occlusion device through the catheter to a target site in the blood vessel for vascular occlusion.

61. The delivery system according to any one of claims 46 to 60, further comprising a deployment device having a main body, wherein the deployment device is configured to connect to the proximal end of the catheter and the proximal end of the pusher.

62. The delivery system according to claim 61, wherein the pusher is advanced along the length of the catheter by applying force to the deployment device.

63. The delivery system according to claim 61 or 62, further comprising an actuator, wherein the operation of the actuator is configured to either retract the catheter into the deployment device or extend the catheter from the body of the deployment device.

64. The delivery system according to claim 63, wherein the actuator is a rotary actuator.

65. The delivery system according to any one of claims 61 to 64, wherein the deployment device further comprises an inlet port that is in fluid communication with the proximal end of the catheter.

66. The delivery system according to claim 65, wherein the inlet port is configured to connect to a fluid supply source, thereby allowing the fluid supply source to flow through the inlet port into the lumen of the catheter and deliver the fluid contained in the fluid supply source to a target blood vessel.

67. The delivery system according to any one of claims 61 to 66, wherein the deployment device further comprises a deployment release, the deployment release being configured to operate to manipulate the position of the deployment hook.

68. The delivery system according to claim 67, wherein the deployment release operation raises the deployment hook to disengage the deployment hook from the proximal connector, or lowers the deployment hook to engage the deployment hook and the proximal connector.

69. The delivery system according to claim 67 or 68, wherein the deployment release is mechanically or electronically coupled to the deployment hook.

70. The delivery system according to any one of claims 67 to 69, wherein the operation of the deployment release includes pressing down the deployment release.

71. A method of blocking blood vessels, a) Inserting the vascular occlusion device according to any one of claims 1 to 45, which is in the compressed state, into the blood vessel, b) A method comprising deploying the occlusion device at a target site within the blood vessel, thereby converting the vascular occlusion device to the uncompressible state, and thereby occluding blood flow within the blood vessel.

72. The method according to claim 71, further comprising advancing the vascular occlusion device through the blood vessel after the insertion step a).

73. The method according to claim 71 or 72, wherein the vascular occlusion device is located inside the lumen of the compressed cartridge.

74. The method according to claim 73, wherein the cartridge comprises a proximal opening and a distal opening, and a lumen extending from the proximal end to the distal end over the length of the cartridge.

75. The method according to claim 74, wherein, prior to step a), the vascular occlusion device is loaded into the lumen of the cartridge.

76. The method according to claim 74 or 75, wherein, prior to step a), the method includes inserting a catheter into the blood vessel, and inserting the vascular occlusion device into the blood vessel includes inserting the vascular occlusion device into the catheter.

77. The method according to claim 76, further comprising attaching the distal opening of the cartridge to the proximal end of the catheter, and transferring the vascular occlusion device from the cartridge to the catheter using a pusher equipped with a deployment shaft and a deployment hook.

78. The method according to claim 77, further comprising reversibly attaching the proximal connector of the vascular occlusion device to the deployment hook of the pusher before transferring the vascular occlusion device from the cartridge to the catheter.

79. The method according to claim 78, wherein reversible attachment includes rotational engagement of the deployment hook of the pusher to the proximal end of the vascular occlusion device.

80. The method according to claim 78 or 79, wherein the method includes advancing the vascular occlusion device along the length of the catheter by applying force to the pusher.

81. The method according to claim 80, wherein deploying the vascular occlusion device involves pushing the vascular occlusion device out of the catheter at the target site, thereby converting the vascular occlusion device to the uncompressible state, and thereby occluding the blood flow in the blood vessel.

82. The method according to claim 81, wherein deploying the vascular occlusion device includes applying a non-moving biasing force to the vascular occlusion device by the pusher and pulling the catheter toward the pusher to hold the vascular occlusion device in place, the vascular occlusion device being pushed out from the catheter at the target site, thereby converting the vascular occlusion device to the uncompressed state, thereby occluding blood flow in the blood vessel.

83. The method according to any one of claims 78 to 82, further comprising separating the pusher from the vascular occlusion device by separating the deployment hook from the proximal connector after converting the vascular occlusion device to the uncompressed state.

84. The method according to claim 83, further comprising: reattaching the deployment hook and the proximal connector after converting the vascular occlusion device to the uncompressed state; and extending the catheter along the length of the vascular occlusion device to convert the vascular occlusion device to at least partially the compressed state.

85. The method according to claim 84, further comprising redeploying the vascular occlusion device to a different location within the target blood vessel.

86. The method of claim 85, further comprising extending the catheter completely along the length of the vascular occlusion device, converting the entire vascular occlusion device into the compressed state, and withdrawing the vascular occlusion device from the body of the subject.

87. The method according to any one of claims 83 to 86, wherein the catheter is connected to an actuator, and the operation of the actuator causes the catheter to be retracted or extended.

88. The method according to claim 87, wherein the actuator is a rotary actuator.

89. The method according to any one of claims 83 to 88, wherein the deployment hook is mechanically or electronically coupled to a deployment release, and by operating the deployment release, the deployment hook rises or falls, thereby engaging and / or disengaging the deployment hook and the proximal connector.

90. The method according to any one of claims 86 to 89, wherein the actuator and the deployment release are located on the deployment device.

91. The method according to any one of claims 76 to 90, further comprising administering a therapeutic agent or diagnostic agent through the catheter.

92. The method according to claim 91, wherein the therapeutic agent is a thrombus-forming agent or an antitumor agent.

93. The method according to any one of claims 71 to 92, wherein the vascular occlusion device is slidably attached to a guide wire.

94. The method according to claim 93, wherein advancing the vascular occlusion device within the target blood vessel includes advancing the vascular occlusion device on the guide wire.

95. The method according to any one of claims 71 to 94, wherein the uncompressed vascular occlusion device occludes at least partially the blood vessel at the target site.

96. The method according to any one of claims 71 to 95, wherein the blood vessel is a vein, artery, graft, stent, arteriole, capillary, splenic artery, gastroduodenal artery, fistula, or graft.

97. A kit comprising a vascular occlusion device according to any one of claims 1 to 45, and one or more additional components.

98. The kit according to claim 97, wherein the one or more additional components comprise one or more of a cartridge, a catheter, a guidewire, a deployment device, and / or a pusher.

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